114 Participants Needed

Fat Cell Injection for Knee Osteoarthritis

Recruiting at 7 trial locations
AH
AW
AL
SS
Overseen BySandeep Samudre, PhD, MPH
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking prescription or over-the-counter pain medications 7 days before any visit, except for the Day 2 Post Treatment Visit. Additionally, certain blood thinners and anti-inflammatory medications must be stopped for a specified period before the injection.

Is fat cell injection for knee osteoarthritis safe?

Research shows that injections of fat-derived cells, like stromal vascular fraction (SVF), are generally safe for treating knee osteoarthritis, with studies reporting minimal and minor complications.12345

How is the treatment using autologous adipose-derived stromal vascular fraction for knee osteoarthritis different from other treatments?

This treatment is unique because it uses a patient's own fat cells, specifically the stromal vascular fraction (SVF), which is injected directly into the knee joint. It is believed to work by interacting with the knee's fat tissue to regulate inflammation and promote healing, offering a novel approach compared to traditional treatments like pain relievers or surgery.12346

What data supports the effectiveness of the treatment for knee osteoarthritis?

Research shows that injecting fat-derived cells into the knee can slow the progression of osteoarthritis and reduce pain, with studies demonstrating safety and noticeable improvements in patients over time.12346

Who Is on the Research Team?

WC

William Cimino, PhD

Principal Investigator

GID BIO

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of either placebo or autologous adipose-derived SVF for treatment of knee osteoarthritis

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary efficacy measured at 12 months post-treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Autologous Adipose-derived Stromal Vascular Fraction
  • GID SVF-2 Device System
Trial Overview The 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.
How Is the Trial Designed?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

GID BIO, Inc.

Lead Sponsor

Trials
5
Recruited
190+

Published Research Related to This Trial

The study demonstrated that injecting autologous adipose-derived stromal vascular cells (SVF) into osteoarthritic knees is safe, with no reported adverse events such as infections or pain flares in 6 patients treated over a year.
Patients experienced significant pain reduction and improved function, as shown by better scores on the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 3 months and maintained these improvements at 1 year.
Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint.Fodor, PB., Paulseth, SG.[2022]
Intra-articular injections of autologous stromal vascular fraction (SVF) significantly improved knee osteoarthritis symptoms, with high-dose patients showing an 89.5% improvement in WOMAC scores after 12 months compared to 0% in the placebo group.
The study, involving 39 patients in a randomized controlled trial, demonstrated that the improvements were dose-dependent and no serious adverse events were reported, indicating both efficacy and safety for SVF as a treatment option.
Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial.Garza, JR., Campbell, RE., Tjoumakaris, FP., et al.[2020]
Adipose-derived stem cell (ADSC) or stromal vascular fraction (SVF) injections are safe and show good clinical and radiological outcomes for knee osteoarthritis treatment, with a low complication rate of 16.15% for minor issues.
The study indicates that ADSCs and SVF can lead to promising improvements in knee osteoarthritis symptoms within 12-24 months, but highlights the need for more standardized follow-up and comparisons with other treatments to confirm efficacy.
Autologous adipose stem cell therapy for knee osteoarthritis: where are we now?Biazzo, A., D'Ambrosi, R., Masia, F., et al.[2021]

Citations

Intra-articular infiltration of adipose-derived stromal vascular fraction cells slows the clinical progression of moderate-severe knee osteoarthritis: hypothesis on the regulatory role of intra-articular adipose tissue. [2021]
Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint. [2022]
Adipose Tissue Stem Cells for Knee Arthritis and Cartilage Lesions: A Three-Year Follow Up. [2023]
Effect of intra-knee injection of autologous adipose stem cells or mesenchymal vascular components on short-term outcomes in patients with knee osteoarthritis: an updated meta-analysis of randomized controlled trials. [2023]
Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. [2020]
Autologous adipose stem cell therapy for knee osteoarthritis: where are we now? [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security