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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
5cc adipose derived stem cells.
cortisone injection
Sanford Orthopedics and Sports Medicine - Fargo
Fargo, North Dakota, United States
Sanford orthopedics and Sports Medicine - Sioux Falls
Sioux Falls, South Dakota, United States
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Adverse event rate
Time frame: at 24 months
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Adverse event rate
Time frame: 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)
Time frame: 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)
Time frame: at 36 months
Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
ASES score compared to baseline (total score = 100)
Time frame: at 24 months
Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
ASES score compared to baseline (total score = 100)
Time frame: at 36 months
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
Time frame: at 36 months
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