Use of neuroprotective therapy in nontraumatic intracranial hemorrhage: results of open-label randomized trial

Aim. To investigate the effectiveness and safety of Cellex® drug (active substance is polypeptides from the brain of pig embryos) in nontraumatic intracranial hemorrhage.

Material and methods. The study included 116 patients with hypertensive intracranial hemorrhage aged between 30 and 80 years. Patients of the treatment group (n = 61) in addition to the basic therapy were administered 0.1 mg (1 mL) of Cellex® once a day for 10 days while patients of the control group (n = 55) only received basic therapy in accordance with the clinical guidelines on management of patients with hypertensive intracranial hemorrhage. For 30 days, dynamics per the Glasgow Coma Scale, stroke severity per the National Institute of Health Stroke Scale (NIHSS), patient disability per the Modified Rankin Scale (mRаnkin), Barthel and Rivermead scales, speech disorders per the Speech Questionnaire, cognitive functions per the Montreal Cognitive Assessment and a number of other characteristics were evaluated.

Results. Percentage of survived patients (96.7 %) was higher in the Cellex® group compared to the control group (p = 0.0237). In the Cellex ® group, speech function per the Speech Questionnaire improved from 17.0 (14.0–22.0) to 24.0 (21.0–27.0) (p = 0.009) while in the control group no significant improvement in speech function was observed. A trend toward more significant decrease in stroke severity per NIHSS, patient disability per the mRаnkin, Barthel and Rivermead scales in the Cellex® group compared to the control group was observed. Cognitive functions per the Montreal Cognitive Assessment improved in the Cellex® group from 14.0 (12.0–22.5) to 20.0 (14.5–25.0) points. No adverse events were observed in the patient group receiving Cellex®.

Conclusion. High efficacy and safety of Cellex® drug in patients with hypertensive intracranial hemorrhage were confirmed.

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