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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated group | Experimental | Twenty subjects will be randomly assigned to receive two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections. |
|
| Control group | No Intervention | Twenty subjects will be randomly assigned to be clinically followed, without any specific intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous mesenchymal cells transplantation | Biological | Two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging spinal cord injury | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional improvement in ASIA (American Spinal Injury Association) grade | The investigators will evaluate the conversion rate from ASIA A to B or C in 12 months. | 12 months |
| Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Ribeiro-dos-Santos, PhD | Contact | +557132816455 | ricardoribeiro@cbtc-hsr.org |
| Name | Affiliation | Role |
|---|---|---|
| Ricardo Ribeiro-dos-Santos, PhD | Hospital São Rafael | Principal Investigator |
| Milena BP Soares, PhD | Hospital São Rafael | Study Director |
| Bruno SF Souza, MD, Msc |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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AIS (ASIA Improvement Scale) degree on the ASIA score will be assessed in order to evaluate sensitivity and motor force in 12 months. |
| 12 months |
| Improvements in sensorial mapping and neuropathic pain | The patients will be submitted to specific questionnaires and clinical examinations in order to evaluate improvements in sensorial mapping and neuropathic pain. | 12 months |
| 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 | Study Chair |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |