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

Cedars-Sinai Medical Center

Status and phase: Enrolling; Early Phase 1

Conditions: Osteoarthritis Hand

Treatments: Drug: local anaesthetic injection; Procedure: Human Adipose Allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT05747469

STUDY00002134

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Prior intervention for the presenting joint (either in the form of cortisone or hyaluronic acid injection or surgery).
• Rheumatoid or other inflammatory arthritis condition
• Collagen vascular disease
• Pregnancy or breast-feeding
• Congestive heart failure
• Chronic obstructive pulmonary disease
• Chronic renal failure
• Those who had medication or oral supplements for the previous 4 weeks that could prolong bleeding time (e.g.; Aspirin, Plavix).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Adipose Allograft Matrix (AAM)

Other group

Description:

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.

Treatment:

Procedure: Human Adipose Allograft

Drug: local anaesthetic injection