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 www.LifebankUSA.com
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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