NCT05747469

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The investigators central 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. The overall aim of the project is to validate the clinical use of AAM for the treatment of early-stage osteoarthritis of the hand in adult patients (\>18 years of age). The specific aims for this project are: 1. To determine the safety of use of Leneva as a lipofilling alternative to autologous fat grafting for arthritis of the hand a. To determine safety, the investigators will evaluate for any adverse reactions to the injection at each of the follow up time-points 2. To determine the efficacy of the technique as measured by clinical outcomes in terms of pain, disability, range of motion and strength a. To determine efficacy, the investigators will measure visual analogue pain scale scores as measures by visual analogue scale, disability scores as measured with DASH scores, and standardized range of motion and strengths scores as measured by the same study administrator at each of the follow up time points 3. To determine patient satisfaction with the procedure a. To determine patient satisfaction, the investigators will administer a survey at each of the follow up time points

Conditions

• Osteoarthritis Hand

Interventions

Type	Name	Description
DRUG	local anaesthetic injection	Subcutaneous local anesthesia with 1% lidocaine without epinephrine is administered to the skin overlying the joint.
PROCEDURE	Human Adipose Allograft	Light axial traction of the digit is used to open the joint space when introducing the 18-gauge needle. Fluoroscopy is used to assist with visualization 1 cc of Leneva is injected into the CMC joint and 0.5 cc in the IP, PIP and DIP joints. The puncture is dressed with a band-aid and coban wrap, which will be worn for 48 hours. Return to work and normal use of the hand is recommended at 48 hours. No narcotics are prescribed.

Timeline

• Start date: 2023-08-28
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-02-28
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study