Rotator Cuff TearPhase 1NCT07803250
Impact of BPC-157 on Recovery Following Rotator Cuff Repair Surgery
A Phase 1 study testing BPC-157 in people with Rotator Cuff Tear, run by University of Arkansas at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- BPC-157
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Active diagnosis of blood borne infectious disease
- Diabetic
- Documented history or diagnosis of autoimmune disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Arkansas for Medical Sciences Medical Center
Little Rock, Arkansas, 72205
Shiloah Kviatkovsky, 619-677-0792, skviatkovsky@uams.edu
Shiloah Kviatkovsky, P.h.D.
About this study
Official title: Impact of BPC-157 on Recovery From 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.
Read more
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.
- Conditions
- Rotator Cuff Tear
- Being tested
- BPC-157, Sham (No Treatment)
- Keywords
- arthroscopic rotator cuff repair, tendon healing, functional recovery, BPC-157
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPC-157Drug
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
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| BPC-157 Group | Experimental | 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. Receives: Drug: BPC-157 |
| Sham | Sham comparator | 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. Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks, and 5 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803250
- Sponsor's protocol ID
- 298969
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of BPC-157 on Recovery From Rotator Cuff Repair Surgery
- ClinicalTrials.gov ID
- NCT07803250
- Acronym / sponsor ID
- 298969
- Conditions
- Rotator Cuff Tear
- Keywords
- arthroscopic rotator cuff repair, tendon healing, functional recovery, BPC-157
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPC-157 Group | Experimental | Drug: BPC-157Participants 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 | Sham comparator | Other: Sham (No Treatment)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPC-157BPC-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. | Drug | BPC-157 Group |
| Sham (No Treatment)Also: PlaceboParticipants 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 | Sham |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Arkansas for Medical Sciences Medical Center
Little Rock, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BPC-157 in people with Rotator Cuff Tear, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Strength (time frame: Baseline, 12 weeks, and 5 months post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.