Fat Cell Injection for Knee Osteoarthritis
(SVF Trial)

Recruiting in Palo Alto (17 mi)

Overseen byClaude T Moorman, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a prospective, non-randomized, interventional, dual site, before-after clinical trial to determine feasibility and safety of a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA).

Research Team

Claude T Moorman, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults aged 18-45 who've had significant knee trauma or surgery between 1 and 20 years ago, leading to Post-Trauma Osteoarthritis (PTOA). They should have ongoing knee pain despite trying at least two treatments like medication or physical therapy. Participants need a BMI under 35, speak English, and be able to attend follow-up visits. Pregnant women, tobacco users, those with recent knee injections or certain medical conditions are excluded.

Inclusion Criteria

Subjects must speak, read, and understand English

I am in good health with a BMI under 35.

Subjects must have an adjusted Western Ontario and McMaster Universities Arthritis Index (WOMAC) (100-point scale) of > 25 and <90

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Exclusion Criteria

I have painful arthritis in my hips, spine, or ankle that affects my knee's condition.

I have a condition like gout, lupus, or severe knee issues.

Subjects that use any form of tobacco

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Treatment Details

Interventions

Adipose Derived (AD) Stromal Vascular Fraction (SVF) (Cell Therapy)

Trial OverviewThe trial is testing the safety and feasibility of a single injection of autologous Adipose Derived Stromal Vascular Fraction (SVF) in treating knee PTOA. It's a before-after study conducted at two sites where participants' own processed fat tissue is used to potentially repair their injured knees.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF)Experimental Treatment1 Intervention

a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA)