Acute cerebral infarction of ischemic etiology
Conditions
Interventions
It will be administered CIGB-845 (epidermal growth factor [EGF] combined with two dose levels of growth hormone releasing peptide [GHRP-6]).
Group I (experimental): CIGB-845 (75 µg EGF + 3.5 mg GHRP-
Epidermal Growth Factor
Peptides
Administration, Intravenous
CIGB-845,
recombinant Epidermal Growth Factor,
GHRP-6
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Compliance with the diagnostic criteria (patients of both sexes with a focal neurologic defects caused by disturbances in blood supply to a particular brain area). 2. Age between 18 and 80 years, including both. 3. Time between onset of symptoms and start of administration of CIGB-845 less than 12 hours. 4. Willingness of the patient (or family) through the granting of informed consent (oral). In a second moment (once the patient is stabilized) the investigator must obtain the written consent of the patient, who may freely decide whether to accept or not to continue the investigation.
Exclusion criteria
Exclusion criteria: 1. Coma (Glasgow Coma Scale less than 8). 2. Points in the NIHSS 20 scale. 3. When the neurological defect can be explained by a different entity to ICA. 4. Patients with neurological symptoms or signs return to normal before treatment begins. 5. Severe uncontrolled hypertension (systolic> 185 mm Hg or diastolic BP> 110 mm Hg) not descend after treatment. 6. Low blood pressure (systolic <95 mm Hg) unresponsive to standard therapy. 7. Method of installation box with seizures. 8. Patients diagnosed with malignancies. 9. Pregnancy or breastfeeding at the time of inclusion in the study (reported by the patient or family). 10. Mental incapacity obvious to issue consent and act accordingly to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Adverse Events (AEs). The EA will be measured as -Occurrence of AEs (Yes, No), - AEs Description (name of event), - AEs Intensity (mild, moderate, severe). Measuring time: daily in Week 1 (time management starts CIGB-845) and at months 1, 3 and 6. Laboratory test (numerical values of blood chemistry tests: blood count, hematocrit, white blood cell count with differential, ALT, AST, glucose, creatinine, urea, uric acid, alkaline phosphatase, total protein, albumin, bilirubin, cholesterol, coagulogram and electrolytes). Measuring time: at baseline (before the first administration of CIGB-845), at 72 hours, at hospital discharge (7th day) and assessments for the months 1, 3 and 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disability (according to Rankin scale). Measuring time: at hospital discharge and at 3 and 6 months including the patient in the study. Neurologic deficit level (NIHSS scale, National Institute of Heath Stroke Scale). Measuring time: at hospital discharge and at 3 and 6 months post-inclusion. Ability to perform daily activities (according to Barthel index). Measuring time: at hospital discharge and at 3 and 6 months post-inclusion. Infarct volume (Computed Axial Tomography). Measuring time: the inclusion in the study, the 4th and the 7th day after starting treatment. | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernandez Bernal
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed