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

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Kessler Foundation

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial uses a patient's own processed fat to treat shoulder pain in people with spinal cord injuries who haven't improved with other treatments. The fat helps heal the shoulder by providing cushioning and regenerative cells.

Eligibility Criteria

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

I am between 18 and 70 years old.

I have had shoulder pain for over 6 months despite treatment.

I have shoulder pain confirmed by an ultrasound to be due to rotator cuff issues.

My shoulder pain has been at least a 4 out of 10 in the past week.

I use a wheelchair for most of my daily activities but can exercise.

My shoulder pain has been at least a 4 out of 10 in the past week.

I have had a spinal cord injury between my neck and lower back over a year ago.

Exclusion Criteria

I have received MFAT treatment before.

I cannot undergo the procedure due to an infection, bleeding disorder, or because I'm on blood thinners.

Treatment Details

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.

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.