Traumatic spinal cord injury, chronically established, associated with syringomyelia and neurological deficit considered irreversible.
Conditions
Interventions
Product Name: Células mesenquimales troncales adultas autólogas de medula ósea expandidas
Product Code: CME-LEM4
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: células mesenquimale
Sponsors
Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Post-traumatic spinal cord injury patients (Level A, B, C or D in ASIA scales), with associated syringomyelia extended at least in three vertebral segments, and neurological stable clinic for at least 6 months prior to study start. 2.Previous studies of Neurophysiology, MRI and Urology (if neurogenic bladder data exist) and defecatory activity (if neurogenic intestine signs exist) to allow useful baseline, in order that they can be compared with the same scans at the end of the follow uo period, and to obtain objective data of potential efficacy. 3.Age between 18 and 70 years. 4.Neuroimagin (MR) that allow to confirm the syringomyelic cavity existence extended at lest 3 vertebral segments. 5.Men and women of childbearing age must compromisse to use contraceptives from the time at which the removal of cells from the bone marrow is performed until 6 months after the celular administration. 6.Possibility of follow up and commitment to perform ambulatory physical therapy, at least one hour per day, five days per week, throughout all treatment period. 7.Written informed consent, according to the law in force. 8.Hematologic, creatinine, SGOT and SGPT parameters, within the normal range, according to laboratory standards. However, slight modifications that are considered significant in the context of treatment to be performed, according to the criterion of the research team, are accepted. 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 5 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 years or above 70. 2. Pregnancy or lactation. 3. Current neoplastic disease or in the previous 5 years (diagnosed or treated). 4. Patients with systemic disease or other pathology that represents an added risk to the cellular therapy treatment or to the surgical operation. 5. Alterations in the genetic study performed to discard risk cell transformation in the expansion process. 6. Patients with doubts about possible cooperation in the maintenance physical therapy or in the controls carried out during the study 7. Neurodegenerative disease added. 8. History of substance abuse, psychiatric disease or allergy to protein products used in the process of cell expansion. 9. Positive serology for HIV and syphilis. 10. Active Hepatitis B or Hepatitis C, according to serology analysis. 11. If in the opinion of the researcher there is some other reason why the patient is not considered candidate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyze the potential clinical efficacy of the administration in the intrathecal compartment, ( intramedullary and in the subarachnoid space), of the medication NC1, to improve the neurological sequels of patients with established chronic spinal cord injury (LEM) and post-traumatic syringomyelia.;Secondary Objective: Confirm the treatment security.;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 spinal cord morphology in neuroimaging studies (MRI). -Changes in urodynamic records and defecatory function.;Timepoint(s) of evaluation of this end point: Efficacy will be assessed taking into account the changes in score of the different scales between the patient inclusion moment in the study and the scores obtained at the end of the follow up period, according to the clinic scales assessment and the objective study results (MR, neurophysiological records, urodynamic records and defecatory activity). | — |
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