BPC-157 to speed healing of acute grade II hamstring strains

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Pentadecapeptide BPC 157 for Accelerated Repair of Acute Grade II Hamstring Strain Confirmed by MRI

This Phase 2 trial will test whether daily subcutaneous BPC-157 for 14 days helps adults 18–45 with MRI-confirmed grade II hamstring strains heal faster and return to sport sooner than placebo while following a standard rehabilitation program.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Hudson Biotech (industry)
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT07437547 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial enrolls adults 18–45 with MRI-confirmed acute grade II hamstring strains and randomizes them 1:1 to daily subcutaneous BPC-157 or matching placebo for 14 days alongside a standardized rehabilitation program. Co-primary endpoints are time to return to unrestricted sport and change in MRI-assessed injury volume at Day 14, with clinical assessments at Days 3, 7, 14, 28, 56 and a 3-month post-return follow-up for recurrence monitoring. Safety is tracked through adverse events, vital signs, laboratory tests, and oversight by an independent Data and Safety Monitoring Committee. Preclinical data suggest BPC-157 may promote tissue protection, angiogenesis, and repair, but human evidence in musculoskeletal injuries is limited.

Who should consider this trial

Good fit: Ideal candidates are physically active adults aged 18–45 with an MRI-confirmed acute grade II hamstring strain within 72 hours who can follow the standardized rehabilitation protocol and attend all study visits.

Not a fit: Patients with grade III tears, tendon avulsions, injuries requiring surgery, recent prior hamstring strain on the same limb, or concurrent lower extremity injuries that interfere with rehab are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, BPC-157 could shorten recovery time and reduce early re-injury, allowing athletes to return to play sooner.

How similar studies have performed: Preclinical animal studies indicate potential benefits of BPC-157 for tissue repair and angiogenesis, but controlled human trials for muscle injuries are limited and the approach remains experimental.

Eligibility criteria

Inclusion Criteria:

* Age 18 to 45 years.
* Acute posterior thigh pain consistent with hamstring strain with onset within 72 hours prior to screening.
* MRI-confirmed grade II hamstring strain of the biceps femoris, semitendinosus, or semimembranosus, with measurable lesion.
* Pre-injury physical activity \>= 3 sessions/week or participation in organized recreational sport.
* Willingness to follow the standardized rehabilitation protocol and attend all study visits.
* For participants of childbearing potential: negative pregnancy test at baseline and agreement to use effective contraception during dosing and for 30 days after last dose.

Exclusion Criteria:

* Grade III hamstring tear, tendon avulsion, or injury requiring surgical management.
* Concomitant lower extremity injury that would interfere with rehabilitation or outcome assessment.
* Prior hamstring strain on the index limb within the past 6 months.
* Use of systemic corticosteroids, anabolic agents, platelet-rich plasma, stem-cell products, or investigational peptides/growth factors within 30 days prior to screening.
* Known bleeding disorder or current therapeutic anticoagulation.
* Significant uncontrolled medical illness (e.g., severe cardiovascular, hepatic, or renal disease) that increases study risk.
* Known allergy or hypersensitivity to components of the investigational product or placebo.
* Pregnant or breastfeeding.
* Current participation in another interventional clinical study or participation within 30 days prior to screening.
* Currently subject to a formal anti-doping testing program (e.g., WADA/USADA-aligned) where use of an investigational peptide could create a regulatory conflict, unless explicitly approved by the relevant authority

Where this trial is running

Shenzhen, Guangdong

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Seni S Lu, Phd

Conditions: Hamstring Muscle Strain, Skeletal Muscle Injury, BPC 157, BPC-157, pentadecapeptide, muscle strain, hamstring injury, sports medicine