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-LEM3
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.Spinal cord injury (Level A, B, C or D in ASIA scales), clinically stable for at least 6 months prior to study start. 2.Previous studies of Neurophysiology, MRI and Urology to allow useful baseline, in order that they can be compared with the same scans following treatment, and to obtain objective data of potential efficacy. 3.Age between 18 and 70 years. 4.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 MSC last administration by lumbar puncture. 5.Possibility of follow up and ability to perform ambulatory physical therapy throughout all treatment period. 6.Written informed consent, according to the law in force. 7.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 9 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 that represents an added risk to treatment. 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 intrathecal administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow mesenchymal troncal cells in the treatment of patients with established chronic spinal cord injury (LEM);Secondary Objective: 1.To confirm the safety of this treatment. 2.To study potential changes of neurotrophic factors levels in CSF (BDNF, GDNF, NGF, CNTF, NT3 and NT4) after subarachnoid administration of CME ;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. ;Timepoint(s) of evaluation of this end point: Efficacy will be assessed taking into account the changes in score of the different scales along the study, compared to the scores before starting treatment, and also comparing neurophysiological and urodynamic records, and marrow morphology baseline data with those obtained in the end of the follow up period (10 months after the start of the treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Will be evaluated the changes in neurotrophic factors levels in CSF (BDNF, GDNF, NGF, CNTF, NT3 and NT4), as well as 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 ContactFundación Investigación Biomédica
Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro
Outcome results
None listed