Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS) — hNSCALS  

Amyotrophic Lateral Sclerosis Clinical Trial

Official title: Intra-spinal Cord Delivery of Human Neural Stem Cells in ALS Patients: Proposal for a Phase I Study/ Trapianto Intramidollare di Cellule Staminali Neurali Umane Come Terapia Putativa Per la SLA: Proposta di un Trial Clinico di Fase I

Status Completed

Clinical Trial Summary

Primary aim of the trial

1. to verify safety and tolerability of expanded human fetal neural stem cells

2. to verify safety and tolerability of a microsurgery human fetal neural stem cells transplantation model

3. to recognize each change in patient's quality of life

Secondary aim of the trial

1. assessment of the impact of human neural stem cells transplantation on the disability of ALS in a clinically significant and measurable way

2. Assessment of the impact of human neural stem cells transplantation on mortality (all causes)

Clinical Trial Description

18 patients diagnosed as definite ALS according to the El Escorial criteria will be recruited during two years. The patients will be divided into 3 groups with different severity. Each group will be less compromised than the group that went before them. Their breathing measurements must be at least 60%. Subjects will receive injections of the human foetal neural stem cells into the spinal cord. A variety of tests and examinations will take place every month for the first year and every three months for the next two in order to monitor the course of the disease and the adverse events. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

• NCT number: NCT01640067
• Study type: Interventional
• Source: Azienda Ospedaliera Santa Maria, Terni, Italy
• Status: Completed
• Phase: Phase 1
• Start date: December 2011
• Completion date: December 2015