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Mesenchymal Stem Cells

Mesenchymal Stem Cells for Knee Osteoarthritis

Phase 1

Waitlist Available

Led By James E Voos, MD

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unilateral chronic knee pain >4 months

Failed non-invasive modalities of treatment

Must not have

Knee Osteoarthritis Subjects: Radiographic findings consistent with Kellgren-Lawrence Stage 4 disease

Knee Osteoarthritis Subjects: Major axial deviation (>5 degrees varus or valgus)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2, 6, 12 and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a single intra-articular injection of autologous bone marrow-derived MSCs is safe and tolerable in patients with knee osteoarthritis or a focal chondral defect.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the bone marrow harvest site or injection site in the knee, allergic reactions to components used during cell processing like DMSO (if sensitive), infection risk from injections, as well as general risks associated with MRIs for those undergoing imaging studies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My condition did not improve with non-surgical treatments.

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I am between 18 and 60 years old.

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I am between 18 and 60 years old.

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I am between 18 and 60 years old with knee osteoarthritis.

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I have been diagnosed with knee osteoarthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My knee pain is due to severe arthritis.

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My knee is significantly bent inward or outward due to arthritis.

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My BMI is over 40, and I have knee osteoarthritis.

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I am not pregnant, breastfeeding, and I agree to use birth control during the study.

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I do not have neurological disorders like epilepsy or Parkinson's.

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I do not have a mental health condition that would stop me from completing the study.

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I have knee osteoarthritis and a history of cancer.

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I have knee osteoarthritis and no history of hepatitis B, C, or HIV.

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I have knee osteoarthritis and need regular medication for heart or lung issues.

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I have knee osteoarthritis with a ligament or meniscus injury.

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I have had a knee infection in the past.

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I have a history of joint inflammation.

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I am currently on medication that weakens my immune system due to my knee osteoarthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2, 6, 12 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2, 6, 12 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 6, 12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Endpoint: Incidence of treatment emergent major adverse events directly related to MSC injection

Secondary study objectives

Secondary Endpoint: Clinical Evaluation of Injection based on functional outcomes scoring using KOOS, IKDC and Lysholm scoring scales.

Secondary Endpoint: Development of Pain following injection based on Visual Analog Scale scoring.

Secondary Endpoint: Reparative potential of intra-articular MSCs based on improvement in cartilage quality using MRI.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Autologous Mesenchymal Stem Cells

2012

Completed Phase 2

~40

0 / 19Eligibility criteria met