Clinical trial: A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis Lateral (NCT02290886)

Eligibility criteria:
Inclusion Criteria:

          1. Women and males over 18-year-old.

          2. Good understanding of the protocol and aptitude to grant the informed assent.

          3. Diagnosis of sporadic ALS, with diagnosis of certainty, that is to say, definite or
             probable, in agreement with the criteria of "El Escorial", of the World Federation of
             Neurology.

          4. Forced vital capacity of at least 50 % of the one that would correspond to them for
             sex, height and age.

          5. More than 6 and less than 36 months of evolution of the disease (from the beginning of
             the symptoms).

          6. Possibility of obtaining, at least, 50gr of adipose tissue.

          7. Treatment with riluzole, for at least, a month before the inclusion.

        Exclusion Criteria:

          1. Any concomitant disease that under investigator's criteria could concern the measures
             of the clinical variables of the trial (hepatic, renal or cardiac insufficiency,
             diabetes mellitus, etc).

          2. Previous therapy with stem cells.

          3. Participation in another clinical trial during 3 months previous to the entry in this
             trial.

          4. Any disease lymphoproliferative

          5. Tracheostomy and /or gastrostomy.

          6. Haemophilia, diathesis hemorrhagic or anticoagulative current therapy.

          7. Hypersensitivity known to the bovine foetal whey or the gentamicin.

          8. Medical precedents of infection of the HIV or any serious condition of
             immunocompromised.

          9. Positive HBV or HCV serology

         10. Levels of creatinine in whey > 3.0 in subjects not submitted to haemodialysis.
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? Entailment