Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2008-12-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stem cell
Autologous bone marrow mononuclear cells intrathecal and intramuscular transplantation
Stem cell
Autologous bone marrow derived mononuclear cells were administered via intrathecal and intramuscular routes.
Control
No cell transplantation was done
No interventions assigned to this group
Interventions
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Stem cell
Autologous bone marrow derived mononuclear cells were administered via intrathecal and intramuscular routes.
Eligibility Criteria
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Inclusion Criteria
* Clear information about date of onset of symptoms, documented contact information and follow up information
Exclusion Criteria
* patients with co-morbidities like presence of acute infections such as Human Immunodeficiency Virus/Hepatitis B Virus/Hepatitis C Virus, malignancies, bleeding tendencies, renal failure, severe liver dysfunction and other acute medical conditions such as respiratory infection and pyrexia.
26 Years
76 Years
ALL
No
Sponsors
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Neurogen Brain and Spine Institute
OTHER
Responsible Party
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Principal Investigators
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Alok K Sharma, MS,MCh
Role: PRINCIPAL_INVESTIGATOR
Neurogen Brain and Spine Institute
Locations
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Neurogen brain and spine institute
Mumbai, Maharashtra, India
Countries
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References
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Chio A, Logroscino G, Traynor BJ, Collins J, Simeone JC, Goldstein LA, White LA. Global epidemiology of amyotrophic lateral sclerosis: a systematic review of the published literature. Neuroepidemiology. 2013;41(2):118-30. doi: 10.1159/000351153. Epub 2013 Jul 11.
Deda H, Inci MC, Kurekci AE, Sav A, Kayihan K, Ozgun E, Ustunsoy GE, Kocabay S. Treatment of amyotrophic lateral sclerosis patients by autologous bone marrow-derived hematopoietic stem cell transplantation: a 1-year follow-up. Cytotherapy. 2009;11(1):18-25. doi: 10.1080/14653240802549470.
Blanquer M, Moraleda JM, Iniesta F, Gomez-Espuch J, Meca-Lallana J, Villaverde R, Perez-Espejo MA, Ruiz-Lopez FJ, Garcia Santos JM, Bleda P, Izura V, Saez M, De Mingo P, Vivancos L, Carles R, Jimenez J, Hernandez J, Guardiola J, Del Rio ST, Antunez C, De la Rosa P, Majado MJ, Sanchez-Salinas A, Lopez J, Martinez-Lage JF, Martinez S. Neurotrophic bone marrow cellular nests prevent spinal motoneuron degeneration in amyotrophic lateral sclerosis patients: a pilot safety study. Stem Cells. 2012 Jun;30(6):1277-85. doi: 10.1002/stem.1080.
Related Links
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The Amyotrophic lateral sclerosis association encourages scientific research to find a cure for ALS and heightens awareness of the nature of the disease.
Other Identifiers
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NGBSI-04
Identifier Type: -
Identifier Source: org_study_id
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