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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00855400

First Posted: March 4, 2009

Last Update Posted: December 2, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

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

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 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

Genetic and Rare Diseases Information Center resources: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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


Enrollment:	11
Study Start Date:	February 2007
Study Completion Date:	February 2010
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Transplant T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation	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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855400

Locations


Spain
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Blanquer M, Moraleda JM, Iniesta F, Gómez-Espuch J, Meca-Lallana J, Villaverde R, Pérez-Espejo MÁ, Ruíz-López FJ, García Santos JM, Bleda P, Izura V, Sáez M, De Mingo P, Vivancos L, Carles R, Jiménez J, Hernández J, Guardiola J, Del Rio ST, Antúnez C, De la Rosa P, Majado MJ, Sánchez-Salinas A, López J, Martínez-Lage JF, Martínez S. Neurotrophic bone marrow cellular nests prevent spinal motoneuron degeneration in amyotrophic lateral sclerosis patients: a pilot safety study. Stem Cells. 2012 Jun;30(6):1277-85. doi: 10.1002/stem.1080.


Responsible Party:	Javier Júdez Gutiérrez, Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier:	NCT00855400 History of Changes
Other Study ID Numbers:	CMN/ELA EudraCT number: 2006-003096-12 ISCIII: EC07/90762
First Submitted:	March 3, 2009
First Posted:	March 4, 2009
Last Update Posted:	December 2, 2010
Last Verified:	December 2010

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


Amyotrophic Lateral Sclerosis Bone marrow Stem cells Autologous Safety

Additional relevant MeSH terms:


Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Pathologic Processes Neurodegenerative Diseases Nervous System Diseases	Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases

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