NCT03167138

Micro-Fragmented Adipose Tissue (Lipogems®) Injection for Chronic Shoulder Pain in Persons With Spinal Cord Injury

Treatment of Chronic Shoulder Pain in Persons With Spinal Cord Injury Using Injection With Autologous Micro-Fragmented Adipose Tissue Under Ultrasound Guidance

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an exploratory pilot study to determine the safety and efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic, nonresponsive shoulder pain due to rotator cuff disease (i.e., rotator cuff tendinopathy) in persons with spinal cord injury (SCI). Twelve (12) persons with SCI who have chronic shoulder pain for longer than 6 months in spite of completing conservative treatment who are diagnosed with rotator cuff disease on examination. Micro-fragmented adipose tissue will be obtained by using a minimal manipulation technique in a closed system (Lipogems®), without the addition of enzymes or any additives. The final product will consist of micronized fat tissue yielding fat clusters with preserved vascular stroma of about 500 microns with intact stromal vascular niches and harboring regenerative cellular elements. Approximately 6 mL of micro-fragmented adipose will be injected into the tendon with a 22-gauge needle under continuous ultrasound guidance. No other biological or pharmacological agents will be used in combination with the micro-fragmented adipose. After 24 hours, subjects will be given a standardized stretching protocol to follow for 4 weeks followed by a formal strengthening program. Participants will be followed for adverse events and changes in shoulder pain intensity on an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine"); the Wheelchair User's Shoulder Pain Index (WUSPI; 15-item disease-specific functional measure of shoulder pain in persons with SCI); the Brief Pain Inventory interference items (BPI-I7; a subscale of 7 items measuring interference with general activity, sleep, mood, relationships, etc.); and a 5-point subject global impression of change (SGIC) scale. Subjects will be examined at 1 month, 2 months, 3 months, and 6 months after the treatment. Follow-up shoulder ultrasound will be performed at 6 months.

Conditions

• Shoulder Pain
• Shoulder Impingement Syndrome
• Rotator Cuff Impingement Syndrome
• Rotator Cuff Tendinitis
• Rotator Cuff Syndrome of Shoulder and Allied Disorders
• Spinal Cord Injuries

Interventions

Type	Name	Description
BIOLOGICAL	Autologous micro-fragmented adipose tissue	Micro-fragmented adipose tissue is obtained from abdominal region or thighs using the Lipogems® system and injected into the injury site under ultrasound guidance.
DEVICE	Lipogems system	The Lipogems® system is a non-enzymatic method to obtain micro-fragmented adipose tissue from the abdominal region or thighs for injection into the injury site.

Timeline

• Start date: 2017-07-14
• Primary completion: 2019-09-06
• Completion: 2020-02-21
• First posted: 2017-05-25
• Last updated: 2020-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study