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Mesenchymal Stem Cells

Mesenchymal Stem Cells for Knee Osteoarthritis

Phase 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2, 6, 12 and 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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.

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 / 6Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor

318 Previous Clinical Trials

340,069 Total Patients Enrolled

4 Trials studying Osteoarthritis

213 Patients Enrolled for Osteoarthritis

Case Western Reserve UniversityOTHER

299 Previous Clinical Trials

246,566 Total Patients Enrolled

1 Trials studying Osteoarthritis

46 Patients Enrolled for Osteoarthritis

James E Voos, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Media Library

Autologous Mesenchymal Stem Cells (Mesenchymal Stem Cells) Clinical Trial Eligibility Overview. Trial Name: NCT03477942 — Phase 1

Osteoarthritis Research Study Groups: Osteoarthritis, Cartilage

Osteoarthritis Clinical Trial 2023: Autologous Mesenchymal Stem Cells Highlights & Side Effects. Trial Name: NCT03477942 — Phase 1

Autologous Mesenchymal Stem Cells (Mesenchymal Stem Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03477942 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for participation in this experiment?

"This clinical trial is accepting 16 patients with arthrosis in the age range of 18 to 60 years. Specifically, women who are not postmenopausal and have no surgical sterilization must take a contraceptive method that has a failure rate less than 1% annually. These might include bilateral tubal ligation, hormone-releasing intrauterine devices, male sterilization etcetera. Additionally, sexual abstinence must be considered relative to the study's duration and patient lifestyle for it to remain reliable. Lastly, knee osteoarthritis subjects being admitted should exhibit chronic pain lasting more than 4 months and have been unresponsive to non-invasive"

Answered by AI

Is this study accepting participants who are over 80 years of age?

"The lower limit for this trial is 18 years of age and the upper limit is 60 years."

Answered by AI

Does Autologous Mesenchymal Stem Cells possess any adverse effects on the health of those who receive it?

"Given the limited amount of data supporting safety and efficacy, Autologous Mesenchymal Stem Cells received a score of 1."

Answered by AI

Is this experiment open to new participants at the moment?

"According to the information found on clinicaltrials.gov, this research is currently searching for participants. This project was first published in October 1st 2018 and has recently been updated on September 9th 2022."

Answered by AI

How many participants are currently involved in this experiment?

"Affirmative. Clinicaltrials.gov has information that illustrates the recruitment of this medical trial, which was first listed on October 1st 2018, is still underway. This research endeavour demands 16 patients to be recruited from a single site."

Answered by AI