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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
Sponsor: InGeneron, Inc.
Summary
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.
Key Details
Gender
All
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
246
Start Date
2022-01-01
Completion Date
2025-12-30
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
Adipose Derived Regenerative Cells
single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
Corticosteroid
a single corticosteroid injection into the associated subacromial space
Locations (11)
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
Texas Center for Cell Therapy and Research
San Antonio, Texas, United States