Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: a Pilot Study

The purpose of this study is to analyze the safety and efficacy of mesenchymal stem cell transplantation through percutaneous injection in patients with chronic spinal cord injury.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Other: Mesenchymal stem cell transplantation

Detailed Description

This is a pilot, open, phase I study, in a prospective cohort. The study population will consist of 5 patients who had spinal cord injury for at least 6 months, with complete paraplegia.

A practitioner, a neurosurgeon and a nurse will review the medical records of 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 with the patient to review and confirm his/her eligibility. If the clinical eligibility is confirmed, the patient will undergo psychosocial evaluation to determine the degree of emotional equilibrium and conditions for participation in the study.

Patients will undergo a series of clinical and neurological evaluations 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 Brasil;
• Electrocardiogram;
• Chest X-Ray, X-ray of knees;
• Bone densitometry;
• Urodynamic studies;
• Somatosensory evoked potential;
• Computed tomography of thoracic and lumbar spine;
• MRI 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. Patients will be recruited for a minimum period of 06 months to follow up with additional laboratory and clinical examinations.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 41253-190
      • Hospital Sao Rafael

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:

• Closed spinal cord injury at thoracic or thoracolumbar level bellow T8, or open spinal cord injury, at the same level, provided that the mechanism of the lesion is a spinal shock, ischemia or hematoma
• ASIA class A
• Signing the written consent

Exclusion Criteria:

• Anatomical transection of the spinal cord
• Spinal cord lesion by sharp objects
• Ongoing infections
• Terminal, neurodegenerative or primary hematological diseases
• Osteopathies which determine a higher risc to the bone marrow puncture
• Coagulopathies
• Severe hepatic, renal or heart failure
• Pregnancy or lactation
• Clinical conditions that hinder the percutaneous injection of the cells such as arthrodesis
• Use of metallic implants near vascular structures (such as cardiac pacemaker or aortic prosthesis) which won't allow patients to perform MRI
• Participation in other clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mesenchymal stem cell transplantation	Other: Mesenchymal stem cell transplantation; Mesenchymal stem cell transplantation through percutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic resonance imaging	After the transplantation of the cells, patients will be followed up by clinical examinations and will perform laboratorial and radiological exams, in order to search for complications of the procedure.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and motor strength on the inferior limbs	AIS (ASIA Improvement Scale) degree on the ASIA score will be assessed in order to evaluate sensitivity and motor strength on the inferior limbs.	Six months
Improvement in urological function	The patients will undergo urodynamic study to evaluate urological improvements.	Six 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.	Six months

Collaborators and Investigators

• Sponsor: Hospital Sao Rafael
• Investigators: Principal Investigator: Ricardo R dos Santos, MD, PhD, Hospital Sao Rafael; Study Chair: Yuri MA Souza, MD, Hospital Sao Rafael; Study Chair: Alexandre S Carvalho-da-Silva, Student, Hospital Sao Rafael

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Mesenchymal stem cell; Spinal cord injury; Stem cell transplantation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: SCI-002