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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cell transplantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cell transplantation | Other | Mesenchymal stem cell transplantation through percutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic resonance imaging | 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. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and motor strength on the inferior limbs | AIS (ASIA Improvement Scale) degree on the ASIA score will be assessed in order to evaluate sensitivity and motor strength on the inferior limbs. | Six months |
| Improvement in urological function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo R dos Santos, MD, PhD | Hospital São Rafael | Principal Investigator |
| Milena BP Soares, PhD | Hospital São Rafael | Study Director |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital São Rafael | Salvador | Estado de Bahia | 41253-190 | Brazil |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D045164 | Mesenchymal Stem Cell Transplantation |
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
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Tomography-guided mesenchymal stem cells injection.
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The patients will undergo urodynamic study to evaluate urological improvements.
| Six 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. | Six months |
| D014947 | Wounds and Injuries |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |