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

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Collaborator: Iniciativa Andaluza en Terapias Avanzadas

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.