A Phase 1 interventional study of BPC-157 and Sham (No Treatment) in Rotator Cuff Tear, sponsored by University of Arkansas. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of Arkansas · Phase 1, Interventional, and Treatment
Among 168 studies in Rotator Cuff Injuries with a site in United States — 40 open to participants now, 50 under way, none of them phase 3. Rotator Cuff Injuries · United States.
Among the 168 studies in Rotator Cuff Injuries with a site in United States, this one is the 95th largest by planned enrollment of the 130 interventional ones, is one of 2 that started in 2027, is one of 8 in phase 1, reaches primary completion later than 34 of the 49 other live ones, and was the 165th registered.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →40 of the 168 studies in Rotator Cuff Injuries with a site in United States are open now, in 9 countries. Each count lists the studies.
Of the 100 Rotator Cuff Injuries studies recruiting now, 40 (40%) set no upper age limit and 41 (41%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →168 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2027.
Median enrollment 60 across the 130 interventional studies, 77 across the 38 observational. Of the 86 that completed or were terminated, 28 (33%) have results posted.
40 of 168 have an industry lead sponsor. The 10 most frequent:
University of Arkansas is the lead sponsor of 399 studies on the registry; 38 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
University of Arkansas has 1 study filed under Rotator Cuff Injuries — fewer than ten, so there is no comparison to draw.
29 of the studies in Rotator Cuff Injuries with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06735170University of MinnesotaTuberoplasty Versus Balloon Spacer | 2026-11-26 |
| NCT07851233Rothman Institute OrthopaedicsPatient Education and Sling Use After Shoulder Surgery | 2026-11-30 |
| NCT06039345University of UtahShoulder RFA Pilot Study | 2026-12 |
| NCT05011331Rhode Island HospitalThe Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome | 2026-12 |
| NCT06669741Texas Bone and JointClinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Incrediwear | 2026-12-01 |
Among the 168 studies in Rotator Cuff Injuries with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: BPC-157
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.
Other: Sham (No Treatment)
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.
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.
Also known as: Placebo
Shoulder Strength
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.
Time frame: Baseline, 12 weeks, and 5 months post operatively
Start is estimated for Jan 2027; primary completion for Aug 2027, 7 months later.
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