BPC 157 for Acute Hamstring Muscle Strain Repair
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-45
SponsorHudson Biotech
About this trial
This randomized, double-blind, placebo-controlled Phase 2 study evaluates whether pentadecapeptide BPC 157 (BPC-157), an investigational peptide, can speed structural healing and functional recovery after an acute grade II hamstring muscle strain. Participants will receive BPC 157 or placebo for 14 days in addition to a standardized rehabilitation program. The co-primary endpoints are time to return to unrestricted sport and change in MRI-assessed injury volume at Day 14.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pentadecapeptide BPC 157
- Placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov