Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears

Study Overview
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Brief Summary
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Extension Study of Protocol RC-001- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection into Partial Thickness Rotator Cuff Tears. Purpose is to investigate the Long- term safety and efficacy of autologous stem cells in patients with partial thickness rotator cuff tears versus a steroid treatment.

Detailed Description
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The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space. The ADRC mixture is generated from the Transpose® RT System, a point-of-care solution for extraction of an autologous regenerative cell mixture from the adipose tissue after a same-day limited liposuction procedure. A pilot clinical study was recently completed using an injection of ADRC compared to a corticosteroid injection for treatment of PTRCTs. Results support the initiation of a pivotal study to study the same.

Official Title
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Extension Study of Protocol RC-001b- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Device: Adipose-derived stem cells
* Device: cortisone injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient completed participation in RC-001 (NCT02918136) study Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial. Exclusion Criteria: none

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adipose-derived stem cell injection<br>Ultrasound guided injection of 5cc adipose derived stem cells | Device: Adipose-derived stem cells<br>* 5cc adipose derived stem cells.<br>|
| Active Comparator: cortisone injection<br>Ultrasound guided injection of cortisone | Device: cortisone injection<br>* cortisone injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term Safety as indicated through adverse event rate between ADSC and TAU arms | Adverse event rate | at 24 months | 
| Long term Safety as indicated through adverse event rate between ADSC and TAU arms | Adverse event rate | at 36 months | 
| Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires | Short form-36 score compared to baseline (total score = 800) | at 24 months | 
| Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires | Short form-36 score compared to baseline (total score = 800) | at 36 months | 
| Long term efficacy of pain and function through ASES Shoulder Score health questionnaires | ASES score compared to baseline (total score = 100) | at 24 months | 
| Long term efficacy of pain and function through ASES Shoulder Score health questionnaires | ASES score compared to baseline (total score = 100) | at 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term efficacy will be evaluated through MRIs pre- and post-injection for the therapeutic intent to treat a rotator cuff injury: Percentage improvement in tendon tear size and thickness | Percentage improvement in tendon tear size and thickness | at 36 months |