Adipose Derived MSCs for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether injections of stem cells taken from a participant's own fat can safely and effectively reduce pain from hip osteoarthritis (OA). Researchers are examining the effectiveness of different dosages, with one group receiving a single injection and another group receiving two injections a month apart. Individuals with hip OA symptoms for over three months who have not found relief from treatments like physical therapy or anti-inflammatory medications might be suitable candidates. 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 innovative therapy.
Do I need to stop my current medications to join the trial?
The trial requires that you stop taking herbal therapies or supplements 4 weeks before joining and avoid them until 30 days after treatment. You must also have a stable dose of non-steroidal anti-inflammatory medications for at least 4 weeks before starting and maintain it until 30 days after treatment. If you are on anticoagulant medications, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using a person's own fat-derived cells is generally safe for individuals with osteoarthritis. In one study, patients who received a single injection of these cells reported significant pain relief and improved movement. Another review found these cells effective and safe, even for older patients.
For those considering two injections, evidence also supports their safety. Multiple studies have found that both single and repeated injections improve pain without major safety concerns. Overall, these treatments appear well-tolerated, making them promising options for managing hip osteoarthritis.12345Why are researchers excited about this trial's treatment?
Unlike standard treatments for osteoarthritis, which often rely on pain relief through medications like NSAIDs or corticosteroid injections, the treatment using Autologous Adipose Derived Mesenchymal Stromal Cells (MSCs) is unique because it utilizes the body's own cells to potentially repair and regenerate damaged tissue. This innovative approach harnesses MSCs extracted from a patient's own fat tissue, offering a personalized treatment option that may promote healing and reduce inflammation directly at the affected site. Researchers are excited about this treatment because it offers a promising alternative that could not only alleviate symptoms but also address the underlying causes of osteoarthritis, potentially leading to longer-lasting relief. Additionally, the delivery method via ultrasound-guided injections ensures precise placement of the cells, enhancing treatment effectiveness.
What evidence suggests that autologous adipose derived mesenchymal stromal cells might be an effective treatment for osteoarthritis?
Research has shown that using a person's own fat cells, known as AD-MSCs, might help treat osteoarthritis. Studies have found that patients receiving these cells experienced noticeable relief from knee osteoarthritis symptoms, with less pain and improved joint function. In this trial, participants will receive either a single injection or two injections of AD-MSCs into the hip. AD-MSCs provide quick pain relief and lasting benefits. These encouraging results suggest they might also effectively treat hip osteoarthritis.26789
Who Is on the Research Team?
Aaron J Krych
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with chronic hip osteoarthritis (OA) pain, who've tried conservative treatments without surgery plans for the next year. Participants must be able to walk unassisted and agree to use contraception if of childbearing potential. Exclusions include pregnancy, allergies to study drugs, recent injections in the target hip, BMI over 35, certain medication use, infectious diseases like HIV or hepatitis, history of cancer except some skin cancers, drug abuse or significant cardiovascular and other systemic diseases.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 single dose or two doses of autologous culture-expanded adipose-derived mesenchymal stromal cells (AMSCs) via ultrasound guided intra-articular hip injection
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of cartilage thickness, hip scores, and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Adipose Derived Mesenchymal Stromal Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor