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?

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 early stage osteoarthritis. The hypothesis is that use of AAM injected directly into the joint will show improvements in pain and disability while providing a safe, off-the-shelf alternative which can obviate the need for, and risks associated with, current treatment options with autologous fat transfer. As standard of care, routine strength, pain scale scores (VAS) and range of motion will be recorded, a baseline disability survey (DASH score) will also be administered. After these have all been recorded and administered in a separate visit the patient will undergo the lipofilling procedure. The subject population will include patients over the age of 18 who present with joint pain of the hand with radiographic evidence of osteoarthritis.

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.

Pregnancy or breast-feeding

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+