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

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ClinicalTrials.gov Identifier: NCT01254539
Recruitment Status : Completed
First Posted : December 6, 2010
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Hospital Universitario Virgen de la Arrixaca
Hospital General Universitario Morales Meseguer
Diógenes Foundation
Information provided by (Responsible Party):
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Tracking Information
First Submitted Date  ICMJE December 3, 2010
First Posted Date  ICMJE December 6, 2010
Last Update Posted Date March 30, 2017
Study Start Date  ICMJE October 2010
Actual Primary Completion Date November 20, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2010)
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 NCT01254539 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2010)
  • 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 ]
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 (Extension CMN/ELA)
Official Title  ICMJE Phase I/II Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)
Brief Summary 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.
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. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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).
Publications * Not Provided

*   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: December 3, 2010)
63
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 20, 2015
Actual Primary Completion Date November 20, 2015   (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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 NCT01254539
Other Study ID Numbers  ICMJE Extension CMN/ELA
2006-003096-12 ( EudraCT Number )
EC07/90762 ( Other Identifier: ISCIII )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party 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
  • Instituto de Salud Carlos III
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital General Universitario Morales Meseguer
  • Diógenes Foundation
Investigators  ICMJE
Study Director: Jose María Moraleda Jiménez, M.D. PhD. Hospital Universitario Virgen de la Arrixaca
PRS Account Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Verification Date November 2015

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