Clinical trial: The Evaluation of the Effect of Mesenchymal Stem Cells on the Immune System of Patients With ALS (NCT04651855)

Eligibility criteria:
Inclusion Criteria:

          1. Adult patients (at least 18 years old)

          2. The minimum patient's weight is not less than 40 kg

          3. Diagnosis of sporadic ALS, definite or probable, as defined by El Escorial World
             Federation of Neurology criteria

          4. History of ALS symptoms less than 2 years duration from the first symptoms of the
             disease

          5. More than 6 months from diagnosis of the disease

          6. Disease progression at 6 past months at least 3 points during this period of time

          7. ALSFRS-R scale of at least 30 at screening appointment

          8. Forced vital capacity >70% of predicted value for age, gender and height

          9. Treatment with stable dose of riluzole before baseline visit (for at least 1 month)

         10. Capable of providing written informed consent

         11. Able to comply with study requirements and willing to follow all study procedures and
             follow-up visits

         12. Women of child-bearing age and men with partners of child-bearing potential must agree
             to use two forms of contraceptive therapy throughout the course of the trial

         13. Women of child-bearing age must undergo pregnancy test

         14. Polish-language native speakers or patients who are proficient in the Polish language

        Exclusion Criteria:

          1. Pregnancy or breastfeeding

          2. Tracheostomy

          3. Ventilator dependence

          4. Renal disease with creatinine >2mg/dl

          5. Liver disease with ALT, AST or GGTP 2-fold higher than upper normal limit

          6. Positive test for HBV, HCV, HIV with NAT method

          7. Positive tests for syphilis

          8. Any other clinically significant abnormalities on laboratory evaluation

          9. Any condition that would compromise ability of undergoing lumbar puncture

         10. Active systemic disease

         11. Autoimmune disease (Hashimoto disease under control is allowed)

         12. Uncontrolled diabetes

         13. Pulmonary disease that could affect interpretation of spirometry

         14. Neurological concomitant disease

         15. Unstable psychiatric concomitant disease

         16. High risk of suicide

         17. History of substance abuse within past year

         18. History of malignancy, within the previous 5 years, including melanoma with exception
             of localized skin cancers

         19. Any other clinically significant medical condition that can compromise patient's
             safety in the opinion of the investigator

         20. Treatment with immunomodulatory drugs (for example immunoglobulins, corticosteroids or
             other immunosuppressant) in last 6 months

         21. Participation in another clinical trial in last 6 months

         22. Previous cellular therapy of any kind

         23. Hypersensitivity to any component used in the cell culture

         24. Nuchal rigidity and other signs of meningitis

         25. Patients on chronic anticoagulation treatment (heparin/ warfarin/acenocoumarol/(N)OAC)
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.


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? 1