Stem Cell Therapy for Amyotrophic Lateral Sclerosis

NCT01984814 | Withdrawn Phase 2 DMC

• 1 other identifier: NGBSI-04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Duration of survival

  56 months

Study Arms (2)

Stem cell

EXPERIMENTAL

Autologous bone marrow mononuclear cells intrathecal and intramuscular transplantation

Biological: Stem cell

Control

NO INTERVENTION

No cell transplantation was done

Interventions

Stem cell BIOLOGICAL

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

Stem cell

Eligibility Criteria

• Age: 26 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the diagnoses of definite amyotrophic lateral sclerosis.
• Clear information about date of onset of symptoms, documented contact information and follow up information

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurogen Brain and Spine Institute: lead

Study Sites (1)

Neurogen brain and spine institute

Mumbai, Maharashtra, 400071, India

Location

Related Publications (3)

• 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.

  PMID: 23860588 BACKGROUND

• 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.

  PMID: 19012065 BACKGROUND

• 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.

  PMID: 22415951 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alok K Sharma, MS,MCh

  Neurogen Brain and Spine Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 15, 2013
• Study Start: December 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 25, 2018

Record last verified: 2018-10

Locations

IN (1)