Study Purpose: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).
Amyotrophic Lateral Sclerosis
Type of Intervention:
Intravenous administration of placebo, Intravenous administration of 1 million of MSC, Intravenous administration of 2 million of MSC, Intravenous administration of 4 million of MSC
Phase 1/Phase 2
Study Chair(s)/Principal Investigator(s):
Óscar Fernández, MD, Hospital Regional U. de Málaga
Coordinating Center Contact Information
Full Study Summary:
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.
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Estimated Study Start Date:
07 / 01 / 2014
Estimated Study Completion Date:
03 / 02 / 2022
Posting Last Modified Date:
04 / 06 / 2022
Date Study Added to neals.org:
11 / 14 / 2014
Can participants use Riluzole?
1. Women and males over 18-year-old.
2. Good understanding of the protocol and aptitude to grant the informed assent.
3. Diagnosis of sporadic ALS, with diagnosis of certainty, that is to say, definite or probable, in agreement with the criteria of "El Escorial", of the World Federation of Neurology.
4. Forced vital capacity of at least 50 % of the one that would correspond to them for sex, height and age.
5. More than 6 and less than 36 months of evolution of the disease (from the beginning of the symptoms).
6. Possibility of obtaining, at least, 50gr of adipose tissue.
7. Treatment with riluzole, for at least, a month before the inclusion.
1. Any concomitant disease that under investigator's criteria could concern the measures of the clinical variables of the trial (hepatic, renal or cardiac insufficiency, diabetes mellitus, etc).
2. Previous therapy with stem cells.
3. Participation in another clinical trial during 3 months previous to the entry in this trial.
4. Any disease lymphoproliferative
5. Tracheostomy and /or gastrostomy.
6. Haemophilia, diathesis hemorrhagic or anticoagulative current therapy.
7. Hypersensitivity known to the bovine foetal whey or the gentamicin.
8. Medical precedents of infection of the HIV or any serious condition of immunocompromised.
9. Positive HBV or HCV serology
10. Levels of creatinine in whey > 3.0 in subjects not submitted to haemodialysis.
Hospital Regional Universitario Reina Sofía
Hospital Regional Universitario de Málaga
Hospital Universitario Virgen Macarena, Servicio de Neurología
Hospital Universitario Virgen del Rocío