Clinical trial NCT02152657: Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal cord injury
Stem cell transplantation
Mesenchymal stem cell
Lead sponsor: Hospital Sao Rafael
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Tomography-guided mesenchymal stem cells injection.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Closed spinal cord injury at thoracic or thoracolumbar level bellow T8, or open spinal cord injury, at the same level, provided that the mechanism of the lesion is a spinal shock, ischemia or hematoma
* ASIA class A
* Signing the written consent

Exclusion Criteria:

* Anatomical transection of the spinal cord
* Spinal cord lesion by sharp objects
* Ongoing infections
* Terminal, neurodegenerative or primary hematological diseases
* Osteopathies which determine a higher risc to the bone marrow puncture
* Coagulopathies
* Severe hepatic, renal or heart failure
* Pregnancy or lactation
* Clinical conditions that hinder the percutaneous injection of the cells such as arthrodesis
* Use of metallic implants near vascular structures (such as cardiac pacemaker or aortic prosthesis) which won't allow patients to perform MRI
* Participation in other clinical trial

Primary outcomes:
measure: Magnetic resonance imaging
timeFrame: Six months
Secondary outcomes:
measure: Sensitivity and motor strength on the inferior limbs
timeFrame: Six months
measure: Improvement in urological function
timeFrame: Six months
measure: Improvements in sensorial mapping and neuropathic pain
timeFrame: Six months
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital São Rafael
state: Bahia
Study officials:
affiliation: Hospital São Rafael
name: Ricardo R dos Santos, MD, 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: Yuri MA Souza, MD
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: Alexandre S Carvalho-da-Silva, Student
role: STUDY_CHAIR
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