Autologous Fat Grafting for the Treatment of Chronic Tendinopathy

NCT07748793 | Not Yet Recruiting

• 2 other identifiers: 26-060303411621156
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether a one-time injection of a person's own concentrated fat (micro-fragmented adipose tissue, or MFAT) can reduce pain and improve function in adults (ages 18-80) with chronic tendinopathy - tendon pain lasting more than 3 months (for example, in the shoulder, elbow, hip, knee, or Achilles) - that has not improved with usual treatments such as physical therapy, cortisone shots, or platelet-rich plasma. The main questions it aims to answer are:

• Does injecting a person's own concentrated fat into a painful tendon reduce tendon pain?
• Does it improve how well the tendon works, how long does any improvement last, and is the procedure safe? This is a single-group study, so there is no separate comparison group; each participant's pain, function, and ultrasound results after treatment are compared with their own measurements taken before treatment. Participants will:
• Have a one-time procedure in which a small amount of fat is removed from the abdomen by liposuction (under local numbing), concentrated, and injected into the painful tendon using ultrasound guidance.
• Complete short pain and function questionnaires and have ultrasound imaging of the tendon at study visits.
• Be followed for about 12 months, with a phone or video check-in 3-7 days after the procedure, a 2-week skin check of the fat-removal site, and visits at 6 weeks, 3 months, 6 months, and 12 months.

Conditions

Chronic Tendinopathy

Keywords

Micro-fragmented adipose tissue; MFAT; autologous fat grafting; adipose-derived stem cells; regenerative medicine; orthobiologics; percutaneous tenotomy,; ultrasound-guided injection; chronic tendinopathy; tendinopathy; lateral epicondylitis; rotator cuff tendinopathy; Achilles tendinopathy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Patient-Reported Pain Intensity (Numeric Rating Scale, NRS) at 6 Months

  Pain in the affected tendon is self-reported on the 11-point Numeric Rating Scale (NRS), an integer from 0 to 10 where 0 = no pain and 10 = worst pain imaginable. The outcome is the mean change from baseline (pre-procedure) to Month 6, calculated as the Month 6 score minus the baseline score. A negative change indicates improvement; a lower score is a better outcome.

  Baseline (pre-procedure) and Month 6

Secondary Outcomes (72)

• Change From Baseline in Patient-Reported Pain (NRS) at Week 6

  Baseline, Week 6

• Change From Baseline in Patient-Reported Pain (NRS) at Month 3

  Baseline, Month 3

• Change From Baseline in Patient-Reported Pain (NRS) at Month 12

  Baseline, Month 12

• Mean Change From Baseline in LEFS at Week 6

  Baseline - Week 6

• Mean Change From Baseline in LEFS at Month 3

  Baseline - Month 3

Study Arms (1)

Micro-Fragmented Adipose Tissue (MFAT) Injection

EXPERIMENTAL

All participants receive a single, one-time autologous fat grafting procedure (no comparison group). A small volume of abdominal fat (5-15 cc) is harvested by manual liposuction under local anesthesia and concentrated by gentle manual rolling on non-adherent (Telfa) dressings to create micro-fragmented adipose tissue (MFAT). Under ultrasound guidance, the target tendon undergoes percutaneous tenotomy (needle fenestration) to disrupt scar tissue, followed by intratendinous injection of 1-3 cc of concentrated MFAT. Participants are then followed for 12 months with patient-reported pain and function questionnaires and ultrasound imaging. This is a single-arm, open-label study in which each participant serves as their own baseline control.

Procedure: Micro-Fragmented Adipose Tissue (MFAT) injection

Interventions

Micro-Fragmented Adipose Tissue (MFAT) injection PROCEDURE

Autologous microfragmented adipose tissue (MFAT), i.e., mechanically concentrated autologous lipoaspirate, prepared and delivered in a single, same-day, point-of-care procedure. Under local anesthesia, 5-15 cc of subcutaneous abdominal fat is harvested by small-volume manual liposuction. The lipoaspirate is sterilely rinsed and concentrated by manual rolling on a non-adherent (Telfa) dressing; no enzymatic (collagenase) digestion, cell isolation, culture, or expansion is performed (minimal manipulation). Under ultrasound guidance, percutaneous tenotomy (needle fenestration) of the target tendon is performed, followed by a single intratendinous injection of 1-3 cc of the concentrated graft into the area of tendinopathy. One-time administration; route is percutaneous intratendinous injection. No exogenous cells, additives, scaffolds, or culture are used; the graft is autologous and delivered within the same surgical procedure.

Micro-Fragmented Adipose Tissue (MFAT) Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years.
• Tendinopathy at any tendon location (e.g., rotator cuff/supraspinatus, lateral epicondyle, gluteal/hip, Achilles, patellar).
• Confirmed tendon pathology: pain at the tendon site for \> 3 months AND pathology confirmed on ultrasound.
• Failure of conservative treatment (e.g., activity modification, physical therapy, NSAIDs, corticosteroid injection, and/or PRP) for at least 6 weeks.
• Able to provide informed consent and complete questionnaires in English.

You may not qualify if:

• Full-thickness tendon tear.
• Prior surgery at the target tendon site.
• Injection or other intervention at the target tendon site within the prior 6 months.
• Pregnancy or breastfeeding.
• Active local or systemic infection, bleeding diathesis or anticoagulation precluding the procedure, or other condition that in the investigator's judgment makes participation unsafe.
• Moderate-to-high-grade arthritis in the adjacent joint.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• The Plastic Surgery Foundation: collaborator

Study Sites (1)

Department of Rehabilitation Medicine WCMC

New York, New York, 10065, United States

Location

Related Publications (9)

• Fick B, Stover DW, Chimenti RL, Hall MM. The Safety of Ultrasound Guided Tenotomy and Debridement for Upper and Lower Extremity Tendinopathies: A Retrospective Study. Iowa Orthop J. 2021 Dec;41(2):82-90.

  PMID: 34924874 BACKGROUND

• Aljerian A, Abi-Rafeh J, Hemmerling T, Gilardino MS. Complications of Aesthetic Liposuction Performed in Isolation: A Systematic Literature Review and Meta-Analysis. Plast Surg (Oakv). 2024 Feb;32(1):19-32. doi: 10.1177/22925503221078693. Epub 2022 Feb 21.

  PMID: 38433796 BACKGROUND

• Jo CH, Chai JW, Jeong EC, Oh S, Kim PS, Yoon JY, Yoon KS. Intratendinous Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Rotator Cuff Disease: A First-In-Human Trial. Stem Cells. 2018 Sep;36(9):1441-1450. doi: 10.1002/stem.2855. Epub 2018 Jul 16.

  PMID: 29790618 BACKGROUND

• Strong AL, Rubin JP, Kozlow JH, Cederna PS. Fat Grafting for the Treatment of Scleroderma. Plast Reconstr Surg. 2019 Dec;144(6):1498-1507. doi: 10.1097/PRS.0000000000006291.

  PMID: 31764674 BACKGROUND

• Palumbo Piccionello A, Riccio V, Senesi L, Volta A, Pennasilico L, Botto R, Rossi G, Tambella AM, Galosi L, Marini C, Vullo C, Gigante A, Zavan B, De Francesco F, Riccio M. Adipose micro-grafts enhance tendinopathy healing in ovine model: An in vivo experimental perspective study. Stem Cells Transl Med. 2021 Nov;10(11):1544-1560. doi: 10.1002/sctm.20-0496. Epub 2021 Aug 16.

  PMID: 34398527 BACKGROUND

• Oshita T, Tobita M, Tajima S, Mizuno H. Adipose-Derived Stem Cells Improve Collagenase-Induced Tendinopathy in a Rat Model. Am J Sports Med. 2016 Aug;44(8):1983-9. doi: 10.1177/0363546516640750. Epub 2016 Apr 11.

  PMID: 27159294 BACKGROUND

• Nourissat G, Berenbaum F, Duprez D. Tendon injury: from biology to tendon repair. Nat Rev Rheumatol. 2015 Apr;11(4):223-33. doi: 10.1038/nrrheum.2015.26. Epub 2015 Mar 3.

  PMID: 25734975 BACKGROUND

• Hopkins C, Fu SC, Chua E, Hu X, Rolf C, Mattila VM, Qin L, Yung PS, Chan KM. Critical review on the socio-economic impact of tendinopathy. Asia Pac J Sports Med Arthrosc Rehabil Technol. 2016 Apr 22;4:9-20. doi: 10.1016/j.asmart.2016.01.002. eCollection 2016 Apr.

  PMID: 29264258 BACKGROUND

• Kaux JF, Forthomme B, Goff CL, Crielaard JM, Croisier JL. Current opinions on tendinopathy. J Sports Sci Med. 2011 Jun 1;10(2):238-53.

  PMID: 24149868 BACKGROUND

MeSH Terms

Conditions

Tendinopathy; Tennis Elbow

Interventions

long-chain-alcohol O-fatty-acyltransferase; Injections

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Elbow Tendinopathy; Elbow Injuries; Arm Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jaspal Singh, MD

  Department of Rehabilitation Medicine | Weill Cornell Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terrence Green

CONTACT

(212) 746-9224; teg7008@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)