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barbara
06-18-2010, 12:39 AM
(Reuters) - Adult patients with leukemia fare just as well when they get stem cell transplants taken from a cord blood bank as they do from a well-suited adult donor, U.S. researchers said on Tuesday.


They said umbilical cord transplants are a viable option for adults with leukemia who urgently need a bone marrow transplant to replace cells destroyed by chemotherapy or radiation treatments, but cannot find a donor.

"What we found is when you look at the outcome of leukemia-free survival, which is the likelihood of a patient being alive without disease, it's the same whether you are transplanting using an adult graft which is from an adult donor or a cord blood unit," said Dr. Mary Eapen of the Medical College of Wisconsin, whose study appears in the journal Lancet Oncology.

Cord blood worked even if it was not a great match, Eapen said in a telephone interview.

Only about half of all white adult patients can find a suitable donor, and the odds are much lower if the patient is African American or Asian, Eapen said.

"In general ... if you don't have an acceptable tissue match with a donor, your chances of having a complication are higher and it can result in death," she said.

But that is less so with stem cells from umbilical cord blood. "The body is more tolerant to the cells in the placental blood, even though they are not a perfect match."

Eapen and colleagues analyzed data from 216 transplant centers worldwide. They compared the results of 165 patients 16 or older with acute leukemia who had been received umbilical cord blood to 888 adults given unrelated stem cell transplants, and 472 who had been given unrelated donor bone marrow.

After two years, all the patient groups were equally likely to survive and be free of leukemia regardless of graft source.

"The beauty of umbilical cord blood is you can use that for transplant patients who are not a perfect match and still come up with an acceptable endpoint, which is leukemia-free survival," Eapen said.

She said most transplants being done with cord blood use public cord blood banks, in which parents have donated blood from their infant's umbilical cord.

These have undergone strict testing to ensure the cells are safe and well preserved.

Private cord blood banks, such as those run by Cord Blood America Inc, typically collect and store cord blood for private use for an individual or family member, she said.

In an accompanying comment, Paul Szabolcs of Duke University Medical Center in Durham, North Carolina, said the analysis should bolster efforts to increase donations to public cord blood banks, particularly by minorities, who have the most trouble finding a matched donor.

Public cord blood banks cover the costs to collect, test and store umbilical cord blood. Information on how to donate can be found at www.marrow.org.

Kaye
06-23-2010, 07:24 AM
The Gamida Cell-Teva Joint Venture Receives FDA Fast Track Designation for StemEx(R) for Leukemia and Lymphoma

StemEx, an experimental stem cell therapy product, is being developed for patients with blood cancers who cannot find a matched related bone marrow donor.

Published: Monday, 21 Jun 2010 | 7:00 AM ET

JERUSALEM, Jun 21, 2010 (BUSINESS WIRE) -- Gamida Cell announced today that the Gamida Cell-Teva Joint Venture has received an FDA Fast Track Designation for StemEx, in development as an alternative to a bone marrow transplant for patients with blood cancers such as leukemia and lymphoma.

The fast track programs of the Food and Drug Administration (FDA) are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs (fast track products).

The letter sent by the Department of Health and Human Services to the Gamida Cell-Teva Joint Venture stated: your request meets the criteria for the Fast Track designation. Therefore, we are designating as a Fast Track development program the investigation of StemEx (ex vivo expanded cord blood) as a supportive treatment to enhance hematopoietic re-constitution of umbilical cord blood cell transplant to improve 100-day post-transplant mortality in adults and adolescents who receive myeloablative therapy for high risk hematological malignancies.

About StemEx StemEx is a graft of stem/progenitor cells isolated and expanded from a portion of a single unit of umbilical cord blood and transplanted in combination with non-expanded cells from the same unit. StemEx is now being studied in an international, phase III, clinical trial at leading transplant centers in the U.S., Europe and Israel. StemEx has orphan drug designation in the U.S. and in Europe, in addition to long term patent protection. For more information about StemEx or about the StemEx study, please visit www.stemexstudy.com.