Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, South Korea
NCT Number: NCT02474342
The purpose of this study is to evaluate safety and efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells injection in patient with Rotator Cuff disease.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Seoul, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Participants should meet all the inclusion criteria. Patients must consent in writing to participate in the study by signing and dating an informed consent document approved by IRB indicating that the patient has been informed of all pertinent aspects of the study prior to completing any of the screening procedures
Inclusion criteria
Exclusion criteria
Participants who met a single condition were excluded from the study
Time frame: 24 weeks
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
Time frame: 24 weeks
The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24weeks
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24 weeks
Time frame: 24 weeks
The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale
Time frame: 24 weeks
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using body weight
Time frame: 24 weeks
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using body temperature
Time frame: 24 weeks
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate
Time frame: 24 weeks
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure
Time frame: 24 weeks
The measures are composite.
Time frame: 24 weeks
The measures are composite.
Time frame: 24weeks
The measures are composite.
Seoul National University Hospital
Other
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Rotator Cuff Disease
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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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