Autologous Fat Grafting for the Treatment of Chronic Tendinopathy
ConditionChronic Tendinopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWeill Medical College of Cornell University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Adipose Stem/Stromal Cells for Enthesis/Tendon Therapy (ASSET) Injection
Procedure/SurgeryASSET 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Adipose Stem/Stromal Cells for Enthesis/Tendon Therapy (ASSET) InjectionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline (pre-procedure) and Month 6Secondary outcomes
1
Change From Baseline in Patient-Reported Pain (NRS) at Week 6
Onset and durability of pain relief are assessed using the same 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at the non-primary time point. The outcome is the mean change from baseline at Week 6. (score minus baseline score). A negative change indicates improvement; a lower score is a better outcome.
Time frame
Baseline, Week 62
Change From Baseline in Patient-Reported Pain (NRS) at Month 3
Onset and durability of pain relief are assessed using the same 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at the non-primary time point. The outcome is the mean change from baseline at Month 3 (score minus baseline score). A negative change indicates improvement; a lower score is a better outcome.
Time frame
Baseline, Month 33
Change From Baseline in Patient-Reported Pain (NRS) at Month 12
Onset and durability of pain relief are assessed using the same 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at the non-primary time point. The outcome is the mean change from baseline at Month 12 (score minus baseline score). A negative change indicates improvement; a lower score is a better outcome.
Time frame
Baseline, Month 124
Mean Change From Baseline in LEFS at Week 6
The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.
Time frame
Baseline - Week 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
The Plastic Surgery Foundation
Collaborator
Source ClinicalTrials.gov