Back to resultsStem Cell Therapy for Amyotrophic Lateral Sclerosis
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Withdrawn
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Stem cell
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
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.
Sites / Locations
- Neurogen brain and spine institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Stem cell
Control
Arm Description
Autologous bone marrow mononuclear cells intrathecal and intramuscular transplantation
No cell transplantation was done
Outcomes
Primary Outcome Measures
Duration of survival
Secondary Outcome Measures
Full Information
NCT ID
NCT01984814
First Posted
November 8, 2013
Last Updated
October 23, 2018
Sponsor
Neurogen Brain and Spine Institute
1. Study Identification
Unique Protocol Identification Number
NCT01984814
Brief Title
Stem Cell Therapy for Amyotrophic Lateral Sclerosis
Official Title
The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on the Survival Duration in Amyotrophic Lateral Sclerosis - A Retrospective Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stem cell
Arm Type
Experimental
Arm Description
Autologous bone marrow mononuclear cells intrathecal and intramuscular transplantation
Arm Title
Control
Arm Type
No Intervention
Arm Description
No cell transplantation was done
Intervention Type
Biological
Intervention Name(s)
Stem cell
Intervention Description
Autologous bone marrow derived mononuclear cells were administered via intrathecal and intramuscular routes.
Primary Outcome Measure Information:
Title
Duration of survival
Time Frame
56 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alok K Sharma, MS,MCh
Organizational Affiliation
Neurogen Brain and Spine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurogen brain and spine institute
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400071
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
23860588
Citation
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.
Results Reference
background
PubMed Identifier
19012065
Citation
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.
Results Reference
background
PubMed Identifier
22415951
Citation
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.
Results Reference
background
Links:
URL
http://www.alsa.org/
Description
The Amyotrophic lateral sclerosis association encourages scientific research to find a cure for ALS and heightens awareness of the nature of the disease.
Learn more about this trial
Stem Cell Therapy for Amyotrophic Lateral Sclerosis
We'll reach out to this number within 24 hrs