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Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury Spinal Cord Injury

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02574585
Recruitment Status : Not yet recruiting
First Posted : October 14, 2015
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Biological: Autologous mesenchymal cells transplantation Phase 2

Detailed Description:

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:

  • 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 Brazil;
  • Electrocardiogram;
  • Chest X-Ray;
  • Bone densitometry;
  • Urodynamic studies;
  • Somatosensory evoked potential;
  • Computed tomography of thoracic and lumbar spine;
  • Magnetic resonance imaging 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial for the Evaluation of Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury
Anticipated Study Start Date : December 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Treated group
Twenty subjects will be randomly assigned to receive two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.
Biological: Autologous mesenchymal cells transplantation
Two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.
No Intervention: Control group
Twenty subjects will be randomly assigned to be clinically followed, without any specific intervention.


Outcome Measures

Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging spinal cord injury [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Functional improvement in ASIA (American Spinal Injury Association) grade [ Time Frame: 12 months ]
    The investigators will evaluate the conversion rate from ASIA A to B or C in 12 months.

  2. Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force) [ Time Frame: 12 months ]
    AIS (ASIA Improvement Scale) degree on the ASIA score will be assessed in order to evaluate sensitivity and motor force in 12 months.

  3. Improvements in sensorial mapping and neuropathic pain [ Time Frame: 12 months ]
    The patients will be submitted to specific questionnaires and clinical examinations in order to evaluate improvements in sensorial mapping and neuropathic pain.


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Blunt spinal cord injury at thoracolumbar level, between T1 and L2, or penetrating spinal cord injury, at the same level, provided that the mechanism of injury had been spinal shock, ischemia or hematoma, with at least 12 months of injury;
  • ASIA grade A;
  • Signing of the written consent.

Exclusion Criteria:

  • Spinal cord injuries by sharp objects, firearms, and not traumatic or congenital causes, even if at different levels of the spinal cord;
  • Concomitant brain injuries;
  • Diabetes mellitus type 1 or 2 as defined by fasting glucose above 126 mg / use of medication and medical history;
  • Infectious processes in acute and / or chronic course, confirmed by additional tests and / or medical history;
  • Immunodeficiency, autoimmune diseases and neoplastic processes, confirmed by additional tests and / or medical history;
  • Terminal, neurodegenerative, primary hematologic and musculoskeletal diseases confirmed by additional tests and / or past medical history;
  • Osteopathies reflecting increased risk for bone marrow puncture;
  • Coagulopathies;
  • Severe organ failure (heart, kidney or liver), confirmed by additional tests or medical history;
  • Pregnancy or lactation;
  • Clinical complications that hinder or contraindicate the surgical procedure;
  • Use of metallic implants near vascular structures (such as cardiac pacemaker), or other contraindication to magnetic resonance imaging;
  • Psychiatric disorders, psychosocial and cognitive impairment confirmed by medical evaluation;
  • Abusive use of alcohol and / or illegal substances use;
  • Participation in other clinical trial.
Contacts and Locations

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): NCT02574585


Contacts
Contact: Ricardo Ribeiro-dos-Santos, PhD +557132816455 ricardoribeiro@cbtc-hsr.org

Sponsors and Collaborators
Hospital Sao Rafael
Investigators
Principal Investigator: Ricardo Ribeiro-dos-Santos, 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: 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
More Information

Responsible Party: Ricardo Ribeiro dos Santos, PhD, Hospital Sao Rafael
ClinicalTrials.gov Identifier: NCT02574585     History of Changes
Other Study ID Numbers: SCI-005
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ricardo Ribeiro dos Santos, Hospital Sao Rafael:
Spinal cord injury
Paraplegia
Stem cells
Mesenchymal cells

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