Traumatic or ischemic spinal cord injury, chronically established and considered irreversible
Conditions
Interventions
Product Name: Células mesenquimales troncales adultas autólogas de medula ósea expandidas
Product Code: CME-LEM5
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: células mesenquimale
Sponsors
Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro Majadahonda
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - Changes in the neurophysiological records (somato-sensory evoked potentials, motor evoked potentials and EMG). - 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Contacts
Public ContactUnidad de puesta en marcha
SERMES PLANIFICACION. S.L
Outcome results
None listed