ALS (Amyotrophic Lateral Sclerosis) Clinical Trial
— TCIM-ELAIIOfficial title:
Clinical Trial in Phase II of Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis.
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
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | September 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Diagnosis of ALS defined or probable according to the criteria established by the World Federation of Neurology - Age between 18 and 70 years. - Patient who offers sufficient guarantees of adherence to the protocol. - Neurophysiological data confirming lower motor neuron involvement at the lumbar and cervical level. - Assessment of the motor deficit in the dorsal flexion of both feet (between 3 and 5 points on the MRC scale). Exclusion Criteria: - Mellitus diabetes. - Other diseases that may be associated with polyneuropathies. - Previous history of cerebral stroke. - Previous pathology of the peripheral nervous system that affected one or both lower or upper limbs, with or without clinically evident neurological sequelae. - Pregnant or actively breastfeeding patients - Patients physiologically capable of becoming pregnant, unless they are using a reliable contraceptive method (Annex III) - Patients with cardiac, renal, hepatic, systemic, immune disease that may influence the survival of the patient during the test. - Positive serology for hepatitis B, hepatitis C or HIV. - Clinical and anesthesiological criteria that contraindicate either sedation or the extraction of BM itself (Alteration of the coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, skin alteration in the puncture site, etc.) - Inclusion in other clinical trials in the last 6 months. - Inability to understand informed consent. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinico Universitario Virgen de la Arrixaca | Murcia |
Lead Sponsor | Collaborator |
---|---|
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of serious and non-serious adverse events related to the use of bone marrow mononuclear cells in patients with Amyotrophic Lateral Sclerosis | 48 months from baseline | ||
Primary | D50 index obtained from stimulus intensity curves | This parameter quantifies the number and size of the functional motor units of a given muscle. | 48 months from baseline | |
Secondary | 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 | 48 months from baseline | |
Secondary | 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 | 48 months from baseline | |
Secondary | 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. | 48 months from baseline | |
Secondary | PAMC amplitude: mV | Compound muscle action potential (CMAP) | 48 months from baseline | |
Secondary | PAMC area: mV / ms | Compound muscle action potential (CMAP) | 48 months from baseline | |
Secondary | 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. | 48 months from baseline | |
Secondary | 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. | 48 months from baseline |
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