Rotator Cuff Disease
Conditions
Brief summary
Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large Rotator Cuff Tears
Interventions
Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Low dose: 2.5X10 cells/0.5mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: \- High dose: 5X10 cells/1mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator
Sponsors
Korea University Anam Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female 19 years of age and older * Unilateral shoulder pain with a pain score of 4 or higher. * patients with a symptom duration of at least three months who have not responded to conventional treatments, including analgesics. * patients diagnosed with massive or extensive full-thickness rotator cuff tears confirmed by computed tomography arthrography or magnetic resonance imaging.
Exclusion criteria
* patients diagnosed with small or medium full-thickness rotator cuff tears among study participants with full-thickness rotator cuff tears. * patients who have received subacromial injection therapy in the affected shoulder within the past three months. * patients who have undergone rotator cuff surgery on the affected shoulder within the past six months. * patients exhibiting or suspected of having the following radiological findings: malignant tumors, severe glenohumeral osteoarthritis, or bony abnormalities causing subacromial space narrowing. * patients presenting with symptomatic cervical spine disorders. * patients experiencing bilateral shoulder pain. * patients diagnosed with multiple arthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia. * patients with neurological deficits. * Pregnant or breastfeeding patients * patients unwilling to use effective contraception during the study period. * patients currently infected with HBV, HCV, or HIV, or those with a positive RPR test result. * patients with severe conditions that may affect the study, including cardiovascular diseases, renal diseases, hepatic diseases, endocrine disorders, or malignancies. * patients who are unable to comprehend the questionnaires used for study assessments, including the Visual Analog Scale (VAS), or those with communication difficulties due to psychiatric disorders. * Any other cases deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale(VAS) pain in motion | 12 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. |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the size of rotator cuff tears determined by MRI | 12 months |
| Adverse event | 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree) | 12 months | — |
| Muscle strength (lb) | 12 months | The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale |
| Pulse rate (beats per minute) | 12 months | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate |
| Blood Pressure (mmHg) | 12 months | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure |
| CBC(complete blood count) | 12 months | The measures are composite. |
| Usage amount of rescue medication | 12 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. |
| Frequency of rescue medication | 12 months | The frequency of rescue medication usage is measured to assess how often participants required additional medication to manage symptoms during the study period. |
| Blood Glucose | 12 months | Blood glucose levels are measured to assess glycemic control and detect hyperglycemia or hypoglycemia. |
| BUN/Creatinine Ratio | 12 months | The ratio of blood urea nitrogen (BUN) to creatinine is measured to evaluate kidney function. |
| Serum Total Protein | 12 months | Serum total protein levels are measured to evaluate overall protein status |
| Serum Albumin | 12 months | Serum albumin levels are measured to assess liver function, nutritional status, and oncotic pressure regulation. |
| Serum total bilirubin | 12 months | Serum total bilirubin levels are measured to evaluate liver function |
| Urine Blood | 12 months | Urine blood levels are measured to detect hematuria. Normal range is negative |
| Serum Alkaline Phosphatase(ALP) | 12 months | Serum ALP levels are measured to evaluate liver and bone health. |
| Serum Gamma-Glutamyl Transferase(γ-GTP) | 12 months | Serum γ-GTP levels are measured to assess liver function |
| Serum creatine kinase(CK) | 12 months | Serum creatine kinase levels are measured to assess muscle injury |
| Erythrocyte Sedimentation Rate(ESR) | 12 months | ESR is measured to assess inflammation or detect inflammatory conditions |
| C-Reactive Protein(CRP) | 12 months | Serum CRP levels are measured to evaluate acute inflammation |
| Urine pH Levels | 12 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. |
| Urine Specific Gravity | 12 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 |
| Urine Protein | 12 months | Urine protein levels are measured to assess the presence of proteinuria. Normal range is typically negative or \<20 mg/dL. |
| Urine Glucose | 12 months | Urine glucose levels are measured to detect glycosuria. Normal range is negative. |
| Urine Bilirubin | 12 months | Urine bilirubin levels are measured to assess liver function. Normal range is negative. |
| Number of participants with treatment-related adverse events as assessed by NCI - CTCAE v4.0 | 12 months | 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. |
| Aspartate Transaminase/Alanine Transaminase(AST/ALT) | 12 months | AST and ALT levels are measured to assess liver function |
| Urine Ketone | 12 months | Urine ketone levels are measured to detect ketonuria. Normal range is negative |
| Microscopic Analysis | 12 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. |
Countries
South Korea
Contacts
Primary ContactWoong Kyo Jeong
Outcome results
None listed