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

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ClinicalTrials.gov Identifier: NCT00855400
Recruitment Status : Completed
First Posted : March 4, 2009
Last Update Posted : December 2, 2010
Sponsor:
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Procedure: Laminectomy and bone marrow stem cells transplantation Procedure: Autologous bone marrow cells collection Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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
Study Start Date : February 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : February 2010

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Forced vital capacity [ Time Frame: Every 3 months ]

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

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older 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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 Posted: March 4, 2009    Key Record Dates
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