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May 1, 2007 |
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Top
Stories |
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Legislation and Regulation |
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Clinical
Research |
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Pharmaceutical News |
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Association
News |
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Calendar |
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Job &
Fellowship Connections |
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Monthly Journal |
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eNews
Archives |
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BMT
Tandem Meetings
Feb. 13-17, 2008
San Diego, California |
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A 50-year-old, otherwise healthy man with multiple myeloma has
achieved a minimal disease state with thalidomide plus dexamethsone.
He has an HLA-identical sibling. What’s your recommended therapy?
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Last Month’s Clinical Challenge |
The patient
has stage IVA mantle cell lymphoma in first CR
after R-HyperCVAD. See what you and your
colleagues would do, and a commentary by one
expert.
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Calendar |
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• May
American Society of Pediatric Hematology/Oncology (ASPH/O)
20th Annual Meeting
May 3-6
Metro Toronto Convention Centre
Toronto, Canada
American Transplant Congress
American Society of Transplantation (AST)
May 5-9
Moscone West Conference Center
San Francisco, California
5th Annual International Umbilical Cord Blood Transplantation
Symposium
California Blood Bank Society and Cord Blood Forum
May 11-12
Los Angeles Airport Marriott
Los Angeles, California
Short Course on Preservation of Cells, Tissues and Gametes
University of Minnesota
May 16-18
University of Minnesota Department of Mechanical Engineering
Minneapolis, Minnesota
Approaches to Complex Pathways in Molecular Epidemiology
American Association for Cancer Research (AACR)
May 30-June 2
Hyatt Regency Tamaya
Albuquerque, New Mexico
• June
American Society of Clinical Oncology (ASCO)
43rd Annual Meeting
June 1-7
McCormick Place
Chicago, Illinois
European Hematology Association (EHA)
12th Congress
June 5-7
Neue Messe Vienna
Vienna, Austria
State of the Science Symposium
Blood and Marrow Transplant Clinical Trials Network (BMT CTN)
June 7-8
University of Michigan
Ann Arbor, Michigan
Federation of Clinical Immunology Societies (FOCIS)
7th Annual Conference
June 7-11
Sheraton San Diego Hotel and Marina
San Diego, California
Pan Pacific Lymphoma Conference
University of Nebraska Medical Center
June 11-15
Grand Wailea Resort
Maui, Hawaii
International Society for Stem Cell Research (ISSCR)
5th Annual Meeting
June 17-21
Cairns Convention Centre
Cairns, Queensland, Australia
Methods in Cancer Clinical Research
Federation of European Cancer Societies (FECS),
with American Association for Cancer Research (AACR)
and American Society for Clinical Oncology (ASCO)
June 23-29
Park Hotel Waldhaus
Flims, Switzerland
International Society for Cellular Therapy (ISCT)
13th Annual Meeting
June 24-27
Sydney Convention Center
Sydney, Australia
Molecular Biology in Clinical Oncology
American Association for Cancer Research (ASCO)
June 30-July 7
Given Institute of the University of Colorado
Aspen, Colorado
• July
European Society for Medical Oncology (ESMO)
Annual Meeting
July 5-8
Palazzo dei Congressi Lugamp
Lugano, Switzerland
Euroconference on GVHD/GVL: A Paradigm of Haemopoietic
Transplantation
European School of Haematology (ESH)
and the European Group for Blood and Marrow Transplantation (EBMT)
July 6-9
Antemare Hotel
Sitges, Spain
2008
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 13-17
Manchester Grand Hyatt Hotel
San Diego, California
2009
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 11-15
Tampa Convention Center
Tampa, Florida
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Top
Stories |
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Stem cell treatment effective against Type 1 diabetes
Autologous stem cell treatment has proven effective in
treating 13 patients in Brazil suffering from Type 1 diabetes.
According to a study in the April 11 issue of The Journal of the
American Medical Association, the patients no longer needed to
take insulin for up to 35 months.
