InGeneron, Inc.
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.
Inclusion Criteria: * 1\. Subjects must have completed RC-002. * 2\. Subjects can give appropriate consent. Exclusion Criteria: * 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,…
single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
a single corticosteroid injection into the associated subacromial space