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
|Condition or disease||Intervention/treatment||Phase|
|ALS (Amyotrophic Lateral Sclerosis)||Biological: MNC (Mononuclear cells) Other: Saline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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).
The placebo, 2ml of saline, will be infused like in the experimental arm.
- 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 ]
- 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.
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
|Clinical Universitary Hospital Virgen de la Arrixaca|
|El Palmar, Murcia, Spain, 30120|
|Principal Investigator:||Joaquín A Gómez Espuch, MD||Hospital Universitario Virgen de la Arrixaca|