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Trial record 67 of 537 for:    ALS (Amyotrophic Lateral Sclerosis)

Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis (TCIM/ELA)

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ClinicalTrials.gov Identifier: NCT02286011
Recruitment Status : Unknown
Verified March 2017 by Red de Terapia Celular.
Recruitment status was:  Active, not recruiting
First Posted : November 7, 2014
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
Spanish National Health System
Hospital Universitario Virgen de la Arrixaca
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Public Health Service, Murcia
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Information provided by (Responsible Party):
Red de Terapia Celular

Tracking Information
First Submitted Date  ICMJE October 24, 2014
First Posted Date  ICMJE November 7, 2014
Last Update Posted Date March 30, 2017
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2014)
Rate of serious and non-serious adverse events related to the use of bone marrow mononuclear cells in patients with Amyotrophic Lateral Sclerosis. [ Time Frame: 24 months from baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02286011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2014)
  • Estimated number of motor units (MUNE) [ Time Frame: 24 months from baseline ]
    Several techniques for estimating the MUNE, all based on the relationship between the amplitude or area of compound muscle action potential (CMAP) and amplitude or area corresponding to a single motor unit response. The differences between the techniques are due to the different ways of estimating the amplitude of the responses for individual motor units. The study will use two techniques: Incremental Technique: The unitary amplitude (or area) of individual motor units are calculated from the responses to increasing intensities stimuli near of intensity threshold (Dantes and McComas, 1991) Statistical technique: The unit amplitude (or area) of the individual motor units are calculated from the amplitude variations (or area) of the muscle action potential obtained in response to stimuli from a fixed intensity (Daube, 2006)
  • Compound muscle action potential (CMAP) [ Time Frame: 24 months from baseline ]
    CMAP is registered after supramaximal stimulation intensity (0.1-0.2 ms pulses at 1 Hz) of the common peroneal nerve at the level of the head of the fibula. The electrical stimulus is placed in a fixed position during the entire registration process. CMAP will be recorded simultaneously in 5 positions along longitudinally oriented TA muscle. To determine these 5 positions bony landmarks that are reproducible between members and between different patients will be used.
  • Fiber density (FD) [ Time Frame: 24 months from baseline ]
    Quantifies the average number of muscle fibers per motor unit. It is obtained from single fiber recordings made with electrodes. The average number of motor unit potentials is calculated in 20 different positions in the muscle.
  • Muscle force MRC (Medical Research Council) score [ Time Frame: 24 months from baseline ]
  • Maximum force developed in an isometric contraction of the tibialis anterior (TA) muscle. [ Time Frame: 24 months from baseline ]
    The measurement will be done in Newtons, with a dynamometer during dorsiflexion of the foot (from certain angles).
  • Maximum transversal area of the tibialis anterior (TA) [ Time Frame: 24 months from baseline ]
    The area will be measured in cm2 by echography.
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 Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis
Official Title  ICMJE Phase I Clinical Trial on Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis.
Brief Summary The purpose of this study is to evaluate the safety of Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis by a prospective, single-center, randomized, parallel, double-blind, placebo-controlled phase I clinical trial.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE ALS (Amyotrophic Lateral Sclerosis)
Intervention  ICMJE
  • Biological: MNC (Mononuclear cells)

    The cells are infused into the TA muscle of the lower limb randomized as Group A (experimental) intramuscularly. The infusion is made with a needle, 26 gauge, at 4 points of the TA muscle a specific depth given by the neurophysiological study. The total volume infused will be 2 ml, 0.5 ml at each point.

    For infusion is as painless as possible for the patient to comply exactly with stereotactic indications of neurophysiology, the infusion was made at a uniform controlled rate and for this, the syringe is placed on a Yesargil arm, equipped with a microinjector and controlled infusion device.

  • Other: Saline
    The placebo, 2ml of saline, will be infused like in the experimental arm.
Study Arms  ICMJE
  • Experimental: MNC (Mononuclear cells)

    All patients included in the clinical trial will receive an intramuscular infusion of autologous mononuclear cells (MNC) of Bone Marrow (BM) in TA muscle of one of the lower limb (experimental group). The lower limb on the CMN infuse autologous BM will be determined randomly.

    The average dose is 550 millions of cells (100-1200 million) diluted in 2 ml. saline

    Intervention: Biological: MNC (Mononuclear cells)
  • Placebo Comparator: Saline
    All patients included in the clinical trial will receive an intramuscular infusion of 2 mL of saline (placebo) in the TA muscle of the contralateral limb (group control).
    Intervention: Other: Saline
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 6, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of definite or probable ALS according to the criteria established by the World Federation of Neurology
  • Patient that provides reasonable assurance of adherence to protocol.
  • Neurophysiological data confirming affectation of lower motor neurons in the lumbar region.
  • Assessment of motor deficits in dorsiflexion of both feet (4 or 5 points on the MRC scale)
  • The patient must fulfill all inclusion criteria.

Exclusion Criteria:

  • Diabetes Mellitus.
  • Other diseases that may present with polyneuropathy.
  • Previous history of stroke.
  • Prior Pathology of the peripheral nervous system affecting one or both lower limbs with or without clinically evident neurological sequelae.
  • Pregnant or breastfeeding patients active.
  • Patients physiologically capable of becoming pregnant, unless they are using reliable contraception.
  • Patients with cardiac disease, renal, hepatic, systemic, immune that may influence patient survival during the test.
  • Positive serology for hepatitis B, hepatitis C or HIV.
  • Clinical and anesthesiologic Criteria, contraindicating either sedation or extraction of MO (Altered coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, altered skin puncture site, etc.)
  • Included in other clinical trials in the last 6 months.
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 NCT02286011
Other Study ID Numbers  ICMJE TCIM/ELA
2011-004801-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Red de Terapia Celular
Study Sponsor  ICMJE Red de Terapia Celular
Collaborators  ICMJE
  • Spanish National Health System
  • Hospital Universitario Virgen de la Arrixaca
  • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
  • Public Health Service, Murcia
  • Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Investigators  ICMJE
Principal Investigator: Joaquín A Gómez Espuch, MD Hospital Universitario Virgen de la Arrixaca
PRS Account Red de Terapia Celular
Verification Date March 2017

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