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Trial record 15 of 36 for:    stem cell Spinal Cord Injury AND transplantation

Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete 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: NCT02574572
Recruitment Status : Recruiting
First Posted : October 14, 2015
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ricardo Ribeiro dos Santos, Hospital Sao Rafael

Tracking Information
First Submitted Date  ICMJE April 10, 2015
First Posted Date  ICMJE October 14, 2015
Last Update Posted Date November 28, 2017
Actual Study Start Date  ICMJE September 6, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02574572 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
  • 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.
  • 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.
  • 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.
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 Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury
Official Title  ICMJE Evaluation of the Safety and Potential Effectiveness of Autologous Mesenchymal Stem Cells Transplantation in Subjects With Cervical Chronic and Complete Spinal Cord Injury
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Biological: Autologous mesenchymal cells transplantation
All patients will undergo laminectomy and autologous mesenchymal cells injection into the lesion area.
Study Arms  ICMJE Experimental: Single group
Patients with spinal cord injury that will undergo laminectomy and autologous mesenchymal cells intralesional injection
Intervention: Biological: Autologous mesenchymal cells 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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: Ricardo Ribeiro-dos-Santos, PhD 557132816489 ricardoribeiro@cbtc-hsr.org
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02574572
Other Study ID Numbers  ICMJE SCI-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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 Ribeiro-dos-Santos, PhD Hospital São Rafael
Study Director: Milena BP Soares, PhD Hospital São Rafael
Study Chair: Bruno SF de 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 Fundação Oswaldo Cruz
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
PRS Account Hospital Sao Rafael
Verification Date November 2017

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