Fat Cell Injection for Knee Osteoarthritis

Not currently recruiting at 7 trial locations

Overseen By Jaime R Garza, MD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for knee osteoarthritis, a condition that causes joint pain and limits movement. Researchers aim to determine if injecting a special mix of a person's own fat cells, known as Autologous Adipose-derived Stromal Vascular Fraction, can reduce pain and improve knee function. The study includes two groups: one receives the actual treatment, while the other receives a placebo (an inactive substance). Individuals who have had knee osteoarthritis for at least two years and have not found relief with conservative treatments like physical therapy or injections might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments using a person's own fat cells, known as stromal vascular fraction (SVF), are generally safe for humans. Studies involving hundreds of knees have demonstrated that this treatment is well-tolerated. Patients often report less pain and improved movement after receiving SVF.

One review found that patients remained safe for 12 to 24 months after treatment, with no major side effects. Specifically, no significant negative effects were reported over time. Another study noted a significant reduction in pain, starting just three months after treatment. These findings suggest that the treatment is not only effective but also safe for use in knee osteoarthritis, which involves joint inflammation and pain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for knee osteoarthritis?

Unlike standard treatments for knee osteoarthritis, such as pain relievers, physical therapy, or corticosteroid injections, the Stromal Vascular Fraction (SVF) therapy is unique because it uses a patient's own fat cells. Researchers are excited about this treatment because it leverages the regenerative potential of autologous adipose-derived cells, which might help in tissue repair and reduce inflammation directly within the knee joint. This approach not only targets symptoms but also aims to address the underlying causes of osteoarthritis, potentially offering a more sustainable and innovative solution. Additionally, using the patient's own cells minimizes the risk of rejection or adverse reactions, making it a promising alternative to conventional therapies.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research has shown that using a person's own fat cells, known as stromal vascular fraction (SVF), can help reduce pain and improve movement in people with knee osteoarthritis. In this trial, some participants will receive SVF injections in their index knee. Studies have found that patients who received SVF injections experienced less pain and improved knee function compared to those who did not receive the treatment. One study reported that pain relief began as soon as three months after the treatment. Additionally, the benefits of SVF treatments can last up to 24 months. These findings suggest that SVF could be a promising option for managing knee osteoarthritis symptoms. ^{4 5 6 7 8}

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

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36362308/

Autologous Adipose-Derived Tissue Stromal Vascular ... SVF was recently used to decrease the pain and improve the function of knee osteoarthritis (OA) patients. Primary and/or secondary OA causes ...

2. nature.com nature.com/articles/s41598-025-09398-w

Intraarticular injection of the stromal vascular fraction for ... The results after treatment revealed that the SVF group and the combination therapy group significantly outperformed the control group in terms ...

3. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-024-04034-2

Rapid-acting pain relief in knee osteoarthritis: autologous ... Significant pain reduction was observed with autologous-cultured ADMSCs starting at 3 months (MD = −2.43, 95% CI, −3.99, −0.86), whereas ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0972978X25000947

Efficacy of adipose-derived stem cells and stromal vascular ... Results indicate that ADMSC therapies demonstrate prolonged pain relief and enhanced joint function up to 24 months post-treatment.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932757/

A retrospective single-center cohort study This study aimed to compare the clinical outcomes of SVF and MFAT for knee OA. We hypothesized that SVF provides stronger short-term effects, while MFAT offers ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38386505/

Clinical Evaluation of Safety and Efficacy of a Central ... A heterogenous, autologous cell product, containing mesenchymal stem cells, derived from the patient's subcutaneous adipose tissue with demonstrated safety and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0976566224004739

Safety and efficacy of autologous adipose-derived stem ... All studies reported improved clinical outcomes using autologous adipose-derived stem cells, on 339 knees. Post-treatment increased KOOS, WOMAC, IKS, VAS, and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9658499/

Autologous Adipose-Derived Tissue Stromal Vascular ... Safety of ADMSCs and SVF in knee OA after 12–24 months of clinical follow-up was covered in a review [97]. The Korean Food and Drug Administration (KFDA) ...