Fat Cell Injection for Knee Osteoarthritis

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GID BIO, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if injecting special cells from a patient's own fat can reduce pain and improve function in people with knee osteoarthritis. These cells have been investigated in various studies for their potential to treat knee osteoarthritis by reducing pain and improving function.

Research Team

William Cimino, PhD

Principal Investigator

GID BIO

Eligibility Criteria

This trial is for men and women aged 35-85 with knee osteoarthritis who've tried at least two treatments without success, including physical therapy or injections. They must not have had recent major knee injuries, surgery, or certain other joint conditions. Participants need to understand English, be able to attend follow-up visits, and have a BMI between 22 and 37.

Exclusion Criteria

My knee osteoarthritis is confirmed by MRI as moderate to severe.

I am undergoing a 6-week physical therapy program.

My knee osteoarthritis is confirmed by MRI as moderate to severe.

See 39 more

Treatment Details

Interventions

Autologous Adipose-derived Stromal Vascular Fraction (Cell Therapy)
GID SVF-2 Device System (Procedure)

Trial OverviewThe study tests the safety and effectiveness of a single injection using autologous adipose-derived SVF produced by the GID SVF-2 device system in reducing pain and improving function in patients with knee osteoarthritis.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

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

Subjects will receive an injection of Stromal Vascular Fraction in their index knee

Group II: PlaceboPlacebo Group1 Intervention

Subjects will receive an injection of Lactated Ringers in their index knee