A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
- Conditions
- Partial Thickness Rotator Cuff Tear
- Registration Number
- NCT05400798
- Lead Sponsor
- InGeneron, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 246
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- Subjects must have completed RC-002.
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- Subjects can give appropriate consent.
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- Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane.
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- Subjects whose pain behavior or pain medication usage is, in the opinion of the Investigator, out of proportion to the underlying clinical condition or could interfere with the study-required assessments.
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- Subject is on an active regimen of chemotherapy or radiation-based treatment.
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- Subject is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
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- Uncooperative subjects or those with neurological/psychiatric disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary Endpoint- Safety 12 months Incidence (%) of treatment-related adverse events
- Secondary Outcome Measures
Name Time Method Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline 12 months Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline 12 months Mean improvement in VAS - Pain score compared to baseline 12 months Mean improvement in WORC score compared to baseline 12 months
Trial Locations
- 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
Scroll for more (1 remaining)Arizona Research Center🇺🇸Phoenix, Arizona, United States