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

Status unconfirmed · Early Phase 1

Conditions studied: Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Spinal Cord Injuries

In brief

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.

Key facts

Study ID

NCT03167138

Run by

Kessler Foundation

People needed

10

Starts

2017-07-14

Expected to finish

2020-02-21

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is male or female, 18 to 60 years of age, inclusive.
• The subject has neurological impairment secondary to a spinal cord injury that occurred at least twelve (12) months prior to the Screening Visit and the level of the injury is between C5 and L5, inclusive.
• The subject is non-ambulatory except for exercise purposes and uses a manual or power wheelchair as his/her primary means of mobility (> 40 hours/week).
• 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).
• The average shoulder pain intensity during the week leading up to the Screening Visit should be at least 4 out of 10 on an 11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
• The subject is able and willing to comply with the protocol.
• The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures.

You may not qualify if…

• The subject reports prior Lipogems treatment in the same shoulder.
• The subject reports a history of systemic disorders, such as diabetes or rheumatoid arthritis.
• The subject has contra-indications to the procedure, such as infection, coagulopathy, or is currently taking anti-coagulants.
• The subject reports having a glucocorticoid injection in the past 4 weeks.
• The subject is pregnant (documented by a urine pregnancy test).
• The subject has any medical condition, including psychiatric disease, which would interfere with the interpretation of the study results or the conduct of the study.

Where it is running

• Kessler Institute for Rehabilitation — West Orange, New Jersey, United States

Full record on ClinicalTrials.gov

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