Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Intervention: Adult Autologous Mesenchymal Bone Marrow Cell
Intervention description: Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Analyze clinical efficacy of subarachnoid administration of; autologous BMSC expanded "in vitro"

Summary:

      The study goes on 24 months, with recruiting, treatment and follow period for all patients.
      The first day for each patient will be the first cellular administration. 3 doses will be
      administrated every 3 months from first dose.

      When the clinical trial finishes, it will be done a completed check of all obtained
      parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Incomplete SCI

          2. Neurological deficit clinically stable at least 12 months prior to treatment, and with
             a minimum of one-year evolution after SCI.

          3. Neurophysiological confirmation of incomplete SCI.

          4. The MRI study that morphologically evaluate the SCI.

          5. Age between 18 and 70 years

          6. Thread Men and women will compromise to use anticonceptive issues from first cell´s
             extraction to 6 months after last cell´s administration.

          7. Ability to attend clinical follow-up and perform physical therapy through the
             treatment period.

          8. Written and signed informed consent, according to the local regulation.

          9. Hematologic and creatinin parameters, SGOT and SGPT, within the normal range,
             according to laboratory standards considering that small variations could be accepted
             based on clinical study team criteria.

        Exclusion Criteria:

          1. A classification in ASIA and FRANKEL clinical scales to evaluate the SCI.

          2. Neurophysiological records that confirm the complete SCI.

          3. Age below 18 years or above 70.

          4. Pregnancy or lactation.

          5. Malignancy disease diagnosed or treated within the last 5 years.

          6. Patients with systemic disease that represents and additional risk to treatment.

          7. Patients with uncertain commitment to follow the physical therapy and clinical visits
             as well as patient with a negative input in the previous phycological assessment.

          8. Inability to assess the SCI features through MRI either noise due to spinal
             stabilization systems or any other cause.

          9. Patients currently under hematopoietic growth factors treatment or who required or
             maintained anticoagulation.

         10. Neurodegenerative disease additional.

         11. History of substance abuse, psychiatric disease or allergy to the protein products
             used in the process of cell expansion.

         12. Positive serology for HIV and syphilis.

         13. Active Hepatitis B or Hepatitis C.

         14. With other reason that would consider the patient ineligible for cell therapy
             according to the investigators judgment.