ischemic stroke
Conditions
Interventions
Product Name: adiposse tissue stem alogenic mesenchymal cells expanded
Product Code: Not applicable
Pharmaceutical Form: Infusion
INN or Proposed INN: mesenchymal stem cells
Other descriptive name: AS
Sponsors
Fundación para la Investigación Biomédica del Hospital Clínico San Carlos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Capacity for sign and understand the informed consent form 2. Age between 25 and 70 years old in the inclusion time 3. Man or woman with middle cerebral artery ischemic stroke at least in the 6 months prior to the inclusion 4. Image techniques showing injuries consistent with complete infarction of middle cerebral artery 5. Patients with severe secuelae verified by a 2 Rankin test level or less 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 6
Exclusion criteria
Exclusion criteria: 1. Patients requiring tracheostomy or non-invasive ventilation for more than 16 hours a day. 2. Presence of multiple lacunar infarcts in CT scan or MRI 3. History of intracranial hemorrhage or subarachnoid hemorrhage. 4. Patients who have used antipsychotics at therapeutic doses in the month prior to inclusion. 5. History of cancer in the three years prior to inclusion. 6. Previous ideas of suicide 7. Patients with known history of alcohol or drugs. 8. Patients with a history of heart disease, renal, hepatic, systemic, immune, that can influence patient survival during the test control. 9. Patients with chronic neurological disease like Parkinson's, tremor, neurodegenerative disease, etc. .. 10. History of uncontrolled hypertension. 11. Pregnant or breast-feeding. 12. Potentially fertile women (no hysterectomy without bilateral ovariectomy or post-menopausal for 12 months) that were not committed to use a medically approved method of contraception while receiving study medication and until the completion of the trial. 13. Patients with planned surgery from any cause. 14. Participating in another clinical trial. 15. Patients with immunotherapy. 16. Patients in a mode of institutionalization on brain injury center. 17. Patient location difficult or not possible. 18. Inability to cooperate with the rehabilitation treatment 19. Any other reason deemed by the researcher can influence the patient or clinical trial for their participation of it. 20. Existence of marked cerebral atrophy on brain MRI 21. Patients with acute or chronic active infection including patients with hepatitis B, hepatitis C and HIV.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of functional capacity by RMN, FIM, Rankin and Barthel tests) Evaluation of neurological impairment by NIHSS test Evaluation of quality of life by SF-36;Timepoint(s) of evaluation of this end point: 1 week and 1, 3, 6 and 12 months after infusion | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety evaluation of the intracerebral infusion of adult mesenchymal stem cells in ischaemic stroke.;Secondary Objective: Evaluation of functional capacity (RMN, FIM, Rankin and Barthel tests) Evaluation of neurological impairment (NIHSS test) Evaluation of quality of life (SF-36);Primary end point(s): Detection of cumulative adverse events at 12 months classified according to seriousness, intensity and the establishment of a causal relationship with the drug under investigation. Adverse events spontaneously reported by the patient as well as those detected by the investigator will be assesed.;Timepoint(s) of evaluation of this end point: 1 week and 1, 3, 6 and 12 months after infusion | — |
Countries
Spain
Contacts
Public ContactEsther Olmedilla
Fundación para la Investigación Biomédica del Hospital Clínico San Carlos
Outcome results
None listed