Fat-Derived Cell Therapy for Osteoarthritis

Recruiting at 1 trial location

Overseen By Jennifer Arthurs

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants, Herbal therapies, Antirheumatics, Immunosuppressants

Disqualifiers: Pregnancy, Knee deformity, Infections, Cardiovascular, others

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not require you to stop taking medications for osteoarthritis relief, like non-steroidal anti-inflammatory drugs, as long as your dosage has been stable for at least 4 weeks before starting the trial and is expected to remain stable until 30 days after completing the treatment. However, you must stop taking herbal therapies or supplements 4 weeks before joining the trial and avoid them until 30 days after the treatment cycle.

What data supports the effectiveness of the treatment Autologous Adipose-Derived SVF for osteoarthritis?

Research shows that using the stromal vascular fraction (SVF) from a person's own fat tissue can help reduce pain and improve joint function in people with knee osteoarthritis. Studies have found that this treatment is safe and can lead to noticeable improvements in symptoms for up to a year. ^{1 2 3 4 5}

Is fat-derived cell therapy safe for humans?

Research shows that using fat-derived cells, like stromal vascular fraction (SVF), for treating knee osteoarthritis has been safe for patients over several years. ^{1 2 5 6 7}

How is the Fat-Derived Cell Therapy for Osteoarthritis different from other treatments?

This treatment uses a patient's own fat cells, specifically the stromal vascular fraction (SVF), which has anti-inflammatory and tissue-regenerating properties, to help manage osteoarthritis. Unlike other treatments, it involves injecting these cells directly into the knee joint, potentially offering longer-lasting relief and improvement in joint function compared to standard options like hyaluronic acid injections. ^{2 3 4 6 8}

What is the purpose of this trial?

Researchers are trying to determine the safety and feasibility of autologous, adipose derived stromal vascular fraction injections in the treatment of knee osteoarthritis

Research Team

Shane A Shapiro

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for men and women aged 40-75 with knee osteoarthritis grades 2 or 3, who can walk unassisted and have tried other treatments like physical therapy or anti-inflammatory drugs. Women must not be pregnant but if they become so, will be monitored. Participants should understand the study requirements including fat harvesting and follow-up visits.

Inclusion Criteria

My knee's condition is stable.

I understand and agree to follow the study's treatment plan and procedures.

I have seen my primary care doctor for a check-up within the last year.

Exclusion Criteria

I have not had knee surgery in the past year.

I have a history of blood disorders such as anemia or low platelet counts.

I do not have any ongoing infectious diseases like TB, HIV, hepatitis, or syphilis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a placebo or autologous adipose-derived stromal vascular fraction injections for knee osteoarthritis

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Autologous Adipose-Derived SVF (Stromal Vascular Fraction)
• Placebo

Trial Overview The trial is testing injections of a patient's own adipose-derived stromal vascular fraction (SVF) against a placebo to see if it's safe and works for treating knee osteoarthritis. It involves extracting SVF from the patient’s body fat, then injecting it into their arthritic knee.

Participant Groups

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

Subjects with knee osteoarthritis (OA) will receive Autologous Adipose-Derived SVF (Stromal Vascular Fraction) cells

Group II: Placebo Group Placebo Group 1 Intervention

Subjects with knee osteoarthritis (OA) will be treated with a placebo

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

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]

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

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]

2. 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]

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

Comparative Efficacy of the Stromal-Vascular Fraction Cells of Lipoaspirate and Hyaluronic Acid in the Treatment of Gonarthrosis: Results of an Interim Analysis. [2022]

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. Croatia pubmed.ncbi.nlm.nih.gov

Medicinal signaling cells niche in stromal vascular fraction from lipoaspirate and microfragmented counterpart. [2022]

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

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

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

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