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

What is the Purpose of this Study?

This study focuses on individuals who have been diagnosed with amyotrophic lateral sclerosis (ALS), with symptoms present for less than 3 years.  The purpose of the study is to examine the safety and effectiveness of transplanting cells that have been genetically engineered to produce a growth factor into the motor cortex of ALS patients to determine whether these cells are safe and help protect the motor neuron cells that are damaged. The cells are called neural progenitor cells (NPC). A growth factor is a substance that is required for the stimulation of growth in living cells. The growth factor produced by the cells used in this study is called glial cell line-derived neurotrophic factor, or GDNF.  Therefore, the investigational cells are called “CNS10-NPC-GDNF.”

Researchers aim to determine the safety of delivering CNS10-NPC-GDNF cells into the motor cortex (brain), as well as which dose of the cells is safe to use in people. The cells will be delivered to one side of the brain, into the area that controls movement of one arm and specifically, the hand. 


Eligibility

  • Inclusion:
  • Confirmed diagnosis of ALS (Possible, Lab-supported Probable, Probable or Definite El Escorial Criteria)
  • Duration of ALS symptoms ≤ 36 months
  • Progressive weakness in upper extremities, with EMG supported evidence of denervation in both upper extremities
  • Forced Vital Capacity ≥50% of predicted normal in supine
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Where can I participate?

Beverly : Pablo Avalos

More about this Clinical Trial

What is the full name of this clinical trial?

Human Neural Progenitor Cells Secreting Glial Cell Line-Derived Neurotrophic Factor Delivered to the Motor Cortex for the Treatment of Amyotrophic Lateral Sclerosis

Study Details
Disease Type/Condition

Amyotrophic lateral sclerosis (ALS), Neural Progenitor Cells, Stem Cells

Principal Investigator

Lewis, Richard

Age Group

Adult

Phase

I/II

IRB Number

STUDY00000278

ClinicalTrials.gov ID

NCT05306457

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Pablo Avalos

Email
Pablo.Avalos@cshs.org
Study Detail
Disease Type/Condition

Amyotrophic lateral sclerosis (ALS), Neural Progenitor Cells, Stem Cells

Principal Investigator

Lewis, Richard

Age Group

Adult

Phase

I/II

IRB Number

CNS10-NPC-GDNF

ClinicalTrials.gov ID

NCT05306457

Key Eligibility
ClinicalTrials.gov

Contact
Name

Pablo Avalos

Email
Pablo.Avalos@cshs.org