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Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT02242071
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

Brief Summary:
The effect of autologous bone marrow mononuclear cells on Motor Neuron Disease/Amyotrophic Lateral Sclerosis patients.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Biological: Stem Cell Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on Motor Neuron Disease/Amyotrophic Lateral Sclerosis
Study Start Date : December 2008
Actual Primary Completion Date : March 2015
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Experimental: Stem Cell
bone marrow mononuclear cell transplantation
Biological: Stem Cell
intrathecal autologous bone marrow mononuclear cell transplantation




Primary Outcome Measures :
  1. Amyotrophic Lateral Sclerosis Functional rating scale-revised [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with the diagnosis of definite Motor Neuron Disease/amyotrophic lateral sclerosis.
  • Age 18-80 years

Exclusion Criteria:

  • HIV/HBV/HCV
  • Malignancies
  • Bleeding tendencies
  • Pneumonia
  • Renal failure
  • Severe liver dysfunction
  • Severe anemia [hb < 8]
  • Any bone marrow disorder
  • Space occupying lesion in brain
  • Pregnancy and lactation
  • Other acute medical conditions/infections such as respiratory infection and pyrexia
  • left ventricular ejection fraction < 25%
  • Patient on artificial ventilatory support

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 ClinicalTrials.gov identifier (NCT number): NCT02242071


Locations
India
Neurogen brain and spine institute
Navi Mumbai, Maharashtra, India, 400706
Sponsors and Collaborators
Neurogen Brain and Spine Institute

Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02242071     History of Changes
Other Study ID Numbers: NGBSI-10
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Neurogen Brain and Spine Institute:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Autologous Mononuclear Cell therapy
Stem cells

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases