Stem Cell Therapy for Amyotrophic Lateral Sclerosis

NCT ID: NCT01984814

Last Updated: 2018-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stem cell

Autologous bone marrow mononuclear cells intrathecal and intramuscular transplantation

Group Type EXPERIMENTAL

Stem cell

Intervention Type BIOLOGICAL

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

Control

No cell transplantation was done

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stem cell

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

26 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurogen Brain and Spine Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alok K Sharma, MS,MCh

Role: PRINCIPAL_INVESTIGATOR

Neurogen Brain and Spine Institute

Locations

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Neurogen brain and spine institute

Mumbai, Maharashtra, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 23860588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19012065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22415951 (View on PubMed)

Related Links

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http://www.alsa.org/

The Amyotrophic lateral sclerosis association encourages scientific research to find a cure for ALS and heightens awareness of the nature of the disease.

Other Identifiers

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NGBSI-04

Identifier Type: -

Identifier Source: org_study_id

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