title: The beta-hCG+erythropoietin in acute stroke (BETAS) study: a 3-center, single-dose, open-label, noncontrolled, phase IIa safety trial.
abstract: 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.
authors.affiliation: University of California, Irvine Medical Center, 101 The City Drive South, Building 53, Room 203, Orange, CA 92868-4280, USA. scramer@uci.edu
authors.forename: Steven C
authors.initials: SC
authors.lastname: Cramer
authors.forename: Camille
authors.initials: C
authors.lastname: Fitzpatrick
authors.forename: Michael
authors.initials: M
authors.lastname: Warren
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hill
authors.forename: David
authors.initials: D
authors.lastname: Brown
authors.forename: Laura
authors.initials: L
authors.lastname: Whitaker
authors.forename: Karla J
authors.initials: KJ
authors.lastname: Ryckborst
authors.forename: Lawrence
authors.initials: L
authors.lastname: Plon
mesh_terms: 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
chemical_list: D018997:Chorionic Gonadotropin, beta Subunit, Human; D006454:Hemoglobins; D004921:Erythropoietin