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

10 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Adipose Derived (AD) Stromal Vascular Fraction (SVF) for knee osteoarthritis?

Research shows that injections of stromal vascular fraction (SVF) from fat tissue can be safe and effective for treating knee osteoarthritis, with studies reporting noticeable improvements in pain and joint function over time. ^{1 2 3 4 5}

Is fat cell injection for knee osteoarthritis safe?

Research shows that injections of adipose-derived stromal vascular fraction (SVF) cells for knee osteoarthritis are generally safe, with studies reporting minimal complications and good clinical outcomes in the short to medium term. ^{1 3 4 6 7}

How is the treatment Adipose Derived Stromal Vascular Fraction (SVF) unique for knee osteoarthritis?

This treatment is unique because it involves injecting a patient's own fat cells, specifically the stromal vascular fraction (SVF), directly into the knee joint. This approach is thought to provide mechanical support, reduce inflammation, and promote tissue repair, which is different from traditional treatments that mainly focus on pain relief and inflammation control. ^{2 3 4 8 9}

What is the purpose of this trial?

This is a prospective, non-randomized, interventional, dual site, before-after clinical trial to determine feasibility and safety of a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA).

Research Team

Claude T Moorman, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Short-term results of intra-articular injections of stromal vascular fraction for early knee osteoarthritis. [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

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

5. Germany pubmed.ncbi.nlm.nih.gov

Intra-articular injection of autologous adipose-derived stromal vascular fractions for knee osteoarthritis: a double-blind randomized self-controlled trial. [2022]

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

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

7. England pubmed.ncbi.nlm.nih.gov

The influence of adipose-derived stromal vascular fraction cells on the treatment of knee osteoarthritis. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Assessment of safety and efficacy of intra-articular injection of stromal vascular fraction for the treatment of knee osteoarthritis-a systematic review. [2021]

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

Fresh autologous stromal tissue fraction for the treatment of knee osteoarthritis related pain and disability. [2021]