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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
A Multicenter Phase I/II Clinical Trial, Randomized, Controlled With Placebo, Triple Blind to Evaluate Safety, and Indications of Efficiency of the Intravenous Administration of the Therapy With 3 Doses of MSC in Patients With ASL Moderated to Severe

Clinical Trial 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).

Clinical Trial Description

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). 40 patients will be enrolled and will be randomized into one of the following 4 arms: - 10 patients in the control group (placebo) - 10 patients received a dose of 1 million MSC / kg - 10 patients received a dose of 2 million MSC / kg. - 10 patients received a dose of 4 million MSC / kg The follow-up phase of each patient from the cell infusion/placebo will be 6 months. At the time that each patient completed the follow-up period (i.e., 6 months after the infusion of the cellular product or placebo), the blind will be open, and patients who have been assigned to the control group, will receive the cell product as secondary treatment. These patients will be randomized to receive each of the doses used in the first phase. From this point, they begin a second period of follow up of 6 months. In addition, after 6 months of MSC infusion, every patient will continue in an open extension study for 36 months to assess the safety of MSC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02290886
Study type Interventional
Source Andalusian Network for Design and Translation of Advanced Therapies
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2014
Completion date March 2, 2022
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