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Female stem cells better at regeneration than male
Stem cells from the muscle of female mice are better at
regenerating tissue than those taken from male mice. According
to a study in the April 9 issue of the Journal of Cell Biology,
female cells injected into mice suffering from a disease
analogous to the human genetic disease Duchene muscular
dystrophy produced many more muscle fibers containing dystrophin.
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Two companies seek to launch stem cell
products in 2008
Two companies – Cytori Therapeutics and Osiris Therapeutics
– are seeking to get experimental stem cell products approved by
the Food and Drug Administration and into the U.S. market by
2008. Cytori plans to launch its Celution System in Europe this
year, and Osiris' Prochymal drug could be used to treat acute
graft vs. host disease and Crohn's disease.
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A Word from President Robert Soiffer, MD
“First, do no harm.” That’s always been a good dictum for
physicians. It’s also one that the FDA must keep in mind
as it considers licensing of umbilical cord blood banks.
This past month we had the opportunity to testify before
an FDA panel that is considering how the agency will
license cord blood banks. It’s been known for a long
time that the FDA wants to license cord blood banks, but
it wasn’t until last December that a specific plan was
published in the form of a “guidance document.”
There’s hardly any quarrel with the intent of licensing.
We all welcome assurances that the cellular products
available to our patients are safe and efficacious.
However the licensing plan, as drafted, could have
unintended consequences if it limits patient access to
cord blood products already in storage or that are
collected in non-licensed facilities outside of the
United States.
We urged the FDA to move forward in only carefully
measured steps for a number of reasons:
 The selection of cord blood products is the practice
of medicine. Optimal cell dose and HLA match are
critical to the success of umbilical cord blood
transplantation. To deny a patient access to the most
efficacious product because of a licensing requirement
could compromise the care and possibly the survival of
that patient.
Unlike commercially manufactured drugs that are
approved for mass marketing, each cord blood product is
unique and might be uniquely suited for a particular
patient. At least 250,000 units of cord blood are
preserved in public banks around the world, but often
there is one best match for a patient. It’s likely that
many of these units have been collected or stored using
protocols that don’t precisely match the proposed
requirements for U.S. licensure. But there also is
little reason to conclude that many or most of these
units are not safe and efficacious.
Because of the diversity of the U.S. population, the
best cord blood product frequently may be located in
another country. The volume of imported units being
selected and transplanted is about 20 percent and
growing. This need for imported units is large and
expected to increase because of the genetic diversity of
Americans.
The cord blood banks able to comply with the proposed
licensing requirements are most likely in the United
States and Western Europe. If licensure limits access to
cord blood products, the patients at greatest
disadvantage are certain to be those whose ancestry is
non-Western European. These racial and ethnic
populations already are disadvantaged because of a
smaller pool of registered unrelated volunteer donors of
peripheral blood and bone marrow.
Currently, the transplant physician has ultimate
responsibility for selecting a product that has been
collected, stored, tested and transported in accordance
with professionally recognized standards. Within the
transplant community, those standards have been
developed by FACT-NetCord, which administers an
international system of cord blood bank accreditation.
That accreditation program is expanding rapidly in pace
with cord blood therapies both in the United States and
around the world.
Both FACT-NetCord accreditation and recently enacted
federal law require the evaluation and reporting of
outcomes of therapy for all allogeneic stem cell
transplants, including cord blood transplants. We fully
support these requirements that enable the transplant
community and the government regulators to assess the
safety and efficacy of units obtained from individual
cord blood banks.
In summary, licensing requirements designed to increase
safety could, if not carefully applied, contribute to
mortality. We vigorously support standards and the
efforts of cord blood banks and processing laboratories
to meet those standards, but it is essential to allow
the clinician to evaluate and decide on the safety and
efficacy of transplanting a particular product.
We urged the agency to continue watchful waiting to
evaluate how cord blood therapies evolve under the
current system of clinical judgment by the physician
based on standards and accreditation.
“First, do no harm” was the overriding message.
– Rob |
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Clinical Research |
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Human
sperm from bone marrow?
