Traumatic cerebral injury, chronically established attributed to diffuse axonal injury.
Conditions
Interventions
Product Name: Células mesenquimales troncales adultas autólogas de medula ósea expandidas
Product Code: CME-LEC1
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: células mesenquimale
Sponsors
Fundación de Investigación Biomédica del Hospital Universitario Puerta de Hierro-Majadahonda (FIBM-HUPHM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Traumatic brain injury background with cognitive effect and clinical diagnosis of diffuse axonal injury. 2) Clinical scale studies (GCS, NIF, ASHWORTH, GOAT, DRS) as well as neurophysiology and PET-TAC 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) Possibility of follow-up evolution and neuro-rehabilitation support during the follow-up period. 5) Written informed consent according to the current legislation. 6) 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 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
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 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 stem cells in the treatment of a homogeneous group of patients with established chronic cerebral injury (CCI) and previous diagnosis of diffuse axonal injury.;Secondary Objective: To confirm the treatment safety to the dose raised in the present study;Primary end point(s): Main assessment endpoints will be those related to the possible efficacy of the treatment which will be measured by means of changes in CGS, RSD, GOAT, ASHWORTH and NIF scales and in their subsection, as well as in neurophysiological studies and PET-TAC;Timepoint(s) of evaluation of this end point: Changes in CGS, RSD, GOAT, ASHWORTH and NIF scales: Month 1 baseline, Month 3, Month 6, Month 9 and Month 12 final assessment. Neurophysiological studies and PET-TA: Month 1 baseline and Month 12 final assessment. | — |
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: Month 1 to Month 12. | — |
Countries
Spain
Contacts
Public ContactUnidad de puesta en marcha
SERMES PLANIFICACION. S.L
Outcome results
None listed