40 Participants NeededMy employer runs this trial

Fat Grafting for Chronic Tendinopathy

(ASSET Trial)

TG
Overseen ByTerrence Green
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Weill Medical College of Cornell University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

JS

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

I have had tendon pain for over 3 months, confirmed by an ultrasound scan.
Able to provide informed consent and complete questionnaires in English
I have tried non-surgical treatments for at least 6 weeks without success.
See 2 more

Exclusion Criteria

Pregnancy or breastfeeding
I have a tendon that is completely torn through.
I have had an injection or procedure at the tendon site in the last 6 months.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a one-time procedure where fat is removed from the abdomen, processed, and injected into the painful tendon using ultrasound guidance.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with check-ins and visits at specified intervals.

12 months
Phone or video check-in 3-7 days post-procedure, 2-week skin check, and visits at 6 weeks, 3 months, 6 months, and 12 months

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

Group I: Adipose Stem/Stromal Cells for Enthesis/Tendon Therapy (ASSET) InjectionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

The Plastic Surgery Foundation

Collaborator

Trials
11
Recruited
1,300+

Citations

Orthobiologic Treatments for Tendinopathy

Key Findings PRP and MSCs have shown encouraging results, especially in treating lateral epicondylopathy, patellar tendinopathy, and Achilles ...

REGENERATIVE THERAPY

Consensus and meta-analyses support better longer-term pain/function outcomes than placebo or corticosteroid in chronic plantar fasciitis, although steroids may.

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 ...

Augmenting endogenous repair of soft tissues with nanofibre ...

This review focuses on soft tissue engineering, it will discuss the types scaffolds. We will consider how these properties, in combination, can provide a ...

Artificial Intelligence-Guided Precision Orthobiologics in ...

microfragmented adipose tissue has a combination of tissue architecture, stromal cells, and paracrine mediators that do not lend themselves to ...