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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
Diógenes Foundation
Information provided by:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Tracking Information
First Submitted Date  ICMJE March 3, 2009
First Posted Date  ICMJE March 4, 2009
Last Update Posted Date December 2, 2010
Study Start Date  ICMJE February 2007
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2009)
Forced vital capacity [ Time Frame: Every 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00855400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis
Official Title  ICMJE Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Transplant
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
Interventions:
  • Procedure: Laminectomy and bone marrow stem cells transplantation
  • Procedure: Autologous bone marrow cells collection
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2009)
11
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00855400
Other Study ID Numbers  ICMJE CMN/ELA
EudraCT number: 2006-003096-12
ISCIII: EC07/90762
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Javier Júdez Gutiérrez, Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study Sponsor  ICMJE Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators  ICMJE
  • Carlos III Health Institute
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital General Universitario Morales Meseguer
  • Diógenes Foundation
Investigators  ICMJE
Study Director: Jose Maria Moraleda Jiménez, M.D. Ph.D. Hospital Universitario Virgen de la Arrixaca
PRS Account Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP