NCT02574585

Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury Spinal Cord Injury

Randomized Clinical Trial for the Evaluation of Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hospital Sao Rafael · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to analyze the safety and efficacy of autologous bone marrow mesenchymal stem cell transplantation in patients with thoracolumbar chronic and complete spinal cord injury.

Detailed description

This is a randomized, non-placebo controlled, prospective, phase II clinical trial. The study population will consist of 40 patients who had spinal cord injury for at least 12 months, with thoracolumbar 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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
BIOLOGICAL	Autologous mesenchymal cells transplantation	Two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-12-01
• Completion: 2022-01-01
• First posted: 2015-10-14
• Last updated: 2017-11-28