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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
246
single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
a single corticosteroid injection into the associated subacromial space
Arizona Research Center
Phoenix, Arizona, United States
Biosolutions Clinical Research Center
La Mesa, California, United States
Lotus Clinical Research, LLC
Pasadena, California, United States
Sports and Orthopedic Center
Coral Springs, Florida, United States
Universal Axon Clinical Research
Doral, Florida, United States
Andrews Institute for Orthopedics and Sports Medicine
Gulf Breeze, Florida, United States
Georgia Institute for Clinical Research
Marietta, Georgia, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Sanford Orthopedic Clinic/Research
Sioux Falls, South Dakota, United States
HD Research
Houston, Texas, United States
...and 1 more locations
Primary Endpoint- Safety
Incidence (%) severity and seriousness of adverse events (AEs)
Time frame: 12 months
Primary Endpoint- Safety
Incidence (%) of treatment-related adverse events
Time frame: 12 months
Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline
Time frame: 12 months
Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline
Time frame: 12 months
Mean improvement in VAS - Pain score compared to baseline
Time frame: 12 months
Mean improvement in WORC score compared to baseline
Time frame: 12 months
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