drugset / Trial / NCT02918136

Safety and Efficacy Adipose-Derived Stem Cell Injection Partial Thickness Rotator Cuff Tears

NCT02918136

Completed 18 enrolled InGeneron, Inc.
RandomizedParallel-groupSingle-blindTreatment

Summary

This is a prospective, randomized, multi-site, safety and efficacy study in subjects with rotator cuff injuries. Patients will fall into two categories: treatment group (12 subjects) and non-treatment or control group (six subjects). The treatment group will undergo a small liposuction procedure and receive rotator cuff repair treatment with an ultrasound-guided injection of 5cc adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5cc cortisone injection into the point of injury

Timeline

Start
2016-12
Primary completion
2018-07-31
Completion
2018-12-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cortisone acetate Other / unclassified Other
Subject adipose-derived regenerative cells Cell therapy 5 ml Other

Indications