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Stem Cell Therapy for Amyotrophic Lateral Sclerosis

N

Neurogen Brain and Spine Institute

Status and phase

Withdrawn
Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Biological: Stem cell

Study type

Interventional

Funder types

Other

Identifiers

NCT01984814
NGBSI-04

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

26 to 76 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Stem cell
Experimental group
Description:
Autologous bone marrow mononuclear cells intrathecal and intramuscular transplantation
Treatment:
Biological: Stem cell
Control
No Intervention group
Description:
No cell transplantation was done

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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