Our working hypothesis is that the injection of autologous bone marrow mononuclear cells (BMNC) has a positive effect on the natural loss of motor units and on the increase in the size of the motor unit that occurs in patients with ALS during the evolution of the disease
Our working hypothesis is that the injection of autologous bone marrow mononuclear cells (BMNC) has a positive effect on the natural loss of motor units and on the increase in the size of the motor unit that occurs in patients with ALS during the evolution of the disease. This hypothesis is based on experimental work done in animal models of ALS and the results of our previous phase I clinical trial. In this clinical trial (TCIM / ALS, ClinicalTrials.gov Identifier: NCT02286011) we studied with electrophysiological techniques (in a small number of patients with ALS) the effects of intramuscular injection of a single dose of BMSC in the tibialis anterioris (TA) muscle. . The results indicate that this is a safe procedure and show the presence of a positive and apparently transitory effect on the size and number of motor units of the TA muscle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
* Intramuscular infusion of autologous BM CMN into the TA muscle of one of the lower limbs (experimental side) * Intramuscular infusion of saline solution (placebo) in the TA muscle of the contralateral lower limb (control side)
\- Intramuscular infusion of saline solution (placebo) in the TA muscle of the contralateral lower limb (control side)
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, Spain
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: 48 months from baseline
D50 index obtained from stimulus intensity curves
This parameter quantifies the number and size of the functional motor units of a given muscle.
Time frame: 48 months from baseline
Motor unit number index" (MUNIX)
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
Time frame: 48 months from baseline
Motor unit size index" (MUSIX)
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
Time frame: 48 months from baseline
Fiber density (FD)
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.
Time frame: 48 months from baseline
PAMC amplitude: mV
Compound muscle action potential (CMAP)
Time frame: 48 months from baseline
PAMC area: mV / ms
Compound muscle action potential (CMAP)
Time frame: 48 months from baseline
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Maximum force developed in an isometric contraction of the muscles
The measurement will be made with a dynamometer during dorsiflexion of the foot (from certain angles) and during abduction of the index finger of the hand, respectively.
Time frame: 48 months from baseline
Fuerza muscular (MRC Medical Research Council) score
Muscle strength data will be collected according to the Medical Research Council scale. Muscle strength is graded on a scale of 0 to 5, with 5 being normal muscle strength and 0 being the absence of muscle contraction.
Time frame: 48 months from baseline