The purpose of this study is to analyze the safety and efficacy of autologous bone marrow mesenchymal stem cell transplantation in patients with cervical chronic and complete spinal cord injury.
This is a pilot, phase I study, in a prospective cohort. The study population will consist of 10 patients who had spinal cord injury for at least 12 months, with cervical chronic and complete spinal cord injury, ASIA grade A. A practitioner, a surgeon and a nurse will review the medical records of the 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 to review and confirm his/her eligibility. Patients will undergo a series of clinical and neurological assessments 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 Brazil; * Electrocardiogram; * Chest X-Ray; * Bone densitometry; * Urodynamic studies; * Somatosensory evoked potential; * Computed tomography of thoracic and lumbar spine; * Magnetic resonance imaging 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
All patients will undergo laminectomy and autologous mesenchymal cells injection into the lesion area.
Hospital São Rafael
Salvador, Estado de Bahia, Brazil
RECRUITINGNumber of participants with treatment-related adverse events as assessed by magnetic resonance imaging
Time frame: 12 months
Functional improvement in ASIA (American Spinal Injury Association) grade
The investigators will evaluate the conversion rate from ASIA A to B or C in 12 months.
Time frame: 12 months
Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force)
AIS (ASIA Improvement Scale) degree on the ASIA score will be assessed in order to evaluate sensitivity and motor force in 12 months.
Time frame: 12 months
Improvements in sensorial mapping and neuropathic pain
The patients will be submitted to specific questionnaires and clinical examinations in order to evaluate improvements in sensorial mapping and neuropathic pain.
Time frame: 12 months
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