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

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07803250
Lead Sponsor University of Arkansas
Conditions
(from sponsor)		 Rotator Cuff Tear
Related terms Rotator Cuff Injuries
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov