ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02152657
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ricardo Ribeiro dos Santos, Hospital Sao Rafael

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Other: Mesenchymal stem cell transplantation Not Applicable

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.


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)
Primary Purpose: Treatment
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mesenchymal stem cell transplantation Other: Mesenchymal stem cell transplantation
Mesenchymal stem cell transplantation through percutaneous injection.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Improvement in urological function [ Time Frame: Six months ]
    The patients will undergo urodynamic study to evaluate urological improvements.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Brazil
Hospital São Rafael
Salvador, Bahia, Brazil, 41253-190
Sponsors and Collaborators
Hospital Sao Rafael
Investigators
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

Responsible Party: Ricardo Ribeiro dos Santos, PhD, Hospital Sao Rafael
ClinicalTrials.gov Identifier: NCT02152657     History of Changes
Other Study ID Numbers: SCI-002
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by Ricardo Ribeiro dos Santos, Hospital Sao Rafael:
Spinal cord injury
Stem cell transplantation
Mesenchymal stem cell

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System