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Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Withdrawn
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Stem Cell
Sponsored by
Neurogen Brain and Spine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Autologous Mononuclear Cell therapy, Stem cells

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurogen brain and spine institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell

Arm Description

bone marrow mononuclear cell transplantation

Outcomes

Primary Outcome Measures

Amyotrophic Lateral Sclerosis Functional rating scale-revised

Secondary Outcome Measures

Full Information

First Posted
September 12, 2014
Last Updated
October 23, 2018
Sponsor
Neurogen Brain and Spine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02242071
Brief Title
Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis
Official Title
The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on Motor Neuron Disease/Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurogen Brain and Spine Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Autologous Mononuclear Cell therapy, Stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem Cell
Arm Type
Experimental
Arm Description
bone marrow mononuclear cell transplantation
Intervention Type
Biological
Intervention Name(s)
Stem Cell
Intervention Description
intrathecal autologous bone marrow mononuclear cell transplantation
Primary Outcome Measure Information:
Title
Amyotrophic Lateral Sclerosis Functional rating scale-revised
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Neurogen brain and spine institute
City
Navi Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400706
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis

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