Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT06794294
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2025-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients with Rotator Cuff Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in degeneration score compared to baseline and the rate of change through histological examination', 'timeFrame': '6 months', 'description': '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.\n\nThe 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.'}, {'measure': 'STR (Short tandem repeat) analysis', 'timeFrame': '6 months', 'description': 'STR analysis at post-injection'}, {'measure': 'Visual Analog Scale_pain at night', 'timeFrame': '6 months'}, {'measure': 'Visual Analog Scale(VAS) worst pain', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree)', 'timeFrame': '6 months'}, {'measure': 'Muscle strength (lb)', 'timeFrame': '6 months', 'description': 'The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale'}, {'measure': 'Pulse rate (beats per minute)', 'timeFrame': '6 months', 'description': 'To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate'}, {'measure': 'Blood Pressure (mmHg)', 'timeFrame': '6 months', 'description': 'To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure'}, {'measure': 'CBC(complete blood count)', 'timeFrame': '6 months', 'description': 'The measures are composite.'}, {'measure': 'Usage amount of rescue medication', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Frequency of rescue medication', 'timeFrame': '6 months', 'description': 'The frequency of rescue medication usage is measured to assess how often participants required additional medication to manage symptoms during the study period.'}, {'measure': 'Blood Glucose', 'timeFrame': '6 months', 'description': 'Blood glucose levels are measured to assess glycemic control and detect hyperglycemia or hypoglycemia.'}, {'measure': 'BUN/Creatinine Ratio', 'timeFrame': '6 months', 'description': 'The ratio of blood urea nitrogen (BUN) to creatinine is measured to evaluate kidney function.'}, {'measure': 'Serum Total Protein', 'timeFrame': '6 months', 'description': 'Serum total protein levels are measured to evaluate overall protein status'}, {'measure': 'Serum Albumin', 'timeFrame': '6 months', 'description': 'Serum albumin levels are measured to assess liver function, nutritional status, and oncotic pressure regulation.'}, {'measure': 'Serum total bilirubin', 'timeFrame': '6 months', 'description': 'Serum total bilirubin levels are measured to evaluate liver function'}, {'measure': 'Aspartate Transaminase/Alanine Transaminase(AST/ALT)', 'timeFrame': '6 months', 'description': 'AST and ALT levels are measured to assess liver function'}, {'measure': 'Serum Alkaline Phosphatase(ALP)', 'timeFrame': '6 months', 'description': 'Serum ALP levels are measured to evaluate liver and bone health.'}, {'measure': 'Serum Gamma-Glutamyl Transferase(γ-GTP)', 'timeFrame': '6 months', 'description': 'Serum γ-GTP levels are measured to assess liver function'}, {'measure': 'Serum creatine kinase(CK)', 'timeFrame': '6 months', 'description': 'Serum creatine kinase levels are measured to assess muscle injury'}, {'measure': 'Erythrocyte Sedimentation Rate(ESR)', 'timeFrame': '6 months', 'description': 'ESR is measured to assess inflammation or detect inflammatory conditions'}, {'measure': 'C-Reactive Protein(CRP)', 'timeFrame': '6 months', 'description': 'Serum CRP levels are measured to evaluate acute inflammation'}, {'measure': 'Urine pH Levels', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Urine Specific Gravity', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Urine Protein', 'timeFrame': '6 months', 'description': 'Urine protein levels are measured to assess the presence of proteinuria. Normal range is typically negative or \\<20 mg/dL.'}, {'measure': 'Urine Glucose', 'timeFrame': '6 months', 'description': 'Urine glucose levels are measured to detect glycosuria. Normal range is negative.'}, {'measure': 'Urine Bilirubin', 'timeFrame': '6 months', 'description': 'Urine bilirubin levels are measured to assess liver function. Normal range is negative.'}, {'measure': 'Urine Blood', 'timeFrame': '6 months', 'description': 'Urine blood levels are measured to detect hematuria. Normal range is negative'}, {'measure': 'Urine Ketone', 'timeFrame': '6 months', 'description': 'Urine ketone levels are measured to detect ketonuria. Normal range is negative'}, {'measure': 'Microscopic Analysis', 'timeFrame': '6 months', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Shoulder pain and disability index(SPADI) Score', 'timeFrame': '6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Constant-Murley score', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Visual Analog Scale(VAS) pain in motion', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Changes in the size of rotator cuff tears determined by MRI', 'timeFrame': '6 months'}, {'measure': 'Changes in the size of rotator cuff tears determined by arthroscopy', 'timeFrame': '6 months'}, {'measure': 'Adverse event', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Disease']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female 19 years of age and older.