Clinical trial to evaluate the feasibility and safety of the intracerebral infusion of stem cells in patients with cerebral stroke

• Conditions: ischemic stroke; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-001393-26-ES
• Lead Sponsor: Fundación para la Investigación Biomédica del Hospital Clínico San Carlos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-29
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified