Recruiting

ASSET

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07748793

Conditions

Chronic Tendinopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Chronic Tendinopathy

Study ID

NCT07748793

Start date

Oct 31, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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 concentrated autologous lipoaspirate, known as the Adipose Stem/Stromal Cells for Enthesis/Tendon Therapy (ASSET) therapy. 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 ASSET. 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.

Interventions

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

ASSET 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.

Primary outcome measure

  • Change From Baseline in Patient-Reported Pain Intensity (Numeric Rating Scale, NRS) at 6 Months [ Time Frame: Baseline (pre-procedure) and Month 6 ]

Central Contacts and Locations

Central contacts

Terrence Green

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

Locations

Department of Rehabilitation Medicine WCMC

Recruiting

New York, New York, United States, 10065

Contacts

Jaspal Singh, MD

212-746-1500Jrs9012@med.cornell.edu

Christian Ponce

chp4030@med.cornell.edu

Principal Investigator:

Jaspal Singh, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • Micro-fragmented adipose tissue
  • 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
  • ASSET
  • Adipose Stem/Stromal Cells for Enthesis/Tendon Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.