Clinical trial: A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS) (NCT03482050)

Eligibility criteria:
Main Inclusion Criteria:

          1. El Escorial criteria for probable or definite ALS

          2. Males and and non pregnant females between 18 and 70 years of age

          3. Patients with an ALS-FRS-R score of at least 30 with an ALS diagnosis of two years or
             less

          4. No history of active psychiatric disorder. Patients receiving antidepressants as a
             preventive treatment, with no history of active psychiatric disorder may be included.

          5. Patient has a good understanding of the study and nature of the procedure

          6. Patient provides written informed consent prior to any study procedure

          7. Patients should either be on a stable dose of Riluzole and/or Radicava® (if
             applicable) for at least 30 days, or not be treated with Riluzole and/or Radicava®

          8. Patient is medically able to tolerate immunosuppression regimen

          9. Presence of a willing and able caregiver who understands the need to attend all
             follow-up visits, even if mobility declines

        Main Exclusion Criteria:

          1. Patient has a past infection or a positive test for HBV,HCV or HIV

          2. Patient is in need of respiratory support

          3. Patient has a lower than 10/12 in ALS-FRS-R respiratory parameters or below 70% of
             predicted slow vital capacity (SVC)

          4. Patient has renal failure

          5. Patient has impaired hepatic function

          6. Patient has a Body Mass Index (BMI) of <18.5 or > 30

          7. Patient suffers from significant cardiac disease, diabetes, autoimmune diseases,
             chronic severe infection, malignant disease or any other disease or condition that may
             risk the patient or interfere with the ability to interpret the study results

          8. Patient has systemic inflammation or active infections

          9. Patient has been treated previously with any stem cell therapy

         10. Current use of immunosuppressant medication or use of such medication within 6 weeks
             of Screening visit (Visit 0)

         11. Patient has participated in another clinical treatment trial or received other
             experimental medications outside of a clinical trial within 1 month prior to start of
             this study

         12. Any known immunodeficiency syndrome

         13. Any concomitant disease or condition limiting patient safety to participate
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment