What side effects are associated with this type of intervention?

Common treatments for shoulder pain, such as corticosteroid injections and autologous adipose tissue injections, have specific side effects. Corticosteroid injections can accelerate tendon degeneration and cause further damage over time. Autologous adipose tissue injections, which provide cushioning and regenerative properties, are generally well-tolerated but may cause pain at the injection site, infection, and inflammation.

What prior FDA approvals exist?

Corticosteroid injections are FDA-approved treatments for shoulder pain, providing temporary relief by reducing inflammation. However, they can accelerate tendon degeneration with prolonged use. Emerging treatments like autologous, micro-fragmented adipose tissue (Lipogems®) injections are being studied for their cushioning and regenerative properties due to bioactive elements and pericytes, although specific FDA approval for these treatments is not detailed.

What other types of research exist?

Promising novel alternatives to autologous, micro-fragmented adipose tissue (Lipogems®) injections for shoulder pain include: 1. Calcium Hydroxylapatite (Radiesse) - Known for its regenerative properties and ability to stimulate collagen production. 2. Poly-L-lactic Acid (Sculptra) - Promotes collagen growth and provides long-lasting results. 3. Hyaluronic Acid Fillers - Provide cushioning and hydration, aiding in tissue repair and pain relief.

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Procedure

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

Phase 2

Waitlist Available

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women, 18 to 70 years of age, inclusive

Currently has chronic shoulder pain due to rotator cuff disease in spite of at least 6 months of conservative treatment

Must not have

Report prior MFAT treatment

Have a contra-indication to the procedure, such as infection, coagulopathy, or currently taking anti-coagulant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received MFAT treatment before.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Numerical Rating Scale

Secondary study objectives

Patient Global Impression of Change

Shoulder

Quantitative Ultrasound of the Supraspinatus Tendon

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for shoulder pain include physical therapy, corticosteroid injections, and autologous adipose tissue injections. Physical therapy aims to strengthen muscles and improve joint mobility, thereby reducing pain and preventing further injury. Corticosteroid injections provide temporary relief by reducing inflammation but may accelerate tendon degeneration over time. Autologous adipose tissue injections, such as Lipogems®, offer cushioning and filling of structural defects in the shoulder. These injections are rich in bioactive elements and regenerative perivascular cells (pericytes), which promote tissue repair and reduce inflammation. This matters for shoulder pain patients as it provides a regenerative treatment option that not only alleviates pain but also supports tissue healing and long-term joint health.

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