Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-26 @ 9:27 AM
Study NCT ID:
NCT01834066
Status:
UNKNOWN
Last Update Posted:
2014-09-17
First Post:
2013-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Muscular Dystrophy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}], 'ancestors': [{'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-16', 'studyFirstSubmitDate': '2013-02-26', 'studyFirstSubmitQcDate': '2013-04-15', 'lastUpdatePostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significant Improvement in Muscle strength by using Kinetics Muscle testing or by using MMT( manual muscle test }score', 'timeFrame': '6 Months'}], 'secondaryOutcomes': [{'measure': '-Improvement of daily living scale and baseline in EMG(electromyography)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['muscular Dystrophy stem cell'], 'conditions': ['Muscular Dystrophy', 'Duchenne Muscular Dystrophy,']}, 'descriptionModule': {'briefSummary': 'This Study is single arm, single centre trial to check the safety and efficacy of Bone Marrow derived autologous cell(100 million per dose) for the patient with Duchenne Muscular Dystrophy.', 'detailedDescription': 'Muscular dystrophy is a group of inherited disorders that involve muscle weakness and loss of muscle tissue, which get worse over time. Duchenne muscular dystrophy is caused by a defective gene for dystrophin (a protein in the muscles). However, it often occurs in people without a known family history of the condition. slowly progress diseases.it causes Muscle weaknesses, Difficulty with motor skills ,Progressive difficulty walking.Breathing difficulties and heart disease,Frequent falls,weak limbs,lose motor Function.Begins in the legs and pelvis, but also occurs less severely in the arms, neck, and other areas of the body.Trouble getting up from a lying position or climbing stairs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with Diagnose of Duchenne Muscular Dystrophy.\n* Aged in between 6 to 25 Years.\n* Willingness to undergo Bone Marrow derived Autologous cell Therapy.\n* Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.\n* Ability and willingness to regular visit to hospital for protocol procedures and follow up\n\nExclusion Criteria:\n\n* Patient who is not Diagnose of Duchenne Muscular Dystrophy.\n* Patient with History of Immunodeficiency HIV+,Hepatitis B ,HBV and TPPA+,Tumor Markers+\n* History of Life threatening allergic or immune -Mediated Reaction.\n* the site of bone marrow aspiration potentially limiting Procedure.\n* Alcohol and drug abuse / dependence.\n* Patients with History of Hypertension and Hypersensitive.'}, 'identificationModule': {'nctId': 'NCT01834066', 'acronym': 'mdp', 'briefTitle': 'Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Muscular Dystrophy.', 'organization': {'class': 'OTHER', 'fullName': 'Chaitanya Hospital, Pune'}, 'officialTitle': "Safety and Efficacy of Bone Marrow Autologous Cells in Muscular Dystrophy. It is Self Funded (Patients' Own Funding) Clinical Trial", 'orgStudyIdInfo': {'id': '00101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'STEM CELL', 'description': 'Intra thecal transplantation of autologous Stem Cell MNCs', 'interventionNames': ['Biological: Stem Cell']}], 'interventions': [{'name': 'Stem Cell', 'type': 'BIOLOGICAL', 'otherNames': ['Intravenous transfer of Autologous Stem Cell ( MNCs )'], 'description': 'Intralesional transfer of Autologous Stem cell (MNCs) per dose. 6 doses in 3 months', 'armGroupLabels': ['STEM CELL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '411009', 'city': 'Pune', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Sachin P Jamadar, D ORTHO', 'role': 'CONTACT', 'email': 'sac2751982@gmail.com', 'phone': '+918888788880'}, {'name': 'ANANT E BAGUL, MS ORTHO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chaitnany Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}], 'centralContacts': [{'name': 'Sachin P Jamadar, D.Ortho', 'role': 'CONTACT', 'email': 'sac2751982@gmail.com', 'phone': '+918888788880'}], 'overallOfficials': [{'name': 'ANANT E BAGUL, MS ORTHO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHAITANYA HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chaitanya Hospital, Pune', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'C0- Investigator', 'investigatorFullName': 'Dr. Sachin Jamadar', 'investigatorAffiliation': 'Chaitanya Hospital, Pune'}}}}