{ "schemaVersion": "1.0.0", "datasetVersion": "1.0.0", "reviewedAt": "2026-08-15", "title": "LifeScore seven-peptide claim-transfer audit", "boundary": "Editorial evidence synthesis, not medical advice, treatment guidance, a molecule score or proof that an untested claim is false.", "licence": { "licence": "CC-BY-4.0", "licensor": "lifescore", "covers": "The transfer-gate scheme, the coding decisions, the claim-record extraction and the original summary text written by lifescore Edge.", "doesNotCover": "The FDA briefing packages and the cited publications, which are referenced rather than reproduced; and the underlying facts, which are not subject to copyright.", "note": "The licence grants only such rights as the licensor holds." }, "auditorIndependence": { "auditor": "lifescore Edge", "publisher": "lifescore", "declared": [ "Edge does not currently carry advertising, sponsorships, affiliate links or paid placements.", "The people and organizations covered do not approve articles before publication.", "None of the audited parties commissioned, funded, reviewed or saw this audit before publication.", "lifescore sells no peptide, compounded or approved, and holds no position on any of the seven substances." ], "limits": [ "This audit was not externally peer reviewed.", "The auditor is the publication itself; there is no institutional affiliation and no third-party editorial board.", "Authorship is organizational rather than individual, so the coding cannot be attributed to a named expert with a public track record.", "Independence from a commercial interest is not a claim of expertise, and it does not make a coding decision correct." ], "standardsUrl": "https://lifesco.re/edge/methodology/" }, "method": { "selection": { "question": "Which claims for seven FDA-reviewed peptides were tested in people?", "selectionRule": "The set is exactly the seven peptide pairs — each a free base and its acetate — reviewed at the FDA Pharmacy Compounding Advisory Committee meeting of 23-24 July 2026. It was not assembled by us.", "notPresentedAs": "The set is not presented as the seven most popular peptides. Selection followed the FDA agenda; no popularity, market or evidence-strength criterion of ours entered it.", "meetingRecordUrl": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "primarySources": "Seven dated FDA briefing packages, one per substance, plus the molecule-specific evidence cards that retain each original-paper source map.", "unitOfComparison": "The exact substance x form x route x population x outcome, not the peptide label and not the paper count.", "reviewedOn": "2026-08-15", "limits": [ "A `stop` means the available record cannot carry the written broad claim. It does not prove that the molecule cannot have an effect.", "The seven-row comparison is not a claim-complete extraction for the six non-BPC-157 substances; their complete detail stays in the individual evidence cards.", "Registry entries describe sponsor-reported plans and status, not efficacy or safety results.", "Human cells, cadaver tissue and endogenous peptide measurements are human biology, not administered-human treatment evidence.", "Authorship or citation concentration neither validates nor invalidates a result; it identifies the need for independent replication.", "FDA briefing packages are regulator evidence reviews for a compounding question. They are not exhaustive global systematic reviews, and the committee votes are not drug approvals." ] }, "gates": { "identity": { "question": "Is the substance in the human record the one the public claim is sold under - same molecule, same form, same finished preparation?", "verdicts": { "partial": "The substance is involved, but its form, preparation or finished product differs from the marketed article or was never verified.", "stop": "The human record belongs to a different molecule." } }, "administration": { "question": "Was the substance given to a person and the result observed?", "verdicts": { "pass": "Administered to people and observed.", "stop": "No administered-human record was located.", "pending": "A registered trial is administering it, with no results posted at the review date. This records publication status only; it implies nothing about what the results will show." } }, "outcome": { "question": "Was the result the claim promises actually measured, in people the claim addresses?", "verdicts": { "partial": "The claimed result was measured, but the measurement does not carry it: uncontrolled, very small, or not converging across reports.", "stop": "The claimed result was not measured. Either nothing was administered, or what was measured is a mechanism or biomarker standing in for the claim rather than the claim itself.", "pending": "The study that would measure it has not reported. This records publication status only." } }, "replication": { "question": "Has the exact claim been repeated by a team capable of failing it, outside the originating research network?", "verdicts": { "stop": "No independent repeat of the claim was located." } } }, "transferUnit": [ "exact identity and form", "route and formulation", "population", "claim and outcome", "independent replication" ], "bpc157ProtocolVersion": "0.1.0-proposed", "bpc157FieldDictionary": { "resultDirection": "supports, mixed, null, harm-signal, or not-evaluable; never a molecule-level score", "exactClaimSupport": "Whether the record supports only the exact claim as written, including its route, population, outcome and observation window", "evidenceStage": "One protocol-defined evidence stage; registry-only is not a result", "identityConfidence": "Confidence that the reported material resolves to an exact form; uncertain is preserved rather than inferred", "mismatchReasons": "Controlled reasons why the source cannot transfer to a broader marketed claim", "sourceReportedRegimen": "Source-fidelity provenance only; deliberately omitted from the compact public table and never treatment guidance" } }, "sources": [ { "label": "FDA meeting record and all seven briefing packages", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026" }, { "label": "FDA BPC-157 briefing", "url": "https://www.fda.gov/media/193343/download" }, { "label": "FDA Emideltide briefing", "url": "https://www.fda.gov/media/193344/download" }, { "label": "FDA Epitalon briefing", "url": "https://www.fda.gov/media/193345/download" }, { "label": "FDA KPV