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WithdrawnNCT01984814Updated Oct 25, 2018

Stem Cell Therapy for Amyotrophic Lateral Sclerosis

A Phase 2 interventional study of Stem cell in Amyotrophic Lateral Sclerosis, sponsored by Neurogen Brain and Spine Institute. Withdrawn at 1 site in India. Open to participants aged 26 Years to 76 Years. Per ClinicalTrials.gov, last updated 2018-10-25.

Sponsored by Neurogen Brain and Spine Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
26 Years to 76 Years
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Amyotrophic Lateral Sclerosis
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

Browse Motor Neuron Disease studies →

Lead sponsor

Neurogen Brain and Spine Institute is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
26 Years to 76 Years
Sexes eligible
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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Stem cell

    Autologous bone marrow mononuclear cells intrathecal and intramuscular transplantation

    Biological: Stem cell

  • No intervention
    Control

    No cell transplantation was done

Interventions

  • BiologicalStem cell

    Autologous bone marrow derived mononuclear cells were administered via intrathecal and intramuscular routes.

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What researchers measure

Primary outcomes

  1. Duration of survival

    Time frame: 56 months

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Study locations

1 site
  • Neurogen brain and spine institute
    Mumbai, Maharashtra 400071, India
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References and documents

Publications

  • 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. PubMed 23860588 ↗
  • 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. PubMed 19012065 ↗
  • 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. PubMed 22415951 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01984814
Lead sponsor
Neurogen Brain and Spine Institute
Responsible party
Sponsor
First posted
Nov 15, 2013
Start date
Dec 2008
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Oct 25, 2018

Study contacts

Alok K Sharma, MS,MCh
principal investigator · Neurogen Brain and Spine Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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