Adipose Allograft for Hand Arthritis
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.12345Why 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.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an injection of adipose allograft matrix (AAM) into the small joints of the hand
Follow-up
Participants are monitored for safety and effectiveness, including assessments of pain, disability, range of motion, and strength
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?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor
Musculoskeletal Transplant Foundation
Collaborator
Citations
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 ...
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=9Use 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-handUse 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 ...
Adipose Tissue-Derived Therapies for Osteoarthritis
Adipose tissue-derived therapies have great potential to promote cartilage regeneration, reduce inflammation, and improve joint function.
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.
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 ...
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