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History of Changes for Study: NCT02574572
Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury
Latest version (submitted November 27, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 9, 2015 None (earliest Version on record)
2 November 27, 2017 Recruitment Status, Study Status and Oversight
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Study NCT02574572
Submitted Date:  October 9, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: SCI-003
Brief Title: Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury
Official Title: Evaluation of the Safety and Potential Effectiveness of Autologous Mesenchymal Stem Cells Transplantation in Subjects With Cervical Chronic and Complete Spinal Cord Injury
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2015
Overall Status: Recruiting
Study Start: October 2015
Primary Completion: December 2016 [Anticipated]
Study Completion: December 2016 [Anticipated]
First Submitted: April 10, 2015
First Submitted that
Met QC Criteria:
October 9, 2015
First Posted: October 14, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 9, 2015
Last Update Posted: October 14, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hospital Sao Rafael
Responsible Party: Principal Investigator
Investigator: Ricardo Ribeiro dos Santos
Official Title: PhD
Affiliation: Hospital Sao Rafael
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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 cervical chronic and complete spinal cord injury.
Detailed Description:

This is a pilot, phase I study, in a prospective cohort. The study population will consist of 10 patients who had spinal cord injury for at least 12 months, with cervical 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.

Open or close this module Conditions
Conditions: Spinal Cord Injury
Keywords: Spinal cord injury
Mesenchymal cells
Stem cells
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 10 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Single group
Patients with spinal cord injury that will undergo laminectomy and autologous mesenchymal cells intralesional injection
Biological: Autologous mesenchymal cells transplantation
All patients will undergo laminectomy and autologous mesenchymal cells injection into the lesion area.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging
[ 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Blunt spinal cord injury at cervical level, between C5 and C7, 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.
Open or close this module Contacts/Locations
Central Contact Person: Ricardo Ribeiro-dos-Santos, PhD
Telephone: 557132816489
Email: ricardoribeiro@cbtc-hsr.org
Study Officials: Ricardo Ribeiro-dos-Santos, PhD
Principal Investigator
Hospital São Rafael
Milena BP Soares, PhD
Study Director
Hospital São Rafael
Bruno SF de Souza, MD, Msc
Study Chair
Hospital São Rafael
Ticiana F Larocca, MD, Msc
Study Chair
Hospital São Rafael
Rodrigo L Alves, MD, PhD
Study Chair
Hospital São Rafael
Carolina T Macedo, MD, MSc
Study Chair
Hospital São Rafael
André C Matos, MD
Study Chair
Hospital São Rafael
Cristiane F Villarreal, PhD
Study Chair
Fundação Oswaldo Cruz
Antônio Olímpio S Moura, MD
Study Chair
Hospital São Rafael
Eduardo Brazão, MD
Study Chair
Hospital São Rafael
Kátia N Silva, MSc
Study Chair
Hospital São Rafael
Daniela N Silva, MSc
Study Chair
Hospital São Rafael
Clarissa LM de Souza, MD
Study Chair
Hospital São Rafael
Locations: Brazil, Bahia
Hospital São Rafael
[Recruiting]
Salvador, Bahia, Brazil, 41253190
Contact:Contact: Ticiana F Larocca, MD, MSc +557132816489 ticiana@cbtc-hsr.org
Contact:Contact: Carolina T Macedo, MD, MSc +557132816489 carolthe@hotmail.com
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Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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