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

NCT02574585 | Unknown Phase 2 DMC

• 1 other identifier: SCI-005
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury; Paraplegia; Stem cells; Mesenchymal cells

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging spinal cord injury

  12 months

Secondary Outcomes (3)

• Functional improvement in ASIA (American Spinal Injury Association) grade

  12 months

• Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force)

  12 months

• Improvements in sensorial mapping and neuropathic pain

  12 months

Study Arms (2)

Treated group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Twenty subjects will be randomly assigned to be clinically followed, without any specific intervention.

Interventions

Autologous mesenchymal cells transplantation BIOLOGICAL

Two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.

Treated group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Sao Rafael: lead

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricardo Ribeiro-dos-Santos, PhD

  Hospital São Rafael

  PRINCIPAL INVESTIGATOR

• Milena BP Soares, PhD

  Hospital São Rafael

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Central Study Contacts

Ricardo Ribeiro-dos-Santos, PhD

CONTACT

+557132816455; ricardoribeiro@cbtc-hsr.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: October 14, 2015
• Study Start: December 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: November 28, 2017

Record last verified: 2017-11