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

• ClinicalTrials.gov Identifier: NCT02574585
• Recruitment Status: Unknown
• First Posted: October 14, 2015
• Last Update Posted: November 28, 2017
• Sponsor: Hospital Sao Rafael
• Information provided by (Responsible Party): Ricardo Ribeiro dos Santos, Hospital Sao Rafael

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 thoracolumbar chronic and complete spinal cord injury.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injury	Biological: Autologous mesenchymal cells transplantation	Phase 2

Detailed Description:

This is a randomized, non-placebo controlled, prospective, phase II clinical trial. The study population will consist of 40 patients who had spinal cord injury for at least 12 months, with thoracolumbar 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Clinical Trial for the Evaluation of Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury
• Estimated Study Start Date: December 2019
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: January 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treated group; 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; Two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.
No Intervention: Control group; Twenty subjects will be randomly assigned to be clinically followed, without any specific intervention.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• 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.

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.

Contacts and Locations

Contacts

Contact: Ricardo Ribeiro-dos-Santos, PhD; +557132816455; ricardoribeiro@cbtc-hsr.org

Sponsors and Collaborators

Hospital Sao Rafael

Investigators

• Principal Investigator: Ricardo Ribeiro-dos-Santos, PhD; Hospital São Rafael
• Study Director: Milena BP Soares, PhD; Hospital São Rafael
• Study Chair: 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

More Information

• Responsible Party: Ricardo Ribeiro dos Santos, PhD, Hospital Sao Rafael
• ClinicalTrials.gov Identifier: NCT02574585
• Other Study ID Numbers: SCI-005
• First Posted: October 14, 2015
• Last Update Posted: November 28, 2017
• Last Verified: November 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ricardo Ribeiro dos Santos, Hospital Sao Rafael:

Spinal cord injury; Paraplegia; Stem cells; Mesenchymal cells

Additional relevant MeSH terms:

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