Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: a Pilot Study
|ClinicalTrials.gov Identifier: NCT02152657|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : April 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Other: Mesenchymal stem cell transplantation||Not Applicable|
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;
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Tomography-guided mesenchymal stem cells injection.|
|Masking:||None (Open Label)|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2016|
|Experimental: Mesenchymal stem cell transplantation||
Other: Mesenchymal stem cell transplantation
Mesenchymal stem cell transplantation through percutaneous injection.
- Magnetic resonance imaging [ Time Frame: Six months ]After the transplantation of the cells, patients will be followed up by clinical examinations and will perform laboratorial and radiological exams, in order to search for complications of the procedure.
- Sensitivity and motor strength on the inferior limbs [ Time Frame: Six months ]AIS (ASIA Improvement Scale) degree on the ASIA score will be assessed in order to evaluate sensitivity and motor strength on the inferior limbs.
- Improvement in urological function [ Time Frame: Six months ]The patients will undergo urodynamic study to evaluate urological improvements.
- Improvements in sensorial mapping and neuropathic pain [ Time Frame: Six months ]The patients will be submitted to specific questionnaires and clinical examinations in order to evaluate improvements in sensorial mapping and neuropathic pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152657
|Hospital São Rafael|
|Salvador, Bahia, Brazil, 41253-190|
|Principal Investigator:||Ricardo R dos Santos, MD, PhD||Hospital São Rafael|
|Study Director:||Milena BP Soares, PhD||Hospital São Rafael|
|Study Chair:||Bruno SF Souza, MD, Msc||Hospital São Rafael|
|Study Chair:||Ticiana F Larocca, MD, Msc||Hospital São Rafael|
|Study Chair:||Rodrigo L Alves, MD, PhD||Hospital São Rafael|
|Study Chair:||Yuri MA Souza, MD||Hospital São Rafael|
|Study Chair:||André C Matos, MD||Hospital São Rafael|
|Study Chair:||Cristiane F Villarreal, PhD||Hospital São Rafael|
|Study Chair:||Alexandre S Carvalho-da-Silva, Student||Hospital São Rafael|