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Procedure

Fat Tissue Injection vs Corticosteroid Injection for Shoulder Pain in Spinal Cord Injury (MFAT-SCI Trial)

Phase 2
Recruiting
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Neurological impairment secondary to a spinal cord injury or disorder that occurred at least twelve (12) months prior to the Screening Visit and the level of the injury is between C6 and L5, inclusive
Non-ambulatory except for exercise purposes and uses a manual or power wheelchair as his/her primary means of mobility (> 40 hours/week)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Approved for 60 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

MFAT-SCI Trial Summary

This trial is studying a new treatment for shoulder pain in people with chronic spinal cord injury. The new treatment is an injection of fat tissue, and the study will compare it to the standard-of-care corticosteroid injection.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, risk of infection, and possible allergic reactions to materials used during the procedure. Long-term side effects are unknown but could involve changes in fat distribution around the injected area.

MFAT-SCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a spinal cord injury between my neck and lower back over a year ago.
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I use a wheelchair for most of my daily activities but can exercise.
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My shoulder pain has been at least a 4 out of 10 in the past week.
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I have had a spinal cord injury between my neck and lower back over a year ago.
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I have had shoulder pain for over 6 months despite treatment.
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My shoulder pain has been at least a 4 out of 10 in the past week.
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I use a wheelchair for most of my daily activities but can exercise.
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I have shoulder pain confirmed by an ultrasound to be due to rotator cuff issues.
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My shoulder pain has been at least a 4 out of 10 in the past week.
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I have had a spinal cord injury between C6 and L5 over a year ago.
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I am between 18 and 70 years old.
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I have had shoulder pain for over 6 months despite treatment.

MFAT-SCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Numerical Rating Scale
Secondary outcome measures
Patient Global Impression of Change
Shoulder
Quantitative Ultrasound of the Supraspinatus Tendon
+2 more

Awards & Highlights

Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

MFAT-SCI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Micro-Fragmented Adipose TissueExperimental Treatment1 Intervention
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.
Group II: CorticosteroidActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lipogems
2017
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor
171 Previous Clinical Trials
10,608 Total Patients Enrolled
2 Trials studying Shoulder Pain
16 Patients Enrolled for Shoulder Pain

Media Library

Lipogems (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04136743 — Phase 2
Shoulder Pain Research Study Groups: Corticosteroid, Micro-Fragmented Adipose Tissue
Shoulder Pain Clinical Trial 2023: Lipogems Highlights & Side Effects. Trial Name: NCT04136743 — Phase 2
Lipogems (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04136743 — Phase 2
Shoulder Pain Patient Testimony for trial: Trial Name: NCT04136743 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being administered this medication in the current trial?

"The clinical trial is recruiting patients, as is evident from the information available on clinicaltrials.gov. This particular study was posted on 6/14/2019, with the most recent update taking place on 10/12/2022. They are currently looking for 24 participants at 1 location."

Answered by AI

What is the most severe outcome that could result from Lipogems?

"There is some data supporting Lipogems's safety, but none yet to suggest that it is effective. It received a score of 2."

Answered by AI

Would I be able to join this clinical trial?

"The requirements to sign up for this study are shoulder pain and being between 18-70 years old. Currently, the team is working on recruiting 24 individuals."

Answered by AI

Are elderly citizens being recruited for this test?

"According to the eligibility requirements, patients taking part in this trial must be aged between 18 and 70. There are a total of 234 clinical trials available for minors and 1467 research studies involving seniors."

Answered by AI

For what medical purposes is Lipogems typically employed?

"While ophthalmia, sympathetic is often the primary reason that Lipogems are used, this medication can also help patients suffering from branch retinal vein occlusion, and macular edema."

Answered by AI

Will this experiment still be enrolling new participants?

"That is correct. The clinicaltrials.gov website says that the study is actively recruiting patients. This trial was first posted on June 14th, 2019 and was last updated October 12th, 2020. They are looking for a total of 24 volunteers at a single location."

Answered by AI

Who else is applying?

What state do they live in?
California
New York
How old are they?
18 - 65
What site did they apply to?
Kessler Foundation
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Well I developed shoulder pain between 10 and 15 years ago and I think it was from using a walker for so many years and that damaged my shoulders.
PatientReceived no prior treatments
~4 spots leftby Feb 2025