Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: a Pilot Study

NCT ID: NCT02152657

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mesenchymal stem cell transplantation

Group Type: EXPERIMENTAL

Mesenchymal stem cell transplantation

Intervention Type: OTHER

Mesenchymal stem cell transplantation through percutaneous injection.

Interventions

Mesenchymal stem cell transplantation

Mesenchymal stem cell transplantation through percutaneous injection.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Sao Rafael

OTHER

Sponsor Role: lead

Responsible Party

Ricardo Ribeiro dos Santos

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricardo R dos Santos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital São Rafael

Milena BP Soares, PhD

Role: STUDY_DIRECTOR

Hospital São Rafael

Bruno SF Souza, MD, Msc

Role: STUDY_CHAIR

Hospital São Rafael

Ticiana F Larocca, MD, Msc

Role: STUDY_CHAIR

Hospital São Rafael

Rodrigo L Alves, MD, PhD

Role: STUDY_CHAIR

Hospital São Rafael

Yuri MA Souza, MD

Role: STUDY_CHAIR

Hospital São Rafael

André C Matos, MD

Role: STUDY_CHAIR

Hospital São Rafael

Cristiane F Villarreal, PhD

Role: STUDY_CHAIR

Hospital São Rafael

Alexandre S Carvalho-da-Silva, Student

Role: STUDY_CHAIR

Hospital São Rafael

Locations

Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Countries

Brazil

Other Identifiers

SCI-002

Identifier Type: -

Identifier Source: org_study_id