StroMel for Osteoarthritis

Recruiting at 1 trial location

Overseen By Mukesh Kumar

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Akan Biosciences, LLC

Must not be taking: Corticosteroids, Biologics, Immunosuppressants, others

Disqualifiers: Rheumatoid arthritis, Active infection, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, you must not have taken them within 6 weeks before screening. Also, if you have had intra-articular treatments like corticosteroids or biologics, you should not have received them within 6 months before screening.

How is the treatment StroMel different from other osteoarthritis treatments?

StroMel, which involves the use of stromal vascular fraction (SVF) cells, is unique because it uses a cell-based approach to regenerate damaged cartilage in osteoarthritis patients. Unlike traditional treatments, SVF cells have anti-inflammatory effects and can transform into connective tissue cells, potentially offering more stable and long-lasting improvements in joint function and pain relief. ^{1 2 3 4 5}

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous StroMel™ for the treatment of moderate to severe OA of the knee joint

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Treatment Details

Interventions

• StroMel

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+

References

1. Czech Republic pubmed.ncbi.nlm.nih.gov

[Application of stem cells in orthopedics]. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Time- and Kellgren⁻Lawrence Grade-Dependent Changes in Intra-Articularly Transplanted Stromal Vascular Fraction in Osteoarthritic Patients. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Comparative Efficacy of the Stromal-Vascular Fraction Cells of Lipoaspirate and Hyaluronic Acid in the Treatment of Gonarthrosis: Results of an Interim Analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: long-term follow up of a multicenter randomized controlled clinical trial (phase I/II). [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Large-scale gene expression profiling data of bone marrow stromal cells from osteoarthritic donors. [2020]