The beta-hCG+erythropoietin in acute stroke (BETAS) study: a 3-center, single-dose, open-label, noncontrolled, phase IIa safety trial.
OBJECTIVE
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.
Cramer
Steven C
SC
University of California, Irvine Medical Center, 101 The City Drive South, Building 53, Room 203, Orange, CA 92868-4280, USA. scramer@uci.edu
Fitzpatrick
Camille
C
Warren
Michael
M
Hill
Michael D
MD
Brown
David
D
Whitaker
Laura
L
Ryckborst
Karla J
KJ
Plon
Lawrence
L
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D018997:Chorionic Gonadotropin, beta Subunit, Human / Q000008:administration & dosage* / Q000009:adverse effects*; D004359:Drug Therapy, Combination; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D020521:Stroke / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D020246:Venous Thrombosis / Q000209:etiology; D055815:Young Adult
D018997:Chorionic Gonadotropin, beta Subunit, Human; D006454:Hemoglobins; D004921:Erythropoietin