Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 677 for:    amyotrophic lateral sclerosis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
ALS (Amyotrophic Lateral Sclerosis) Biological: MNC (Mononuclear cells) Other: Saline Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial on Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis.
Study Start Date : November 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
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

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.


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).
Other: Saline
The placebo, 2ml of saline, will be infused like in the experimental arm.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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)


  2. 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.

  3. 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.

  4. Muscle force MRC (Medical Research Council) score [ Time Frame: 24 months from baseline ]
  5. 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).

  6. Maximum transversal area of the tibialis anterior (TA) [ Time Frame: 24 months from baseline ]
    The area will be measured in cm2 by echography.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286011


Locations
Layout table for location information
Spain
Clinical Universitary Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Sponsors and Collaborators
Red de Terapia Celular
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
Layout table for investigator information
Principal Investigator: Joaquín A Gómez Espuch, MD Hospital Universitario Virgen de la Arrixaca

Publications of Results:
Layout table for additonal information
Responsible Party: Red de Terapia Celular
ClinicalTrials.gov Identifier: NCT02286011     History of Changes
Other Study ID Numbers: TCIM/ELA
2011-004801-25 ( EudraCT Number )
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases