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Stem Cell Therapy

Fat-Derived Cell Therapy for Osteoarthritis

Phase 1

Recruiting

Led By Shane A Shapiro

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Clinically stable target knee.

Male or female ages 40-75 years

Must not have

Surgery on the index knee within 1 year of study enrollment.

History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Summary

This trial is testing whether it is safe and feasible to inject a person's own fat-derived cells into their knee to treat osteoarthritis.

Who is the study for?

This trial is for men and women aged 40-75 with knee osteoarthritis grades 2 or 3, who can walk unassisted and have tried other treatments like physical therapy or anti-inflammatory drugs. Women must not be pregnant but if they become so, will be monitored. Participants should understand the study requirements including fat harvesting and follow-up visits.Check my eligibility

What is being tested?

The trial is testing injections of a patient's own adipose-derived stromal vascular fraction (SVF) against a placebo to see if it's safe and works for treating knee osteoarthritis. It involves extracting SVF from the patient’s body fat, then injecting it into their arthritic knee.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site such as pain or swelling, infection risk due to the procedure, and any adverse effects related to fat harvesting like bruising or discomfort.

Eligibility Criteria

Inclusion Criteria

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

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My knee's condition is stable.

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I am between 40 and 75 years old.

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I can walk on my own without any help.

Exclusion Criteria

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

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I have not had knee surgery in the past year.

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I have a history of blood disorders such as anemia or low platelet counts.

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I do not have any ongoing infectious diseases like TB, HIV, hepatitis, or syphilis.

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I am on long-term medication that weakens my immune system.

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I am currently taking blood thinners or clopidogrel.

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I have a condition like rheumatoid arthritis or lupus.

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I have had falls needing medical help or have trouble walking steadily.

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I cannot have MRI scans due to health reasons or I choose not to have them.

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I have a blood vessel or nerve condition in one of my legs.

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I do not have major heart, brain, kidney, liver, bone, or hormone-related health issues.

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I have a specific knee condition like arthritis or CPPD.

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I have had a joint infection in my knee.

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I have not been on a stable dose of NSAIDs for 4 weeks.

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I need X-rays due to major issues with my body's alignment.

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My knee locks, catches, or suddenly gives way.

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I currently use tobacco or nicotine products.

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My knee's shape is unusual due to a birth defect or injury, affecting treatment.

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My knee arthritis is graded from mild to severe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adverse Events

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SVF (Stromal Vascular Fraction) GroupExperimental Treatment1 Intervention

Subjects with knee osteoarthritis (OA) will receive Autologous Adipose-Derived SVF (Stromal Vascular Fraction) cells

Group II: Placebo GroupPlacebo Group1 Intervention

Subjects with knee osteoarthritis (OA) will be treated with a placebo

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,255 Previous Clinical Trials

3,835,376 Total Patients Enrolled

28 Trials studying Osteoarthritis

2,820 Patients Enrolled for Osteoarthritis

Shane A ShapiroPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

1 Trials studying Osteoarthritis

Media Library

Autologous Adipose-Derived SVF (Stromal Vascular Fraction) (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03940950 — Phase 1

Osteoarthritis Research Study Groups: Placebo Group, SVF (Stromal Vascular Fraction) Group

Osteoarthritis Clinical Trial 2023: Autologous Adipose-Derived SVF (Stromal Vascular Fraction) Highlights & Side Effects. Trial Name: NCT03940950 — Phase 1

Autologous Adipose-Derived SVF (Stromal Vascular Fraction) (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03940950 — Phase 1

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