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

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ClinicalTrials.gov Identifier: NCT03167138
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Trevor Dyson-Hudson, M.D., Kessler Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Shoulder Impingement Syndrome Rotator Cuff Impingement Syndrome Rotator Cuff Tendinitis Rotator Cuff Syndrome of Shoulder and Allied Disorders Spinal Cord Injuries Biological: Autologous micro-fragmented adipose tissue Device: Lipogems system Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Treatment of Chronic Shoulder Pain in Persons With Spinal Cord Injury Using Injection With Autologous Micro-Fragmented Adipose Tissue Under Ultrasound Guidance
Actual Study Start Date : July 14, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autologous micro-fragmented adipose tissue
Injection (under ultrasound guidance) of autologous micro-fragmented adipose tissue obtained from abdominal region or thighs using the Lipogems® system.
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.
Other Name: Lipogems

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.
Other Name: Lipogems technological process




Primary Outcome Measures :
  1. Numerical Rating Scale [ Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment. ]
    Shoulder pain intensity will also be assessed weekly using a numerical rating scale (NRS). Subjects will be asked to rate their average pain, most severe pain, and least severe pain during the past week using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "pain as bad as you can imagine." An 11-point NRS measure of pain intensity allows for comparison across clinical trials of chronic pain treatment and is recommended as a core outcome measure for chronic pain clinical trials.


Secondary Outcome Measures :
  1. Wheelchair User's Shoulder Pain Index (WUSPI) [ Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment. ]
    The WUSPI is a 15-item self-report instrument that measures shoulder pain intensity in wheelchair users during various ADLs, such as transfers, loading a wheelchair into a car, wheelchair mobility, dressing, bathing, overhead lifting, driving, performing household chores, and sleeping. Each item is scored using a 10cm visual analog scale (VAS) which is anchored at the ends with "no pain" and "worst pain ever experienced." Individual item scores are summed to arrive at a total index score, which ranges from 0 to 150.

  2. Patient Global Impression of Change [ Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment. ]
    Subjects will be asked to rate on a 7-point scale overall impression following treatment as compared to the previous measurement interval. The 7-point PGIC scale (anchored by "very much improved" and "very much worse") is used to measure global treatment effect.

  3. Brief Pain Inventory interference items (BPI-I7) [ Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment. ]
    The Brief Pain Inventory (BPI) was developed by Cleeland, and has been used in a number of investigations of chronic pain. Its pain interference subscale has been used in several investigations of pain in SCI. In its original version the subscale (BPI-I7) consisted of 7 items measuring interference with general activity, sleep, mood, relationships, etc.). For uses with an SCI sample, in item 3 of BPI-I7, ''walking ability'' is replaced by "ability to get around."

  4. Physical Examination of the Shoulder Score (PESS) [ Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment. ]
    The Physical Examination of the Shoulder Score (PESS) is obtained by performing a series of eleven commonly used physical examination maneuvers for rotator cuff disease and shoulder pain that are graded 0 (no pain), 1 (equivocal for pain), or 2 (pain present).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167138


Contacts
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Contact: Trevor A. Dyson-Hudson, M.D. 973-324-3576 tdysonhudson@kesslerfoundation.org
Contact: Gerard A. Malanga, M.D. 973-998-8301 gmalangamd@hotmail.com

Locations
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United States, New Jersey
Kessler Institute for Rehabilitation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Trevor A. Dyson-Hudson, M.D.    973-324-3576    tdysonhudson@kesslerfoundation.org   
Contact: Matthew Weiner    973-324-3515    mweiner@kesslerfoundation.org   
Principal Investigator: Gerard A. Malanga, M.D.         
Sub-Investigator: Steven C. Kirshblum, M.D.         
Sub-Investigator: Chris Cherian, M.D.         
Sub-Investigator: Reina Nakamura, M.D.         
Sponsors and Collaborators
Kessler Foundation
Investigators
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Principal Investigator: Trevor A. Dyson-Hudson, M.D. Kessler Foundation

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Responsible Party: Trevor Dyson-Hudson, M.D., Director, Spinal Cord Injury Research, Kessler Foundation
ClinicalTrials.gov Identifier: NCT03167138     History of Changes
Other Study ID Numbers: R-957-17
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Trevor Dyson-Hudson, M.D., Kessler Foundation:
Shoulder pain
Rotator cuff disease
Spinal cord injuries
Mesenchymal stromal cells
Regenerative medicine
Rehabilitation

Additional relevant MeSH terms:
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Spinal Cord Injuries
Rotator Cuff Injuries
Wounds and Injuries
Spinal Cord Diseases
Trauma, Nervous System
Shoulder Injuries
Tendon Injuries
Shoulder Pain
Tendinopathy
Shoulder Impingement Syndrome
Syndrome
Disease
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Rupture
Muscular Diseases