Adipose Derived Regenerative Cells
Devicesingle injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
NCT Number: NCT05400798
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.
Interested in participating?
Request Info30 year–75 year
All sexes
Interventional
Not applicable
Arizona Research Center, Phoenix, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
a single corticosteroid injection into the associated subacromial space
Time frame: 12 months
Incidence (%) severity and seriousness of adverse events (AEs)
Time frame: 12 months
Incidence (%) of treatment-related adverse events
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
InGeneron, Inc.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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