briefing", "url": "https://www.fda.gov/media/193346/download" }, { "label": "FDA MOTS-c briefing", "url": "https://www.fda.gov/media/193347/download" }, { "label": "FDA Semax briefing", "url": "https://www.fda.gov/media/193348/download" }, { "label": "FDA TB-500 briefing", "url": "https://www.fda.gov/media/193349/download" }, { "label": "BPC-157 Phase 2 registry record", "url": "https://clinicaltrials.gov/study/NCT07437547" }, { "label": "MOTS-c Phase 2a registry record", "url": "https://clinicaltrials.gov/study/NCT07505745" } ], "substanceComparisons": [ { "id": "bpc-157", "peptide": "BPC-157", "claim": "Repairs soft tissue and speeds recovery", "humanRecord": "Five reported human programs plus three current registry records", "observed": "Two uncontrolled clinic reports recorded narrow self-reported symptom signals; one short two-person IV record reported no measured biomarker change.", "boundary": "The routes, populations and outcomes do not establish general healing, recovery or safety.", "gates": { "identity": "partial", "administration": "pass", "outcome": "partial", "replication": "stop" }, "sourceUrl": "https://www.fda.gov/media/193343/download", "detailPath": "/edge/is-bpc-157-supported-by-human-evidence/" }, { "id": "kpv", "peptide": "KPV", "claim": "Heals wounds and inflammatory conditions", "humanRecord": "No administered-human study or case report located", "observed": "Human-derived cells and excised cadaver skin appear in the literature, but no person received KPV in the record FDA located.", "boundary": "Human material is not administered-human evidence; efficacy, dosing and safety remain untested in people.", "gates": { "identity": "partial", "administration": "stop", "outcome": "stop", "replication": "stop" }, "sourceUrl": "https://www.fda.gov/media/193346/download", "detailPath": "/edge/does-kpv-have-human-evidence/" }, { "id": "tb-500", "peptide": "TB-500", "claim": "Repairs muscle, tendon or wounds", "humanRecord": "No administered-human TB-500 record located", "observed": "Human studies involve full-length or recombinant thymosin beta-4 products, not the seven-amino-acid TB-500 fragment.", "boundary": "A parent peptide's clinical record does not transfer to a fragment sold under another identity.", "gates": { "identity": "stop", "administration": "stop", "outcome": "stop", "replication": "stop" }, "sourceUrl": "https://www.fda.gov/media/193349/download", "detailPath": "/edge/what-separates-tb-500-from-thymosin-beta-4/" }, { "id": "mots-c", "peptide": "MOTS-c", "claim": "Improves human metabolism", "humanRecord": "One 120-person Phase 2a trial is recruiting; no results are posted", "observed": "Existing human studies measured the body's own MOTS-c around exercise or metabolic status rather than administering it as treatment.", "boundary": "Endogenous association and a registry plan do not establish a treatment effect.", "gates": { "identity": "partial", "administration": "pending", "outcome": "pending", "replication": "stop" }, "sourceUrl": "https://clinicaltrials.gov/study/NCT07505745", "detailPath": "/edge/does-mots-c-have-human-metabolic-evidence/" }, { "id": "emideltide", "peptide": "Emideltide / DSIP", "claim": "Treats chronic insomnia", "humanRecord": "Several small historical intravenous sleep studies", "observed": "Tiny studies produced mixed sleep-laboratory signals; the more interpretable placebo comparisons did not converge on a reliable clinical benefit.", "boundary": "No study tested the nominated subcutaneous route, and the IV record does not establish an adequately characterized insomnia treatment.", "gates": { "identity": "partial", "administration": "pass", "outcome": "partial", "replication": "stop" }, "sourceUrl": "https://www.fda.gov/media/193344/download", "detailPath": "/edge/does-emideltide-dsip-improve-sleep/" }, { "id": "semax", "peptide": "Semax", "claim": "Improves cognition in healthy people", "humanRecord": "Human intranasal studies exist across several populations", "observed": "Healthy-volunteer studies measured short-term brain-network changes, while stroke and pain reports used different populations and outcomes.", "boundary": "No replicated, well-controlled study established better memory, attention or daily cognitive function in healthy adults.", "gates": { "identity": "partial", "administration": "pass", "outcome": "stop", "replication": "stop" }, "sourceUrl": "https://www.fda.gov/media/193348/download", "detailPath": "/edge/what-does-human-evidence-show-about-semax/" }, { "id": "epitalon", "peptide": "Epitalon", "claim": "Improves sleep or extends human life", "humanRecord": "One small controlled human biomarker study relevant to the sleep story", "observed": "Sublingual AEDG changed a melatonin metabolite in selected women; longevity findings came from cells, mice or the different preparation epithalamin.", "boundary": "The human study measured neither sleep nor longevity, and evidence for epithalamin does not transfer to Epitalon.", "gates": { "identity": "partial", "administration": "pass", "outcome": "stop", "replication": "stop" }, "sourceUrl": "https://www.fda.gov/media/193345/download", "detailPath": "/edge/does-epitalon-improve-sleep-or-longevity/" } ], "bpc157ClaimRecords": [ { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-HUM-001", "fragmentId": "record-bpc-hum-001", "substance": "BPC-157", "sourceSubstance": "PL 14736 / BPC-157", "form": "not reported", "identityConfidence": "uncertain", "route": "rectal enema", "formulation": "enema; excipients not reported", "population": "32 healthy male volunteers; 24 received PL 14736 and 8 placebo", "claim": "Short-term rectal-enema tolerability in healthy men", "outcome": "Attributed adverse events and reported headache or flatulence", "timepoint": "Single administration and seven repeated daily administrations", "evidenceStage": "human-administered-safety-or-pk", "design": "Placebo-controlled phase 1 study reported only in meeting abstracts", "comparator": "Placebo enema", "sampleRandomized": 32, "sampleAnalyzed": "not reported", "resultDirection": "not-evaluable", "resultSummary": "The abstracts reported no significant attributed adverse events and no obvious difference in headache or flatulence frequency or severity versus placebo.", "effectEstimate": "Numerical adverse-event counts were not reported.", "exactClaimSupport": "limited-observation-only", "mismatchReasons": [ "abstract-only", "small-short-study", "form-unresolved", "insufficient-safety-characterization" ], "publicationStatus": "meeting-abstract-only", "registryStatus": "not found", "authors": [ "Marija Veljaca and collaborators" ], "institutions": [ "Historical PL 14736 development program; institution not resolved in accessible abstracts" ], "funding": "not reported", "conflicts": "not reported", "patentAudit": "No exact-name BPC-157 patent intersection was verified for recurring author Marija Veljaca in the bounded 2026-08-14 Google Patents screen.", "citationAudit": "The meeting abstracts were not resolved as OpenAlex works; no reproducible cited-by denominator is reported.", "limitations": [ "Original abstract text was not publicly located.", "The FDA dossier is the accessible source for design, exposure and outcome details.", "Form, assay detail, numerical adverse-event counts and complete analysis methods are unresolved." ], "sourceIds": [ "VELJACA-2002", "VELJACA-2003", "FDA-BPC-2026" ], "sourceUrl": "https://www.fda.gov/media/193343/download", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Both passes agree with FDA pages 40-41 and Appendix 1; inaccessible original abstracts remain a provenance limitation, not an efficacy conflict." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-HUM-002", "fragmentId": "record-bpc-hum-002", "substance": "BPC-157", "sourceSubstance": "PL 14736 / BPC-157", "form": "not reported", "identityConfidence": "uncertain", "route": "rectal enema", "formulation": "enema; excipients not reported", "population": "32 healthy male volunteers; 24 received PL 14736 and 8 placebo", "claim": "Systemic pharmacokinetic characterization after rectal enema", "outcome": "Plasma BPC-157 measured by HPLC-MS/MS", "timepoint": "After rectal-enema administration", "evidenceStage": "human-administered-safety-or-pk", "design": "Placebo-controlled phase 1 study reported only in meeting abstracts", "comparator": "Placebo enema", "sampleRandomized": 32, "sampleAnalyzed": "not reported", "resultDirection": "not-evaluable", "resultSummary": "Most reported plasma concentrations were undetected or below the assay lower limit of quantification; further assay and time-course details were not available.", "effectEstimate": "No extractable Cmax, Tmax, AUC or half-life.", "exactClaimSupport": "no", "mismatchReasons": [ "below-quantification", "abstract-only", "assay-details-missing", "form-unresolved" ], "publicationStatus": "meeting-abstract-only", "registryStatus": "not found", "authors": [ "Marija Veljaca and collaborators" ], "institutions": [ "Historical PL 14736 development program; institution not resolved in accessible abstracts" ], "funding": "not reported", "conflicts": "not reported", "patentAudit": "No exact-name BPC-157 patent intersection was verified for recurring author Marija Veljaca in the bounded 2026-08-14 Google Patents screen.", "citationAudit": "The meeting abstracts were not resolved as OpenAlex works; no reproducible cited-by denominator is reported.", "limitations": [ "Original abstract text was not publicly located.", "The FDA dossier is the accessible source for design, exposure and outcome details.", "Form, assay detail, numerical adverse-event counts and complete analysis methods are unresolved." ], "sourceIds": [ "VELJACA-2002", "VELJACA-2003", "FDA-BPC-2026" ], "sourceUrl": "https://www.fda.gov/media/193343/download", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Both passes agree with FDA pages 40-41 and Appendix 1; inaccessible original abstracts remain a provenance limitation, not an efficacy conflict." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-HUM-003", "fragmentId": "record-bpc-hum-003", "substance": "BPC-157", "sourceSubstance": "PL 14736 / BPC-157", "form": "not reported", "identityConfidence": "uncertain", "route": "rectal enema", "formulation": "liquid enema; excipients not reported", "population": "53 people with mild-to-moderate ulcerative colitis; inclusion definition unclear", "claim": "Two-week rectal-enema treatment improves mild-to-moderate ulcerative-colitis activity", "outcome": "Change in incompletely defined Disease Activity Index", "timepoint": "Two weeks", "evidenceStage": "human-administered-clinical-outcome", "design": "Multicenter randomized double-blind placebo-controlled phase 2 study reported as a meeting abstract", "comparator": "Placebo enema", "sampleRandomized": 53, "sampleAnalyzed": 46, "resultDirection": "not-evaluable", "resultSummary": "FDA reports mean changes of -3.2 for PL 14736 and -1.6 for placebo, with an estimated between-group difference of 1.6 and a 95% interval from -4.84 to 1.62.", "effectEstimate": "Between-group interval includes no difference; analysis definition and sign convention are insufficiently documented.", "exactClaimSupport": "no", "mismatchReasons": [ "abstract-only", "endpoint-definition-incomplete", "interval-includes-null", "form-unresolved", "enema-does-not-transfer-to-other-routes" ], "publicationStatus": "meeting-abstract-only", "registryStatus": "not found", "authors": [ "M Ruenzi", "M Stolte", "Marija Veljaca", "K Oreskovic", "J Peterson", "UCS Group" ], "institutions": [ "Historical PL 14736 development program; participating centers not resolved" ], "funding": "not reported", "conflicts": "not reported", "patentAudit": "No exact-name BPC-157 patent intersection was verified for recurring author Marija Veljaca in the bounded screen.", "citationAudit": "The meeting abstract was not resolved as an OpenAlex work; no reproducible cited-by denominator is reported.", "limitations": [ "Only a meeting abstract was located and the accessible extraction is in the FDA dossier.", "Primary endpoint definition, eligibility, statistical methods and post-treatment follow-up are incomplete.", "The FDA-reported between-group interval includes no difference and the sign convention is not sufficiently documented for independent reinterpretation." ], "sourceIds": [ "RUENZI-2005", "FDA-BPC-2026" ], "sourceUrl": "https://www.fda.gov/media/193343/download", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Both passes agree that the abstract cannot support an efficacy conclusion; the numerical FDA transcription is retained without recalculation." