Last updated on February 2018

Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Amyotrophic Lateral Sclerosis
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Age between 18 and 70
  2. Possible, probable or definite ALS following El Escorial Revised Criteria (Brooks, 2000)
  3. ALSFRS-r 30 at enrollment
  4. Forced Vital Capacity 65% of the height and weight standard
  5. No-pregnancy agreement
  6. Regional accessibility to the study site
  7. Capability to give away agreed consensus
  8. Patients will be followed at Academic Institutions at their hometown

Exclusion Criteria:

  1. Previous cellular therapy
  2. Incapacity to lay still during bone marrow aspirate or intrathecal MSC injections
  3. Personal history of auto-Immune, myeloproliferative or myelodysplastic diseases, leukemia, lymphoma, whole-body irradiation, hip fracture, severe scoliosis or incapacity to undergo any of the study's proposed procedures
  4. Any other disease that may interfere with the study
  5. Any other neurological diseases
  6. Aspartate or alanine aminotransferases elevated >3x normality upper limit
  7. Serum creatinine >2x normality upper limit
  8. Hepatitis B and C, HIV, HTLV I and II and syphilis
  9. Immunosuppressant drug use within 6 weeks from the study's screening
  10. Pregnancy or breast-feeding
  11. Acquired or inherited Immunodeficiency
  12. Participation in other clinical trials
  13. Non-invasive ventilation, tracheostomy or diaphragm pacing
  14. Substance abuse within one year and other unstable mental health diseases according to researcher's judgement
  15. Gastrostomy or any alternative feeding means
  16. Inappropriate in-vitro MSC expansion

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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