NCT02492516

Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Royan Institute · Other Government
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only therapeutic option now. Recently several studies have shown that stem cell transplantation is safe and can be effective in reduction of disease progression and increase of quality of life.

Detailed description

the study is perform with 8 patients who has sporadic form of ALS with(ALS-Functional Rating Test) ALS-FRS\> 24 and (Forced Vital Capacity) FVC\>40% . The adipose sample is provide from healthy donors with abdominal lipoaspiration. After isolation and culture of mesenchymal stem cells, the cells are injected intravenously (2 million cells/kg). All the patients will be followed for 12 months at 72hours, 2months, 4 months, 6 months and 12 months after transplantation to find the adverse events. During follow up the assessments including: ALS-FRS, FVC and electromyography and serologic tests.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	mesenchymal stem cells	mesenchymal stem cells injection via peripheral vein.

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-03-01
• Completion: 2017-04-01
• First posted: 2015-07-08
• Last updated: 2017-04-28

Locations

1 site across 1 country: Iran