Safety and Efficacy Adipose-Derived Stem Cell Injection Partial Thickness Rotator Cuff Tears
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|ClinicalTrials.gov Identifier: NCT02918136|
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : February 11, 2021
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
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear - Partial Thickness||Biological: Adipose derived regenerative cells Drug: Cortisone Injectable||Not Applicable|
The primary objectives of this study were to evaluate the safety of adult Adipose-Derived Stem Cell (ADRC) injection into partial thickness rotator cuff tears as indicated through adverse event rate and efficacy of pain and function through Rand short form-36 questionnaire and ASES Shoulder Score health questionnaires.
The secondary objective of this study was to assess the efficacy of adult ADRC injection into partial thickness rotator cuff tears through MRIs pre-and post-injection for the therapeutics intent to treat a rotator cuff injury.
Patients enrolled on this study received either ADRC (i.e., investigational treatment group) or TAU (i.e., control group). The investigational treatment group underwent a small liposuction procedure and received rotator cuff repair treatment with an ultrasound-guided injection of 5cc ADRCs into the point of injury. The control group received a 5cc cortisone injection. All patients, regardless of treatment, were followed up as indicated on the schedule of events table in the clinical study protocol.
Two clinical trial sites (Sioux Falls, SD and Fargo ND) enrolled subjects in this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Safety and Efficacy of Adult Adipose-Derived Stem Cell Injections Into Partial Thickness Rotator Cuff Tears|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||December 13, 2018|
Experimental: adipose-derived stem cell injection
ultrasound guided injection of 5cc of adipose-derived stem cells (ADSCs)
Biological: Adipose derived regenerative cells
Other Name: ADRCs
Active Comparator: cortisone injection
ultrasound guided injection of cortisone
Drug: Cortisone Injectable
Other Name: steroid
- safety evaluation as indicated by collection of adverse events [ Time Frame: enrollment through 12months of follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918136
|United States, North Dakota|
|Sanford Orthopedics and Sports Medicine - Fargo|
|Fargo, North Dakota, United States, 58103|
|United States, South Dakota|
|Sanford orthopedics and Sports Medicine - Sioux Falls|
|Sioux Falls, South Dakota, United States, 57104|
|Principal Investigator:||Jason Hurd, M.D.||Sanford Orthopedics & Sports Medicine - Sioux Falls, SD|