Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-28 @ 7:26 AM
Study NCT ID:
NCT04528550
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2020-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A 2:1 ratio of randomization (intervention group: control group) was used.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-05', 'studyFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Spinal Injury Association (ASIA) Impairment Scale', 'timeFrame': 'baseline, 1 month, 3 months, 6 months and 12 months post-treatment', 'description': "Change in sensory and motor function as measured by the American Spinal Injury Association (ASIA) Impairment Scale. The ASIA Impairment Scale describes a person's functional impairment (both motor and sensory) as a result of their spinal cord injury. The scale has 5 levels, ranging from A (complete) to E (normal)."}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': '1 month post-treatment', 'description': 'Any abnormal signs, symptoms, findings, or diseases that emerge or worsen relative to baseline in 1 month post-treatment will be recorded as adverse event'}, {'measure': 'Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test', 'timeFrame': 'baseline, 3 months, 6 months and 12 months post-treatment', 'description': 'Change in sensory and motor function will be measured by SSEP and MED test'}, {'measure': 'Residual urine test', 'timeFrame': 'baseline, 3 months, 6 months and 12 months post-treatment', 'description': 'Change in residual urine as measured by ultrasound test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of intrathecal transplantation of autologous bone marrow-derived mononuclear cells for the treatment of traumatic acute spinal cord injury. Spinal cord injury can be divided into three phases, which are acute (within 2 weeks), sub-acute (2 weeks to 6 months), and chronic (over 6 months). Early treatment is the key to improve the prognosis, however, the majority of clinic trails nowadays are focusing on sub-acute or chronic phase because it takes 4-6 weeks to expand the autologous stem cells. In this study, the investigators will treat patients with acute spinal cord injury with autologous bone marrow-derived mononuclear cells and compare with the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 60 years\n* Traumatic spinal cord injury\n* ASIA Impairment Scale A-D\n* The injury must be within two weeks\n* Patients submitted written informed consent\n\nExclusion Criteria:\n\n* Traumatic spinal cord injury with brain injury or peripheral nerve injury\n* Patients with severe multiple injuries and unstable vital signs\n* Non-traumatic spinal cord injury caused by spinal tumors, hematoma, myelitis, etc.\n* Patients with central spinal cord injury\n* Patients with a completely transected spinal cord\n* Patients with fever or acute infection\n* Ongoing infectious disease, such as tuberculosis, HIV, hepatitis, syphilis, etc.\n* Patients with anemia, coagulopathy, and other known blood system diseases\n* Patients with malignant tumour\n* Patients with neurodegenerative diseases, or any neuropathies\n* Patients with ankylosing spondylitis\n* Patients with a previous history of spinal surgery\n* Patients who are pregnant or possibly pregnant\n* Patients with psychiatric, addictive or any other mental disorders that can not give a truly informed consent\n* Patients who are participating in other clinical trials'}, 'identificationModule': {'nctId': 'NCT04528550', 'briefTitle': 'Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'Intrathecal Transplantation of Autologous Bone Marrow-derived Mononuclear Cells for Treating Traumatic Acute Spinal Cord Injury', 'orgStudyIdInfo': {'id': '202082201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autologous bone marrow-derived mononuclear cells', 'description': 'Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection in acute phase. Each included patient will receive a single dose of 100 million autologous bone marrow-derived mononuclear cells.', 'interventionNames': ['Biological: Autologous bone marrow-derived mononuclear cells']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Included patients will receive the same amount of saline through lumbar injection.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Autologous bone marrow-derived mononuclear cells', 'type': 'BIOLOGICAL', 'description': 'Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection.', 'armGroupLabels': ['Autologous bone marrow-derived mononuclear cells']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Included patients will receive the same amount of saline through lumbar injection.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200003', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoguang Li, M.D.', 'role': 'CONTACT', 'email': 'Chzhhospital@163.com', 'phone': '86-21-81885045'}], 'facility': 'Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xuhua Lu, M.D.', 'role': 'CONTACT', 'email': 'xuhualu@hotmail.com', 'phone': '86-21-81885793'}, {'name': 'Bangke Zhang, M.D.', 'role': 'CONTACT', 'email': 'zbk12345@163.com', 'phone': '8618301783716'}], 'overallOfficials': [{'name': 'Xuhua Lu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Changzheng Hospotal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Traumatic Orthopaedic Department', 'investigatorFullName': 'Xuhua Lu', 'investigatorAffiliation': 'Shanghai Changzheng Hospital'}}}}