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

NCTNCT07803250Other id298969

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Not yet recruiting
Phase: Phase 1
Enrollment: 30 participants (estimated)
Sponsor: University of Arkansas · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 1 Jan 2027 (estimated)
Primary completion: 1 Aug 2027 (estimated)
Completion: 1 Aug 2027 (estimated)
First posted: 3 Sept 2026
Last update posted: 3 Sept 2026
Conditions: Rotator Cuff Tear

Timeline

1 trial · 1 not yet recruiting

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20272028

Ph 1
Impact of BPC-157 on Recovery Following Rotator Cuff Repair Surgery
NCT07803250
est. 1 Jan 2027 to est. 1 Aug 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

BPC-157Drug
Sham (No Treatment)Other

Arms2

Experimental
BPC-157 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.
Sham comparator
Sham
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Shoulder Strength
Time frame · Baseline, 12 weeks, and 5 months post operatively
Registry description
Isometric shoulder abduction strength will be assessed using a handheld dynamometer. Strength measurements will focus on shoulder abduction and external rotation at 0° abduction. Three trials will be recorded, and the average peak force will be used as the outcome value. Testing will be performed by a blinded evaluator using a standardized protocol.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

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Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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