Fat-Derived Cell Therapy for Osteoarthritis

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for knee osteoarthritis using injections made from a person's own fat cells, known as Autologous Adipose-Derived SVF (Stromal Vascular Fraction). The main goal is to determine if these injections are safe and feasible for patients. Two groups will participate: one will receive the actual treatment, and the other will receive a placebo (a harmless substance with no therapeutic effect). Individuals with long-standing knee osteoarthritis who have tried other treatments, such as physical therapy or anti-inflammatory medications, but still experience issues might be suitable candidates. Participants should be able to walk without assistance and have a stable knee condition. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

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.

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

Research has shown that using a person's own fat cells for injections is generally safe for treating knee osteoarthritis. In studies with similar treatments, patients did not experience major side effects. Follow-up data from 12 to 24 months indicate that these treatments are well-tolerated. Many patients reported benefits such as reduced pain and improved movement. The Korean Food and Drug Administration has also recognized the safety of these treatments. Overall, current evidence suggests that this method is safe for people. ^{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 management with NSAIDs, corticosteroid injections, or physical therapy, autologous adipose-derived stromal vascular fraction (SVF) therapy is unique because it uses the patient's own fat cells to potentially repair damaged tissues. What makes this treatment stand out is its regenerative approach, as SVF is rich in stem cells and growth factors that might help in regenerating cartilage and reducing inflammation. Researchers are excited about SVF because it represents a shift from merely managing symptoms to potentially healing the underlying causes of osteoarthritis, offering a more sustainable and long-term solution.

What evidence suggests that autologous adipose-derived SVF might be an effective treatment for knee osteoarthritis?

Research has shown that injections of a person's own fat cells, known as stromal vascular fraction (SVF), can help with knee osteoarthritis. Studies have found that this treatment can reduce pain and improve joint function in people with osteoarthritis. In this trial, participants in the SVF (Stromal Vascular Fraction) Group will receive this treatment. One study found that using SVF led to significantly less pain and better movement compared to a group that did not receive the treatment. Another study reported that these benefits, such as long-lasting pain relief and improved joint function, can last up to 24 months after treatment. These findings suggest that SVF injections might be a promising option for managing knee osteoarthritis symptoms. ^{5 6 7 8 9}

Who Is on the Research Team?

Shane A Shapiro

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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.

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.

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.

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.

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.

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 ...

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) ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02967874

Autologous Adipose-Derived Stromal Vascular Fraction ...

The general objective of this study is to evaluate safety and clinical efficacy of a single intra-articular injection of freshly isolated auto-SVFs for the ...