Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative Therapy

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

February 28, 2013

Study Completion Date

June 30, 2015

Conditions
Hematologic MalignanciesAcute Myeloid LeukemiaLymphoid LeukemiaChronic Myeloid LeukemiaHodgkin's DiseaseNon-Hodgkin's LymphomaMyelodysplastic Syndromes
Interventions
DRUG

StemEx®

The stem/progenitor cell based product composed of ex vivo expanded allogeneic umbilical cord blood cells, which is infused to subject at a rate of 1-3 ml/min in combination with non-manipulated cells derived from the same cord blood unit.

Trial Locations (30)

1097

Szent Laszlo & Szent Istvan Hospital, Budapest

10029

Mount Sinai Medical Center, One Gustave L Levy Place, BOX 1410, New York

15224

The Western Pennsylvania Hospital, Pittsburgh

15232

University of Pittsburgh Cancer Institute/UPMC Cancer Centers, Pittsburgh

22903

University of Virginia, Hematopoietic Stem Cell Transplant Program, West Complex 1300 Jefferson Park Av, Charlottesville

28007

Hospital General Universitario Gregorio Marañón, Doctor Esquerdo 46 , Madrid

31096

Rambam Medical Center, PO Box 9602, Haifa

44106

Case Western Reserve University, Cleveland

46009

Hospital Universitario La Fe, Av Campanar 21, Valencia

46010

Hospital Clínico Universitario de Valencia, Avda. Blasco Ibañez, 17, Valencia

52621

Chaim Sheba Medical Center, Tel Litwinsky

53226

Medical College of Wisconsin Division of Neoplastic Diseases and Related Disorders, Milwaukee

Medical College of Wisconsin Pediatric Blood and Marrow Transplant Program, Milwaukee

60153

Cardinal Bernardin Cancer Center, Loyola University Stritch School of Medicine, Maywood

60614

Northwestern University School of Medicine, Stem Cell Transplant Program, Children's Memorial Hospital, Chicago

78229

Texas Transplant Institute, San Antonio

80045

The Children's Hospital, B115, University of Colorado Health Sciences Center, Aurora

90095-1781

UCLA's Jonsson Comprehensive Cancer Center, Los Angeles

92868-3874

Children's Hospital of Orange County, Orange

07601

The Cancer Center at Hackensack University Medical Center, Hackensack

NY 10065

Cornell University, Joan & Sanford I. Weill Medical College, New York

Unknown

Steven and Alexandra Cohen Children's Medical Center of New York, New York

P.O.B 12000

Hebrew University Hospital Ein-Karem, Department of Bone Marrow Transplantation And Cancer Immunotherapy, Jerusalem

00165

Ospedale Pedriatrico Bambino Gesù, Roma

00133

Universita di Roma Tor Vergata, Via Oxford 81, Roma

85 - 50134

Ospedale di Careggi BMT Unit Department of Haematology, Viale Morgagni, Florence

167 - 08025

Hospital de la Santa Creu i Sant Pau, C/ Sant Antoni Maria Claret, Barselona

08916

Hospital Germans Trias i Pujol, Carretera de Canyet S/n, Badalona

08035

Hospital Universitario Vall d´Hebrón (Pediatrics), Passeig de La Vall d´Hebrón 119-129, Barcelona

Hospital Universitario Vall d´Hebrón, Passeig de La Vall d´Hebrón 119-129, Barcelona

All Listed Sponsors
lead

Gamida Cell -Teva Joint Venture Ltd.

OTHER

NCT00469729 - Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative Therapy | Biotech Hunter | Biotech Hunter