Health TrialsbyHealthPanel

BPC 157 for Acute Hamstring Muscle Strain Repair

ConditionsHamstring Muscle StrainSkeletal Muscle Injury
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Pentadecapeptide BPC 157

    Drug

    subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days.

  • Placebo

    Drug

    subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Arm 1: Experimental - BPC 157Experimental treatment 2 interventions
Group B: Arm 2: Placebo Comparator - PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Time to return to unrestricted sport participation (days)

defined as clearance by a blinded sports medicine clinician and completion of a standardized functional performance battery without pain-limited stopping.

Time frame
8 Weeks
2

Change from baseline to Day 14 in MRI-assessed hamstring injury volume (cm^3), measured by blinded central radiology review.

Time frame
14 Days

Secondary outcomes

1

Change in pain during activity on a 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain).

Time frame
56 Days
2

Hamstring strength limb symmetry index (LSI) by isokinetic dynamometry

Time frame
56 Days
3

Change in Lower Extremity Functional Scale (LEFS; 0-80, higher scores indicate better function)

Time frame
56 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hudson Biotech

Lead sponsor

Source ClinicalTrials.gov
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