Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Patients greater than 18 years, with presentation to the Cedars Sinai hand clinic for joint pain of the hand carpometacarpal, interphalangeal, proximal interphalangeal, and distal interphalangeal joints (CMC, IP, PIP or DIP joints).

• Radiographic evidence of osteoarthritis.

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Joel C Program Manager
joel.arnold@cshs.org
(310) 423-4614
Backup
Laura Program Manager
laura.sarmeinto@cshs.org
(310) 423-4295
Time Frame
Start Date: 2023-08-28
Estimated Completion Date: 2025-01
Participants
Target number of participants: 20
Treatments
Other: Adipose Allograft Matrix (AAM)
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.
Related Therapeutic Areas
Sponsors
Collaborators: Musculoskeletal Transplant Foundation
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov