Fat Tissue Injection vs Corticosteroid Injection for Shoulder Pain in Spinal Cord Injury
(MFAT-SCI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for shoulder pain in individuals with chronic spinal cord injuries. It compares an injection of fat tissue (Lipogems), which contains cells that might aid healing, to the usual corticosteroid injections (such as Dexamethasone) that can sometimes wear down tendons over time. Suitable candidates have had a spinal cord injury for at least a year, often use a wheelchair, and experience ongoing shoulder pain despite trying other treatments for six months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from an innovative therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently taking anti-coagulants or have had a glucocorticoid injection in the past 4 weeks, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that micro-fragmented adipose tissue (Lipogems) injections are generally safe. In one study with 18 participants, no serious side effects occurred, indicating the treatment is well-tolerated.
Other studies have examined the safety of these injections in various contexts. Results demonstrated that participants experienced only minor side effects, suggesting Lipogems could be a safe option for managing shoulder pain.
Since this treatment is in a Phase 2 trial, there is already some evidence of safety from earlier research. This phase focuses more on the treatment's effectiveness rather than just its safety. Overall, the available data suggests that Lipogems is a promising option with a good safety record.12345Why are researchers excited about this study treatment for shoulder pain?
Researchers are excited about using micro-fragmented adipose tissue for shoulder pain in spinal cord injury patients because it takes a different approach than traditional treatments like corticosteroid injections. Unlike corticosteroids, which primarily reduce inflammation, this treatment utilizes the body's own fat tissue to promote healing and potentially repair damaged areas. Delivered via a precise ultrasound-guided injection, the use of natural fat tissue might offer fewer side effects and a more sustainable relief by encouraging tissue regeneration. This novel method could be a game-changer for patients seeking alternatives to standard anti-inflammatory drugs.
What evidence suggests that this trial's treatments could be effective for shoulder pain in spinal cord injury?
This trial will compare the effectiveness of micro-fragmented fat tissue injections (Lipogems®) with corticosteroid injections for treating shoulder pain in individuals with spinal cord injury. Research has shown that injections of micro-fragmented fat tissue might help treat shoulder pain, particularly from rotator cuff issues. Studies have found that these injections can reduce pain and improve shoulder movement in people with persistent shoulder pain. The treatment uses processed fat tissue, injected to aid healing and repair. This tissue contains cells that help regenerate damaged areas. Although more research is needed, early results suggest that Lipogems® could be a promising alternative to traditional treatments like corticosteroid injections, which can sometimes harm tendons over time.14567
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with chronic shoulder pain due to rotator cuff disease, who have had a spinal cord injury between C6 and L5 at least one year ago. Participants must be wheelchair users (over 40 hours/week) and have not found relief from pain after six months of conservative treatment. They cannot join if they have systemic disorders like diabetes or rheumatoid arthritis, previous adipose tissue injections, contraindications like infection or coagulopathy, are pregnant, or recently had corticosteroid injections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a micro-fragmented adipose tissue injection or a corticosteroid injection under ultrasound guidance
Rehabilitation
Participants follow a standardized stretching protocol for 4 weeks followed by a formal strengthening program
Follow-up
Participants are monitored for adverse events and changes in shoulder pain intensity, with assessments at 1, 2, 3, and 6 months post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Lipogems
Trial Overview
The study compares the effectiveness of Lipogems®, an injection of micro-fragmented adipose tissue guided by ultrasound, against dexamethasone (a corticosteroid) for relieving chronic shoulder pain in wheelchair users with spinal cord injuries. The goal is to see if Lipogems® can provide better long-term relief without the potential tendon damage associated with repeated steroid use.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive a single injection of micro-fragmented adipose tissue into the lesion (e.g. tear, subacromial bursa, glenohumeral joint, acromioclavicular joint) under ultrasound guidance using an 18 gauge x 3.5 inch needle.
Participants will receive a corticosteroid injection (BMS, Kenacort-A 40 mg \[triamcinolone acetonide\]) into the subacromial space under direct ultrasound guidance by means of a 5-mL syringe with a 22-guage needle.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kessler Foundation
Lead Sponsor
Published Research Related to This Trial
Citations
Micro-Fragmented Adipose Tissue (Lipogems®) Injection ...
The purpose of this study is to explore the safety and efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance ...
A pilot study to evaluate micro-fragmented adipose tissue ...
MFAT injection under ultrasound guidance is potentially a safe and efficacious treatment for refractory shoulder pain caused by rotator cuff disease in ...
Lipogems Research
The device is FDA Cleared for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, ...
A pilot study to evaluate micro-fragmented adipose tissue ...
A pilot study to evaluate micro-fragmented adipose tissue injection under ultrasound guidance for the treatment of refractory rotator cuff ...
Pilot Study Evaluating Autologous, Micro-Fragmented ...
Autologous MFAT injections under ultrasound-guidance appear to be safe, and may be efficacious for treating chronic, recalcitrant shoulder pain in wheelchair ...
A pilot study to evaluate micro-fragmented adipose tissue ...
This pilot study's purpose was to establish safety and treatment effects of micro-fragmented adipose tissue (MFAT) injections under ultrasound ...
7.
lipogems.com
lipogems.com/wp-content/uploads/2023/11/Malanga_Rotator-cuff-disease-in-SCI_1year-_2021-1.pdfA pilot study to evaluate micro-fragmented adipose tissue ...
A recent case series of 18 able-bodied participants reported positive findings after injection with autologous, micro-fragmented adipose tissue.
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