Clinical trial NCT02574585: Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury Spinal Cord Injury
Official title: Randomized Clinical Trial for the Evaluation of Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Cord Injury
Keywords: Spinal cord injury
Paraplegia
Stem cells
Mesenchymal cells
Lead sponsor: Hospital Sao Rafael
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Blunt spinal cord injury at thoracolumbar level, between T1 and L2, or penetrating spinal cord injury, at the same level, provided that the mechanism of injury had been spinal shock, ischemia or hematoma, with at least 12 months of injury;
* ASIA grade A;
* Signing of the written consent.

Exclusion Criteria:

* Spinal cord injuries by sharp objects, firearms, and not traumatic or congenital causes, even if at different levels of the spinal cord;
* Concomitant brain injuries;
* Diabetes mellitus type 1 or 2 as defined by fasting glucose above 126 mg / use of medication and medical history;
* Infectious processes in acute and / or chronic course, confirmed by additional tests and / or medical history;
* Immunodeficiency, autoimmune diseases and neoplastic processes, confirmed by additional tests and / or medical history;
* Terminal, neurodegenerative, primary hematologic and musculoskeletal diseases confirmed by additional tests and / or past medical history;
* Osteopathies reflecting increased risk for bone marrow puncture;
* Coagulopathies;
* Severe organ failure (heart, kidney or liver), confirmed by additional tests or medical history;
* Pregnancy or lactation;
* Clinical complications that hinder or contraindicate the surgical procedure;
* Use of metallic implants near vascular structures (such as cardiac pacemaker), or other contraindication to magnetic resonance imaging;
* Psychiatric disorders, psychosocial and cognitive impairment confirmed by medical evaluation;
* Abusive use of alcohol and / or illegal substances use;
* Participation in other clinical trial.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging spinal cord injury
timeFrame: 12 months
Secondary outcomes:
measure: Functional improvement in ASIA (American Spinal Injury Association) grade
timeFrame: 12 months
measure: Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force)
timeFrame: 12 months
measure: Improvements in sensorial mapping and neuropathic pain
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital São Rafael
name: Ricardo Ribeiro-dos-Santos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital São Rafael
name: Milena BP Soares, PhD
role: STUDY_DIRECTOR
affiliation: Hospital São Rafael
name: Bruno SF Souza, MD, Msc
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Ticiana F Larocca, MD, Msc
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Rodrigo L Alves, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Carolina T Macedo, MD, MSc
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: André C Matos, MD
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Cristiane F Villarreal, PhD
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Antônio Olímpio S Moura, MD
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Eduardo Brazão, MD
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Kátia N Silva, MSc
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Daniela N Silva, MSc
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Clarissa LM de Souza, MD
role: STUDY_CHAIR
References: