Administration of bone marrow adult autologous mesenchymal cells expanded in chronically establish low injuries of the spinal cord

Phase 1

• Conditions: Traumatic or ischemic spinal cord injury, chronically established and considered irreversible; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-000975-10-ES
• Lead Sponsor: Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro Majadahonda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-22
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To analyze the potential clinical efficacy of intrathecal administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow mesenchymal troncal cells in the treatment of a homogeneous group of patients with established chronic spinal cord injury in the lower segments of the backbone (lumbar region);Secondary Objective: To confirm the treatment safety to the dose raised in the present study;Primary end point(s): - Changes in ASIA scales and its subsections, as well as in IANR-SCIFRS, PENN, ASHWORTH, EVA, GEFFNER and BDS scales.<br>- Changes in the neurophysiological records (somato-sensory evoked potentials, motor evoked potentials and EMG).<br>- Changes in urodynamic, defaecatory funtion and gait records.;Timepoint(s) of evaluation of this end point: Efficacy will be assessed taking into account the changes in score of the different scales and records along the study, comparing the final values with those ones which were obtained before the treatment initiation.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Will be evaluated the possible adverse effects during CME administration, development of complications and other adverse effects after it and during the follow up period;Timepoint(s) of evaluation of this end point: During follow up period.