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-HUM-004", "fragmentId": "record-bpc-hum-004", "substance": "BPC-157", "sourceSubstance": "PL 14736 / BPC-157", "form": "not reported", "identityConfidence": "uncertain", "route": "rectal enema", "formulation": "liquid enema; excipients not reported", "population": "53 people with mild-to-moderate ulcerative colitis; inclusion definition unclear", "claim": "Two-week rectal-enema safety in ulcerative colitis", "outcome": "Adverse-event frequency and adverse-event withdrawals", "timepoint": "Two weeks", "evidenceStage": "human-administered-safety-or-pk", "design": "Multicenter randomized double-blind placebo-controlled phase 2 study reported as a meeting abstract", "comparator": "Placebo enema", "sampleRandomized": 53, "sampleAnalyzed": 46, "resultDirection": "not-evaluable", "resultSummary": "The abstract reported similar adverse-event types and frequency; three PL 14736 and two placebo participants withdrew after adverse events described mainly as disease progression.", "effectEstimate": "No complete event table or exposure-adjusted estimate.", "exactClaimSupport": "limited-observation-only", "mismatchReasons": [ "abstract-only", "small-short-study", "incomplete-safety-monitoring", "form-unresolved" ], "publicationStatus": "meeting-abstract-only", "registryStatus": "not found", "authors": [ "M Ruenzi", "M Stolte", "Marija Veljaca", "K Oreskovic", "J Peterson", "UCS Group" ], "institutions": [ "Historical PL 14736 development program; participating centers not resolved" ], "funding": "not reported", "conflicts": "not reported", "patentAudit": "No exact-name BPC-157 patent intersection was verified for recurring author Marija Veljaca in the bounded screen.", "citationAudit": "The meeting abstract was not resolved as an OpenAlex work; no reproducible cited-by denominator is reported.", "limitations": [ "Only a meeting abstract was located and the accessible extraction is in the FDA dossier.", "Primary endpoint definition, eligibility, statistical methods and post-treatment follow-up are incomplete.", "The FDA-reported between-group interval includes no difference and the sign convention is not sufficiently documented for independent reinterpretation." ], "sourceIds": [ "RUENZI-2005", "FDA-BPC-2026" ], "sourceUrl": "https://www.fda.gov/media/193343/download", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Both passes agree that the abstract cannot support an efficacy conclusion; the numerical FDA transcription is retained without recalculation." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-HUM-005", "fragmentId": "record-bpc-hum-005", "substance": "BPC-157", "sourceSubstance": "BPC 157", "form": "not reported", "identityConfidence": "uncertain", "route": "intra-articular knee injection", "formulation": "Compounded solution in sodium-phosphate buffer with benzyl alcohol", "population": "17 clinic patients with heterogeneous knee-pain diagnoses; 16 contacted, including 12 BPC-157-only recipients", "claim": "Intra-articular BPC-157 is followed by self-reported knee-pain improvement", "outcome": "Participant-reported significant knee-pain improvement", "timepoint": "Telephone follow-up, usually six to twelve months after injection", "evidenceStage": "human-administered-clinical-outcome", "design": "Single-clinic retrospective chart review with later telephone survey", "comparator": "None", "sampleRandomized": "not applicable", "sampleAnalyzed": 16, "resultDirection": "supports", "resultSummary": "Eleven of twelve contacted BPC-157-only recipients reported significant improvement; the study had no control group or validated prespecified pain instrument.", "effectEstimate": "11/12 BPC-157-only recipients reported improvement.", "exactClaimSupport": "yes-for-observed-self-report-only", "mismatchReasons": [ "uncontrolled", "retrospective", "self-reported", "heterogeneous-diagnoses", "form-unresolved", "no-structural-healing-outcome" ], "publicationStatus": "peer-reviewed-article", "registryStatus": "not found", "authors": [ "Edwin Lee", "Blake Padgett" ], "institutions": [ "Institute for Hormonal Balance, Orlando, Florida", "University of Central Florida College of Medicine" ], "funding": "not reported", "conflicts": "Authors did not provide a conflict statement in the accessible paper; patients paid for product and procedure.", "patentAudit": "No exact-name BPC-157 patent intersection was verified for Edwin Lee in the bounded screen.", "citationAudit": "OpenAlex reported 15 citing works on 2026-08-14; this is metadata coverage, not a quality measure.", "limitations": [ "No randomization, control group, blinded assessment or prespecified validated outcome instrument.", "Diagnoses and follow-up were heterogeneous; one participant was unreachable.", "Four participants received BPC-157 with thymosin beta-4 and are not used for the BPC-157-only claim record.", "No post-treatment imaging established tissue repair, cartilage growth or structural healing." ], "sourceIds": [ "LEE-PADGETT-2021", "FDA-BPC-2026", "OPENALEX-2026-08-14", "GOOGLE-PATENTS-2026-08-14" ], "sourceUrl": "https://pubmed.ncbi.nlm.nih.gov/34324435/", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Pass 2 corrected the narrow analyzable efficacy denominator to the 12 BPC-157-only recipients and excludes the four combination recipients." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-HUM-006", "fragmentId": "record-bpc-hum-006", "substance": "BPC-157", "sourceSubstance": "BPC 157", "form": "not reported", "identityConfidence": "uncertain", "route": "intra-articular knee injection", "formulation": "Compounded solution in sodium-phosphate buffer with benzyl alcohol", "population": "17 clinic patients with heterogeneous knee-pain diagnoses; 16 contacted, including 12 BPC-157-only recipients", "claim": "Intra-articular BPC-157 is safe", "outcome": "Participant-reported adverse events", "timepoint": "Retrospective telephone follow-up", "evidenceStage": "human-administered-safety-or-pk", "design": "Single-clinic retrospective chart review with later telephone survey", "comparator": "None", "sampleRandomized": "not applicable", "sampleAnalyzed": 16, "resultDirection": "not-evaluable", "resultSummary": "The paper states that no adverse events were noted, but safety monitoring was retrospective, unstructured and too small to characterize safety.", "effectEstimate": "No coded adverse-event table.", "exactClaimSupport": "limited-observation-only", "mismatchReasons": [ "uncontrolled", "retrospective", "small-sample", "informal-safety-ascertainment", "form-unresolved" ], "publicationStatus": "peer-reviewed-article", "registryStatus": "not