Clinical Trial Phase I/II, 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 Moderate to Severe

Full Study Summary:

Clinical trial phase I/II, multicentric, 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.

• Eligibility Criteria

  Gender:

  Female, Male

  Minimum Age:

  18

  Maximum Age:

  N/A

  Min Vital Capacity (% predicted normal):

  50

  Time since Symptom Onset:

  <36 months

  Time since Diagnosis:

  Can participants use Riluzole?

  Yes

  
  

  Inclusion Criteria:
  -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 Criteria:
  -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.

• Site Contact Information

  Hospital Universitario Virgen Macarena, Servicio de Neurologia
  Guillermo Navarro, MD / .(JavaScript must be enabled to view this email address) / Seville,
  Spain

  Hospital Universitario Virgen del Rocio
  Celedonio Marquez, MD / .(JavaScript must be enabled to view this email address) / Seville,
  Spain

  University Regional Hospital Carlos Haya
  Victoria Fernandez, MD / .(JavaScript must be enabled to view this email address) / Malaga,
  Spain

  Hospital Regional Universitario Reina Sofia
  Eduardo Aguera, MD / .(JavaScript must be enabled to view this email address) / Cordoba,
  Spain