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

This study has been completed.
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Hospital Universitario Virgen de la Arrixaca
Hospital General Universitario Morales Meseguer
Fundación Diógenes
Information provided by (Responsible Party):
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier:
NCT01254539
First received: December 3, 2010
Last updated: March 29, 2017
Last verified: November 2015
December 3, 2010
March 29, 2017
October 2010
November 20, 2015   (Final data collection date for primary outcome measure)
Forced vital capacity [ Time Frame: Every 3 months ]
Same as current
Complete list of historical versions of study NCT01254539 on ClinicalTrials.gov Archive Site
  • Neurological variables: The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALS-FRS), Medical Research Council (MRC) and Norris scales [ Time Frame: Every 3 months ]
  • Absence of adverse events [ Time Frame: Every week / month depending on the study phase ]
  • Neurophysiological variables: Electromyography, polysomnography, evoked potentials [ Time Frame: Every 3 months ]
  • Neuroradiological variables: Spinal Magnetic Resonance Imaging (MRI) [ Time Frame: Every 3 months ]
  • Respiratory variables: Maximal inspiratory pressure (PIM), Maximal expiratory pressure (PEM), sniff nasal, oxymetry. [ Time Frame: Every 3 months ]
  • Psychological variables: Health Questionnaire (EuroQol-5D), The Profile of Mood States (POMS) [ Time Frame: Every 3 months ]
  • Neurological variables: 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 ]
  • Neurophysiological variables: Electromyography, polysomnography, evoked potentials [ Time Frame: Every 3 months ]
  • Neuroradiological variables: Spinal RMN [ Time Frame: Every 3 months ]
  • Respiratory variables: PIM(VR), PEM (CPT), sniff nasal, PO2, PCO2, oxymetry [ Time Frame: Every 3 months ]
  • Psychological variables: EuroQol-5D, POMS [ Time Frame: Every 3 months ]
Not Provided
Not Provided
 
Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)
Phase I/II Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)
The purpose of this clinical trial is to assess the feasibility and the security of the intraspinal and intrathecal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis patients.
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. Moreover, the clinical trial (Study NCT00855400 on www.ClinicalTrials.gov) conducted by our research group to determine the safety and efficacy of Autologous Stem Cell transplantation in Amyotrophic Lateral Sclerosis in humans, found that this procedure is feasible and safe. Continuing with that study, we have designed a phase I/II clinical trial to check the feasibility of the intraspinal and intrathecal infusion of autologous bone marrow stem cells.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
  • Procedure: Laminectomy and bone marrow stem cells transplantation

    Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient.

    T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation

  • Procedure: Intrathecal infusion of autologous bone marrow stem cells

    Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient.

    Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells.

  • Procedure: Intrathecal infusion of placebo (saline solution).
    Patients were infused 2 ml of saline solution
  • Experimental: Autologous bone marrow stem cells intraspinal transplantation
    T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
    Intervention: Procedure: Laminectomy and bone marrow stem cells transplantation
  • Experimental: Intrathecal infusion of autologous bone marrow stem cells
    Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells.
    Intervention: Procedure: Intrathecal infusion of autologous bone marrow stem cells
  • Placebo Comparator: Intrathecal infusion of placebo (saline solution).
    Patients were infused 2 ml of saline solution
    Intervention: Procedure: Intrathecal infusion of placebo (saline solution).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
November 20, 2015
November 20, 2015   (Final data collection date for primary outcome measure)

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 18 and less than 70 years old
  • Forced Vital Capacity ≥ 50%
  • Total time of oxygen saturation <90% inferior to 5% 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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01254539
Extension CMN/ELA
2006-003096-12 ( EudraCT Number )
EC07/90762 ( Other Identifier: ISCIII )
Yes
Not Provided
Not Provided
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
  • Instituto de Salud Carlos III
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital General Universitario Morales Meseguer
  • Fundación Diógenes
Study Director: Jose María Moraleda Jiménez, M.D. PhD. Hospital Universitario Virgen de la Arrixaca
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
November 2015

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