NCT02290886

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

A Multicenter Phase I/II Clinical Trial, 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 Moderated to Severe

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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 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. 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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
OTHER	Intravenous administration of placebo
DRUG	Intravenous administration of 1 million of MSC
DRUG	Intravenous administration of 2 million of MSC
DRUG	Intravenous administration of 4 million of MSC

Timeline

• Start date: 2014-07-01
• Primary completion: 2022-03-02
• Completion: 2022-03-02
• First posted: 2014-11-14
• Last updated: 2022-04-06

Locations

4 sites across 1 country: Spain