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Celgene Cellular Therapeutics Announces Clinical Transplant of Human Placenta-Derived Stem Cells.

-- First Application is Pediatric Patient with Acute Lymphoblastic Leukemia (ALL) --

-- Study in Collaboration with Louisiana State University Children's Hospital and Morgan Stanley Children's Hospital of NewYork-Presbyterian and Columbia University Medical Center

WARREN, N.J. -- Celgene Cellular Therapeutics (CCT), a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced the clinical application of a human placenta-derived stem cells (HPDSCs) for hematopoietic reconstitution. The groundbreaking transplant occurred at the LSU Health Sciences Center Children's Hospital (LSU) on March 28, 2008 to treat a pediatric patient with Acute Lymphoblastic Leukemia (ALL), a cancer of the bone marrow and blood. Following the birth of the patient's sibling in December 2007, HPDSCs, along with cord blood, were collected and cryo-preserved and both products were used in the transplant.

CCT owns proprietary technologies for collecting, processing, and storing HPDSCs. HPDSCs are immature and versatile stem cells with potentially broad therapeutic applications in, for example, leukemia and other hematological malignancies, solid tumor cancers, and autoimmune diseases. CCT is also conducting research on other types of stem cells derived from the placenta that are obtained via additional proprietary methodologies.

The transplant is part of a multicenter clinical trial being conducted at LSU, together with Morgan Stanley Children's Hospital of NewYork-Presbyterian and Columbia University Medical Center using HPDSCs for patients with a range of disorders including cancers and non-malignancies. It is a single-arm study with a primary objective of assessing the safety of transplantation of umbilical cord blood augmented with HPDSCs from the same donor, with a secondary objective of assessing potential restoration of normal hematopoiesis and immune function with this combination of cells. Patients will be monitored carefully post-transplant for up to 24 months to monitor safety outcomes, engraftment, and survival.

"The patient is doing extremely well and, in fact, was discharged from the hospital one-to-two weeks earlier compared to traditional cord blood transplants," said Lolie C. Yu, M.D., Professor of Pediatrics, Division Chief of the Pediatric Heme-Onc Program, Director of the BMT Program at LSUHSC/Children's Hospital. "Neutrophil engraftment occurred earlier than anticipated in this proof-of-principle study further raising our hopes regarding the benefits of this treatment."

There is considerable anticipation around the potential of HPDSCs. An independent study headed by researchers from UCLA published earlier this year declared that blood-forming stem cells originate in the placenta in laboratory animals.

"We are excited to advance our study of the placenta as a source of stem cells that have the ability to effectively treat patients worldwide," said Robert Hariri, M.D., Ph.D., CEO of Celgene Cellular Therapeutics. "We are pleased with this first positive step in our effort to bring this cutting-edge therapy to the clinic to treat sufferers with a variety of devastating diseases."

"For the first time, we are transplanting human placenta-derived stem cells to treat patients with a variety of cancers and non-malignant diseases," said Mitchell Cairo, M.D., who leads the clinical trial at Morgan Stanley Children's Hospital and Columbia University Medical Center, and is Chief of the Pediatric Blood and Marrow Transplantation Division at Morgan Stanley Children's Hospital of NewYork-Presbyterian and Professor of Pediatrics, Medicine and Pathology at Columbia University College of Physicians and Surgeons. "Our hope is that HPDSCs, in conjunction with cord blood stem cells, will expedite engraftment and improve treatment for patients."

Expectant parents can cryo-preserve HPDSCs for future use through Celgene's cord blood bank, LifebankUSA. For more information visit or call 1-877-LifebankUSA toll-free.

About LifebankUSA

LifebankUSA, a Celgene company, is one of the largest cord blood banks in the world, and has provided cord blood banking services for tens of thousands of families worldwide. It has released dozens of stem cell units for transplant worldwide to treat numerous life-threatening diseases. LifebankUSA is also the first bank to allow families to collect and preserve stem cells derived from the placenta, as well as the umbilical cord (Placenta-Cord banking), to rebuild blood and the immune system, including red blood cells, white blood cells, and platelets. What further sets LifebankUSA apart is an active involvement in research along with its parent company Celgene, in a commitment to further the science of stem cells to help ensure a more promising future for both placenta-derived and umbilical cord blood stem cell therapeutics.

About Celgene Cellular Therapeutics

Celgene Cellular Therapeutics, a wholly owned subsidiary of Celgene Corporation, is an innovative leader in stem cell therapy and biomaterials. CCT has a laboratory devoted to research on stem cells derived from the human placenta and umbilical cord - both of which are non-controversial sources of stem cells. Research on placental stem cells by CCT has uncovered a variety of critical biological activities creating opportunities in regenerative medicine. Cell-based therapy offers the possibility of providing disease-modifying outcomes that could potentially treat currently incurable diseases.

This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company's filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.
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Publication:Business Wire
Date:May 2, 2008
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