drugset / Trial / NCT05306457

CNS10-NPC-GDNF Delivered to the Motor Cortex for ALS

NCT05306457 ↗

Non-randomizedSequentialOpen-labelTreatment

Summary

The investigator is examining the safety of transplanting cells, that have been engineered to produce a growth factor, into the motor cortex (brain) of patients with Amyotrophic Lateral Sclerosis (ALS). The cells are called neural progenitor cells, which are a type of stem cell that can become several different types of cells in the nervous system. These cells have been derived to specifically become astrocytes, which is a type of neural cell. The growth factor is called glial cell line-derived neurotrophic factor, or GDNF. GDNF is a protein that promotes the survival of many types of neural cells. Therefore, the cells are called "CNS10-NPC-GDNF." The investigational treatment has been tested in people by delivering it to the spinal cord. However, it has only been delivered to the motor cortex of animals. In this study, we want to learn if CNS10-NPC-GDNF cells are safe to transplant into the motor cortex (brain) of people.

Timeline

Start
2022-05-08
Primary completion
2026-10
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject CNS10-NPC-GDNF Cell therapy 5.25e+06 cells Other
Subject CNS10-NPC-GDNF Cell therapy 1.05e+07 cells Other