Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-27 @ 1:23 AM
Study NCT ID:
NCT04326959
Status:
UNKNOWN
Last Update Posted:
2020-07-15
First Post:
2020-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007627', 'term': 'Keloid'}], 'ancestors': [{'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017077', 'term': 'Culture Media, Conditioned'}, {'id': 'D000089282', 'term': 'Secretome'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D003470', 'term': 'Culture Media'}, {'id': 'D019995', 'term': 'Laboratory Chemicals'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055442', 'term': 'Metabolome'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-14', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alfa SMA-1', 'timeFrame': '3 month after injection', 'description': 'Biomarker'}, {'measure': 'Collagen type 1', 'timeFrame': '3 moth after injection', 'description': 'Biomarker'}], 'secondaryOutcomes': [{'measure': 'Core Biopsy/Histopathology', 'timeFrame': '3 month after injection', 'description': 'Too evaluate histology of keloid'}, {'measure': 'Ultrasonography', 'timeFrame': '3 month after injection', 'description': 'To see image inside the body'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Keloid', 'Allogeneic Mesenchymal Stem Cells', 'Umbilical Cord', 'Conditioned Medium'], 'conditions': ['Keloid']}, 'descriptionModule': {'briefSummary': 'The clinical trial will be carried out at the Gatot Soebroto Army Central Hospital, Jakarta and planned from June 2020 to December 2020. Clinical trials of Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs) and Conditioned Medium Umbilical Cord-Mesenchymal Stem Cells (CM UC-MSCs) for Keloid were designed in three groups. Group 1 injected with The UC-MSCs at a dose of 2 million cells / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at a dose of 1 cc / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at the same dose 3 weeks later. Group 3 injected with Triamcinolon acetonide (TA) at a dose of 40 mg / cc / cm3 using 1 cc (27 G) syringe and booster with TA at 3 weeks later. The study subjects each group amounted to 7 patients suffering from Keloid. Patients were evaluated for 3 months after injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgery history of more than 3 months\n* Has keloid that the maximum size is 15 cm and thickness is 3-5 mm\n\nExclusion Criteria:\n\n* Patients with kidney failure\n* Pregnancy\n* Breastfeeding\n* Liver dysfunction\n* Blood disorders\n* Currently receiving immunosuppressant therapy (chemotherapy or steroids)\n* Refusing to participate in the study'}, 'identificationModule': {'nctId': 'NCT04326959', 'acronym': 'Keloid', 'briefTitle': 'Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT. Prodia Stem Cell Indonesia'}, 'officialTitle': 'Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Regression: Immunohistochemistry, Histopathology and Imaging Study', 'orgStudyIdInfo': {'id': 'CT/KLD/03/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UC-MSCs + CM', 'description': 'A patient will be given UC-MSCs 2 million cells / cm3. After 3 weeks, the patient will be given CM 1 cc / cm3. The maximum size of Keloid is 15 cm per patient.', 'interventionNames': ['Biological: Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium', 'Biological: Conditioned Medium']}, {'type': 'EXPERIMENTAL', 'label': 'CM + CM', 'description': 'A patient will be given CM 1 cc / cm3. After 3 weeks, the patient will be given CM 1 cc / cm3. The maximum size of Keloid is 15 cm per patient.', 'interventionNames': ['Biological: Conditioned Medium']}, {'type': 'EXPERIMENTAL', 'label': 'Triamcinolon acetonide', 'description': 'A patient will be given Triamcinolone acetonide 40 mg / cc / cm3. After 3 weeks the patient will be given Triamcinolone acetonide 40 mg/cc / cm3. The maximum size of Keloid is 15 cm per patient.', 'interventionNames': ['Biological: Triamcinolone Acetonide']}], 'interventions': [{'name': 'Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium', 'type': 'BIOLOGICAL', 'description': 'Injection of Allogeneic Umbilical Cord Mesenchymal Stem Cells 2 million cell/cm3 in Nacl 1 cc/million cell and booster with Conditioned Medium 1 cc/cm3 in 3 weeks later. All treatment via intralesional injection. The maximum size of the keloid is 15 cm.', 'armGroupLabels': ['UC-MSCs + CM']}, {'name': 'Conditioned Medium', 'type': 'BIOLOGICAL', 'otherNames': ['Secretome'], 'description': 'Injection of Conditioned Medium 1 cc/cm3 and booster with Conditioned Medium 1 cc/cm3 in 3 weeks later. All treatment via intralesional injection. The maximum size of the keloid is 15 cm.', 'armGroupLabels': ['CM + CM', 'UC-MSCs + CM']}, {'name': 'Triamcinolone Acetonide', 'type': 'BIOLOGICAL', 'description': 'Injection of Triamcinolone Acetonide 40 mg/cc/cm3 and booster in 3 weeks later. All treatment via intralesional injection. The maximum size of the keloid is 15 cm.', 'armGroupLabels': ['Triamcinolon acetonide']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Anastasia Dessy Harsono, Master', 'role': 'CONTACT', 'email': 'anastasia.bedahplastik@gmail.com', 'phone': '087888363270'}, {'name': 'Cynthia Retna Sartika, Doctor', 'role': 'CONTACT', 'email': 'c.sartika@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT. Prodia Stem Cell Indonesia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}