Phase I Clinical Trial on Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis.

Red de Terapia Celular1 site in 1 country20 target enrollmentNovember 2014

ConditionsALS (Amyotrophic Lateral Sclerosis)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ALS (Amyotrophic Lateral Sclerosis)
Sponsor: Red de Terapia Celular
Enrollment: 20
Locations: 1
Primary Endpoint: Rate of serious and non-serious adverse events related to the use of bone marrow mononuclear cells in patients with Amyotrophic Lateral Sclerosis.
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety of Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis by a prospective, single-center, randomized, parallel, double-blind, placebo-controlled phase I clinical trial.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

December 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Red de Terapia Celular

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of definite or probable ALS according to the criteria established by the World Federation of Neurology
•Patient that provides reasonable assurance of adherence to protocol.
•Neurophysiological data confirming affectation of lower motor neurons in the lumbar region.
•Assessment of motor deficits in dorsiflexion of both feet (4 or 5 points on the MRC scale)
•The patient must fulfill all inclusion criteria.

Exclusion Criteria

•Diabetes Mellitus.
•Other diseases that may present with polyneuropathy.
•Previous history of stroke.
•Prior Pathology of the peripheral nervous system affecting one or both lower limbs with or without clinically evident neurological sequelae.
•Pregnant or breastfeeding patients active.
•Patients physiologically capable of becoming pregnant, unless they are using reliable contraception.
•Patients with cardiac disease, renal, hepatic, systemic, immune that may influence patient survival during the test.
•Positive serology for hepatitis B, hepatitis C or HIV.
•Clinical and anesthesiologic Criteria, contraindicating either sedation or extraction of MO (Altered coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, altered skin puncture site, etc.)
•Included in other clinical trials in the last 6 months.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Muscle force MRC (Medical Research Council) score(24 months from baseline)
Estimated number of motor units (MUNE)(24 months from baseline)
Compound muscle action potential (CMAP)(24 months from baseline)
Fiber density (FD)(24 months from baseline)
Maximum force developed in an isometric contraction of the tibialis anterior (TA) muscle.(24 months from baseline)
Maximum transversal area of the tibialis anterior (TA)(24 months from baseline)