Last updated on April 2018

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


Brief description of study

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).

Detailed Study 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.

Clinical Study Identifier: NCT02290886

Contact Investigators or Research Sites near you

Start Over

Eduardo Aguera, MD

Hospital Regional Universitario Reina Sof a
Cordoba, Spain
  Connect »

Guillermo Navarro, MD

Hospital Universitario Virgen Macarena, Servicio de Neurolog a
Seville, Spain
  Connect »

Celedonio Marquez, MD

Hospital Universitario Virgen del Roc o
Seville, Spain
  Connect »

Victoria Fernández, MD

Hospital Regional Universitario de M laga
Málaga, Spain
  Connect »