Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis

NCT00855400 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2010-12-02

No results posted yet for this study

Summary

The purpose of this clinical trial is to asses the feasibility and the security of the intraspinal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis patients.

Conditions

Interventions

PROCEDURE

Laminectomy and bone marrow stem cells transplantation

T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation

PROCEDURE

Autologous bone marrow cells collection

Autologous bone marrow cells collection under sedation. Sixty mL are obtained and processed through a ficoll gradient.

Sponsors & Collaborators

  • Carlos III Health Institute

    collaborator OTHER_GOV
  • Hospital Universitario Virgen de la Arrixaca

    collaborator OTHER
  • Hospital General Universitario Morales Meseguer

    collaborator OTHER
  • Diógenes Foundation

    collaborator OTHER
  • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

    lead OTHER

Principal Investigators

  • Jose Maria Moraleda Jiménez, M.D. Ph.D. · Hospital Universitario Virgen de la Arrixaca

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-10-31
Completion
2010-02-28

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00855400 on ClinicalTrials.gov