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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.

Timeline

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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,212 Previous Clinical Trials
3,767,008 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

Frequently Asked Questions

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

Does this experimental procedure require subjects to be of a particular age?

"This research is open to those aged 40 or older but not exceeding the age of 70."

Answered by AI

How many individuals have volunteered for this experiment?

"Affirmative. The clinical trial is actively in session, as per the information on clinicaltrials.gov; it was first introduced on July 1st 2019 and last updated on May 26th 2022. 30 participants will be accepted at 2 different locations for this medical study."

Answered by AI

Are there any vacancies left for participants in this clinical experiment?

"Indeed, clinicaltrials.gov displays that this trial is currently seeking participants - it was posted on July 1st 2019 and last updated on May 26th 2022. Specifically, the study requires 30 subjects across 2 locations to be recruited."

Answered by AI

To whom is this research open for participation?

"This clinical trial requires 30 participants, within the ages of 40 to 70 who suffer from arthrosis. Other prerequisites for enrolment include: Females with childbearing potential must take a pregnancy test and use adequate contraception (hormonal or barrier method or abstinence) between screening and 1 year after drug treatment ends; females with childbearing potential are defined as either premenopausal without sterilization surgery, or post-menopausal for less than 2 years; urine tests will be conducted prior to administering study drugs while serum tests can be done at a central lab; candidates should also have no issues walking unaided by any device such as walkers"

Answered by AI

Could you elucidate the potential risks associated with Autologous Adipose-Derived SVF (Stromal Vascular Fraction) treatments?

"There is limited data backing Autologous Adipose-Derived SVF's safety and efficacy, thus it received a score of 1."

Answered by AI
~3 spots leftby Dec 2024