Intrathecal administration of bone marrow adult autologous stem mesenchymal cells expanded in chronically established low injuries of the spinal cord

Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro Majadahonda0 sites15 target enrollmentJune 22, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro Majadahonda
Enrollment: 15
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

June 22, 2017

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro Majadahonda

•1\. Clinically stable spinal injury in the low level of the cord (underneath the dorsal region) at least in the 6 months prior to the recruitment.
•2\. Clinical scale studies, as well as neurophysiology, urodynamic, of stool function and of the functioning studies that would allow to have useful baseline values with the purpose of being able to be compared with the same examinations after the study and obtain objective data of possible efficacy.
•3\. Aged between 18 and 70 years old.
•4\. Men and women in childbearing age must be committed to using birth control measures from the moment in which the cell removal of their bone marrow is performed up to 6 months after the last administration of CME through lumbar puncture for safety.
•5\. Possibility of monitoring progress and commitment of performing outpatient physiotherapy throughout the whole treatment period.
•6\. Written informed consent according to the current legislation.
•7\. Hematologic parameters and of creatinine, SGOT and SGPT within normal range according to the laboratory standards, accepting, nonetheless, modifications that are considered not significant in the context of the treatment to be carried out according to the clinical criteria of the research team.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\. Age below 18 or over 70\.
•2\. Pregnancy or lactation.
•3\. Patients with systemic disease that is considered by the research team to represent an added risk to the treatment.
•4\. Alterations in the performed genetic study to rule out risk of cell transformation in the expansion process.
•5\. Patients with doubts regarding their possible cooperation in the physiotherapy maintenance or controls during the study.
•6\. Added neurodegenerative disease.
•7\. Current or past drug addiction or psychiatric disease, as well as current or past cancer disease that may interfere in the study to the investigators’ opinion.
•8\. HIV Positive serology and/or syphillis or allergy to protein products used in the cell expansion process.
•9\. Active Hepatitis B or Hepatitis C, according to the serology analysis.
•10\. If in the opinion of the investigator there is some other cause for which the patient is not considered to be a candidate for the study.