\n* Patients with unilateral shoulder pain lasting for at least 3months\n* Patients who do not respond to conservative treatment.\n* Patients who have not responded to sufficient non-surgical treatments, including medication, injection therapy, physical therapy, or exercise therapy, for more than 3 months\n* Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US).\n* Patients without any restrictions on clinical trial procedures, including hospitalization.\n\nExclusion Criteria:\n\n* Patients who have received subacromial injection therapy on the affected shoulder within the past 3 months.\n* Patients who have undergone rotator cuff surgery on the affected shoulder within the past 6 months\n* Patients with a history of receiving stem cell therapy for the shoulder.\n* Patients with the following shoulder conditions: complete rotator cuff tear, adhesive capsulitis, or isolated acromioclavicular joint arthropathy.\n* Patients showing or suspected of having the following radiological findings: malignancy, severe osteoarthritis of the glenohumeral joint, or skeletal abnormalities decreasing the subacromial space.\n* Patients presenting with symptomatic cervical spine disorders.\n* Patients with concurrent bilateral shoulder pain\n* Patients with polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia.\n* Patients with neurological deficit\n* Pregnant women or lactating mothers.\n* Patients unwilling to use effective contraception during the clinical trial period.\n* Patients with current HBV, HCV, or HIV infections, or those with a positive RPR test.\n* Patients with severe diseases that may affect the clinical trial, including cardiovascular disease, renal disease, liver disease, endocrine disorders, or malignancies.\n* Patients who are unable to understand the questionnaires used for assessing their clinical status, including the Visual Analogue Scale (VAS), or those with psychiatric disorders impairing communication.\n* Patients who do not wish to participate in the clinical trial or are unable to comply with follow-up schedules.\n* Patients who have participated in another clinical trial within the last 3 months.\n* Patients deemed unsuitable for participation in this clinical trial at the investigator's discretion"}, 'identificationModule': {'nctId': 'NCT06794294', 'briefTitle': 'Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients with Rotator Cuff Disease', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ASB-IP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients diagnosed with partial-thickness rotator cuff tear', 'interventionNames': ['Biological: Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell']}], 'interventions': [{'name': 'Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell', 'type': 'BIOLOGICAL', 'description': 'Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell\n\n1. Injection dosage and volume of the study drugs:\n\n * Low dose: 1x10⁷ cells/3mL\n2. Number of injections: Only once during the study period\n3. Device: Ultrasound\n4. Injection technique: Injection into the lesion by investigator\n\nBiological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell\n\n1. Injection dosage and volume of the study drugs:\n\n * Mid dose: 5x10⁷ cells/3mL\n2. Number of injections: Only once during the study period\n3. Device: Ultrasound\n4. Injection technique: Injection into the lesion by investigator\n\nBiological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell\n\n1. Injection dosage and volume of the study drugs:\n\n * High dose: 1x10e8 cells/3mL\n2. Number of injections: Only once during the study period\n3. Device: Ultrasound\n4. Injection technique: Injection into the lesion by investigator', 'armGroupLabels': ['Patients diagnosed with partial-thickness rotator cuff tear']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07061', 'city': 'Seoul', 'state': 'Korea', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'eunmiahn@scorlab.kr', 'phone': '+82-2-870-3246'}], 'facility': 'Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'KeeJeong Bae, Principal Investigator', 'role': 'CONTACT', 'email': 'grant903@gmail.com', 'phone': '+82-10-5202-7469'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}