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
Study Purpose:
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).
Disease:
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALSStudy Type:
Interventional TrialStudy Category:
Stem CellStudy Status:
Not enrollingPhase:
Phase IIStudy Chair(s)/Principal Investigator(s):
Oscar Fernandez, MD, Hospital Regional U. de Malaga
Clinicaltrials.gov ID (11 digit #):
NCT02290886Neals Affiliated?
NoCoordinating Center Contact Information
Oscar Fernandez, MD / .(JavaScript must be enabled to view this email address)
Ana Cardesa / .(JavaScript must be enabled to view this email address) / + 34 955 04 83 66
Malaga, Spain
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.