NCT05400798
A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
Enrolling by Invitation
NAAges 30–75InterventionalInGeneron, Inc.
~246 participants
Updated 2025-08-17 on ClinicalTrials.gov
What's tested:Adipose Derived Regenerative CellsCorticosteroid
At a glance
Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Endpoint- Safety
Measured over 12 months
+1 more outcome measured
Conditions
Where it's being run
11 sites across 7 statesFlorida3
California2
Texas2
Arizona1
Georgia1
Louisiana1
South Dakota1
Study leadership
- Christopher Alt, MD · STUDY_DIRECTOR · InGeneron, Inc.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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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.
What this trial measures
- Primary Endpoint- Safety12 months
Incidence (%) severity and seriousness of adverse events (AEs)
- Primary Endpoint- Safety12 months
Incidence (%) of treatment-related adverse events