The 27 Harvard University cell lines join 13 from Children's Hospital Boston added earlier this month to a NIH stem cell registry. Human embryonic stem cells are the precursors to every type of tissue. Cell "lines", or colonies, are grown from the collected inner cells of an embryo destroyed in the process of collection. Researchers hope to study organ development, screen drugs and someday perhaps grow rejection-free transplant tissues from the cells.
In an Oct. 12 application for NIH approval, the Harvard researchers had noted they gathered the embryos from donations by fertility clinic patients, using consent forms that listed their use as diabetes research. For that reason, "NIH-funded research with this line is limited," says the registry, to "study the embryonic development of (tissue) with a focus on pancreatic formation," with the aim of "producing cells that produce insulin, for transplantation into diabetics. An advisory committee last week had recommended the limitation, and Collins apparently agreed with their recommendation.
The Harvard cells have been used in privately-funded studies of ALS, Alzheimer's disease, Huntington's disease, Parkinson's disease, spinal injury, heart disease, cancer infertility and other ailments. A Proceedings of the National Academies of Science journal report last year called them the "gold standard" for comparison with cells claimed to possess tissue-forming properties.
The approval puts 40 cell lines on the NIH registry, beating the Bush Administration 2001 to 2008 total of 21 lines on its registry.
Photo By Dan Vergano
Photo: In this file photo originally made available by Advanced Cell Technology in 2006, a single cell is removed from a human embryo to be used in generating embryonic stem cells for scientific research. (AP)
USA TODAY Staff
12/14/2009 5:56:37 PM
Additional comment from Harvard:
From Doug Melton, Co-Director of the Harvard Stem Cell Institute:
"We're delighted to learn that the NIH has lifted the restrictions on using human embryonic stem cells as it will speed our work and that of many other researchers.
When President Obama, last March spoke so powerfully about returning science to its rightful place in establishing our national priorities and policies, we were all relieved and optimistic about the future. In the intervening period the NIH has proceeded with a deliberative process and come to a compromise solution on what cell lines it believes should be eligible for funding.
Their choices are not entirely aligned with the equally careful and deliberative processes used by Harvard University, and ESCRO committee,and Independent Institutional Review Boards over the last eight years,but I understand that political considerations and changes in public perception influenced their decisions. Thus, while the new policy is not what I expected after hearing the President's speech, it is a significant improvement and a cause for celebration among scientists and patients."
From B. D. Colen, spokesman for Harvard Stem Cell Institute:
“We’re extremely pleased that these Harvard stem cell lines will be available to advance the understanding of diabetes and the development of treatments for those suffering in the global diabetes pandemic.
We remain convinced that Harvard’s IRB was correct in making these lines available for additional types of research, and was in line with the best ethical practices and procedures at the time. But we do understand NIH taking a careful, extremely conservative and cautious approach to this issue at this time
TYPE 1 DIABETES: STEM CELLS CLINICAL TRIAL
In VICTORIES & SUCCESS STORIES on September 14, 2009
Doctors: Carlos E. B. Couri, MD, PhD; Maria C. B. Oliveira, MD; Ana B. P. L. Stracieri, MD, PhD; Daniela A. Moraes, MD; Fabiano Pieroni, MD, PhD; George M. N. Barros, MD; Maria Isabel A. Madeira, MD; Kelen C. R. Malmegrim, PhD; Maria C. Foss-Freitas, MD, PhD; Belinda P. Simões, MD, PhD; Edson Z. Martinez, PhD; Milton C. Foss, MD, PhD; Richard K. Burt, MD; Júlio C. Voltarelli, MD, PhD
C-Peptide Levels and Insulin Independence Following Autologous Nonmyeloablative Hematopoietic Stem Cell Transplantation in Newly Diagnosed Type 1 Diabetes Mellitus
JAMA. 2009;301(15):1573-1579.
Context In 2007, the effects of the autologous nonmyeloablative hematopoietic stem cell transplantation (HSCT) in 15 patients with type 1
diabetes mellitus (DM) were reported. Most patients became insulin free with normal levels of glycated hemoglobin A1c (HbA1c) during a mean 18.8-month follow-up.
To investigate if this effect was due to preservation of beta-cell mass, continued monitoring was performed of C-peptide levels after stem cell transplantation in the
15 original and 8 additional patients.
Objective To determine
C-peptide levels after autologous nonmyeloablative HSCT in patients with newly diagnosed type 1 DM during a longer follow-up.
Design, Setting, and Participants
A prospective phase 1/2 study of 23 patients with type 1 DM (aged 13-31 years) diagnosed in the previous 6
weeks by clinical findings with hyperglycemia and confirmed by measurement of serum levels of anti–glutamic acid decarboxylase antibodies.
