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NCT07748793NARecruiting

Autologous Fat Grafting for the Treatment of Chronic Tendinopathy

Weill Medical College of Cornell University

Start Date

10/31/2026

Completion Date

7/1/2028

Summary

The goal of this clinical trial is to learn whether a one-time injection of a person's own processed fat tissue (autologous lipoaspirate), a procedure called Adipose Stem/Stromal Cells for Enthesis/Tendon Therapy (ASSET), 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.

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria 1. Age 18-80 years. 2. Tendinopathy at any tendon location (e.g., rotator cuff/supraspinatus, lateral epicondyle, gluteal/hip, Achilles, patellar). 3. Confirmed tendon pathology: pain at the tendon site for \> 3 months AND pathology confirmed on ultrasound. 4. Failure of conservative treatment (e.g., activity modification, physical therapy, NSAIDs, corticosteroid injection, and/or PRP) for at least 6 weeks. 5. Able to provide informed consent and complete questionnaires in English. Exclusion Criteria 1. Full-thickness tendon tear. 2. Prior surgery at the target tendon site. 3. Injection or other intervention at the target tendon site within the prior 6 months. 4. Pregnancy or breastfeeding. 5. Active local or systemic infection, bleeding diathesis or anticoagulation precluding the procedure, or other condition that in the investigator's judgment makes participation unsafe. 6. Moderate-to-high-grade arthritis in the adjacent joint.

Interventions

PROCEDURE

Adipose Stem/Stromal Cells for Enthesis/Tendon Therapy (ASSET) Injection

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Conditions

Chronic Tendinopathy

Locations

Department of Rehabilitation Medicine WCMC

New York, New York 10065

United States