Fat Cell Injection for Knee Osteoarthritis

(SVF Trial)

Overseen By Mario Cuadra, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Wake Forest University Health Sciences

Must not be taking: Oral steroids, Immunosuppressants

Disqualifiers: Gout, Rheumatoid arthritis, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether injecting a special type of cells from a participant's own fat, known as Adipose Derived Stromal Vascular Fraction (SVF), is safe and feasible for treating knee pain from past injuries. It targets individuals with post-traumatic osteoarthritis (a type of arthritis that develops after an injury) in their knees. Ideal participants have experienced significant knee injuries or surgeries over a year ago and continue to suffer from knee pain despite trying at least two other treatments, such as pain medication or physical therapy. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

You will need to stop taking any prescription or over-the-counter pain and anti-inflammatory medications for 7 days before any visit. If you are on anticoagulation therapy, it must be stopped before the injection.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using Adipose Derived (AD) Stromal Vascular Fraction (SVF) for knee osteoarthritis is generally safe. SVF, made from cells taken from a person's own fat tissue, is well-tolerated by the body. Many studies report that people receiving SVF treatment did not experience major side effects. The treatment has also been linked to reduced pain and improved joint movement.

For example, one study found that SVF is a safe option that may help relieve pain and improve movement in people with knee osteoarthritis. Another study involving 339 knees showed positive results without serious side effects. These findings suggest that SVF could be a promising and safe treatment option for knee osteoarthritis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for knee osteoarthritis, which often include pain relievers and physical therapy, the treatment being tested uses a single injection of Adipose Derived Stromal Vascular Fraction (SVF) from the patient's own fat cells. This approach is unique because it leverages the body's natural repair mechanisms, potentially reducing inflammation and promoting tissue regeneration directly in the knee joint. Researchers are excited about this treatment because it offers a more personalized and potentially less invasive alternative to current options, with the added possibility of longer-lasting relief and improved joint function.

What evidence suggests that this treatment might be an effective treatment for knee osteoarthritis?

Research has shown that Adipose Derived (AD) Stromal Vascular Fraction (SVF) can reduce pain and improve knee function in people with knee osteoarthritis. One study found that patients experienced less pain and better knee movement after receiving SVF injections. After 12 months, those who received SVF therapy reported a noticeable decrease in pain compared to other treatments. Additionally, SVF proved more effective than other treatments in relieving pain and improving function. This trial will evaluate the effects of a single injection of autologous AD SVF for treating knee post-traumatic osteoarthritis (PTOA). These findings suggest that SVF injections may effectively manage knee osteoarthritis symptoms. ^{5 6 7 8 9}

Who Is on the Research Team?

Claude T Moorman, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

1 year

Visits at Month 1, Month 3, Month 6, and Year 1

What Are the Treatments Tested in This Trial?

Interventions

• Adipose Derived (AD) Stromal Vascular Fraction (SVF)

Trial Overview The 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.

How Is the Trial Designed?

Group I: a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

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]

Intra-articular injection of adipose-derived stromal vascular fraction (SVF) cells in 57 patients with knee osteoarthritis showed significant improvements in knee extension and pain scores over a 12-month follow-up period, indicating its efficacy as a treatment.

The treatment led to better clinical outcomes, as measured by the WOMAC, VAS, and KOOS scores, with no significant changes in the hip-knee-ankle angle, suggesting that SVF cell therapy is a promising and innovative approach for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of adipose-derived stromal vascular fraction cells on the treatment of knee osteoarthritis. Tsubosaka, M., Matsumoto, T., Sobajima, S., 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11145973/

Efficacy of stromal vascular fraction for knee osteoarthritis Our study demonstrated that intra-articular administration of SVF can lead to reduced pain and improved knee function in patients with primary knee OA. More ...

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

Efficacy of adipose-derived stem cells and stromal vascular ... At 12 months, SVF therapy achieved significant short-term pain reduction, with a mean VAS improvement of 18.10 points, compared to 16.92 points for ADMSC- ...

3. 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 ...

4. 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 ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10744886/

Stromal Vascular Fraction Therapy for Knee Osteoarthritis SVF was considered a safe treatment for knee OA and could hold promise in terms of pain, functionality, and improvement of anatomical structure.

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

Clinical Evaluation of Safety and Efficacy of a Central ... Stromal vascular fraction (SVF) is a heterogenous, autologous cell product, containing mesenchymal stem cells, derived from the patient's subcutaneous adipose ...

8. 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 ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02726945

Adipose-derived SVF for the Treatment of Knee OA This is a pivotal study. The study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells processed with ...