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Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis

NCT02286011 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-03-30

No results posted yet for this study

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.

Conditions

  • ALS (Amyotrophic Lateral Sclerosis)

Interventions

BIOLOGICAL

MNC (Mononuclear cells)

The cells are infused into the TA muscle of the lower limb randomized as Group A (experimental) intramuscularly. The infusion is made with a needle, 26 gauge, at 4 points of the TA muscle a specific depth given by the neurophysiological study. The total volume infused will be 2 ml, 0.5 ml at each point. For infusion is as painless as possible for the patient to comply exactly with stereotactic indications of neurophysiology, the infusion was made at a uniform controlled rate and for this, the syringe is placed on a Yesargil arm, equipped with a microinjector and controlled infusion device.

OTHER

Saline

The placebo, 2ml of saline, will be infused like in the experimental arm.

Sponsors & Collaborators

  • Spanish National Health System

    collaborator OTHER

  • Hospital Universitario Virgen de la Arrixaca

    collaborator OTHER

  • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

    collaborator OTHER

  • Public Health Service, Murcia

    collaborator OTHER

  • Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

    collaborator OTHER

  • Red de Terapia Celular

    lead INDUSTRY

Principal Investigators

  • Joaquín A Gómez Espuch, MD · Hospital Universitario Virgen de la Arrixaca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02286011 on ClinicalTrials.gov