MedTrace Logo

A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis Lateral

NCT02290886 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-04-06

No results posted yet for this study

Summary

A multicenter phase I/II Clinical trial,randomized, controlled with placebo, triple blind to evaluate the safety of the intravenous administration of 3 doses of autologous mesenchymal stem cells cells from adipose tissue in patients with Amyotrophic Lateral Sclerosis (ALS).

Conditions

Interventions

OTHER

Intravenous administration of placebo

DRUG

Intravenous administration of 1 million of MSC

DRUG

Intravenous administration of 2 million of MSC

DRUG

Intravenous administration of 4 million of MSC

Sponsors & Collaborators

  • Iniciativa Andaluza en Terapias Avanzadas

    collaborator OTHER

  • Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

    lead OTHER

Principal Investigators

  • Óscar Fernández, MD · Hospital Regional U. de Málaga

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2022-03-02
Completion
2022-03-02

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT02290886 on ClinicalTrials.gov