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

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.

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.