found", "authors": [ "Edwin Lee", "Blake Padgett" ], "institutions": [ "Institute for Hormonal Balance, Orlando, Florida", "University of Central Florida College of Medicine" ], "funding": "not reported", "conflicts": "Authors did not provide a conflict statement in the accessible paper; patients paid for product and procedure.", "patentAudit": "No exact-name BPC-157 patent intersection was verified for Edwin Lee in the bounded screen.", "citationAudit": "OpenAlex reported 15 citing works on 2026-08-14; this is metadata coverage, not a quality measure.", "limitations": [ "No randomization, control group, blinded assessment or prespecified validated outcome instrument.", "Diagnoses and follow-up were heterogeneous; one participant was unreachable.", "Four participants received BPC-157 with thymosin beta-4 and are not used for the BPC-157-only claim record.", "No post-treatment imaging established tissue repair, cartilage growth or structural healing." ], "sourceIds": [ "LEE-PADGETT-2021", "FDA-BPC-2026", "OPENALEX-2026-08-14", "GOOGLE-PATENTS-2026-08-14" ], "sourceUrl": "https://pubmed.ncbi.nlm.nih.gov/34324435/", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Pass 2 corrected the narrow analyzable efficacy denominator to the 12 BPC-157-only recipients and excludes the four combination recipients." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-HUM-007", "fragmentId": "record-bpc-hum-007", "substance": "BPC-157", "sourceSubstance": "BPC-157", "form": "not reported", "identityConfidence": "uncertain", "route": "intravesical injections into bladder uroepithelium", "formulation": "Compounded injectable solution; excipients not reported", "population": "12 women aged 39-76 with moderate-to-severe interstitial cystitis and prior pentosan-polysulfate nonresponse", "claim": "One intravesical BPC-157 procedure is followed by improved interstitial-cystitis symptoms", "outcome": "Global Response Assessment and participant-reported symptom resolution", "timepoint": "Six-week clinical follow-up; most questionnaires at four to six months", "evidenceStage": "human-administered-clinical-outcome", "design": "Single-clinic uncontrolled retrospective pilot with Global Response Assessment", "comparator": "None", "sampleRandomized": "not applicable", "sampleAnalyzed": 12, "resultDirection": "supports", "resultSummary": "All 12 participants scored 5/5 on the Global Response Assessment; ten reported complete resolution and two reported 80% improvement.", "effectEstimate": "12/12 rated significantly improved in an uncontrolled selected sample.", "exactClaimSupport": "yes-for-observed-self-report-only", "mismatchReasons": [ "uncontrolled", "retrospective", "self-reported", "selected-private-clinic-sample", "variable-follow-up", "form-unresolved" ], "publicationStatus": "peer-reviewed-article", "registryStatus": "not found", "authors": [ "Edwin Lee", "Christopher Walker", "Bahram Ayadi" ], "institutions": [ "UroGyn Specialists of Florida", "University of Central Florida College of Medicine" ], "funding": "No funding statement located in the paper", "conflicts": "Authors declared no conflict; all participants paid for BPC-157 and received no honorarium.", "patentAudit": "No exact-name BPC-157 patent intersection was verified for Edwin Lee in the bounded screen.", "citationAudit": "OpenAlex reported 5 citing works on 2026-08-14; this is metadata coverage, not a quality measure.", "limitations": [ "No sham control, blinding or prespecified statistical comparison.", "Small selected private-clinic sample with self-reported outcome and variable questionnaire timing.", "Product identity and form were not independently verified.", "The paper's causal and safety conclusions exceed what the design can establish." ], "sourceIds": [ "LEE-WALKER-AYADI-2024", "FDA-BPC-2026", "OPENALEX-2026-08-14", "GOOGLE-PATENTS-2026-08-14" ], "sourceUrl": "https://pubmed.ncbi.nlm.nih.gov/39325560/", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Both passes preserve the reported patient experience but narrow support to an uncontrolled self-report in this sample." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-HUM-008", "fragmentId": "record-bpc-hum-008", "substance": "BPC-157", "sourceSubstance": "BPC-157", "form": "not reported", "identityConfidence": "uncertain", "route": "intravesical injections into bladder uroepithelium", "formulation": "Compounded injectable solution; excipients not reported", "population": "12 women aged 39-76 with moderate-to-severe interstitial cystitis and prior pentosan-polysulfate nonresponse", "claim": "One intravesical BPC-157 procedure is safe", "outcome": "Dropout, reported symptoms and post-procedural complications", "timepoint": "Through reported follow-up", "evidenceStage": "human-administered-safety-or-pk", "design": "Single-clinic uncontrolled retrospective pilot with Global Response Assessment", "comparator": "None", "sampleRandomized": "not applicable", "sampleAnalyzed": 12, "resultDirection": "not-evaluable", "resultSummary": "No participant dropped out and the paper reports no adverse events or listed post-procedural complications, but the sample and design cannot characterize safety.", "effectEstimate": "0/12 reported events in the paper's limited ascertainment.", "exactClaimSupport": "limited-observation-only", "mismatchReasons": [ "uncontrolled", "small-sample", "informal-safety-ascertainment", "form-unresolved" ], "publicationStatus": "peer-reviewed-article", "registryStatus": "not found", "authors": [ "Edwin Lee", "Christopher Walker", "Bahram Ayadi" ], "institutions": [ "UroGyn Specialists of Florida", "University of Central Florida College of Medicine" ], "funding": "No funding statement located in the paper", "conflicts": "Authors declared no conflict; all participants paid for BPC-157 and received no honorarium.", "patentAudit": "No exact-name BPC-157 patent intersection was verified for Edwin Lee in the bounded screen.", "citationAudit": "OpenAlex reported 5 citing works on 2026-08-14; this is metadata coverage, not a quality measure.", "limitations": [ "No sham control, blinding or prespecified statistical comparison.", "Small selected private-clinic sample with self-reported outcome and variable questionnaire timing.", "Product identity and form were not independently verified.", "The paper's causal and safety conclusions exceed what the design can establish." ], "sourceIds": [ "LEE-WALKER-AYADI-2024", "FDA-BPC-2026", "OPENALEX-2026-08-14", "GOOGLE-PATENTS-2026-08-14" ], "sourceUrl": "https://pubmed.ncbi.nlm.nih.gov/39325560/", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Both passes preserve the reported patient experience but narrow support to an uncontrolled self-report in this sample." