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

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

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.

Inclusion Criteria:

• Males and Females, 18 years old or older
• Body mass index of 20.0 to 34.9 kg/m2
• Pre-operative MRI demonstrating a full thickness tear of the posterosuperior rotator cuff less than 2.5 cm in anteroposterior dimension
• Scheduled for an aRCR at UAMS with Dr. Ryan Hill, Dr. Paul Inclan, or Dr. Justin Rabinowitz
• COVID-19 negative and/or asymptomatic

Exclusion Criteria:

• Previous RCR
• Pregnant or breastfeeding status
• Current drug and alcohol abuse · History of platelet-rich plasma injection, other platelet-based product or biologic injection in the past 12 months in the ipsilateral shoulder
• Lack of decisional capacity
• Having undergone hormone replacement therapy in the last 12 months
• Having undergone testosterone replacement therapy in the last 12 months
• Active diagnosis of blood borne infectious disease
• Diabetic
• Documented history or diagnosis of autoimmune disease