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

Spinal Cord Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152657
• Other study ID #: SCI-002
• Status: Completed
• Phase: N/A
• First received: May 20, 2014
• Last updated: April 25, 2017
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Hospital Sao Rafael
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Other:
• Mesenchymal stem cell transplantation
Mesenchymal stem cell transplantation through percutaneous injection.

Locations

Country	Name	City	State
Brazil	Hospital São Rafael	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Rafael

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Improvement in urological function	The patients will undergo urodynamic study to evaluate urological improvements.	Six months
Secondary	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