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-HUM-009", "fragmentId": "record-bpc-hum-009", "substance": "BPC-157", "sourceSubstance": "BPC-157", "form": "not reported", "identityConfidence": "uncertain", "route": "intravenous infusion", "formulation": "Compounded BPC-157 diluted in normal saline", "population": "Two relatively healthy adults aged 58 and 68, both previously exposed to intravenous BPC-157", "claim": "Two consecutive intravenous BPC-157 infusions are safe", "outcome": "Solicited immediate adverse events", "timepoint": "During infusions through 24 hours after the second infusion", "evidenceStage": "human-administered-safety-or-pk", "design": "Single-center uncontrolled short-term pilot", "comparator": "Within-person baseline only", "sampleRandomized": "not applicable", "sampleAnalyzed": 2, "resultDirection": "not-evaluable", "resultSummary": "Neither of two previously exposed participants reported the solicited adverse reactions during the very short observation window.", "effectEstimate": "0/2 reported solicited events.", "exactClaimSupport": "limited-observation-only", "mismatchReasons": [ "two-participants", "previously-exposed", "no-control", "very-short-follow-up", "form-unresolved" ], "publicationStatus": "peer-reviewed-article", "registryStatus": "not found", "authors": [ "Edwin Lee", "Kailynd Burgess" ], "institutions": [ "Institute for Hormonal Balance, Orlando, Florida", "Access Medical Labs" ], "funding": "The paper states that the research received no funding", "conflicts": "Authors declared no conflict; both participants paid $1,000 for product and laboratory work and volunteered to support continued compounding.", "patentAudit": "No exact-name BPC-157 patent intersection was verified for Edwin Lee in the bounded screen.", "citationAudit": "OpenAlex reported 3 citing works on 2026-08-14; this is metadata coverage, not a quality measure.", "limitations": [ "Two previously exposed participants cannot characterize uncommon, delayed or first-exposure harms.", "No placebo, blinding, formal adverse-event coding or follow-up beyond the next day.", "The observed laboratory range cannot establish general safety." ], "sourceIds": [ "LEE-BURGESS-2025", "FDA-BPC-2026", "OPENALEX-2026-08-14", "GOOGLE-PATENTS-2026-08-14" ], "sourceUrl": "https://pubmed.ncbi.nlm.nih.gov/40131143/", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Both passes agree on the observed short window; the paper's broader safety language is not carried into the exact-claim conclusion." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-HUM-010", "fragmentId": "record-bpc-hum-010", "substance": "BPC-157", "sourceSubstance": "BPC-157", "form": "not reported", "identityConfidence": "uncertain", "route": "intravenous infusion", "formulation": "Compounded BPC-157 diluted in normal saline", "population": "Two relatively healthy adults aged 58 and 68, both previously exposed to intravenous BPC-157", "claim": "Two consecutive intravenous BPC-157 infusions cause no clinically meaningful short-term laboratory or vital-sign change", "outcome": "Selected vital signs, metabolic, blood-count, cardiac, thyroid and inflammation biomarkers", "timepoint": "Baseline through 24 hours after the second infusion", "evidenceStage": "human-administered-pd-or-biomarker", "design": "Single-center uncontrolled short-term pilot", "comparator": "Within-person baseline only", "sampleRandomized": "not applicable", "sampleAnalyzed": 2, "resultDirection": "null", "resultSummary": "The authors reported no clinically meaningful change in the selected measures across the two participants and three measurement days.", "effectEstimate": "Individual values only; no inferential estimate.", "exactClaimSupport": "yes-for-observed-window-only", "mismatchReasons": [ "two-participants", "no-control", "multiple-selected-biomarkers", "very-short-follow-up", "cannot-establish-general-safety" ], "publicationStatus": "peer-reviewed-article", "registryStatus": "not found", "authors": [ "Edwin Lee", "Kailynd Burgess" ], "institutions": [ "Institute for Hormonal Balance, Orlando, Florida", "Access Medical Labs" ], "funding": "The paper states that the research received no funding", "conflicts": "Authors declared no conflict; both participants paid $1,000 for product and laboratory work and volunteered to support continued compounding.", "patentAudit": "No exact-name BPC-157 patent intersection was verified for Edwin Lee in the bounded screen.", "citationAudit": "OpenAlex reported 3 citing works on 2026-08-14; this is metadata coverage, not a quality measure.", "limitations": [ "Two previously exposed participants cannot characterize uncommon, delayed or first-exposure harms.", "No placebo, blinding, formal adverse-event coding or follow-up beyond the next day.", "The observed laboratory range cannot establish general safety." ], "sourceIds": [ "LEE-BURGESS-2025", "FDA-BPC-2026", "OPENALEX-2026-08-14", "GOOGLE-PATENTS-2026-08-14" ], "sourceUrl": "https://pubmed.ncbi.nlm.nih.gov/40131143/", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Both passes agree on the observed short window; the paper's broader safety language is not carried into the exact-claim conclusion." