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

Primary Purpose

Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff Impingement Syndrome

Status

Unknown status

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Autologous micro-fragmented adipose tissue

Lipogems system

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder pain, Rotator cuff disease, Spinal cord injuries, Mesenchymal stromal cells, Regenerative medicine, Rehabilitation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kessler Institute for Rehabilitation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous micro-fragmented adipose tissue

Arm Description

Injection (under ultrasound guidance) of autologous micro-fragmented adipose tissue obtained from abdominal region or thighs using the Lipogems® system.

Outcomes

Primary Outcome Measures

Numerical Rating Scale

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

Wheelchair User's Shoulder Pain Index (WUSPI)

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.

Patient Global Impression of Change

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.

Brief Pain Inventory interference items (BPI-I7)

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."

Physical Examination of the Shoulder Score (PESS)

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).

Full Information

NCT ID

NCT03167138

First Posted

May 24, 2017

Last Updated

February 12, 2020

Sponsor

Kessler Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03167138

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 14, 2017 (Actual)

Primary Completion Date

September 6, 2019 (Actual)

Study Completion Date

February 21, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Shoulder pain, Rotator cuff disease, Spinal cord injuries, Mesenchymal stromal cells, Regenerative medicine, Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Single Group Assignment

Masking

None (Open Label)

Masking Description

No masking

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autologous micro-fragmented adipose tissue

Arm Type

Experimental

Arm Description

Injection (under ultrasound guidance) of autologous micro-fragmented adipose tissue obtained from abdominal region or thighs using the Lipogems® system.

Intervention Type

Biological

Intervention Name(s)

Autologous micro-fragmented adipose tissue

Other Intervention Name(s)

Lipogems

Intervention Description

Micro-fragmented adipose tissue is obtained from abdominal region or thighs using the Lipogems® system and injected into the injury site under ultrasound guidance.

Intervention Type

Device

Intervention Name(s)

Lipogems system

Other Intervention Name(s)

Lipogems technological process

Intervention Description

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.

Primary Outcome Measure Information:

Title

Numerical Rating Scale

Description

Time Frame