AzTrials
AzTrials

Osteoarthritis HandEarly Phase 1NCT05747469

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

A Early Phase 1 study testing local anaesthetic injection and Human Adipose Allograft in people with Osteoarthritis Hand, run by Cedars-Sinai Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Osteoarthritis Hand
What is being tested?
local anaesthetic injection and Human Adipose Allograft
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
28 Aug 2023to 1 Jan 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

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.

Read the 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
  2. To determine safety, the investigators will evaluate for any adverse reactions to the injection at each of the follow up time-points
  3. To determine the efficacy of the technique as measured by clinical outcomes in terms of pain, disability, range of motion and strength
  4. 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
  5. 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
Being tested
local anaesthetic injection, Human Adipose Allograft

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • local anaesthetic injectionDrug

    Also called Lidocaine

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

  • Human Adipose AllograftProcedure or surgery

    Also called Leneva

    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.

Study groups in NCT05747469
Study groupRoleWhat they receive
Adipose Allograft Matrix (AAM)OtherUsing 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.
Receives: Drug: local anaesthetic injection; Procedure: Human Adipose Allograft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Range of Motion

    Measured with a standardized goniometer

    Measured: Pre-procedure

  2. Range of Motion

    Measured with a standardized goniometer

    Measured: 6 weeks

  3. Range of Motion

    Measured with a standardized goniometer

    Measured: 6 month

  4. Range of Motion

    Measured with a standardized goniometer

    Measured: 12 months

  5. Strength Measures

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

    Measured: Pre-procedure

  6. Strength Measures

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

    Measured: 6 weeks

  7. Strength Measures

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

    Measured: 6 months

  8. Strength Measures

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

    Measured: 12 months

  9. Pain scale scores

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

    Measured: Pre-procedure

  10. Pain scale scores

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

    Measured: 6 weeks

  11. Pain scale scores

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

    Measured: 6 months

  12. Pain scale scores

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

    Measured: 12 months

  13. 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.

    Measured: Pre-procedure

  14. 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.

    Measured: 6 weeks

  15. 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.

    Measured: 6 months

  16. 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.

    Measured: 12 months

  17. 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.

    Measured: Day of procedure

  18. 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.

    Measured: 6 weeks

  19. 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.

    Measured: 6 months

  20. 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.

    Measured: 12 months

Secondary outcomes (1)
  1. Incidence of Adverse Events

    Recording of adverse events

    Measured: 0-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2023
  2. Study start28 Aug 2023
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05747469
Sponsor's protocol ID
STUDY00002134
Status last verified
Nov 2025
First submitted
5 Feb 2023
Last updated
2 Jan 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Heyworth BE, Lee JH, Kim PD, Lipton CB, Strauch RJ, Rosenwasser MP. Hylan versus corticosteroid versus placebo for treatment of basal joint arthritis: a prospective, randomized, double-blinded clinical trial. J Hand Surg Am. 2008 Jan;33(1):40-8. doi: 10.1016/j.jhsa.2007.10.009.

    PubMed 18261664
  • 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.

    PubMed 31592943
  • Holland C, Jaeger L, Smentkowski U, Weber B, Otto C. Septic and aseptic complications of corticosteroid injections: an assessment of 278 cases reviewed by expert commissions and mediation boards from 2005 to 2009. Dtsch Arztebl Int. 2012 Jun;109(24):425-30. doi: 10.3238/arztebl.2012.0425. Epub 2012 Jun 15.

    PubMed 22787504
  • McGarry JG, Daruwalla ZJ. The efficacy, accuracy and complications of corticosteroid injections of the knee joint. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1649-54. doi: 10.1007/s00167-010-1380-1. Epub 2011 Jan 11.

    PubMed 21222099
  • Buck-Gramcko D. [Denervation of the wrist joint and interphalageal joints]. Handchirurgie. 1969;1(4):179-81. No abstract available. German.

    PubMed 5409431
  • Lucht U, Vang PS, Munck J. Soft tissue interposition arthroplasty for osteoarthritis of the carpometacarpal joint of the thumb. Acta Orthop Scand. 1980 Oct;51(5):767-71. doi: 10.3109/17453678008990872.

    PubMed 7468170
  • Deb R, Sauerbier M, Rauschmann MA. [History of arthroplasty for finger joints]. Orthopade. 2003 Sep;32(9):770-8. doi: 10.1007/s00132-003-0518-y. German.

    PubMed 14508641
  • Bruser P. [Modified volar plate arthroplasty for posttraumatic and idiopathic osteoarthritis of the metacarpophalangeal and proximal interphalangeal joints]. Orthopade. 2008 Dec;37(12):1180-6. doi: 10.1007/s00132-008-1324-3. German.

    PubMed 18972098
  • Swanson AB. Disabling arthritis at the base of the thumb: treatment by resection of the trapezium and flexible (silicone) implant arthroplasty. J Bone Joint Surg Am. 1972 Apr;54(3):456-71. No abstract available.

    PubMed 5055148
  • Swanson AB. Flexible implant arthroplasty for arthritic finger joints: rationale, technique, and results of treatment. J Bone Joint Surg Am. 1972 Apr;54(3):435-55. No abstract available.

    PubMed 5055146
  • Heers G, Grifka J, Borisch N. [First results after implantation of a pyrocarbon-endoprosthesis in patients with degenerative arthritis]. Z Orthop Ihre Grenzgeb. 2006 Nov-Dec;144(6):609-13. doi: 10.1055/s-2006-955189. German.

    PubMed 17187336
  • IJsselstein CB, van Egmond DB, Hovius SE, van der Meulen JC. Results of small-joint arthrodesis: comparison of Kirschner wire fixation with tension band wire technique. J Hand Surg Am. 1992 Sep;17(5):952-6. doi: 10.1016/0363-5023(92)90476-6.

    PubMed 1401814
  • Herold C, Rennekampff HO, Groddeck R, Allert S. Autologous Fat Transfer for Thumb Carpometacarpal Joint Osteoarthritis: A Prospective Study. Plast Reconstr Surg. 2017 Aug;140(2):327-335. doi: 10.1097/PRS.0000000000003510.

    PubMed 28369017
  • Damia E, Chicharro D, Lopez S, Cuervo B, Rubio M, Sopena JJ, Vilar JM, Carrillo JM. Adipose-Derived Mesenchymal Stem Cells: Are They a Good Therapeutic Strategy for Osteoarthritis? Int J Mol Sci. 2018 Jun 30;19(7):1926. doi: 10.3390/ijms19071926.

    PubMed 29966351
  • Black LL, Gaynor J, Adams C, Dhupa S, Sams AE, Taylor R, Harman S, Gingerich DA, Harman R. Effect of intraarticular injection of autologous adipose-derived mesenchymal stem and regenerative cells on clinical signs of chronic osteoarthritis of the elbow joint in dogs. Vet Ther. 2008 Fall;9(3):192-200.

    PubMed 19003780

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing local anaesthetic injection and Human Adipose Allograft in people with Osteoarthritis Hand, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Range of Motion (time frame: Pre-procedure). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05747469, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in