Phase II clinical trial of intramuscular infusion of autologous bone marrow stem cells in patients with amyotrophic lateral sclerosis

Phase 1

• Conditions: Amyotrophic Lateral Sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-002302-46-ES
• Lead Sponsor: Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-09
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 100

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 that offers sufficient guarantees of adherence to the protocol.
- Neurophysiological data that confirm lower motor neuron involvement at lumbar and cervical level.
- Assessment of the motor deficit in the dorsiflexion of both feet (between 3 and 5 points on the MRC scale).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Mellitus diabetes.
- Other diseases that may occur with polyneuropathies.
- Previous history of cerebral stroke.
- Previous pathology of the peripheral nervous system that affects one or both lower or upper limbs, with or without clinically evident neurological sequelae.
- Pregnant or breast-feeding patients
- Patients who are physiologically capable of becoming pregnant, unless they are using a reliable method of contraception (Annex III)
- Patients with cardiac, renal, hepatic, systemic, immune disease that may influence the patient's survival during the trial.
- Positive serology for hepatitis B, hepatitis C or HIV.
- Clinical and anesthesiological criteria that contraindicate either sedation or the extraction of MO 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified