Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis - Full Text View

Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (CMN/ELA)

This study is ongoing, but not recruiting participants.

First Received: March 3, 2009 No Changes Posted

Sponsors and Collaborators:	Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia Carlos III Health Institute Hospital Universitario Virgen de la Arrixaca Hospital General Universitario Morales Meseguer Fundación Diógenes
Information provided by:	Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier:	NCT00855400

Purpose

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.

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis	Procedure: Laminectomy and bone marrow stem cells transplantation Procedure: Autologous bone marrow cells collection	Phase I Phase II

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis

Further study details as provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:

Primary Outcome Measures:

Forced vital capacity [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ALS-FRS, MRC and Norris scales [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Absence of adverse events [ Time Frame: Every week / month depending on the study phase ] [ Designated as safety issue: Yes ]

Enrollment:	11
Study Start Date:	February 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855400

Locations

Spain, Murcia
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120

Sponsors and Collaborators

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Carlos III Health Institute

Hospital Universitario Virgen de la Arrixaca

Hospital General Universitario Morales Meseguer

Fundación Diógenes

Investigators

Study Director:

Jose Maria Moraleda Jiménez, M.D. Ph.D.

Hospital Universitario Virgen de la Arrixaca

More Information

No publications provided

Responsible Party:	Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia ( Javier Júdez Gutiérrez )
Study ID Numbers:	CMN/ELA, EudraCT number: 2006-003096-12, ISCIII: EC07/90762
Study First Received:	March 3, 2009
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00855400 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:

Amyotrophic Lateral Sclerosis
Bone marrow
Stem cells
Autologous
Safety

Study placed in the following topic categories:

Lou Gehrig's Disease
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases

Sclerosis
Neurodegenerative Diseases
Degenerative Motor System Disease
Motor Neuron Disease

Additional relevant MeSH terms:

Pathologic Processes
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Nervous System Diseases

Central Nervous System Diseases
Sclerosis
Neurodegenerative Diseases
Motor Neuron Disease

ClinicalTrials.gov processed this record on May 06, 2009