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NCT Number: NCT07803250

Impact of BPC-157 on Recovery Following 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.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Arkansas for Medical Sciences Medical Center

Little Rock, Arkansas, 72205, United States

Location contact

Ryan Hill, M.D.

SUB_INVESTIGATOR

Shiloah Kviatkovsky

CONTACT

[email protected]

619-677-0792

Shiloah Kviatkovsky, P.h.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BPC-157

Drug

BPC-157 is a synthetic pentadecapeptide derived from human gastric juice. It has demonstrated pro-angiogenic, cytoprotective, and tissue-regenerative effects in multiple preclinical models of musculoskeletal injury, including tendon and ligament healing. Although widely discussed in experimental and anecdotal contexts, BPC-157 has not undergone formal human clinical trials and remains an investigational compound not approved by the FDA. This study is designed to explore its potential role in promoting tendon regeneration and functional recovery in a postoperative orthopaedic setting.

Sham (No Treatment)

Other

Participants in this group will not receive any active treatment or placebo injections. This sham group serves as a no-treatment control to evaluate the natural course of postoperative recovery following arthroscopic rotator cuff repair without investigational intervention. Participants will continue to receive standard postoperative care and rehabilitation in accordance with institutional protocols. This group is included to help differentiate the effects of BPC-157 from both placebo and routine recovery.

Other names: Placebo

Primary outcomes

Shoulder Strength

Time frame: Baseline, 12 weeks, and 5 months post operatively

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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

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

Important dates

Study start: 2027
Primary completion: 2027
Study completion: 2027
First posted: Sep 3, 2026
Registry last updated: Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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