Mesenchymal Stem Cells for Knee Osteoarthritis

Overseen By James E Voos, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University Hospitals Cleveland Medical Center

Must not be taking: Immunosuppressants

Disqualifiers: Obesity, Cardiac disease, Neurologic, Psychiatric, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 day

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. ^{1 2 3 4 5}

Why 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. ^{5 6 7 8 9}

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

I have had knee pain in one knee for more than 4 months.

My condition did not improve with non-surgical treatments.

You have signs of mild to moderate wear and tear on your joint cartilage seen in imaging tests like MRI or X-rays.

Exclusion Criteria

I haven't had major surgery except for diagnosis in the last 4 weeks.

Criterion: You cannot have certain metal implants in your body, low levels of certain blood cells, a history of allergic reactions to Dimethyl sulfoxide (DMSO), recent treatment for alcohol or drug abuse, or any major health changes in the last 2 weeks.

My knee pain is due to severe arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Bone Marrow Harvest

Patients undergo a bone marrow harvest procedure at the Dahms Clinical Research Unit

1 day

1 visit (in-person)

Treatment

Intra-articular injection of 50x10^6 MSCs after MSCs are isolated and expanded

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at 7 days, 2, 6, 12, and 24 months

24 months

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Mesenchymal Stem Cells

Trial Overview

The trial is testing whether injecting one's own mesenchymal stem cells into the knee can help treat osteoarthritis or cartilage injuries without surgery. It's a phase I pilot study where participants will receive an injection after their stem cells are harvested and grown. They'll be monitored over two years for safety and improvements in pain and joint function using physical exams and questionnaires.

How Is the Trial Designed?

Group I: Osteoarthritis Experimental Treatment 1 Intervention

The OA subgroup will be patients aged 18-60 years who have chronic knee pain due to early OA that have not responded to conservative, non-invasive measures such as physical therapy, medications, and activity modification.

Group II: Cartilage Experimental Treatment 1 Intervention

The focal chondral defect subgroup will be patients aged 18-60 years who participate in recreational or professional sports and are symptomatic from a focal chondral defect shown on MRI.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Published Research Related to This Trial

The study evaluated the safety of intra-articular injections of adipose-derived stromal cells (ASCs) in 18 patients with severe knee osteoarthritis (OA) and found no serious adverse events, indicating that the treatment is safe.

Patients receiving low-dose ASCs reported significant improvements in pain and function after 6 months, suggesting potential efficacy, although further controlled studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Pers, YM., Rackwitz, L., Ferreira, R., et al.[2022]

In a study involving 30 participants with knee osteoarthritis, autologous adipose-derived mesenchymal stem cell (ADMSC) therapy was found to be safe, with no serious adverse events reported.

Both treatment groups receiving ADMSC injections showed significant improvements in pain and function after 12 months, and MRI results suggested that the therapy may help slow down disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose-derived mesenchymal stem cell therapy in the treatment of knee osteoarthritis: a randomized controlled trial. Freitag, J., Bates, D., Wickham, J., et al.[2019]

Citations

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Preclinical animal trials assessing chondral defect repair have indicated successful results using MSC-impregnated scaffolds.32 33 Histological analysis has ...

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Intra-articular injection of autologous culture-expanded ADMSCs provided significant pain relief and functional improvements in patients with KL grade 3 ...

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The purpose of this study is to explore the efficacy and safety of autologous adipose mesenchymal stem cells in the treatment of early knee arthritis.

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Autologous-cultured adipose-derived mesenchymal stem cells (ADMSCs) and stromal vascular fractions (SVFs) have emerged as potential regenerative ...