Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT05122234
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2021-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-13', 'studyFirstSubmitDate': '2021-11-13', 'studyFirstSubmitQcDate': '2021-11-13', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of inflamation marker levels', 'timeFrame': 'Day 0 (before intervention), day 7, day 14', 'description': 'The inflamatory marker assessed in this study is IL-6, IL-10, LIF, VEGF, and Ferritin. The inflamatory marker level will assess on day 0 (before intervention), day 7 after intervention, and day 14 after intervention.'}], 'secondaryOutcomes': [{'measure': 'Assessment of clinical outcome', 'timeFrame': 'before and after intervention (maximum 14 days after intervention)', 'description': 'Clinical outcome assessed in this study were body temperature, oxygen saturation, respiratory rate, shortness of breath, cough, and phlegm on cough.'}, {'measure': 'Assessment of laboratory routine', 'timeFrame': 'before and after intervention (maximum 14 days after intervention)', 'description': 'Laboratory routine assessed in this study is NLR, lymphocyte count, thrombocytes count, CRP, blood gas analysis, bilirubin, albumin, SGOT, SGPT, ureum/creatinin, glomerular filtration rate (GFR), electrolyte, myoglobin, troponin, D-dimer.'}, {'measure': 'Assessment of photo thorax', 'timeFrame': 'before and after intervention (maximum 14 days after intervention)', 'description': 'Photo thorax will assess before and after intervention'}, {'measure': 'Assessment of RT-PCR conversion', 'timeFrame': 'before and after intervention (maximum 14 days after intervention)', 'description': 'RT-PCR conversion will assess before and after intervention'}, {'measure': 'Mortality rate', 'timeFrame': 'maximum 14 days after intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe Covid-19', 'secretome', 'mesenchymal stem cell', 'cytokine'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study is a multi-centre randomized controlled trial involving severe covid-19 patients. The intervention group will receive mesenchymal stem cell secretomes and standard covid-19 therapy, while the control group receive placebo and standard covid-19 therapy. Clinical presentation, inflamatory marker, laboratory and radiological parameters, RT-PCR conversion, safety profile, and mortality rate will be monitored for a maximum of 14 days after intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All individuals aged 18 to 65 years\n2. It has been confirmed positive for COVID-19 by throat swab / sputum / brochoalveolar lavage (BAL) with real-time reverse transcription polymerase chain reaction (RT-PCR)\n3. Categorized as a severe case of COVID-19 patient\n4. Agree to participate and sign the informed consent\n\nExclusion Criteria:\n\n1. History of allergy to penicillin, streptomycin, and amphotericin-B\n2. Have any cancer conditions\n3. Active in other intervention studies\n4. Have had other intervention studies in the last 3 months'}, 'identificationModule': {'nctId': 'NCT05122234', 'briefTitle': 'Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Effectiveness and Safety Profile of Mesenchymal Stem Cell Secretomes as a Treatment for Severe Cases of COVID-19', 'orgStudyIdInfo': {'id': '54/FI/P-KCOVID-19.2B3/IX/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Secretome - mesenchymal stem cell group (n = 20)', 'description': 'This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy', 'interventionNames': ['Biological: Injection of secretome - mesenchymal stem cell', 'Drug: Standard treatment of Covid-19']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control ( n= 20)', 'description': 'This group will be given placebo and COVID-19 standard therapy', 'interventionNames': ['Other: Placebo', 'Drug: Standard treatment of Covid-19']}], 'interventions': [{'name': 'Injection of secretome - mesenchymal stem cell', 'type': 'BIOLOGICAL', 'description': 'Secretome will be given once at a dose of 15 ml per administration dissolved in 100 ml of normal saline. The administration is done intravenously for 60 minutes.', 'armGroupLabels': ['Secretome - mesenchymal stem cell group (n = 20)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Normal saline', 'armGroupLabels': ['Control ( n= 20)']}, {'name': 'Standard treatment of Covid-19', 'type': 'DRUG', 'description': 'Standard treatment of Covid-19 based on national protocol.', 'armGroupLabels': ['Control ( n= 20)', 'Secretome - mesenchymal stem cell group (n = 20)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'RSUP Fatmawati', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'RSUP Persahabatan', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'RSUPN Dr. Cipto Mangunkusumo', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}, {'city': 'Depok', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Rumah Sakit Universitas Indonesia', 'geoPoint': {'lat': -6.4, 'lon': 106.81861}}], 'overallOfficials': [{'name': 'Murdani Abdullah, Prof. M.D., PhD, FACG, FASGE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departemen of Internal Medicine, Faculty of Medicine, University of Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. M.D., PhD, FACG, FASGE', 'investigatorFullName': 'Murdani abdullah', 'investigatorAffiliation': 'Indonesia University'}}}}