BPC-157 for Rotator Cuff Injury

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Arkansas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

Body mass index of 20.0 to 34.9 kg/m2
I do not have COVID-19 or any symptoms of it.
I am 18 years old or older.
See 2 more

Exclusion Criteria

Pregnant or breastfeeding status
Current drug and alcohol abuse
I have had previous radiation therapy to the chest area.
See 7 more

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

Group I: BPC-157 GroupExperimental Treatment1 Intervention
Group II: ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials
500
Recruited
153,000+