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

What Was Tested

This registered phase 1 trial tested BPC-157.

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).

Twenty patients undergoing aRCR will be enrolled and randomly assigned to receive either BPC-157 or a saline placebo.

It had two arms (groups): BPC-157 Group (experimental) and Sham (sham comparator).

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.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 30 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males and Females, 18 years old or older. Body mass index of 20.0 to 34.9 kg/m2. Scheduled for an aRCR at UAMS with Dr. Ryan Hill, Dr. Paul Inclan, or Dr. Justin Rabinowitz. COVID-19 negative and/or asymptomatic.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: previous rcr; pregnant or breastfeeding status; lack of decisional capacity.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the BPC-157 group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind BPC-157 study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2027-01-01 with completion listed for 2027-08-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Shoulder Strength (time frame: Baseline, 12 weeks, and 5 months post operatively).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of BPC-157 in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the BPC-157 compound page, all human trials.