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Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large Rotator Cuff Tears
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients diagnosed with Full-Thickness Rotator Cuff Tears, Including Massive and Large Tears | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell | Biological | Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell
Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale(VAS) pain in motion | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the size of rotator cuff tears determined by MRI | 12 months | |
| Adverse event | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree) | 12 months | |
| Muscle strength (lb) | The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Woong Kyo Jeong | Contact | 82-10-4047-2878 | drshoulder@korea.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anamh Hospital | Recruiting | Seoul | Korea | 02841 | South Korea |
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| 12 months |
| Pulse rate (beats per minute) | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate | 12 months |
| Blood Pressure (mmHg) | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure | 12 months |
| CBC(complete blood count) | The measures are composite. | 12 months |
| Usage amount of rescue medication | 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. | 12 months |
| Frequency of rescue medication | The frequency of rescue medication usage is measured to assess how often participants required additional medication to manage symptoms during the study period. | 12 months |
| Blood Glucose | Blood glucose levels are measured to assess glycemic control and detect hyperglycemia or hypoglycemia. | 12 months |
| BUN/Creatinine Ratio | The ratio of blood urea nitrogen (BUN) to creatinine is measured to evaluate kidney function. | 12 months |
| Serum Total Protein | Serum total protein levels are measured to evaluate overall protein status | 12 months |
| Serum Albumin | Serum albumin levels are measured to assess liver function, nutritional status, and oncotic pressure regulation. | 12 months |
| Serum total bilirubin | Serum total bilirubin levels are measured to evaluate liver function | 12 months |
| Aspartate Transaminase/Alanine Transaminase(AST/ALT) | AST and ALT levels are measured to assess liver function | 12 months |
| Serum Alkaline Phosphatase(ALP) | Serum ALP levels are measured to evaluate liver and bone health. | 12 months |
| Serum Gamma-Glutamyl Transferase(γ-GTP) | Serum γ-GTP levels are measured to assess liver function | 12 months |
| Serum creatine kinase(CK) | Serum creatine kinase levels are measured to assess muscle injury | 12 months |
| Erythrocyte Sedimentation Rate(ESR) | ESR is measured to assess inflammation or detect inflammatory conditions | 12 months |
| C-Reactive Protein(CRP) | Serum CRP levels are measured to evaluate acute inflammation | 12 months |
| Urine pH Levels | 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. | 12 months |
| Urine Specific Gravity | 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 | 12 months |
| Urine Protein | Urine protein levels are measured to assess the presence of proteinuria. Normal range is typically negative or <20 mg/dL. | 12 months |
| Urine Glucose | Urine glucose levels are measured to detect glycosuria. Normal range is negative. | 12 months |
| Urine Bilirubin | Urine bilirubin levels are measured to assess liver function. Normal range is negative. | 12 months |
| Urine Blood | Urine blood levels are measured to detect hematuria. Normal range is negative | 12 months |
| Urine Ketone | Urine ketone levels are measured to detect ketonuria. Normal range is negative | 12 months |
| Microscopic Analysis | 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. | 12 months |
| Number of participants with treatment-related adverse events as assessed by NCI - CTCAE v4.0 | all adverse and unintended signs (including abnormal laboratory test results), symptoms, or diseases that occur in research subjects who have been administered the investigational drug. | 12 months |