Interim Results Of Clinical Study Using Aldagen's Product To Isolate Stem Cells From Cord Blood Presented At American Society Of Hematology

Main Category: Stem Cell Research
Also Included In: Blood / Hematology;  Transplants / Organ Donations;  Clinical Trials / Drug Trials
Article Date: 12 Dec 2006 - 0:00 PDT

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Aldagen, Inc. today announced the presentation of data from a clinical trial using its ALDESORT(R) product to isolate stem cells from cord blood. The trial is being conducted by Joanne Kurtzberg, MD, the Duke University physician who pioneered the use of umbilical cord blood as a treatment for fatal childhood cancers and genetic diseases in 1993. Dr. Kurtzberg presented positive interim results of the study at the 48th Annual Meeting of the American Society of Hematology in Orlando, Florida.

About the Study

ALDESORT enriches a unique population of stem and progenitor cells from cord blood that contribute to neutrophil and platelet engraftment and to immune reconstitution following transplantation. The primary goal of the clinical study is to determine if transplanting these enriched cells is safe. The study will also indicate if transplanting these cell populations could result in accelerated engraftment and lead to more favorable clinical outcomes compared to a historical control group from the Cord Blood Transplantation Trial (COBLT) study, a multicenter Phase II study sponsored by the National Heart, Lung and Blood Institute.

At the time of the interim analysis, eleven pediatric patients with cancer or genetic diseases were transplanted with unrelated donor umbilical cord blood and a supplement of cord cells isolated using ALDESORT. Overall survival at 180 days was 90.9%, compared to an overall survival at 180 days of 57% in COBLT study. The cumulative incidence of neutrophil engraftment by day 42 was 90.9% (p=0.001) and platelet engraftment by day 100 was 79.5% (p=0.003).

"The findings of this study once again show the promise of transplanting stem cells from umbilical cord blood to treat children with resistant cancers and genetic diseases," said Dr. Kurtzberg. "The infusion of cells enriched with ALDESORT has had no adverse effects and appears to improve the speed and efficacy of cord blood transplantations."

About Cord Blood Transplants

Umbilical cord (UBC) stem cells are located in the umbilical cord and placenta of a newborn at birth. After the baby has been delivered and the umbilical cord has been cut, blood is drawn from the umbilical cord. It is a completely non-invasive procedure with absolutely no risk to either mother or child. Umbilical cord stem cells are not embryonic stem cells. More than 4000 cord blood transplantations have been performed worldwide. Dr. Kurtzberg and her team at Duke University have treated and saved more children with cancers and rare genetic diseases than any other center in the world.

About ALDESORT(R)

Aldagen's ALDESORT product is a set of proprietary reagents that can be used with currently available cell sorting systems to isolate a highly potent population of stem and progenitor cells from human bone marrow, peripheral blood and cord blood. The unique chemistry incorporated into the ALDESORT product allows the isolation of stem and progenitor cells based on the elevated expression of an intracellular enzyme, aldehyde dehydrogenase (ALDH).

About Aldagen, Inc.

Aldagen is a clinical-stage regenerative medicine company developing and commercializing products to treat vascular and degenerative diseases. The company's proprietary products can identify and isolate potent, highly effective adult stem and progenitor cells which can be quickly administered to regenerate or repair tissue. The company's lead product, ALDESORT, is currently being tested at Texas Heart Institute and Duke University in three clinical studies for ischemic heart failure, critical limb ischemia and cord blood transplantation. To learn more about Aldagen's products for preparing optimal cell populations for adult stem and progenitor cell therapy, the Company invites you to visit its website at http://www.aldagen.com.

Aldagen, Inc
http://www.aldagen.com

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