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-REG-001", "fragmentId": "record-bpc-reg-001", "substance": "BPC-157", "sourceSubstance": "Bepecin / PCO-02 / BPC-157", "form": "not reported", "identityConfidence": "uncertain", "route": "oral tablet", "formulation": "PCO-02 tablet", "population": "Estimated 42 healthy volunteers in Tijuana, Mexico", "claim": "Oral PCO-02 safety in healthy volunteers", "outcome": "Any adverse event", "timepoint": "Six months", "evidenceStage": "registered-only", "design": "Randomized quadruple-masked placebo-controlled phase 1 registry record", "comparator": "PCO-03 placebo tablets", "sampleRandomized": 42, "sampleAnalyzed": "not reported", "resultDirection": "not-evaluable", "resultSummary": "The registry planned this outcome but has stale status and no posted results or matched publication.", "effectEstimate": "No result available.", "exactClaimSupport": "no-result", "mismatchReasons": [ "registry-only", "status-unknown", "no-results", "form-unresolved" ], "publicationStatus": "no-results-publication-located", "registryStatus": "unknown; last known active, not recruiting; record not updated since 2015-12-22", "authors": [ "Rufino Menchaca (registry principal investigator)" ], "institutions": [ "PharmaCotherapia d.o.o.", "Hospital Angeles Tijuana" ], "funding": "Industry lead sponsor: PharmaCotherapia d.o.o.", "conflicts": "not reported", "patentAudit": "No investigator-level patent match was established in this pilot.", "citationAudit": "Not applicable until a results work is matched.", "limitations": [ "Registry status is stale and no results are posted.", "A 2016 results submission was later unreleased for an unknown reason according to registry history metadata.", "No peer-reviewed publication was matched by identifier or study characteristics." ], "sourceIds": [ "NCT02637284", "FDA-BPC-2026" ], "sourceUrl": "https://clinicaltrials.gov/study/NCT02637284", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Two registry-module passes agree: the study is evidence of a plan, not a result." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-REG-002", "fragmentId": "record-bpc-reg-002", "substance": "BPC-157", "sourceSubstance": "Bepecin / PCO-02 / BPC-157", "form": "not reported", "identityConfidence": "uncertain", "route": "oral tablet", "formulation": "PCO-02 tablet", "population": "Estimated 42 healthy volunteers in Tijuana, Mexico", "claim": "Oral PCO-02 pharmacokinetics in healthy volunteers", "outcome": "Cmax, Tmax, AUC and elimination half-life", "timepoint": "168 hours", "evidenceStage": "registered-only", "design": "Randomized quadruple-masked placebo-controlled phase 1 registry record", "comparator": "PCO-03 placebo tablets", "sampleRandomized": 42, "sampleAnalyzed": "not reported", "resultDirection": "not-evaluable", "resultSummary": "The registry planned pharmacokinetic outcomes but has no posted values or matched publication.", "effectEstimate": "No result available.", "exactClaimSupport": "no-result", "mismatchReasons": [ "registry-only", "status-unknown", "no-results", "form-unresolved" ], "publicationStatus": "no-results-publication-located", "registryStatus": "unknown; last known active, not recruiting; record not updated since 2015-12-22", "authors": [ "Rufino Menchaca (registry principal investigator)" ], "institutions": [ "PharmaCotherapia d.o.o.", "Hospital Angeles Tijuana" ], "funding": "Industry lead sponsor: PharmaCotherapia d.o.o.", "conflicts": "not reported", "patentAudit": "No investigator-level patent match was established in this pilot.", "citationAudit": "Not applicable until a results work is matched.", "limitations": [ "Registry status is stale and no results are posted.", "A 2016 results submission was later unreleased for an unknown reason according to registry history metadata.", "No peer-reviewed publication was matched by identifier or study characteristics." ], "sourceIds": [ "NCT02637284", "FDA-BPC-2026" ], "sourceUrl": "https://clinicaltrials.gov/study/NCT02637284", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Two registry-module passes agree: the study is evidence of a plan, not a result." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-REG-003", "fragmentId": "record-bpc-reg-003", "substance": "BPC-157", "sourceSubstance": "Pentadecapeptide BPC 157", "form": "not reported", "identityConfidence": "uncertain", "route": "subcutaneous injection", "formulation": "Identical-appearing prefilled syringe; composition not reported", "population": "Planned 120 participants with acute MRI-confirmed grade II hamstring strain in Shenzhen, China", "claim": "Subcutaneous BPC-157 accelerates return to unrestricted sport after acute grade II hamstring strain", "outcome": "Days to clinician-cleared unrestricted sport plus functional battery", "timepoint": "Eight weeks", "evidenceStage": "registered-only", "design": "Randomized quadruple-masked placebo-controlled phase 2 trial with standardized rehabilitation", "comparator": "Matching placebo plus the same rehabilitation program", "sampleRandomized": 120, "sampleAnalyzed": "not yet available", "resultDirection": "not-evaluable", "resultSummary": "The randomized trial is recruiting and has no posted results.", "effectEstimate": "No result available.", "exactClaimSupport": "no-result", "mismatchReasons": [ "registry-only", "recruiting", "no-results", "dose-and-form-unresolved" ], "publicationStatus": "no-results-publication-located", "registryStatus": "recruiting; no results posted", "authors": [ "Hudson Biotech registry team; individual investigator not listed" ], "institutions": [ "Hudson Biotech", "Peking University Shenzhen Hospital" ], "funding": "Industry lead sponsor: Hudson Biotech", "conflicts": "not reported", "patentAudit": "No sponsor or investigator patent match was established in this pilot.", "citationAudit": "Not applicable until a results work is matched.", "limitations": [ "Registry-only planned outcomes cannot establish efficacy or safety.", "Dose, form and product identity are not reported.", "The registry maps both active and placebo intervention names to both arms, creating an internal arm-label ambiguity." ], "sourceIds": [ "NCT07437547" ], "sourceUrl": "https://clinicaltrials.gov/study/NCT07437547", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Two registry-module passes agree on status and outcomes; arm-label ambiguity remains explicit." