Fat Tissue Injection vs Corticosteroid Injection for Shoulder Pain in Spinal Cord Injury

(MFAT-SCI Trial)

Overseen By Trevor A. Dyson-Hudson, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kessler Foundation

Must not be taking: Anti-coagulants, Glucocorticoids

Disqualifiers: Diabetes, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 day

24 Participants Needed

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.

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 fat tissue injection safe for treating shoulder pain in spinal cord injury?

Research on fat tissue injections, specifically using adipose-derived stem cells, suggests they are generally safe in humans, as seen in a study where a patient with spinal cord injury tolerated the procedure well without severe adverse events. ^{1 2 3 4 5}

How does the treatment Lipogems differ from other treatments for shoulder pain in spinal cord injury?

Lipogems is unique because it uses fat tissue injections, which can provide a source of progenitor cells and deliver therapeutic genes, potentially reducing inflammation and promoting tissue repair. This approach is different from traditional corticosteroid injections, which primarily focus on reducing inflammation without the regenerative potential of fat tissue. ^{3 4 5 6 7}

What data supports the effectiveness of the treatment for shoulder pain in spinal cord injury patients?

The research shows that corticosteroid injections, which are part of the treatment being studied, are confirmed therapies for shoulder pain in spinal cord injury patients. Additionally, micro-fragmented adipose tissue injections have been explored for their safety and potential benefits in treating shoulder pain in similar populations. ^{8 9 10 11 12}

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 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.

Exclusion Criteria

I have received MFAT treatment before.

I have a chronic condition like diabetes or rheumatoid arthritis.

I do not have any health conditions that could affect the study's results.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a micro-fragmented adipose tissue injection or a corticosteroid injection under ultrasound guidance

1 day

1 visit (in-person)

Rehabilitation

Participants follow a standardized stretching protocol for 4 weeks followed by a formal strengthening program

4 weeks

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

6 months

4 visits (in-person)

Treatment Details

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.

Participant Groups

Group I: Micro-Fragmented Adipose Tissue Experimental Treatment 1 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: Corticosteroid Active Control 1 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.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Findings from Research

In a pilot study involving 10 wheelchair users with chronic shoulder pain due to rotator cuff disease, ultrasound-guided injections of micro-fragmented adipose tissue (MFAT) showed no significant adverse events, indicating a good safety profile.

Significant reductions in pain scores were observed at 6 and 12 months post-injection, with 77.8% of participants experiencing clinically meaningful improvements, suggesting that MFAT injections may be an effective treatment option for refractory shoulder pain in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study to evaluate micro-fragmented adipose tissue injection under ultrasound guidance for the treatment of refractory rotator cuff disease in wheelchair users with spinal cord injury. Hogaboom, N., Malanga, G., Cherian, C., et al.[2022]

The CELLTOP study is investigating the safety and efficacy of intrathecal injections of autologous adipose tissue-derived mesenchymal stem cells (AD-MSCs) in patients with spinal cord injury, with initial results showing that the first patient tolerated the procedure well without severe adverse events.

After receiving 100 million AD-MSCs, the patient demonstrated meaningful neurological improvement over 18 months, suggesting that this regenerative approach may offer potential benefits for restoring function in spinal cord injury cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury. Bydon, M., Dietz, AB., Goncalves, S., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided versus blind subacromial bursa corticosteroid injection for paraplegic spinal cord injury patients with rotator cuff tendinopathy: a randomized, single-blind clinical trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Transfer Technique Is Associated With Shoulder Pain and Pathology in People With Spinal Cord Injury: A Cross-Sectional Investigation. [2017]

3. England pubmed.ncbi.nlm.nih.gov

A pilot study to evaluate micro-fragmented adipose tissue injection under ultrasound guidance for the treatment of refractory rotator cuff disease in wheelchair users with spinal cord injury. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Rotator cuff repairs in individuals with paraplegia. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided platelet-rich plasma injection for the treatment of recalcitrant rotator cuff disease in wheelchair users with spinal cord injury: A pilot study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

CELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of methylprednisolone therapy for the injured rat spinal cord. [2022]

8. Austria pubmed.ncbi.nlm.nih.gov

Gene-activated fat grafts for the repair of spinal cord injury: a pilot study. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Human Adipose-Derived Stem Cells Combined with Nano-Hydrogel Promote Functional Recovery after Spinal Cord Injury in Rats. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Neuroprotection, Recovery of Function and Endogenous Neurogenesis in Traumatic Spinal Cord Injury Following Transplantation of Activated Adipose Tissue. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Technical aspects of spinal cord injections for cell transplantation. Clinical and translational considerations. [2011]

12. United States pubmed.ncbi.nlm.nih.gov

Bone marrow stem cells and polymer hydrogels--two strategies for spinal cord injury repair. [2022]