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

Evaluation of the Safety and Potential Effectiveness of Autologous Mesenchymal Stem Cells Transplantation in Subjects With Cervical Chronic and Complete Spinal Cord Injury

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Biological: Autologous mesenchymal cells transplantation

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: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ricardo Ribeiro-dos-Santos, PhD; Phone Number: 557132816489; Email: ricardoribeiro@cbtc-hsr.org

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 41253190
      • Recruiting
      • Hospital Sao Rafael
      • Contact: Ticiana F Larocca, MD, MSc; Phone Number: +557132816489; Email: ticiana@cbtc-hsr.org
      • Contact: Carolina T Macedo, MD, MSc; Phone Number: +557132816489; Email: carolthe@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional improvement in ASIA (American Spinal Injury Association) grade	The investigators will evaluate the conversion rate from ASIA A to B or C in 12 months.	12 months
Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force)	AIS (ASIA Improvement Scale) degree on the ASIA score will be assessed in order to evaluate sensitivity and motor force in 12 months.	12 months
Improvements in sensorial mapping and neuropathic pain	The patients will be submitted to specific questionnaires and clinical examinations in order to evaluate improvements in sensorial mapping and neuropathic pain.	12 months

Collaborators and Investigators

• Sponsor: Hospital Sao Rafael
• Investigators: Study Chair: Carolina T Macedo, MD, MSc, Hospital Sao Rafael; Principal Investigator: Ricardo Ribeiro-dos-Santos, PhD, Hospital Sao Rafael; Study Chair: Bruno SF de Souza, MD, Msc, Hospital Sao Rafael; Study Chair: Cristiane F Villarreal, PhD, Fundacao Oswaldo Cruz; Study Chair: Antônio Olímpio S Moura, MD, Hospital Sao Rafael; Study Chair: Eduardo Brazão, MD, Hospital Sao Rafael; Study Chair: Kátia N Silva, MSc, Hospital Sao Rafael; Study Chair: Daniela N Silva, MSc, Hospital Sao Rafael; Study Chair: Clarissa LM de Souza, MD, Hospital Sao Rafael

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: October 9, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Stem cells; Spinal cord injury; Mesenchymal cells
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: SCI-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No