Scientists in Germany have created male germ cells that
contain spermatagonial stem cells, an early version of sperm
cells. According to a report to be published in the journal
Reproduction: Gamete Biology, researchers isolated human mesenchymal stem cells from bone marrow they had extracted from
male volunteers and stimulated them using a type of vitamin A to
develop into germ cells.
Researchers
reproduce development of leukemia in mice
Researchers in Canada have been able to reproduce the
evolution of human blood stem cells into leukemia stem cells,
then watch the disease unfold in lab mice. According to a report
published in the April 27 issue of the journal Science, all the
animals tested developed leukemia with the same characteristics
and patterns experienced by people with the disease.
One gene governs renewal of embryonic and adult stem cells
A single gene, called Zfx, governs self-renewal in both
embryonic and hematopoietic adult stem cells. According to a
report in the April 20 issue of the journal Cell, this discovery
might enable scientists to boost the self-renewal of different
kinds of stem cells, which could help in producing embryonic
stem cells for use in medical research or potential future
treatments.
Baxter testing heart disease treatment
Baxter International Inc. is performing a clinical trial of
a treatment that aims to use stem cells to repair heart tissue
damaged by a lack of oxygen, thus providing relief from angina.
Patients participating in the trial, which is based on
autologous stem cell transplants, have previously failed to
respond to surgery and drugs. The treatment uses Baxter's cell
separation technology to isolate CD34 cells.
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Pharmaceutical News |
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Companies apply for extended use of Campath cancer drug
Genzyme Corp. and Bayer HealthCare Pharmaceuticals Inc. have
filed with the Food and Drug Administration for an extended use
of their Campath drug, which is approved to treat B-cell chronic
lymphocytic leukemia in patients that have been treated with an
alkylating agent and have failed fludarabine therapy. The
companies hope to get added approval for Campath as a first-line
treatment for this cancer.
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Association
News |
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May 15 deadline for State of Science Symposium
The deadline is May 15 for registration for the BMT CTN
State of the Science Symposium, to be held June 7-8 at the
University of Michigan. Organized by the Blood and Marrow
Transplant Clinical Trials Network, the symposium will identify
the most compelling research opportunities in 12 separate areas.
Web site is resource for emergency radiation incidents
A Web site for helping BMT physicians respond to radiation
incidents has been created by the Radiation Injury Treatment
Network (RITN), a joint project of ASBMT and the National Marrow
Donor Program.
NMDP given HIPAA exemption
Transplant centers may provide patient-specific information
to the National Marrow Donor Program without fear of violating
patient privacy rules, according to a legal opinion from the
federal government.
10 selected for first research training course
Ten new clinicians and investigators have been selected to
participate in the first ASBMT Transplant Clinical Research
Training Course, to be held in mid-July in Keystone, Colo.
Measurement and reporting of treatment outcomes
Two sessions at the recent BMT Tandem Meetings addressed
details and ramifications of mandatory measurement and reporting
of treatment outcomes for related and unrelated allogeneic blood
transplants. The presentations are available online, free of
charge, for viewing or download.
Transplants exceed 16,000 annually in U.S.
Currently there are more than 16,000 hematopoietic stem cell
transplants performed annually in the United States, according
to estimates from the Center for International Blood and Marrow
Transplant Research.
BMTR looks at post-transplant patient care
Post-transplant patient care is the topic of Blood and
Marrow Transplantation Reviews, currently en route to ASBMT
members and an additional 10,000 hematologists/oncologists.
Included in the issue are presentations from a recent NMDP
symposium on identifying patients with good prospects for
long-term survival, the new option of cord blood transplants for
adults, intervention against late complications, the importance
of two-way communications between referring and transplanting
physicians, and the role of clinical trials in improving
transplantation outcomes.
Review considers transplants for aplastic anemia
A review of allogeneic stem cell transplantation for
aplastic anemia appears in the May issue of Biology of Blood and
Marrow Transplantation. Drs. Philippe Armand and Joseph Antin
describe the major improvements that have occurred in
transplantation for aplastic anemia in the past three decades
and suggest the patients in whom transplantation might be
indicated as frontline therapy.
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