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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  11/10/2011
 
Trade Name:  HEMACORD
 
Generic or Proper Name (*):  hematopoietic progenitor cells, cord blood*
 
Indications Studied:  For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
 
Therapeutic Category:  Somatic Cell
 
Ages Studied:  6 months - 52 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Single arm Prospective
 
No Patients:  324
 
No Centers:  27
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
Asian:  0
 
Black:  0
 
Other:  0
 
White:  0
 
Unknown:  0
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
Countries:  0
 
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