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-REG-004", "fragmentId": "record-bpc-reg-004", "substance": "BPC-157", "sourceSubstance": "Pentadecapeptide BPC 157", "form": "not reported", "identityConfidence": "uncertain", "route": "subcutaneous injection", "formulation": "Identical-appearing prefilled syringe; composition not reported", "population": "Planned 120 participants with acute MRI-confirmed grade II hamstring strain in Shenzhen, China", "claim": "Subcutaneous BPC-157 reduces MRI-assessed hamstring injury volume", "outcome": "Change in centrally reviewed MRI injury volume", "timepoint": "Day 14", "evidenceStage": "registered-only", "design": "Randomized quadruple-masked placebo-controlled phase 2 trial with standardized rehabilitation", "comparator": "Matching placebo plus the same rehabilitation program", "sampleRandomized": 120, "sampleAnalyzed": "not yet available", "resultDirection": "not-evaluable", "resultSummary": "The randomized trial is recruiting and has no posted results.", "effectEstimate": "No result available.", "exactClaimSupport": "no-result", "mismatchReasons": [ "registry-only", "recruiting", "no-results", "dose-and-form-unresolved" ], "publicationStatus": "no-results-publication-located", "registryStatus": "recruiting; no results posted", "authors": [ "Hudson Biotech registry team; individual investigator not listed" ], "institutions": [ "Hudson Biotech", "Peking University Shenzhen Hospital" ], "funding": "Industry lead sponsor: Hudson Biotech", "conflicts": "not reported", "patentAudit": "No sponsor or investigator patent match was established in this pilot.", "citationAudit": "Not applicable until a results work is matched.", "limitations": [ "Registry-only planned outcomes cannot establish efficacy or safety.", "Dose, form and product identity are not reported.", "The registry maps both active and placebo intervention names to both arms, creating an internal arm-label ambiguity." ], "sourceIds": [ "NCT07437547" ], "sourceUrl": "https://clinicaltrials.gov/study/NCT07437547", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Two registry-module passes agree on status and outcomes; arm-label ambiguity remains explicit." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-REG-005", "fragmentId": "record-bpc-reg-005", "substance": "BPC-157", "sourceSubstance": "Parlay Recover gummies containing Body Protection Compound (BPC)-157", "form": "not reported", "identityConfidence": "uncertain", "route": "oral gummy", "formulation": "Commercial peptide gummy", "population": "40 physically active US adults aged 18-65 with recurrent post-exercise musculoskeletal symptoms", "claim": "BPC-157-labeled gummies change systemic inflammation", "outcome": "Change in high-sensitivity C-reactive protein", "timepoint": "Baseline to week 8", "evidenceStage": "registered-only", "design": "Single-group open-label industry study registered after study completion", "comparator": "None", "sampleRandomized": "not applicable", "sampleAnalyzed": "not reported", "resultDirection": "not-evaluable", "resultSummary": "The completed, retrospectively registered single-group study has no posted results.", "effectEstimate": "No result available.", "exactClaimSupport": "no-result", "mismatchReasons": [ "registry-only", "retrospective-registration", "no-control", "no-results", "finished-product-identity-unresolved" ], "publicationStatus": "no-results-publication-located", "registryStatus": "completed 2025-11-01; first submitted 2026-08-03; no results posted", "authors": [ "Parlay Wellness registry team; individual investigator not listed" ], "institutions": [ "Parlay Wellness", "Citruslabs" ], "funding": "Industry lead sponsor: Parlay Wellness; industry collaborator: Citruslabs", "conflicts": "not reported", "patentAudit": "No sponsor or investigator patent match was established in this pilot.", "citationAudit": "Not applicable until a results work is matched.", "limitations": [ "The registry was first submitted about nine months after reported study completion.", "No comparator, blinding, posted results or matched publication.", "Finished-product identity and the contribution of BPC-157 versus other product attributes are unresolved." ], "sourceIds": [ "NCT07752381" ], "sourceUrl": "https://clinicaltrials.gov/study/NCT07752381", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Discovered in the 2026-08-14 current registry pass; a second module read confirmed completion, retrospective registration timing and absent results." } }, { "schemaVersion": "0.1.0", "datasetVersion": "0.1.0-pilot", "recordId": "BPC-REG-006", "fragmentId": "record-bpc-reg-006", "substance": "BPC-157", "sourceSubstance": "Parlay Recover gummies containing Body Protection Compound (BPC)-157", "form": "not reported", "identityConfidence": "uncertain", "route": "oral gummy", "formulation": "Commercial peptide gummy", "population": "40 physically active US adults aged 18-65 with recurrent post-exercise musculoskeletal symptoms", "claim": "BPC-157-labeled gummies change systemic inflammation", "outcome": "Change in interleukin-6", "timepoint": "Baseline to week 8", "evidenceStage": "registered-only", "design": "Single-group open-label industry study registered after study completion", "comparator": "None", "sampleRandomized": "not applicable", "sampleAnalyzed": "not reported", "resultDirection": "not-evaluable", "resultSummary": "The completed, retrospectively registered single-group study has no posted results.", "effectEstimate": "No result available.", "exactClaimSupport": "no-result", "mismatchReasons": [ "registry-only", "retrospective-registration", "no-control", "no-results", "finished-product-identity-unresolved" ], "publicationStatus": "no-results-publication-located", "registryStatus": "completed 2025-11-01; first submitted 2026-08-03; no results posted", "authors": [ "Parlay Wellness registry team; individual investigator not listed" ], "institutions": [ "Parlay Wellness", "Citruslabs" ], "funding": "Industry lead sponsor: Parlay Wellness; industry collaborator: Citruslabs", "conflicts": "not reported", "patentAudit": "No sponsor or investigator patent match was established in this pilot.", "citationAudit": "Not applicable until a results work is matched.", "limitations": [ "The registry was first submitted about nine months after reported study completion.", "No comparator, blinding, posted results or matched publication.", "Finished-product identity and the contribution of BPC-157 versus other product attributes are unresolved." ], "sourceIds": [ "NCT07752381" ], "sourceUrl": "https://clinicaltrials.gov/study/NCT07752381", "verification": { "extractor": "lifescore Edge", "pass1": { "status": "complete", "date": "2026-08-14", "method": "Structured extraction from the accessible original article, registry record or FDA dossier" }, "pass2": { "status": "complete", "date": "2026-08-14", "method": "Fresh field-by-field re-read against source tables, methods, results and disclosures" }, "lastVerified": "2026-08-14", "adjudication": "Discovered in the 2026-08-14 current registry pass; 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a second module read confirmed completion, retrospective registration timing and absent results." } } ] }