Clareo Health | A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
InGeneron, Inc.
Age
30–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1\. Subjects must have completed RC-002.
2\. Subjects can give appropriate consent.
You may not be if
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.
