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

NCT02574572 | Unknown Phase 1 DMC

• 1 other identifier: SCI-003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury; Mesenchymal cells; Stem cells

Outcome Measures

Primary Outcomes (1)

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

  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 (1)

Single group

EXPERIMENTAL

Patients with spinal cord injury that will undergo laminectomy and autologous mesenchymal cells intralesional injection

Biological: Autologous mesenchymal cells transplantation

Interventions

Autologous mesenchymal cells transplantation BIOLOGICAL

All patients will undergo laminectomy and autologous mesenchymal cells injection into the lesion area.

Single 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 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.

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

Study Sites (1)

Hospital São Rafael

Salvador, Estado de Bahia, 41253190, Brazil

RECRUITING

Related Publications (1)

• Macedo CT, de Freitas Souza BS, Villarreal CF, Silva DN, da Silva KN, de Souza CLEM, da Silva Paixao D, da Rocha Bezerra M, da Silva Moura Costa AO, Brazao ES, Marins Filho JP, Matos AC, Dos Santos RR, Soares MBP. Transplantation of autologous mesenchymal stromal cells in complete cervical spinal cord injury: a pilot study. Front Med (Lausanne). 2024 Sep 12;11:1451297. doi: 10.3389/fmed.2024.1451297. eCollection 2024.

  PMID: 39328312 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ricardo Ribeiro-dos-Santos, PhD

  Hospital São Rafael

  PRINCIPAL INVESTIGATOR

• Milena BP Soares, PhD

  Hospital São Rafael

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Central Study Contacts

Ricardo Ribeiro-dos-Santos, PhD

CONTACT

557132816489; ricardoribeiro@cbtc-hsr.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: September 6, 2017
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

BR (1)