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Rotator Cuff Pain due to Spinal Cord Injury - Healing Genes
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Rotator Cuff Pain due to Spinal Cord Injury

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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


Phase Not Applicable

DESCRIPTION:

Doctors at the  Kessler Institute for Rehabilitation in West Orange are recruiting patients with rotator cuff disease related to chronic spinal cord injury who are seeking surgical repair to trial a promising new treatment for joint pain. This treatment uses adipose (fat) tissue to provide cushioning and contains regenerative cells called pericytes that may reduce shoulder pain without need for surgery.

This investigatory treatment (called Lipogems®) withdraws adipose tissue which is then injected to the rotator tendon. Physical therapy will continue for 4 weeks, with total follow up at 1 month, 2 months, 3 months, and 6 months.


PATIENT MUST:

  • Be 18 to 70 years of age
  • Have 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
  • Not have a history of systemic disorders, such as diabetes or rheumatoid arthritis

THE STUDY INVOLVES:

  1. Prescreening at the study site to confirm eligibility of the patient to participate.
  2. Micro-fragmented adipose tissue is obtained from abdominal region or thighs using the Lipogems® system and injected into the injury site under ultrasound guidance.
  3. Physical therapy will continue for 4 weeks, with total follow up at 1 month, 2 months, 3 months, and 6 months.

LOCATIONS AND CONTACTS:

Trials will take place at the Kessler Institute for Rehabilitation in West Orange, NJ. Map.

Contacts:

Trevor A. Dyson-Hudson, M.D.  |  973-324-3576  |   [email protected]

Gerard A. Malanga, M.D.  |  973-998-8301  |  [email protected]

 

 

 

SPONSOR INFORMATION:

Kessler Foundation

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03167138

 

 

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