Fat Grafting for Chronic Tendinopathy
(ASSET Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether injecting a person’s own processed fat, known as Micro-Fragmented Adipose Tissue (MFAT), can reduce pain and improve function in painful tendons. It targets individuals who have experienced tendon pain for more than three months without relief from standard treatments like physical therapy or cortisone shots. Participants will undergo a one-time procedure where fat is extracted from their abdomen, processed, and injected into the affected tendon. The study aims to determine if this approach reduces pain and enhances tendon function. Ideal candidates have confirmed tendon pain that has not improved with conventional treatments. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for persistent tendon pain.
What prior data suggests that this procedure is safe for treating chronic tendinopathy?
Research has shown that treatments using Micro-Fragmented Adipose Tissue (MFAT), like the one in this study, are generally safe and well-tolerated. Studies have found that patients receiving MFAT injections for tendon problems often experience fewer side effects compared to treatments like corticosteroids. In one study, researchers used MFAT to treat rotator cuff disease, a shoulder issue, with positive results and no serious side effects reported.
This treatment uses a person's own fat, reducing the risk of allergic reactions. While mild discomfort or swelling at the injection site can occur, these effects are usually temporary. Overall, MFAT has demonstrated a good safety record in similar treatments, suggesting it should be safe for managing long-term tendon pain.12345Why are researchers excited about this trial?
Unlike the standard treatments for chronic tendinopathy, which often include physical therapy, anti-inflammatory medications, or even surgery, the treatment using Micro-Fragmented Adipose Tissue (MFAT) injection offers a novel approach by utilizing the body's own fat cells. This method involves harvesting a small amount of fat from the patient, processing it to concentrate the beneficial cells, and then injecting these directly into the affected tendon. The excitement around this treatment stems from its potential to not only relieve pain but also promote healing by harnessing the regenerative properties of the adipose stem/stromal cells. This approach could offer a less invasive and potentially more effective alternative to current options, with the added benefit of using the patient's own cells for treatment.
What evidence suggests that this treatment might be an effective treatment for chronic tendinopathy?
Research has shown that injecting a person's own processed fat, known as Micro-Fragmented Adipose Tissue (MFAT), might help reduce pain and improve movement in individuals with chronic tendon problems. In this trial, all participants will undergo a single, one-time autologous fat grafting procedure using MFAT. Studies have found that patients receiving MFAT injections reported less pain and improved movement in the affected tendons. This treatment uses special cells from the patient's own fat to aid healing and reduce swelling in the injured tendon. Early results indicate that many patients experience relief for several months. Although more research is needed, these initial findings offer hope for those whose tendon pain hasn't improved with standard treatments.
Who Is on the Research Team?
Jaspal Singh, MD
Principal Investigator
Department of Rehabilitation Medicine | Weill Cornell Medicine
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 who have had tendon pain (like tennis elbow or tendinitis) for over 3 months that hasn't improved with standard treatments such as physical therapy, cortisone shots, or platelet-rich plasma.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a one-time procedure where fat is removed from the abdomen, processed, and injected into the painful tendon using ultrasound guidance.
Follow-up
Participants are monitored for safety and effectiveness after treatment with check-ins and visits at specified intervals.
What Are the Treatments Tested in This Trial?
Interventions
- Micro-Fragmented Adipose Tissue (MFAT) injection
Trial Overview
Researchers are testing if a one-time injection of a person's own concentrated fat (taken from their abdomen and processed) into the painful tendon can reduce pain and improve function. There is no comparison group; each person serves as their own control.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
The Plastic Surgery Foundation
Collaborator
Citations
Orthobiologic Treatments for Tendinopathy
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wellnessdoctorrx.com
wellnessdoctorrx.com/orthobiologic-treatment-advances-for-musculoskeletal-health/amp/Orthobiologic Treatment Advances for Musculoskeletal Health - EP ...
Microfragmented Adipose Tissue MFAT. MFAT may be useful when tissue support or scaffolding is needed, such as: Tendon gaps; Focal soft tissue defects ...
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microfragmented adipose tissue has a combination of tissue architecture, stromal cells, and paracrine mediators that do not lend themselves to ...
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