Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT02574585|
Recruitment Status : Not yet recruiting
First Posted : October 14, 2015
Last Update Posted : November 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Biological: Autologous mesenchymal cells transplantation||Phase 2|
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;
- 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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial for the Evaluation of Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||January 2022|
Experimental: Treated group
Twenty subjects will be randomly assigned to receive two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.
Biological: Autologous mesenchymal cells transplantation
Two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.
No Intervention: Control group
Twenty subjects will be randomly assigned to be clinically followed, without any specific intervention.
- Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging spinal cord injury [ Time Frame: 12 months ]
- Functional improvement in ASIA (American Spinal Injury Association) grade [ Time Frame: 12 months ]The investigators will evaluate the conversion rate from ASIA A to B or C in 12 months.
- Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force) [ Time Frame: 12 months ]AIS (ASIA Improvement Scale) degree on the ASIA score will be assessed in order to evaluate sensitivity and motor force in 12 months.
- Improvements in sensorial mapping and neuropathic pain [ Time Frame: 12 months ]The patients will be submitted to specific questionnaires and clinical examinations in order to evaluate improvements in sensorial mapping and neuropathic pain.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574585
|Contact: Ricardo Ribeiro-dos-Santos, PhDfirstname.lastname@example.org|
|Principal Investigator:||Ricardo Ribeiro-dos-Santos, 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:||Carolina T Macedo, MD, MSc||Hospital São Rafael|
|Study Chair:||André C Matos, MD||Hospital São Rafael|
|Study Chair:||Cristiane F Villarreal, PhD||Hospital São Rafael|
|Study Chair:||Antônio Olímpio S Moura, MD||Hospital São Rafael|
|Study Chair:||Eduardo Brazão, MD||Hospital São Rafael|
|Study Chair:||Kátia N Silva, MSc||Hospital São Rafael|
|Study Chair:||Daniela N Silva, MSc||Hospital São Rafael|
|Study Chair:||Clarissa LM de Souza, MD||Hospital São Rafael|