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

This study is ongoing, but not recruiting participants.
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: September 19, 2013
Last verified: December 2010

December 3, 2010
September 19, 2013
October 2010
October 2014   (final data collection date for primary outcome measure)
Forced vital capacity [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Absence of adverse events [ Time Frame: Every week / month depending on the study phase ] [ Designated as safety issue: Yes ]
  • Neurophysiological variables: Electromyography, polysomnography, evoked potentials [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Neuroradiological variables: Spinal Magnetic Resonance Imaging (MRI) [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Respiratory variables: Maximal inspiratory pressure (PIM), Maximal expiratory pressure (PEM), sniff nasal, oxymetry. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Psychological variables: Health Questionnaire (EuroQol-5D), The Profile of Mood States (POMS) [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Neurological variables: 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 ]
  • Neurophysiological variables: Electromyography, polysomnography, evoked potentials [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Neuroradiological variables: Spinal RMN [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Respiratory variables: PIM(VR), PEM (CPT), sniff nasal, PO2, PCO2, oxymetry [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Psychological variables: EuroQol-5D, POMS [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Active, not recruiting
63
November 2014
October 2014   (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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01254539
Extension CMN/ELA, 2006-003096-12, EC07/90762
Yes
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
December 2010

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