Safety and Tolerability of StroMel™ in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint

Part of paid clinical trials in Gaithersburg, Maryland.

Sponsor
Akan Biosciences, LLC
Study ID
NCT04750252
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Osteo Arthritis Knee

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • StroMel — BIOLOGICAL
    Autologous MSC

Study Details

The aim of this trial is to evaluate the safety and tolerability of autologous StroMel™ for the treatment of moderate to severe OA of the knee joint.

Key Dates

Start date
Oct 1, 2025
Status verified
Jan 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Subjects with moderate to severe OA of the Knee

Primary Outcome Measure

Safety of StroMel in subjects with moderate to severe OA of the kneee [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MukeshGaithersburgMaryland20879
Mukesh Kumar, PhD
2407504893

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