StroMel for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called StroMel to determine its safety and effectiveness for individuals with moderate to severe osteoarthritis (OA) of the knee. The primary goal is to assess whether this new approach can reduce knee pain and improve mobility for those affected by this condition. It suits individuals who have had knee OA for some time, have tried at least two treatments like pain relievers or physical therapy without much success, and continue to experience significant knee pain. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
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.
Is there any evidence suggesting that StroMel is likely to be safe for humans?
Research has shown that treatments like StroMel, including Cellistem, have been tested in people and appear safe. Studies have found that injecting various amounts into the knee is both safe and effective. Participants in these studies tolerated the treatment without major safety issues. This suggests that StroMel might be safe for treating knee osteoarthritis, but further research is needed to confirm this.12345
Why do researchers think this study treatment might be promising?
StroMel is unique because it uses mesenchymal stem cells (MSCs) to target osteoarthritis in a way that standard treatments like NSAIDs, corticosteroids, or physical therapy do not. Researchers are excited because MSCs have the potential to repair damaged cartilage and reduce inflammation directly at the cellular level, offering a regenerative approach rather than just symptom relief. This could mean longer-lasting improvement and possibly even slowing the progression of osteoarthritis, which is a game-changer compared to current treatments that primarily focus on managing pain and swelling.
What evidence suggests that StroMel might be an effective treatment for osteoarthritis?
Research has shown that Stromal Vascular Fraction (SVF) therapies can reduce pain and improve movement in people with knee osteoarthritis (OA). One study found that SVF enhanced knee function and lessened pain in individuals with mild to moderate OA. Another study highlighted the benefits of combining SVF with platelet-rich plasma to improve joint function and repair tissue. Mesenchymal stromal cells (MSCs), a component of SVF, have shown promise in reducing pain and improving joint stiffness and movement. These findings suggest that StroMel, the investigational treatment under study in this trial, could effectively treat knee OA.678910
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive autologous StroMel™ for the treatment of moderate to severe OA of the knee joint
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- StroMel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Akan Biosciences, LLC
Lead Sponsor