Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-04 @ 3:29 PM
Study NCT ID:
NCT05921058
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2023-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089282', 'term': 'Secretome'}], 'ancestors': [{'id': 'D055442', 'term': 'Metabolome'}, {'id': 'D008660', 'term': 'Metabolism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Mesenchymal stem cell placebo and secretome using injections that are similar in shape and color'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was divided into two groups, namely, control and treatment. Both received intervention in the form of a 1.5 cc injection on the scheduled day'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-25', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-06-25', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lupus Disease activity', 'timeFrame': 'Change of Lupus Disease Activity at 1 months', 'description': 'The data collected were MEX SLEDAI score (range 0-32) before and after therapy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Messenchymal Stem Cell Secretome', 'Lupus'], 'conditions': ['Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '34912736', 'type': 'RESULT', 'citation': 'Pratama YS, Pradiptakirana R, Rachmah A, Prabowo NA. Autoimmune Thrombocytopenia in SLE and COVID-19. Eur J Case Rep Intern Med. 2021 Nov 3;8(11):002863. doi: 10.12890/2021_002863. eCollection 2021.'}, {'pmid': '34181079', 'type': 'RESULT', 'citation': 'Sholihah MM, Kusuma TRH, Hanif MI, Prabowo NA. Letter to the Editor on Type 1 diabetes onset triggered by COVID-19. Acta Diabetol. 2021 Sep;58(9):1283-1284. doi: 10.1007/s00592-021-01761-3. Epub 2021 Jun 28. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This research is a clinical trial of administering mesenchymal stem cell secretome to lupus patients.', 'detailedDescription': 'This research is experimental. The study was conducted on 30 SLE patient subjects. the treatment group who got the mesenchymal stem cell secretome on the 1st, 2nd day, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th days. ESR, hs-CRP, C3, C4, interlukin 6, anti-ds-DNA antibody, MEX SLEDAI score, and assessment of drug side effects before and after therapy were collected. Statistical test with paired difference test with p \\< 0.05'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lupus paatients\n\nExclusion Criteria:\n\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05921058', 'briefTitle': 'The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Sebelas Maret'}, 'officialTitle': 'The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients', 'orgStudyIdInfo': {'id': 'NAP05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Messenchymal stem cell secretome', 'description': 'The hypoxic mesenchymal stem cell secretome has been developed up to chapter 7, stored at -196 C to -135 C in cryopreservation, and has passed quality tests.', 'interventionNames': ['Drug: Secretome']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Nacl 0,9% infusion', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Secretome', 'type': 'DRUG', 'otherNames': ['Messenchymal stem cell Concitioned Media'], 'description': 'Mesenchymal stem cell secretome obtained from Kalbe Pharma Company', 'armGroupLabels': ['Messenchymal stem cell secretome']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['NaCl 0,9% infusion'], 'description': 'NaCl 0,9% infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Surakarta', 'state': 'Middle Java', 'country': 'Indonesia', 'facility': 'Moewardi General Hospital', 'geoPoint': {'lat': -7.55611, 'lon': 110.83167}}], 'overallOfficials': [{'name': 'Nurhasan Agung Prabowo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitas Sebelas Maret'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Sebelas Maret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. Ph.D', 'investigatorFullName': 'Arief Nurudhin', 'investigatorAffiliation': 'Universitas Sebelas Maret'}}}}