Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT03067857
Status:
UNKNOWN
Last Update Posted:
2018-06-06
First Post:
2017-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}, {'id': 'D010244', 'term': 'Bulbar Palsy, Progressive'}], 'ancestors': [{'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-04', 'studyFirstSubmitDate': '2017-02-25', 'studyFirstSubmitQcDate': '2017-02-28', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Functional Rating Scale - via questionnaire', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change in Appel Scale', 'timeFrame': '4 months'}, {'measure': 'Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)', 'timeFrame': '4 months'}, {'measure': 'Change in Forced Vital Capacity (FVC)', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Motor Neuron Disease', 'Amyotrophic Lateral Sclerosis', 'Primary Lateral Sclerosis', 'Progressive Muscular Atrophy', 'Progressive Bulbar Palsies']}, 'descriptionModule': {'briefSummary': 'Herein, the investigators study the safety and efficacy of transplanting purified autologous bone marrow-derived stem cells transplanted via the intrathecal route by interventional radiology and the intravenous route.', 'detailedDescription': 'A motor neuron disease (MND) is any of several neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. They include amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), progressive muscular atrophy (PMA), progressive bulbar palsy (PBP) and pseudobulbar palsy; spinal muscular atrophies are also sometimes included in the group.They are neurodegenerative diseases that cause increasing disability and eventually, death.\n\nIn spite of intensive research, motor neuron diseases (MNDs) are still incurable. Some of the key factors in this failure to find a cure have been the lack of human cell-based disease models for molecular analysis and drug screening and the difficulty of obtaining homogeneous populations of specific cell types for clinical applications. Stem cell biology has the potential to transform our understanding of disease processes and to revolutionize our approach to develop novel therapies for MNDs.\n\nIn this study, the investigators suggest a protocol for the treatment of MND by transplantation of purified autologous bone marrow-derived stem cells via the intrathecal and intravenous route.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '24 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age 24-20 years old\n* Patients with the diagnosis of definite Motor Neuron Disease\n\nExclusion Criteria:\n\n* HIV/HBV/HCV\n* Malignancies\n* Bleeding\n* Pneumonia\n* Renal failure\n* liver dysfunction\n* Severe anemia (hb \\< 8)\n* Bone Marrow diseases\n* Pregnancy and lactation\n* Acute medical conditions/infections such as respiratory infections\n* ventilatory support'}, 'identificationModule': {'nctId': 'NCT03067857', 'briefTitle': 'Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease', 'organization': {'class': 'OTHER', 'fullName': 'Stem Cells Arabia'}, 'officialTitle': 'Autologous Purified Bone-Marrow-Derived Stem Cell Therapy for Motor Neuron Disease', 'orgStudyIdInfo': {'id': 'SCA-MND1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stem Cells', 'description': 'Intravenous and Intrathecal thecal transplantation via interventional radiology of purified autologous bone-marrow derived specific stem cell populations.', 'interventionNames': ['Biological: Stem Cells']}], 'interventions': [{'name': 'Stem Cells', 'type': 'BIOLOGICAL', 'description': 'Autologous bone marrow-derived stem cell populations injected via the intravenous and intrathecal routes.', 'armGroupLabels': ['Stem Cells']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stem Cells Arabia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}