Autologous micro-fragmented adipose tissue for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord Injury+5 MoreAutologous micro-fragmented adipose tissue - Biological
Eligibility
18 - 70
All Sexes
What conditions do you have?
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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 Syndrome
  • Shoulder Impingement Syndrome
  • Shoulder Pain
  • Rotator Cuff Tendinitis
  • Rotator Cuff Impingement Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.

Week 24
Brief Pain Inventory interference items (BPI-I7)
Numerical Rating Scale
Patient Global Impression of Change
Physical Examination of the Shoulder Score (PESS)
Wheelchair User's Shoulder Pain Index (WUSPI)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Autologous micro-fragmented adipose tissue
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Autologous micro-fragmented adipose tissue · No Placebo Group · Phase < 1

Autologous micro-fragmented adipose tissueExperimental Group · 2 Interventions: Autologous micro-fragmented adipose tissue, Lipogems system · Intervention Types: Biological, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.

Who is running the clinical trial?

Kessler FoundationLead Sponsor
155 Previous Clinical Trials
10,305 Total Patients Enrolled
Trevor A. Dyson-Hudson, M.D.Principal InvestigatorKessler Foundation
5 Previous Clinical Trials
255 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 7 Total Inclusion Criteria

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