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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00855400
First received: March 3, 2009
Last updated: December 1, 2010
Last verified: December 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Additional 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
Study First Received: March 3, 2009
Last Updated: December 1, 2010
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

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

ClinicalTrials.gov processed this record on August 19, 2014