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

Amyotrophic Lateral Sclerosis Clinical Trial

— CMN/ELA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855400
• Other study ID #: CMN/ELA
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 3, 2009
• Last updated: December 1, 2010
• Start date: February 2007
• Est. completion date: February 2010

Study information

• Verified date: December 2010
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Procedure:
• Laminectomy and bone marrow stem cells transplantation
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
• Autologous bone marrow cells collection
Autologous bone marrow cells collection under sedation. Sixty mL are obtained and processed through a ficoll gradient.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia

Sponsors (5)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia	Carlos III Health Institute, Fundación Diógenes, Hospital General Universitario Morales Meseguer, Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced vital capacity		Every 3 months	No
Secondary	ALS-FRS, MRC and Norris scales		Every 3 months	No
Secondary	Absence of adverse events		Every week / month depending on the study phase	Yes