Abstract:
BACKGROUND AND PURPOSE:Animal data suggest the use of beta-human chorionic gonadotropin followed by erythropoietin to promote brain repair after stroke. The current study directly translated these results by evaluating safety of this sequential growth factor therapy through a 3-center, single-dose, open-label, noncontrolled, Phase IIa trial. METHODS:Patients with ischemic stroke 24 to 48 hours old and National Institutes of Health Stroke Scale score of 6 to 24 started a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation). This study also evaluated performance of serially measured domain-specific end points. RESULTS:A total of 15 patients were enrolled. Two deaths occurred, neither related to study medications. No safety concerns were noted among clinical or laboratory measures, including screening for deep vein thrombosis and serial measures of serum hemoglobin. In several instances, domain-specific end points provided greater insight into impairments as compared with global outcome measures. CONCLUSIONS:Results support the safety of this sequential, 2-growth factor therapy initiated 24 to 48 hours after stroke onset.
journal_name
Strokejournal_title
Strokeauthors
Cramer SC,Fitzpatrick C,Warren M,Hill MD,Brown D,Whitaker L,Ryckborst KJ,Plon Ldoi
10.1161/STROKEAHA.109.574343subject
Has Abstractpub_date
2010-05-01 00:00:00pages
927-31issue
5eissn
0039-2499issn
1524-4628pii
STROKEAHA.109.574343journal_volume
41pub_type
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