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

You may be eligible if

• Inclusion:
• 1. Confirmed diagnosis of ALS (Possible, Lab-supported Probable, Probable or Definite El Escorial Criteria)
• 2. Duration of ALS symptoms ≤ 36 months
• 3. Progressive weakness in upper extremities, with EMG supported evidence of denervation in both upper extremities
• 4. Forced Vital Capacity ≥50% of predicted normal in supine
• 5. Age: 18 years or older
• 6. Able to provide Informed Consent
• 7. Be geographically accessible to the study site and able to travel to study site for required visits
• 8. Have caregiver to assist in the transportation and care required by participation in the study
• 9. Not taking riluzole and/or edaravone or on a stable dose for ≥ 30 day
• 10. For women of child bearing capacity, negative pregnancy test prior to surgery and willingness to use birth control for the duration of the trial.
• 11. Medically able to undergo craniotomy as determined by the site PI and/or investigators
• 12. Medically able to tolerate the immunosuppression regimen as determined by the site PI
• Exclusion:
• 1. Using invasive ventilatory assistance
• 2. Diagnosis of another active or unstable medical illness that may interfere with study participation at discretion of PI
• 3. Presence of any of the following conditions:
• 1. Current drug or alcohol abuse
• 2. Any known immunodeficiency syndrome
• 3. Unstable medical condition
• 4. Unstable psychiatric illness including psychosis and untreated major depression within 90 days of screening
• 4. Persons of child bearing capacity not willing to practice birth control
• 5. Receiving any investigational device/biologic/drug in the past 30 days or any previous exposure to stem cell therapy
• 6. Any condition in the upper extremities that precludes serial strength or coordination testing
• 7. Any condition that the investigators feel may pose complications for the surgery
• 8. Any condition or ALS disease phenotype that the site PI feels may interfere with participation in the study or in the interpretation of study endpoints
• 9. Allergy to Beta-Lactam antibiotics
• 10. Donor Specific Antibodies (DSA) ≥ 2500MFI or CPRA ≥ 20%
• 11. Contraindications to MRI