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

NCT05747469 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: STUDY00002134
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis Hand

Outcome Measures

Primary Outcomes (20)

• Range of Motion

  Measured with a standardized goniometer

  Pre-procedure

• Range of Motion

  Measured with a standardized goniometer

  6 weeks

• Range of Motion

  Measured with a standardized goniometer

  6 month

• Range of Motion

  Measured with a standardized goniometer

  12 months

• Strength Measures

  Strength to grip, key pinch and tip pinch, as measured by Jamar dynamometer device)

  Pre-procedure

• Strength Measures

  Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)

  6 weeks

• Strength Measures

  Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)

  6 months

• Strength Measures

  Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)

  12 months

• Pain scale scores

  Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)

  Pre-procedure

• Pain scale scores

  Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)

  6 weeks

• Pain scale scores

  Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)

  6 months

• Pain scale scores

  Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)

  12 months

• Disability Measurement

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (1)

• Incidence of Adverse Events

  0-12 months

Study Arms (1)

Adipose Allograft Matrix (AAM)

OTHER

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; Procedure: Human Adipose Allograft

Interventions

local anaesthetic injection DRUG

Subcutaneous local anesthesia with 1% lidocaine without epinephrine is administered to the skin overlying the joint.

Also known as: Lidocaine

Adipose Allograft Matrix (AAM)

Human Adipose Allograft PROCEDURE

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.

Also known as: Leneva

Adipose Allograft Matrix (AAM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Musculoskeletal Transplant Foundation: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (27)

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MeSH Terms

Interventions

Anesthesia, Local; Lidocaine

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Meghan McCullough, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 28, 2023
• Study Start: August 28, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-11

Locations

US (1)