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

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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

Tracking Information
First Submitted Date  ICMJE May 20, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date April 26, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02152657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • 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.
  • Improvement in urological function [ Time Frame: Six months ]
    The patients will undergo urodynamic study to evaluate urological improvements.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: a Pilot Study
Official Title  ICMJE Not Provided
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Tomography-guided mesenchymal stem cells injection.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Other: Mesenchymal stem cell transplantation
Mesenchymal stem cell transplantation through percutaneous injection.
Study Arms  ICMJE Experimental: Mesenchymal stem cell transplantation
Intervention: Other: Mesenchymal stem cell transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2014)
5
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02152657
Other Study ID Numbers  ICMJE SCI-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ricardo Ribeiro dos Santos, Hospital Sao Rafael
Study Sponsor  ICMJE Hospital Sao Rafael
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hospital Sao Rafael
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP