Mesenchymal Stem Cells for Knee Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment option using mesenchymal stem cells (MSCs) for knee issues such as osteoarthritis and cartilage defects. Researchers aim to determine if injecting these cells directly into the knee can repair or regenerate damaged tissue, providing a non-surgical alternative for those who haven't found relief through other treatments. The trial includes two groups: one with knee osteoarthritis and another with cartilage defects, making it suitable for individuals with persistent knee pain or difficulty with sports due to these conditions. 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on medications for active cardiac or respiratory disease, or if you are on immunosuppressive medications, you may not be eligible to participate.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that using mesenchymal stem cells (MSCs) for knee treatments is generally safe. In past studies, patients who received injections of their own MSCs (stem cells taken from their own body) experienced significant pain relief and improved knee function. These treatments were well-tolerated, with no major safety issues.
For example, one study using MSCs from fat tissue showed promising results for people with knee osteoarthritis, including less pain and better movement. While most studies have used stem cells from fat tissue, they provide useful insights into the safety of using similar stem cells from bone marrow, which are used in this trial.
This trial is in the first phase, focusing on safety and understanding how the body responds to the treatment. Early-phase trials closely monitor any side effects to ensure safety remains a priority.12345Why are researchers excited about this trial's treatment?
Researchers are excited about using autologous mesenchymal stem cells for knee osteoarthritis because these cells offer a regenerative approach, unlike traditional treatments like pain medications or physical therapy, which mainly manage symptoms. Mesenchymal stem cells are special because they can potentially repair and regenerate damaged cartilage, addressing the root cause of the condition rather than just alleviating pain. This treatment could be particularly beneficial for younger, active individuals with early osteoarthritis or specific cartilage defects, offering a promising alternative to more invasive procedures or long-term medication use.
What evidence suggests that this trial's treatments could be effective for knee osteoarthritis and focal chondral defects?
Research has shown that mesenchymal stem cells (MSCs) might help treat knee problems like osteoarthritis and cartilage damage. In this trial, participants will receive injections of their own MSCs. Studies have found that such injections often reduce pain and improve knee mobility. Specifically, individuals with osteoarthritis reported less pain and better mobility, suggesting an improved quality of life. In some studies, MRI scans showed that MSCs might even help regrow knee cartilage. For those with cartilage damage, MRI results indicated signs of cartilage repair and better knee function, making it a possible treatment for active individuals. These findings suggest that MSCs could significantly advance the treatment of knee joint issues.56789
Who Is on the Research Team?
James Voos, MD
Principal Investigator
University Hospitals Cleveland Medical Center
Are You a Good Fit for This Trial?
Adults aged 18-60 with knee osteoarthritis or a focal chondral defect in the knee, who have not found relief through non-invasive treatments. Participants must be able to consent and women of childbearing age should agree to effective contraception or abstinence. Exclusions include severe arthritis stage, major limb misalignment, concurrent serious conditions (like heart disease), high BMI (>40), mental illness affecting study compliance, recent major surgery, immunosuppression, cancer history, MRI contraindications like pacemakers, certain blood disorders and allergies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Bone Marrow Harvest
Patients undergo a bone marrow harvest procedure at the Dahms Clinical Research Unit
Treatment
Intra-articular injection of 50x10^6 MSCs after MSCs are isolated and expanded
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up visits at 7 days, 2, 6, 12, and 24 months
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Mesenchymal Stem Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Hospitals Cleveland Medical Center
Lead Sponsor
Case Western Reserve University
Collaborator