Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, Korea, 07061, South Korea
Location status: Recruiting
NCT Number: NCT06794294
The purpose of this study is to evaluate safety and efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Phase 1 / Phase 2
Seoul, Korea, 07061, South Korea
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell
Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell
Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell
Time frame: 6 months
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. The minimum value is 0 and the maximum value is 10. "0" means no pain and "10" means the worst pain imaginable in the pain section. "0" means no difficulty and "10" means so difficult it requires help in the pain section.
Time frame: 6 months
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: 6 months
Using a ruler, the score is determined by measuring the distance (mm) on the 100mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
When tendon regeneration is identified in the lesion area through arthroscopic examination, a tissue sample approximately 2 mm in diameter is collected from the regenerated site and evaluated using the modified Astrom & Movin scoring system.
The evaluation method consists of seven assessment variables(Fiber structure, Fiber arrangement, Rounding of the nuclei, Variations in cellularity, Increased vascularity, Decreased stainability, Hyalinization), each scored on a scale from 0 to 3, with 0 indicating normal and 3 representing the most severe abnormality. The scores are summed to calculate the tendon degeneration score, which ranges from 0 to 21. A score closer to 0 indicates normal tendon condition, while a score closer to 21 reflects severe degenerative changes.
Time frame: 6 months
STR analysis at post-injection
Time frame: 6 months
Time frame: 6 months
Using a ruler, the score is determined by measuring the distance (mm) on the 100mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: 6 months
Time frame: 6 months
The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale
Time frame: 6 months
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate
Time frame: 6 months
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure
Time frame: 6 months
The measures are composite.
Time frame: 6 months
The total dosage of rescue medication administered to participants during the study period is measured to evaluate the amount of medication required to manage symptoms after treatment.
Time frame: 6 months
The frequency of rescue medication usage is measured to assess how often participants required additional medication to manage symptoms during the study period.
Time frame: 6 months
Blood glucose levels are measured to assess glycemic control and detect hyperglycemia or hypoglycemia.
Time frame: 6 months
The ratio of blood urea nitrogen (BUN) to creatinine is measured to evaluate kidney function.
Time frame: 6 months
Serum total protein levels are measured to evaluate overall protein status
Time frame: 6 months
Serum albumin levels are measured to assess liver function, nutritional status, and oncotic pressure regulation.
Time frame: 6 months
Serum total bilirubin levels are measured to evaluate liver function
Time frame: 6 months
AST and ALT levels are measured to assess liver function
Time frame: 6 months
Serum ALP levels are measured to evaluate liver and bone health.
Time frame: 6 months
Serum γ-GTP levels are measured to assess liver function
Time frame: 6 months
Serum creatine kinase levels are measured to assess muscle injury
Time frame: 6 months
ESR is measured to assess inflammation or detect inflammatory conditions
Time frame: 6 months
Serum CRP levels are measured to evaluate acute inflammation
Time frame: 6 months
Urine pH is measured to assess acidity or alkalinity of the urine. Lower values indicate increased acidity, while higher values indicate increased alkalinity. Normal range is typically 4.5-8.0.
Time frame: 6 months
Urine specific gravity is measured to evaluate urine concentration or dilution. A value closer to 1.000 indicates more diluted urine, while higher values suggest more concentrated urine. protein
Time frame: 6 months
Urine protein levels are measured to assess the presence of proteinuria. Normal range is typically negative or <20 mg/dL.
Time frame: 6 months
Urine glucose levels are measured to detect glycosuria. Normal range is negative.
Time frame: 6 months
Urine bilirubin levels are measured to assess liver function. Normal range is negative.
Time frame: 6 months
Urine blood levels are measured to detect hematuria. Normal range is negative
Time frame: 6 months
Urine ketone levels are measured to detect ketonuria. Normal range is negative
Time frame: 6 months
Microscopic analysis of urine is performed to identify the presence of red blood cells (RBCs), white blood cells (WBCs), crystals, casts, or bacteria, which may indicate infection, inflammation, or other pathological conditions.
Contact information is provided by the study sponsor or research team.
Seoul National University Hospital
Other
A Single Center, Open Label, Phase 1/2a Study to Evaluate Safety and Exploratory Efficacy of Allogenic Umbilical Cord Derived Mesenchymal Stem Cell Treatment in Patients With Rotator Cuff Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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