A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

Study Overview
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Brief Summary
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This is a longitudinal follow-up study of the RC-002 study, in which up to 246 subjects assigned to two randomization arms will be enrolled: an adipose-derived regenerative cell (ADRC) injection arm (ADRC treatment arm) and the SOC corticosteroid injection arm (active control arm). All subjects will be randomly assigned to ADRC treatment or active control arms in a 2:1 ratio and will be followed up for 6 months. The goal of the RC-004 study is to enroll all patients that were enrolled and treated in RC-002 and follow for 3 years.

Official Title
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A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

Conditions
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Partial Thickness Rotator Cuff Tear

Intervention / Treatment
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* Device: Adipose Derived Regenerative Cells
* Device: Corticosteroid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Subjects must have completed RC-002. 2. Subjects can give appropriate consent. Exclusion Criteria: 1. Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane. 2. Subjects whose pain behavior or pain medication usage is, in the opinion of the Investigator, out of proportion to the underlying clinical condition or could interfere with the study-required assessments. 3. Subject is on an active regimen of chemotherapy or radiation-based treatment. 4. Subject is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention. 5. Uncooperative subjects or those with neurological/psychiatric disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adipose Derived Regenerative Cells<br>a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear | Device: Adipose Derived Regenerative Cells<br>* single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear<br>|
| Active Comparator: Corticosteroid<br>a single corticosteroid injection into the subacromial space of the index arm | Device: Corticosteroid<br>* a single corticosteroid injection into the associated subacromial space<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint- Safety | Incidence (%) severity and seriousness of adverse events (AEs) | 12 months | 
| Primary Endpoint- Safety | Incidence (%) of treatment-related adverse events | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline |  | 12 months | 
| Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline |  | 12 months | 
| Mean improvement in VAS - Pain score compared to baseline |  | 12 months | 
| Mean improvement in WORC score compared to baseline |  | 12 months |