Study Purpose:
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 diseaseStudy Status:
Not yet recruiting
Disease:
ALS (Amyotrophic Lateral Sclerosis)
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
MNC (Mononuclear cells), Placebo / Saline
Placebo:
Yes
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Miguel Blanquer Blanquer, MD / email hidden; JavaScript is required / 968 36 95 00
Full Study Summary:
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.
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 Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Estimated Enrollment:
100
Estimated Study Start Date:
05 / 01 / 2021
Estimated Study Completion Date:
09 / 01 / 2023
Posting Last Modified Date:
04 / 19 / 2021
Date Study Added to neals.org:
04 / 19 / 2021
Minimum Age:
18 Years
Maximum Age:
70 Years
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.
Principal Investigator : Teresa Gavilá Lattur, MD
Principal Investigator : Carmen Díaz Marín, MD
Hospital Clinico Universitario Virgen de la Arrixaca
Miguel Blanquer Blanquer / 968359767
Principal Investigator : Miguel Blanquer Blanquer, MD
Murcia 30003
Spain