Fat-Derived Cell Therapy for Osteoarthritis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Shane A Shapiro

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Mayo Clinic

Trial Summary

What is the purpose of this trial?

Researchers are trying to determine the safety and feasibility of autologous, adipose derived stromal vascular fraction injections in the treatment of knee osteoarthritis

Research Team

Shane A Shapiro

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

My knee's condition is stable.

I understand and agree to follow the study's treatment plan and procedures.

I have seen my primary care doctor for a check-up within the last year.

Exclusion Criteria

I have not had knee surgery in the past year.

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

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

Treatment Details

Interventions

• Autologous Adipose-Derived SVF (Stromal Vascular Fraction) (Stem Cell Therapy)
• Placebo (Drug)

Trial Overview 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.

Participant Groups

Group I: SVF (Stromal Vascular Fraction) Group Experimental Treatment 1 Intervention

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

Group II: Placebo Group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine