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

Summary

The purpose of this study is to determine the efficacy and safety of transplanting StemEx® in patients with certain hematological malignancies. For these patients, it is suggested that StemEx® can improve upon the outcome of transplanting a single, unmanipulated cord blood unit by significantly increasing the number of stem/progenitor cells available to the patient.

Conditions

• Hematologic Malignancies
• Acute Myeloid Leukemia
• Lymphoid Leukemia
• Chronic Myeloid Leukemia
• Hodgkin's Disease
• Non-Hodgkin's Lymphoma
• Myelodysplastic 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.

Sponsors & Collaborators

• Gamida Cell -Teva Joint Venture Ltd.

  lead OTHER

Principal Investigators

• Ka Wah Chan, MD · Texas Transplant Institute

• Scott D Rowley, MD · The Cancer Center at Hackensack University Medical Center

• Mary Territo, MD · UCLA Oncology Center

• Patrick Stiff, MD · Loyola University Cardinal Bernardin Cancer Center

• Agha Mounzer, MD · University of Pittsburgh Cancer Institute/UPMC Cancer Centers

• Entezam Sahovic, MD · The Western Pennsylvania Hospital

• Celia Grosskreutz, MD · Icahn School of Medicine at Mount Sinai

• Roger Giller, MD · The Children's Hospital, B115, University of Colorado Health Sciences Center

• Steven Neudorf, MD · Children's Hospital of Orange County

• Ronit Yerushalmi, MD · Chaim Sheba Medical Center

• Tsila Zuckerman, MD · Rambam Health Care Campus

• Christelle Ferra, MD · Germans Trias i Pujol Hospital

• Cristina Arbona, MD · Hospital Clínico Universitario de Valencia

• Guillermo Sanz, MD · Hospital Universitario La Fe

• William Arcese, MD · Universita di Roma Tor Vergata

• Alberto Bosi, MD · Ospedale di Careggi BMT Unit Department of Haematology

• Sonali Chaudhury, MD · Northwestern University School of Medicine, Stem Cell Transplant Program, Children's Memorial Hospital

• Jorge Sierra, MD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

• Igor B. Resnick, MD, PhD · Department of Bone Marrow Transplantation And Cancer Immunotherapy Hebrew University Hospital Ein-Karem, Jerusalem

• Prof. Franco Locatelli, MD · Ospedale Pedriatrico Bambino Gesù

• Dr. Mi Kwon, MD · Hospital General Universitario Gregorio Marañón

• Dr. Pere Barba, MD · Hospital Universitario Vall d´Hebrón

• Dr. Cristina Diaz de Heredia, MD · Hospital Universitario Vall d´Hebrón

• Prof. Mary J Laughlin, MD · Hematopoietic Stem Cell Transplant Program, University of Virginia

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2013-02-28

Completion

2015-06-30

Countries

• United States
• Hungary
• Israel
• Italy
• Spain

Study Locations