Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT04499105
Status:
UNKNOWN
Last Update Posted:
2020-08-06
First Post:
2020-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-04', 'studyFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2020-07-30', 'lastUpdatePostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of Low Back Pain', 'timeFrame': '6 months', 'description': 'Evaluates pain quality using Visual Analog Scale (VAS) from 0 - 10. Zero is no pain at all, one is the the least pain and ten is the most painful. The numbers are expected to be lower after MSC implantation.'}, {'measure': 'Tissue Improvement', 'timeFrame': '6 months', 'description': 'Tissue improvement confirmed by intervertebral disc MRI'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DDD', 'MSC'], 'conditions': ['Degenerative Disc Disease', 'Low Back Pain', 'Disc Degeneration']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectivity and safety of MSC implantation on Degenerative Disc Disease Patients by assessing visual analog scale, ROM improvement and MRI examination.', 'detailedDescription': 'The team plan to conduct research to look at the effectiveness and safety of mesenchymal stem cell implantation therapy in intervertebral disc degeneration patients.\n\nThe use of allogenic mesenchymal stem cells from the umbilical cord was chosen because patients with degeneration of the intervertebral disc are elderly (over 50 years old) so that autologous mesenchymal stem cell administration is not possible in terms of taking the source of cells (bone marrow) nor the quality of mesenchymal stem cells obtained.\n\nThis study will assess the improvement of clinical symptoms (VAS to assess pain scale, ASIA and Frankel scale, as well as assessment of the widening of the lumbar region using the Schober Test), changes in the structure of the intervertebral discs (through MRI examination and grading the degree of intervertebral disc degeneration), conduction function spinal cord nerve (somatosensory evoked potential / SSEP), myelography / EMG, and assessment of the quality of life status of patients using the Oswestry Disability Index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.\n2. No history of metabolic, autoimun and genetic disease(s).\n3. No active infection (HbsAg, HIV, CMV, Rubella).\n4. Agree to participate the study by signing informed consent form.\n\nExclusion Criteria:\n\n1. Patients under 20 years old.\n2. Declined to participate in the study.'}, 'identificationModule': {'nctId': 'NCT04499105', 'acronym': 'MSC', 'briefTitle': 'Effectiveness and Safety of Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Effectiveness and Safety of Allogenic Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients (Clinical Trial)', 'orgStudyIdInfo': {'id': '17-02-0143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesenchymal Stem Cell', 'description': 'Mesenchymal Stem cell + Nacl 0.9%', 'interventionNames': ['Drug: Mesenchymal Stem Cell + NaCl 0,9% 2ml']}], 'interventions': [{'name': 'Mesenchymal Stem Cell + NaCl 0,9% 2ml', 'type': 'DRUG', 'description': 'Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.', 'armGroupLabels': ['Mesenchymal Stem Cell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Ahmad Jabir Rahyussalim, MD,PhD,SpOT', 'role': 'CONTACT', 'email': 'rahyussalim71@ui.ac.id', 'phone': '+62811819466'}, {'name': 'Trie K Kurniawati, SSi', 'role': 'CONTACT', 'email': 'trie3k@ui.ac.id', 'phone': '+628121134311'}, {'name': 'Ahmad Jabir Rahyussalim, MD,PhD,SpOT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Ahmad Jabir Rahyussalim, PhD, SpOT(K)', 'role': 'CONTACT', 'email': 'rahyussalim71@ui.ac.id', 'phone': '+62811819466'}, {'name': 'Tri Kurniawati, S.Si', 'role': 'CONTACT', 'email': 'trie3k@ui.ac.id', 'phone': '+628121134311'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmad Jabir Rahyussalim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. dr. Rahyussalim SpOT(K)', 'investigatorFullName': 'Ahmad Jabir Rahyussalim', 'investigatorAffiliation': 'Indonesia University'}}}}