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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.
 
ClinicalTrials.gov Identifier: NCT01984814
Recruitment Status : Withdrawn
First Posted : November 15, 2013
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

Tracking Information
First Submitted Date  ICMJE November 8, 2013
First Posted Date  ICMJE November 15, 2013
Last Update Posted Date October 25, 2018
Study Start Date  ICMJE December 2008
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2013)
Duration of survival [ Time Frame: 56 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01984814 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Therapy for Amyotrophic Lateral Sclerosis
Official Title  ICMJE The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on the Survival Duration in Amyotrophic Lateral Sclerosis - A Retrospective Control Study
Brief Summary The effect of autologous bone marrow mononuclear cells on duration of survival in Amyotrophic Lateral Sclerosis patients.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE Biological: Stem cell
Autologous bone marrow derived mononuclear cells were administered via intrathecal and intramuscular routes.
Study Arms  ICMJE
  • Experimental: Stem cell
    Autologous bone marrow mononuclear cells intrathecal and intramuscular transplantation
    Intervention: Biological: Stem cell
  • No Intervention: Control
    No cell transplantation was done
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 23, 2018)
0
Original Actual Enrollment  ICMJE
 (submitted: November 14, 2013)
57
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 26 Years to 76 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01984814
Other Study ID Numbers  ICMJE NGBSI-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neurogen Brain and Spine Institute
Study Sponsor  ICMJE Neurogen Brain and Spine Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alok K Sharma, MS,MCh Neurogen Brain and Spine Institute
PRS Account Neurogen Brain and Spine Institute
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP