Status:
COMPLETED
A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis Lateral
Lead Sponsor:
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Collaborating Sponsors:
Iniciativa Andaluza en Terapias Avanzadas
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- Women and males over 18-year-old.
- Good understanding of the protocol and aptitude to grant the informed assent.
- 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.
- Forced vital capacity of at least 50 % of the one that would correspond to them for sex, height and age.
- More than 6 and less than 36 months of evolution of the disease (from the beginning of the symptoms).
- Possibility of obtaining, at least, 50gr of adipose tissue.
- Treatment with riluzole, for at least, a month before the inclusion.
Exclusion
- 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).
- Previous therapy with stem cells.
- Participation in another clinical trial during 3 months previous to the entry in this trial.
- Any disease lymphoproliferative
- Tracheostomy and /or gastrostomy.
- Haemophilia, diathesis hemorrhagic or anticoagulative current therapy.
- Hypersensitivity known to the bovine foetal whey or the gentamicin.
- Medical precedents of infection of the HIV or any serious condition of immunocompromised.
- Positive HBV or HCV serology
- Levels of creatinine in whey \> 3.0 in subjects not submitted to haemodialysis.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02290886
Start Date
July 1 2014
End Date
March 2 2022
Last Update
April 6 2022
Active Locations (4)
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1
Hospital Regional Universitario Reina Sofía
Córdoba, Spain, 14004
2
Hospital Regional Universitario de Málaga
Málaga, Spain, 29010
3
Hospital Universitario Virgen Macarena, Servicio de Neurología
Seville, Spain, 41009
4
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013