DURHAM, NC--(Marketwire - July 29, 2009) - Aldagen, Inc. today announced that it authored a
review article describing the potential of ALDH-bright (ALDH(br)) adult
stem cells to treat cardiovascular diseases. Aldagen's clinical pipeline
includes two therapies composed of ALDH(br) cells for the treatment of
ischemic heart failure and critical limb ischemia (CLI). The article
provides an overview of preclinical research and clinical development
progress and plans for these two indications. The paper appears in the
July/August 2009 issue of Congestive Heart Failure and was authored by
Laurence H. Keller, MD, Chief Medical Officer of Aldagen.
There has been a growing body of research regarding the use of adult stem
cells to treat cardiovascular diseases such as ischemic heart failure and
CLI. The article describes the selection and clinical application of a mix
of potent stem and progenitor cells, referred to as ALDH(br) stem cells,
which include all the cell types thought to be needed for repair of tissue
damaged by insufficient blood supply. Aldagen identifies and isolates these
cells based upon the presence of an intracellular enzyme that is highly
expressed in multiple adult stem and progenitor cell lineages. ALDH(br)
cells can be quickly selected from the patient's own bone marrow, and they
do not need to be expanded or manipulated in any way, enabling a
streamlined manufacturing process and rapid turnaround to the patient.
"Preclinical and clinical research has suggested that ALDH(br) cells may
facilitate the repair of ischemic tissue damage by promoting the creation
of new blood vessels in the injured tissue," said Dr. Keller. "The
advantages of using these selected cells are several-fold: they appear to
contain all the cell types needed for tissue repair; they appear to be more
potent than the broader population of bone marrow cells; we don't have to
place a bet on which cell type or types are the right ones for ischemic
repair; and the cells don't need to be expanded or otherwise manipulated.
The critical limb ischemia and ischemic heart failure populations that we
are studying represent growing patient populations without good treatment
The key findings surrounding ALDH(br) adult stem cells discussed in the
-- ALDH(br) cell populations isolated from bone marrow contain potent
stem and progenitor cells representing all cell types thought to be needed
for ischemic repair and include hematopoietic, endothelial, mesenchymal,
and neural progenitor cells.
-- A preclinical study involving hindlimb ischemia demonstrated that the
ALDH(br) population was highly effective in restoring blood flow to
-- Approximately two-thirds or more of bone marrow cells expressing
surface markers that researchers commonly use to identify various types of
stem cells for use in ischemic repair (e.g., CD34, CD133, CD105) are not
ALDH(br). In the hindlimb ischemia preclinical study the bone marrow cells
that were not ALDH(br) had the same effect as a salt water solution
control, indicating that all of the ischemic repair activity is found in
the ALDH(br) cells.
-- Clinical studies were initiated utilizing this approach for two
indications: CLI and ischemic heart failure.
-- Clinical results for the Phase 1/2 CLI study were very encouraging,
with improvements seen in blood flow and clinical status.
-- Data analysis is under way for 6-month follow-up results for the Phase
1 ischemic heart failure study.
"This article provides a great overview of the promise of Aldagen's adult
stem cell therapies to treat cardiovascular diseases," said Tom Amick,
Chairman and Chief Executive Officer of Aldagen. "We believe we have the
most advanced adult stem cell products in clinical trials for critical limb
ischemia and ischemic heart failure, and look forward to publishing or
presenting clinical data for each of these indications in the second half
About Aldagen, Inc.
Aldagen is a biopharmaceutical company developing proprietary regenerative
cell therapies that target significant unmet medical needs. The company has
four product candidates in clinical trials. Aldagen's most advanced product
candidate, ALD-101, is currently in a pivotal Phase 3 clinical trial to
evaluate its efficacy in improving umbilical cord blood transplants used to
treat inherited metabolic diseases in pediatric patients. The company also
is conducting or supporting Phase 1 or Phase 1/2 clinical trials of three
other product candidates: ALD 151 to improve umbilical cord blood
transplants used in the treatment of leukemia, ALD-301 to treat critical
limb ischemia, and ALD-201 to treat ischemic heart failure. Aldagen's
product candidates consist of specific populations of adult stem cells that
the company isolates using its proprietary technology.