StroMel™ for Moderate to Severe Knee Osteoarthritis

This study is looking at the safety of StroMel™, a treatment made from your own cells (autologous MSC), for people with moderate to severe osteoarthritis (OA) of the knee. Researchers want to see if StroMel™ is safe and well-tolerated over 12 months. You might be able to join if you are between 25 and 65 years old, have a BMI (Body Mass Index) less than 40, and are generally healthy. The study is currently unclear about its recruitment status and plans to enroll 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for 12 months.

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NCT04750252

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

Not Yet Recruiting
PHASE1Ages 25–65InterventionalTreatment
Akan Biosciences, LLC
~20 participants
Updated 2025-01-29 on ClinicalTrials.gov
What's tested:StroMel

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of StroMel in subjects with moderate to severe OA of the kneee
Measured over 12 months
+1 more outcome measured
Osteo Arthritis Knee
1 sites across 1 states
Maryland1

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  • Safety of StroMel in subjects with moderate to severe OA of the kneee12 months

    Presence of adverse events in less than 10% of the study population. Adverse events assessed will be Grade 4 administrative site infection, Grade 3 hypersensitivity/anaphylaxis, \>20% increase in WOMAC pain score, treatment-related disability, and presence of tumors post-treatment.

  • Overall Safety of StroMel12 months

    Summary of all study related AEs and SAEs.