Status:
ENROLLING_BY_INVITATION
A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
Lead Sponsor:
InGeneron, Inc.
Conditions:
Partial Thickness Rotator Cuff Tear
Eligibility:
All Genders
30-75 years
Phase:
NA
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 (...
Eligibility Criteria
Inclusion
- 1\. Subjects must have completed RC-002.
- 2\. Subjects can give appropriate consent.
Exclusion
- 1\. Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane.
- 2\. 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.
- 3\. Subject is on an active regimen of chemotherapy or radiation-based treatment.
- 4\. 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.
- 5\. 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT05400798
Start Date
January 1 2022
End Date
December 30 2025
Last Update
August 17 2025
Active Locations (11)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85053
2
Biosolutions Clinical Research Center
La Mesa, California, United States, 91942
3
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105
4
Sports and Orthopedic Center
Coral Springs, Florida, United States, 33067