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

Osteoarthritis Hand Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747469
• Other study ID #: STUDY00002134
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 28, 2023
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: Joel C Program Manager
• Phone: (310) 423-4614
• Email: joel.arnold[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Osteoarthritis
• Osteoarthritis Hand

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Musculoskeletal Transplant Foundation

Country where clinical trial is conducted

United States, 

References & Publications (27)

Adam Young D, Bajaj V, Christman KL. Award winner for outstanding research in the PhD category, 2014 Society for Biomaterials annual meeting and exposition, Denver, Colorado, April 16-19, 2014: Decellularized adipose matrix hydrogels stimulate in vivo neovascularization and adipose formation. J Biomed Mater Res A. 2014 Jun;102(6):1641-51. doi: 10.1002/jbm.a.35109. Epub 2014 Feb 24. — View Citation

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Brown BN, Freund JM, Han L, Rubin JP, Reing JE, Jeffries EM, Wolf MT, Tottey S, Barnes CA, Ratner BD, Badylak SF. Comparison of three methods for the derivation of a biologic scaffold composed of adipose tissue extracellular matrix. Tissue Eng Part C Methods. 2011 Apr;17(4):411-21. doi: 10.1089/ten.TEC.2010.0342. Epub 2011 Feb 5. — View Citation

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Haas EM, Eisele A, Arnoldi A, Paolini M, Ehrl D, Volkmer E, Giunta RE. One-Year Outcomes of Intraarticular Fat Transplantation for Thumb Carpometacarpal Joint Osteoarthritis: Case Review of 99 Joints. Plast Reconstr Surg. 2020 Jan;145(1):151-159. doi: 10.1097/PRS.0000000000006378. — View Citation

Han TT, Toutounji S, Amsden BG, Flynn LE. Adipose-derived stromal cells mediate in vivo adipogenesis, angiogenesis and inflammation in decellularized adipose tissue bioscaffolds. Biomaterials. 2015 Dec;72:125-37. doi: 10.1016/j.biomaterials.2015.08.053. Epub 2015 Aug 31. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion	Measured with a standardized goniometer	Pre-procedure
Primary	Range of Motion	Measured with a standardized goniometer	6 weeks
Primary	Range of Motion	Measured with a standardized goniometer	6 month
Primary	Range of Motion	Measured with a standardized goniometer	12 months
Primary	Strength Measures	Strength to grip, key pinch and tip pinch, as measured by Jamar dynamometer device)	Pre-procedure
Primary	Strength Measures	Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)	6 weeks
Primary	Strength Measures	Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)	6 months
Primary	Strength Measures	Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)	12 months
Primary	Pain scale scores	Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)	Pre-procedure
Primary	Pain scale scores	Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)	6 weeks
Primary	Pain scale scores	Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)	6 months
Primary	Pain scale scores	Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)	12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Incidence of Adverse Events	Recording of adverse events	0-12 months