NCT00855400

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

Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has changed its natural history. Intraspinal injections of bone marrow mononuclear cells (MNC) have been able to ameliorate the course of ALS in murine models, acting as pumps of trophic factors that keep the motoneurons functional. We have designed a phase I/II clinical trial to check the feasibility of this approach in humans.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-10-01
• Completion: 2010-02-01
• First posted: 2009-03-04
• Last updated: 2010-12-02

Locations

1 site across 1 country: Spain