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
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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