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Impact of BPC-157 on Recovery Following Rotator Cuff Repair Surgery

NCT07803250 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-09-03

No results posted yet for this study

Summary

This study is a randomized, double-blind, placebo-controlled pilot trial investigating the effects of BPC-157 on tendon healing and functional recovery following arthroscopic rotator cuff repair (aRCR). BPC-157 is a synthetic peptide that has demonstrated promising regenerative and anti-inflammatory effects in preclinical animal models of musculoskeletal injury, but it has not yet been studied in formal human clinical trials.

Twenty patients undergoing aRCR will be enrolled and randomly assigned to receive either BPC-157 or a saline placebo. Participants will self-administer subcutaneous injections daily for 90 days following surgery. All other aspects of care will follow the standard postoperative rehabilitation protocol.

The study will assess tendon healing using postoperative MRI, patient-reported outcome measures (PROMs), range of motion (ROM), and muscle strength via handheld dynamometry. Blood samples will also be collected to evaluate biomarkers associated with collagen turnover and inflammation.

The goal of this pilot study is to evaluate the safety, feasibility, and preliminary efficacy of BPC-157 in promoting tendon healing and improving functional outcomes after rotator cuff repair. Results will inform the design of a future larger-scale clinical trial.

Conditions

  • Rotator Cuff Tear

Interventions

DRUG

BPC-157

BPC-157 is a synthetic pentadecapeptide derived from human gastric juice. It has demonstrated pro-angiogenic, cytoprotective, and tissue-regenerative effects in multiple preclinical models of musculoskeletal injury, including tendon and ligament healing. Although widely discussed in experimental and anecdotal contexts, BPC-157 has not undergone formal human clinical trials and remains an investigational compound not approved by the FDA. This study is designed to explore its potential role in promoting tendon regeneration and functional recovery in a postoperative orthopaedic setting.

OTHER

Sham (No Treatment)

Participants in this group will not receive any active treatment or placebo injections. This sham group serves as a no-treatment control to evaluate the natural course of postoperative recovery following arthroscopic rotator cuff repair without investigational intervention. Participants will continue to receive standard postoperative care and rehabilitation in accordance with institutional protocols. This group is included to help differentiate the effects of BPC-157 from both placebo and routine recovery.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2027-08-01
Completion
2027-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803250 on ClinicalTrials.gov