Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears

Study Overview
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Brief Summary
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Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. An important limitation in our ability to successfully rehabilitate these injuries postoperatively and return patients to normal function has to do with the poor quality of the muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate pathways associated with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system. This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients who are undergoing surgical repair of a torn supraspinatus rotator cuff.

Official Title
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A Phase II Study to Evaluate Autologous Stromal Vascular Fraction Cell Therapy to Improve the Repair of Chronically Rotator Cuff Tears

Conditions
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Rotator Cuff Tear, Muscle Atrophy, Tendon Tear

Intervention / Treatment
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* Device: Autologous Stomal Vascular Fraction Material
* Device: Ringer's solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females Age 45-65 years old at the time of enrollment Full-thickness supraspinatus tendon tear with endon retraction ≤ 3 cm Magnetic resonance imaging Goutallier score ≤ grade 2 Completed at least 6 weeks of standard physical therapy but continue to have pain and limited function (failed physical therapy) Sufficient subcutaneous abdominal adipose tissue to allow the recovery of 60-120cc of lipoaspirate Must pass standard of care blood work screening Exclusion Criteria: Any tears of any cuff tendon other than the supraspinatus Magnetic resonance imaging Goutallier scores ≥ 3 Frank signs of glenohumeral osteoarthritis on magnetic resonance imaging A history of previous rotator cuff repair A history of upper extremity fracture or other moderate to severe upper extremity trauma A BMI < 20 or > 35 Pregnant or breast feeding Premenopausal women who are not using contraception Previous abdominal liposuction or any major open abdominal surgery Type I or type II diabetes, or glycated hemoglobin (hemoglobin A1C) values > 6.5 or other metabolic disorders Hypercholesterolemia (total cholesterol ≥240mg/dL) History of cancer Autoimmune disorder or HIV+ status Use of nicotine products Have any other history of major medical illness, disease or other relevant orthopaedic disability Who do not speak English Liodcaine allergy

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients will receive an injection of vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair | Device: Ringer's solution<br>* Ringer's solution<br>|
| Active Comparator: Cell Therapy<br>Patients will receive an injection of stromal vascular fraction material suspended in vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair | Device: Autologous Stomal Vascular Fraction Material<br>* Autologous Stomal Vascular Fraction Material Prepared from the Tissue Genesis® Icellator Cell Isolation System™<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scapular plane abduction strength from baseline, and additional isometric, isokinetic strength measurements to assess supraspinatus function. |  | 2 weeks prior to surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Penn Shoulder score, ASES score and Short Form Global Health scale (PROMIS-SF) from baseline (range 0 minimum to 30 maximum) |  | 2 weeks prior to surgery, 6 weeks after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery | 
| Change in supraspinatus muscle stiffness from baseline, measured by ultrasound shear wave elastrography |  | 1 month prior to surgery, 6 months after surgery, 24 months after surgery | 
| Change in fatty infiltration from baseline, measured by magnetic resonance imaging |  | 1 month prior to surgery, 6 months after surgery, 24 months after surgery |