Fat-Derived Cell Therapy for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for knee osteoarthritis using injections made from a person's own fat cells, known as Autologous Adipose-Derived SVF (Stromal Vascular Fraction). The main goal is to determine if these injections are safe and feasible for patients. Two groups will participate: one will receive the actual treatment, and the other will receive a placebo (a harmless substance with no therapeutic effect). Individuals with long-standing knee osteoarthritis who have tried other treatments, such as physical therapy or anti-inflammatory medications, but still experience issues might be suitable candidates. Participants should be able to walk without assistance and have a stable knee condition. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial does not require you to stop taking medications for osteoarthritis relief, like non-steroidal anti-inflammatory drugs, as long as your dosage has been stable for at least 4 weeks before starting the trial and is expected to remain stable until 30 days after completing the treatment. However, you must stop taking herbal therapies or supplements 4 weeks before joining the trial and avoid them until 30 days after the treatment cycle.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that using a person's own fat cells for injections is generally safe for treating knee osteoarthritis. In studies with similar treatments, patients did not experience major side effects. Follow-up data from 12 to 24 months indicate that these treatments are well-tolerated. Many patients reported benefits such as reduced pain and improved movement. The Korean Food and Drug Administration has also recognized the safety of these treatments. Overall, current evidence suggests that this method is safe for people.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for knee osteoarthritis, which often include pain management with NSAIDs, corticosteroid injections, or physical therapy, autologous adipose-derived stromal vascular fraction (SVF) therapy is unique because it uses the patient's own fat cells to potentially repair damaged tissues. What makes this treatment stand out is its regenerative approach, as SVF is rich in stem cells and growth factors that might help in regenerating cartilage and reducing inflammation. Researchers are excited about SVF because it represents a shift from merely managing symptoms to potentially healing the underlying causes of osteoarthritis, offering a more sustainable and long-term solution.
What evidence suggests that autologous adipose-derived SVF might be an effective treatment for knee osteoarthritis?
Research has shown that injections of a person's own fat cells, known as stromal vascular fraction (SVF), can help with knee osteoarthritis. Studies have found that this treatment can reduce pain and improve joint function in people with osteoarthritis. In this trial, participants in the SVF (Stromal Vascular Fraction) Group will receive this treatment. One study found that using SVF led to significantly less pain and better movement compared to a group that did not receive the treatment. Another study reported that these benefits, such as long-lasting pain relief and improved joint function, can last up to 24 months after treatment. These findings suggest that SVF injections might be a promising option for managing knee osteoarthritis symptoms.56789
Who Is on the Research Team?
Shane A Shapiro
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for men and women aged 40-75 with knee osteoarthritis grades 2 or 3, who can walk unassisted and have tried other treatments like physical therapy or anti-inflammatory drugs. Women must not be pregnant but if they become so, will be monitored. Participants should understand the study requirements including fat harvesting and follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a placebo or autologous adipose-derived stromal vascular fraction injections for knee osteoarthritis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Adipose-Derived SVF (Stromal Vascular Fraction)
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor