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

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Procedure: Laminectomy and bone marrow stem cells transplantation; Procedure: Autologous bone marrow cells collection

• Registration Number: NCT00855400
• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Brief 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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2009-03-03
• Study First Submitted QC: 2009-03-03
• Study First Posted: 2009-03-04
• Primary Completion: 2009-10
• Study Completion: 2010-02
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-01
• Last Update Posted: 2010-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Diagnose established following the World Federation of Neurology criteria
• More than 6 and less than 36 months of evolution of the disease
• Medullar onset of the disease
• More than 20 and less than 65 years old
• Forced Vital Capacity equal or superior to 50%
• Total time of oxygen saturation <90% inferior to 2% of the sleeping time
• Signed informed consent

Exclusion Criteria

• Neurological or psychiatric concomitant disease
• Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube
• Concomitant systemic disease
• Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months
• Inclusion in other clinical trials
• Unability to understand the informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transplant	Laminectomy and bone marrow stem cells transplantation	T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
Transplant	Autologous bone marrow cells collection	T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation

Primary Outcome Measures

Name	Time	Method
Forced vital capacity	Every 3 months

Secondary Outcome Measures

Name	Time	Method
ALS-FRS, MRC and Norris scales	Every 3 months
Absence of adverse events	Every week / month depending on the study phase

Trial Locations

Locations (1)

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain