Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: a Pilot Study
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to analyze the safety and efficacy of mesenchymal stem cell
      transplantation through percutaneous injection in patients with chronic spinal cord injury.
    

Detailed description: 
      This is a pilot, open, phase I study, in a prospective cohort. The study population will
      consist of 5 patients who had spinal cord injury for at least 6 months, with complete
      paraplegia.

      A practitioner, a neurosurgeon and a nurse will review the medical records of patients to
      determine the presence / absence of inclusion / exclusion criteria. If the patient is a
      potential candidate for the study, an interview will be scheduled with the patient to review
      and confirm his/her eligibility. If the clinical eligibility is confirmed, the patient will
      undergo psychosocial evaluation to determine the degree of emotional equilibrium and
      conditions for participation in the study.

      Patients will undergo a series of clinical and neurological evaluations and will also be
      submitted to the following procedures:

        -  Cell blood count;

        -  Biochemical analysis (measurement of electrolytes - sodium, potassium, magnesium);

        -  Renal function tests (urea and creatinine);

        -  Liver function tests;

        -  Coagulation profile;

        -  Metabolic profile (glucose, total cholesterol and fractions);

        -  Urine summary and culture;

        -  Serology required for blood transfusion and marrow transplant in Brasil;

        -  Electrocardiogram;

        -  Chest X-Ray, X-ray of knees;

        -  Bone densitometry;

        -  Urodynamic studies;

        -  Somatosensory evoked potential;

        -  Computed tomography of thoracic and lumbar spine;

        -  MRI of the thoracic and lumbar spine.

      Also as part of the preoperative evaluation, the patients will respond to questions from the
      SF (Short Form) -36 questionnaire (for assessment of quality of life) and the questionnaires
      for the assessment of neuropathic pain.

      Clinical follow-up will be kept for patients who suspend their participation in the study for
      any adverse event and / or laboratory abnormality, or for the patient's own desire, following
      insurance protocols. In addition to the clinical and surgical follow-up, specific medical
      care will be offered to patients who experience adverse events, until stabilization of the
      patient, even if the target date for completion of the study has been exceeded.

      The candidates included in the study will be asked to voluntarily participate and give their
      informed written consent. Patients will be recruited for a minimum period of 06 months to
      follow up with additional laboratory and clinical examinations.
    

Intervention name(s): Mesenchymal stem cell transplantation
Intervention type(s): Other
Intervention description(s): Mesenchymal stem cell transplantation through percutaneous injection.
Intervention model: Single Group Assignment
Intervention model description: Tomography-guided mesenchymal stem cells injection.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal cord injury; Stem cell transplantation; Mesenchymal stem cell