CHICAGO — A treatment that uses adult stem cells to rebuild
failing hearts reduced chest pain and improved activity of severely ill
patients one year after injection, a Northwestern University researcher working
with a Chicago device maker reported Tuesday at a major heart conference.
Though still early, the work of Dr. Douglas Losordo that
uses technology developed by Baxter International Inc. is being watched closely
by the stem cell research community. The trial data, presented Tuesday
afternoon at the American Heart Association scientific conference in Orlando,
is also important in the study of heart disease, the leading cause of death in
the U.S.
Because the group receiving therapy continues to show
reduced angina and improved activity a year after they were injected with their
purified stem cells, Losordo sees that as progress. In early stage clinical
trials, it is critical for researchers to show differences between treatment
and control groups to warrant further study.
“In this study, the treatment groups are separating so
there is further improvement in the treatment group,” said Losordo in a
telephone interview from the meeting. “The curves are separating as we go.
We take that as a good sign.”
The trial of 167 patients, mostly men, showed a range of
improvement in a population that has exhausted most other conventional
treatments with many home-bound or unable to do normal daily activity such as
walking up stairs or shopping for groceries.
“We are not talking that they can do mountain climbing,
but some who had stopped playing golf can do so again,” Losordo said.
Many of these patients have had so-called balloon
angioplasty or open-heart surgery to keep blood flowing and are so weak that
such treatments are no longer an option. Enter the stem cell injections.
The treatment in the trial uses Baxter’s Isolex cell
separation and collection system to extract stem cells from among the many
cells in bone marrow. Once isolated, the cells are injected into the heart via
catheter in hopes of regenerating damaged areas.
Stem cells are building blocks that theoretically can be
manipulated to perform the work of other cell types.
The latest trial is considered the second of three phases of
research needed before Baxter would submit the data to the U.S. Food and Drug
Administration for approval. Final, so-called Phase III trials, generally
involve several hundred patients.
It’s unclear when Baxter and Losordo will begin a next
phase. Baxter’s Isolex is approved by the FDA for use in cancer therapy.
Separately, Baxter has said it has been working to address
FDA concerns over whether Isolex has been in compliance with certain
manufacturing standards.
“More evaluation of the data is needed before Baxter
determines next steps of the trial,” said Baxter spokeswoman Mavis Prall.
“The FDA warning letter does not affect this clinical trial program.”
Via McClatchy-Tribune News Service.
