BPC-157 for Rotator Cuff Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults scheduled to have arthroscopic rotator cuff repair surgery due to a rotator cuff tear. Participants must be able and willing to give consent, follow the study protocol, and self-administer daily injections after surgery.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- BPC-157
Trial Overview
The study compares BPC-157 (a synthetic peptide) with a placebo (saline injection) in people recovering from rotator cuff repair. Participants are randomly assigned to one group, receive daily injections for 90 days, and both groups get standard rehab care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants in this arm will receive BPC-157. BPC-157 will be self-administered via subcutaneous injection once daily for 90 days following arthroscopic rotator cuff repair. All participants will follow the standard postoperative rehabilitation protocol in addition to the study intervention.
Participants in this arm will receive normal saline. Normal saline will be self-administered via subcutaneous injection once daily for 90 days following arthroscopic rotator cuff repair. All participants will follow the standard postoperative rehabilitation protocol in addition to the study intervention.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arkansas
Lead Sponsor
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