StroMel for Osteoarthritis

Recruiting at1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Akan Biosciences, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults aged 25-65 with moderate to severe knee osteoarthritis, a BMI under 40, and who haven't improved after trying at least two OA therapies. Participants should have stable vital signs, a specific pain score on the WOMAC index, suitable knee anatomy for injections, and agree to use effective contraception if of reproductive potential.

Inclusion Criteria

Body Mass Index (BMI) less than 40 kg/m2

Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain

For adults of reproductive potential: use of effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

Exclusion Criteria

I have had a fracture or dislocation in the limb being studied within the last year, or any time with lasting effects.

I haven't had joint injections with specific agents in the last 6 months.

Presence of surgical hardware or other foreign body in the index joint

Treatment Details

Interventions

• StroMel (Stem Cell Therapy)

Trial Overview The trial tests StroMel™'s safety and how well people can tolerate it when used to treat osteoarthritis in the knee. It's an autologous treatment, meaning it uses materials from the patient's own body.

Participant Groups

Group I: Subjects with moderate to severe OA of the Knee Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Akan Biosciences, LLC

Lead Sponsor

Trials

1

Recruited

20+