Fat Cell Injection for Knee Osteoarthritis

Recruiting at 7 trial locations

Overseen By Sandeep Samudre, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GID BIO, Inc.

Must not be taking: Anticoagulants, Immunosuppressants, Steroids, others

Disqualifiers: Rheumatoid arthritis, Lupus, Psoriatic arthritis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

114 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 6}

Who Is on the Research Team?

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.

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?

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

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

Group II: Placebo Placebo Group 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous adipose stem cell therapy for knee osteoarthritis: where are we now? Biazzo, A., D'Ambrosi, R., Masia, F., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Adipose Tissue Stem Cells for Knee Arthritis and Cartilage Lesions: A Three-Year Follow Up. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Autologous adipose stem cell therapy for knee osteoarthritis: where are we now? [2021]