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

December 29, 2025 updated by: Meghan McCullough, MD, Cedars-Sinai Medical Center

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: local anaesthetic injection
Subcutaneous local anesthesia with 1% lidocaine without epinephrine is administered to the skin overlying the joint.
Other Names:
  • Lidocaine
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.
Other Names:
  • Leneva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion
Time Frame: Pre-procedure
Measured with a standardized goniometer
Pre-procedure
Range of Motion
Time Frame: 6 weeks
Measured with a standardized goniometer
6 weeks
Range of Motion
Time Frame: 6 month
Measured with a standardized goniometer
6 month
Range of Motion
Time Frame: 12 months
Measured with a standardized goniometer
12 months
Strength Measures
Time Frame: Pre-procedure
Strength to grip, key pinch and tip pinch, as measured by Jamar dynamometer device)
Pre-procedure
Strength Measures
Time Frame: 6 weeks
Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)
6 weeks
Strength Measures
Time Frame: 6 months
Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)
6 months
Strength Measures
Time Frame: 12 months
Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)
12 months
Pain scale scores
Time Frame: Pre-procedure
Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)
Pre-procedure
Pain scale scores
Time Frame: 6 weeks
Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)
6 weeks
Pain scale scores
Time Frame: 6 months
Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)
6 months
Pain scale scores
Time Frame: 12 months
Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)
12 months
Disability Measurement
Time Frame: Pre-procedure
DASH (Disability of the Arm, Shoulder and Hand) score The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Pre-procedure
Disability Measurement
Time Frame: 6 weeks
DASH (Disability of the Arm, Shoulder and Hand) score The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
6 weeks
Disability Measurement
Time Frame: 6 months
DASH (Disability of the Arm, Shoulder and Hand) score The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
6 months
Disability Measurement
Time Frame: 12 months
DASH (Disability of the Arm, Shoulder and Hand) score The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
12 months
Patient satisfaction
Time Frame: Day of procedure
Five-point Likert scale (from 1 "strong disagree" to 5 "strongly agree") for the following two survey points: Satisfaction of patient with the procedure and would the patient recommend this procedure to others.
Day of procedure
Patient satisfaction
Time Frame: 6 weeks
Five-point Likert scale (from 1 "strong disagree" to 5 "strongly agree") " for the following two survey points: Satisfaction of patient with the procedure and would the patient recommend this procedure to others.
6 weeks
Patient satisfaction
Time Frame: 6 months
Five-point Likert scale (from 1 "strong disagree" to 5 "strongly agree") for the following two survey points: Satisfaction of patient with the procedure and would the patient recommend this procedure to others.
6 months
Patient satisfaction
Time Frame: 12 months
Five-point Likert scale (from 1 "strong disagree" to 5 "strongly agree") for the following two survey points: Satisfaction of patient with the procedure and would the patient recommend this procedure to others.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: 0-12 months
Recording of adverse events
0-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

Musculoskeletal Transplant Foundation

Investigators

  • Principal Investigator: Meghan McCullough, MD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002134

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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