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Regenerative Medicine

Autologous micro-fragmented adipose tissue for Spinal Cord Injury

Phase < 1
Waitlist Available
Led By Trevor A. Dyson-Hudson, M.D.
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject is male or female, 18 to 60 years of age, inclusive.
The subject currently has chronic shoulder pain due to rotator cuff disease in spite of at least 6 months of conservative treatment (Note: rotator cuff disease will be defined as pain over the anterior shoulder, with direct palpation and pain at the shoulder with provocative tests for rotator cuff disease that is confirmed by tendinopathic changes on ultrasound imaging).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Awards & highlights

Study Summary

Rotator cuff disease (i.e., rotator cuff tendinopathy or tear) is a common cause of shoulder pain in persons with chronic spinal cord injury (SCI). It usually resolves with non-operative treatments such as pharmacological agents and physical therapy; however, when this fails, rotator cuff surgery may be the only option. Autologous adipose tissue injection has recently emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells (pericytes). The purpose of this study is to explore the safety and efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic shoulder pain in persons with SCI.

Eligible Conditions
  • Spinal Cord Injury
  • Rotator Cuff Impingement Syndrome
  • Rotator Cuff Tendinitis
  • Rotator Cuff Syndrome
  • Shoulder Pain
  • Shoulder Impingement Syndrome

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numerical Rating Scale
Secondary outcome measures
Brief Pain Inventory interference items (BPI-I7)
Patient Global Impression of Change
Physical Examination of the Shoulder Score (PESS)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Autologous micro-fragmented adipose tissueExperimental Treatment2 Interventions
Injection (under ultrasound guidance) of autologous micro-fragmented adipose tissue obtained from abdominal region or thighs using the Lipogems® system.

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor
172 Previous Clinical Trials
10,643 Total Patients Enrolled
Trevor A. Dyson-Hudson, M.D.Principal InvestigatorKessler Foundation
5 Previous Clinical Trials
255 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Mar 2025