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Stem Cell Therapy for Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01984814
Recruitment Status : Withdrawn
First Posted : November 15, 2013
Last Update Posted : October 25, 2018
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

Brief Summary:
The effect of autologous bone marrow mononuclear cells on duration of survival in Amyotrophic Lateral Sclerosis patients.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Biological: Stem cell Phase 2

Detailed Description:
Survival duration in Amyotrophic Lateral Sclerosis patients who received cellular transplantation was compared to patients who did not receive cellular transplantation. Kaplan-Meier survival analysis was used for this comparison.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on the Survival Duration in Amyotrophic Lateral Sclerosis - A Retrospective Control Study
Study Start Date : December 2008
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: Stem cell
Autologous bone marrow mononuclear cells intrathecal and intramuscular transplantation
Biological: Stem cell
Autologous bone marrow derived mononuclear cells were administered via intrathecal and intramuscular routes.

No Intervention: Control
No cell transplantation was done

Primary Outcome Measures :
  1. Duration of survival [ Time Frame: 56 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with the diagnoses of definite amyotrophic lateral sclerosis.
  • Clear information about date of onset of symptoms, documented contact information and follow up information

Exclusion Criteria:

  • Patients with diagnoses of Progressive Lateral sclerosis, Progressive bulbar plasy, Progressive spinal muscular atrophy, Progressive muscular atrophy, monomelicamyotrophy or madras motor neuron disease.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01984814

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Neurogen brain and spine institute
Mumbai, Maharashtra, India, 400071
Sponsors and Collaborators
Neurogen Brain and Spine Institute
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Principal Investigator: Alok K Sharma, MS,MCh Neurogen Brain and Spine Institute

Additional Information:
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Responsible Party: Neurogen Brain and Spine Institute Identifier: NCT01984814    
Other Study ID Numbers: NGBSI-04
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases