Mesenchymal Stem Cells for Knee Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen byJames Voos, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University Hospitals Cleveland Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

Many patients with osteoarthritis of the knee fail non-operative measures and elect to have knee arthroplasty to improve their quality of life. If successful, intra-articular mesenchymal stem cell (MSC) injections into the knee may offer another viable non-operative treatment modality. Additionally, this modality may have reparative or regenerative potential, which could lead to the first treatment for osteoarthritis that treats the underlying disease as opposed to symptomatic control. Additionally, there are no acceptable non-surgical treatments for focal chondral defects of the knee. Surgical treatments that do exist have diminished outcomes if performed on patients older than age 30-40 years. If successful, intra-articular MSC injections into the knee would represent the first non-operative treatment for focal chondral defects and also represent a potential option for treatment in patients over the age of 30-40 years. This trial will be a prospective, single-center phase I pilot study to evaluate the safety and tolerability of a single intra-articular injection of autologous bone marrow-derived MSCs in 16 subjects, 8 who have knee osteoarthritis and 8 who have a focal chondral defect in the knee. Patients will undergo a bone marrow harvest procedure at the Dahms Clinical Research Unit (DCRU) of University Hospitals Cleveland Medical Center. MSCs will be isolated and expanded. After approximately 2-3 weeks, patients will return for an intra-articular injection of 50x106 MSCs Subsequent study visits will occur on post-injection day 7 and months 2, 6, 12, and 24. Safety of intra-articular injection of MSCs will be evaluated at study visits by interval history, physical examination and assessment of any adverse events that are observed/reported. Additionally, efficacy will be evaluated by having patients complete functional outcome measures including: Visual Analog Score (VAS) for pain, Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) Subjective Knee Form, and Lysholm Knee Scale. These will be completed at the pre-treatment visit and then repeated at the 2, 6, 12, and 24-month follow-up visits. Lastly, T1 rho and T2 mapping on magnetic resonance imaging (MRI) will be used to assess for improved cartilage quality after intra-articular injection of MSCs. An MRI will be obtained at the pre-treatment visit. At the 12 and 24 month follow up visit, additional MRIs will be obtained and analyzed to compare the pre-treatment MRI to post-treatment MRIs.

Research Team

James Voos, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

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.

I am between 18 and 60 years old.

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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.

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Treatment Details

Interventions

Autologous Mesenchymal Stem Cells (Mesenchymal Stem Cells)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: OsteoarthritisExperimental Treatment1 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: CartilageExperimental Treatment1 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.