Adipose Allograft for Hand Arthritis

Overseen By Laura Program Manager

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Aspirin, Plavix

Disqualifiers: Rheumatoid arthritis, Pregnancy, Heart failure, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for early-stage osteoarthritis in the small joints of the hand. Researchers aim to determine if injecting a special fat tissue (human adipose allograft) directly into these joints can reduce pain and improve movement, providing a safer alternative to current methods. It suits individuals over 18 diagnosed with hand osteoarthritis who have not received other treatments like cortisone shots or surgery. As an Early Phase 1 trial, this study focuses on understanding how the treatment works in people, giving participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications or supplements that could prolong bleeding time, like Aspirin or Plavix, for at least 4 weeks before participating.

What prior data suggests that this adipose allograft matrix is safe for treating hand arthritis?

Research shows that fat tissue transplants, known as adipose allografts, for treating arthritis in hand joints are still under investigation. Limited information exists about the safety of this specific use. However, human testing suggests that earlier lab or animal studies produced promising results.

In other cases, similar treatments with adipose allografts have increased certain proteins that help reduce inflammation. While this might indicate safety, treatments can work differently in various body parts.

As this study is in an early phase, the primary goal is to assess the treatment's safety for people. Prospective participants should remember that while researchers are hopeful, they are still learning about the treatment's effects in humans and potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Human Adipose Allograft is unique because it utilizes a natural matrix derived from human fat tissue to directly target hand arthritis. Unlike conventional treatments, such as anti-inflammatory medications or corticosteroid injections, this approach involves injecting a small amount of adipose tissue into the joint space, potentially providing a cushioning effect and promoting healing. Researchers are excited about this treatment because it offers a novel way to potentially reduce inflammation and pain while enhancing joint function, using the body's own biological materials.

What evidence suggests that this treatment might be an effective treatment for hand arthritis?

Research has shown that a treatment called adipose allograft matrix (AAM), which participants in this trial may receive, might help with hand arthritis. Derived from fat tissue, AAM has shown promise in rebuilding cartilage, reducing swelling, and improving joint function. These effects could lead to less pain and better movement in the joints. Although the research remains in the early stages, these initial results suggest that AAM could be a promising option for people with hand osteoarthritis. ^{1 2 3 6 7}

Who Is on the Research Team?

Meghan McCullough, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with hand joint pain and confirmed osteoarthritis in specific joints (CMC, IP, PIP, DIP). It's aimed at those seeking an alternative to current treatments like autologous fat transfer.

Inclusion Criteria

My X-rays show I have osteoarthritis.

Radiographic evidence of osteoarthritis

Exclusion Criteria

I haven't taken Aspirin, Plavix, or similar drugs that could increase bleeding in the last 4 weeks.

I have chronic obstructive pulmonary disease.

I have a collagen vascular disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive an injection of adipose allograft matrix (AAM) into the small joints of the hand

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessments of pain, disability, range of motion, and strength

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Human Adipose Allograft
• local anaesthetic injection

Trial Overview The study tests the safety and effectiveness of injecting Allograft Adipose Matrix into small hand joints affected by osteoarthritis. The goal is to see if this treatment improves pain and function without the risks of traditional methods.

How Is the Trial Designed?

Group I: Adipose Allograft Matrix (AAM) Experimental Treatment 2 Interventions

Using fluoroscopic guidance (X-ray), a needle will be injected into the joint space. 1 cc of Leneva (adipose allograft matrix, MTF Biologics) will be injected into the joint.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Musculoskeletal Transplant Foundation

Collaborator

Trials

22

Recruited

1,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05747469

Use of Allograft Adipose Matrix for Small Joint Arthritis ... The purpose the research is to evaluate the safety and efficacy of injection of adipose allograft matrix (AAM) to the small joints of the hand for treatment ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT05747469

Use of Allograft Adipose Matrix for Small Joint Arthritis of the ... The purpose the research is to evaluate the safety and efficacy of injection of adipose allograft matrix (AAM) to the small joints of the hand for treatment of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05747469?term=AREA%5BConditionSearch%5D(%22Arthritis%22)%20AND%20AREA%5BInterventionSearch%5D(%22anesthetics,%20local%22)&rank=9

Use of Allograft Adipose Matrix for Small Joint Arthritis ... A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and ...

4. ctv.veeva.com ctv.veeva.com/study/use-of-allograft-adipose-matrix-for-small-joint-arthritis-of-the-hand

Use of Allograft Adipose Matrix for Small Joint Arthritis of the ... The purpose the research is to evaluate the safety and efficacy of injection of adipose allograft matrix (AAM) to the small joints of the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12071781/

Adipose Tissue-Derived Therapies for Osteoarthritis Adipose tissue-derived therapies have great potential to promote cartilage regeneration, reduce inflammation, and improve joint function.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2667254525000149

Allograft adipose matrix increases interleukin-10 and ... AAM increases in vitro concentrations of IL-10 and TGF-β1 in osteoarthritic adipocytes and chondrocytes isolated from the knee joint. Keywords.

7. withpower.com withpower.com/trial/early-phase-1-arthritis-1-2023-c29f6

Adipose Allograft for Hand Arthritis The purpose the research is to evaluate the safety and efficacy of injection of adipose allograft matrix (AAM) to the small joints of the hand for treatment ...