Enrollment was November 2003-April 2008, with follow-up until December 2008 at the Bone Marrow Transplantation Unit of the School of Medicine of Ribeirão Preto,
Ribeirão Preto, Brazil.
Hematopoietic stem cells were mobilized via the 2007 protocol.
Main Outcome Measures
C-peptide levels measured during the mixed-meal tolerance test, before, and at different times following HSCT.
Secondary end points included morbidity and mortality from transplantation, temporal changes in exogenous insulin requirements, and serum levels of HbA1c.
Results
During a 7- to 58-month follow-up (mean, 29.8 months; median, 30 months), 20 patients without previous ketoacidosis and not receiving corticosteroids during the preparative regimen became insulin free.
Twelve patients maintained this status for a mean 31 months (range, 14-52 months) and 8 patients relapsed and resumed insulin use at low dose (0.1-0.3 IU/kg).
In the continuous insulin–independent group, HbA1c levels were less than 7.0% and mean (SE) area under the curve (AUC) of C-peptide levels increased significantly from 225.0 (75.2) ng/mL per 2 hours pretransplantation to 785.4 (90.3) ng/mL per 2 hours at 24 months posttransplantation (P < .001) and to 728.1 (144.4) ng/mL per 2 hours at 36 months (P = .001).
In the transient insulin–independent group, mean (SE) AUC of C-peptide levels also increased from 148.9 (75.2) ng/mL per 2 hours pretransplantation to 546.8 (96.9) ng/mL per 2 hours at 36 months (P = .001), which was sustained at 48 months.
In this group, 2 patients regained insulin independence after treatment with sitagliptin, which was associated with increase in C-peptide levels.
Two patients developed bilateral nosocomial pneumonia, 3 patients developed late endocrine dysfunction, and 9 patients developed oligospermia.
There was no mortality.
Conclusion:
After a mean follow-up of 29.8 months following autologous nonmyeloablative HSCT in patients with newly diagnosed type 1 DM, C-peptide levels increased
significantly and the majority of patients achieved insulin independence with good glycemic control.
Trial Registration clinicaltrials.gov Identifier: NCT00315133
Author Affiliations: Departments of Clinical Medicine (Drs Couri, Oliveira, Stracieri, Moraes, Pieroni, Barros, Madeira, Malmegrim, Foss-Freitas, Simões, Foss, and Voltarelli) and Social Medicine (Dr Martinez), School of Medicine of Ribeirão Preto, University of São Paulo, Ribeirão Preto, Brazil; and Division of Immunotherapy, Northwestern University Feinberg School of Medicine, Chicago, Illinois (Dr Burt).
RESEARCH FROM 90'S CURES TYPE 1 DIABETES!
In VICTORIES & SUCCESS STORIES
on September 13, 2009 at 8:36 pmPublished 23 January 2009
Twelve years ago, Irving Weissman discovered a treatment that might have saved the lives of thousands of women with advanced breast cancer,
but pharmaceutical companies weren’t interested in developing the therapy. Though that interest is finally being reignited, Weissman doesn’t pull any punches.
“I hate to say I told you so,” he said.
Weissman, a professor of pathology and developmental biology at Stanford University, spoke Wednesday and Thursday at Columbia University.
Weissman laid out the conceptual foundation of his work—that stem cells are rare, self-renewing, and can regenerate body tissues. Weissman
repeatedly expressed frustration that while many of his discoveries seemed to hold remarkable potential for life-saving treatments, commercial or
regulatory hurdles have prevented his scientific research from benefiting human beings.
One example is
Weissman’s mid-’90s research on type I diabetes, in which he demonstrated the ability to fully cure type I diabetes in mice using stem cells.
But even though the experiments avoided political controversy by using so-called adult stem cells, which do not come from embryos, Weissman ran
into a road block when pharmaceutical companies refused to sponsor clinical trials. The therapy went nowhere. Weissman implied that the pharmaceutical
companies had put profit over principle, preferring to keep diabetes sufferers dependent on costly insulin than to cure them once and for all.
“He (Weissman) has a long history of being at the forefront of his field,” Arthur Palmer, professor of structural biology at Columbia said, remarking that
Weissman has never been afraid to challenge scientific orthodoxy.
via Scientist Revives Research.
Stem Cell Hype Flows Both Ways
By Dr. Lee Silver
Scientists working at Novocell, Inc. in San Diego, CA have reported a stunning advance in the race to move embryonic stem cells from the
province of basic scientific research into the arena of clinical trials for patients suffering from diabetes. Type I diabetes results from the
degeneration of specialized cells in the pancreas (called beta-cells) that produce the hormone insulin. In healthy individuals, a rise in blood
sugar after a meal induces beta-cells to secrete insulin, which enables other cells to absorb and utilize the sugar as fuel; when blood sugar
levels drop, insulin production is turned down. In diabetics, insulin regulation fails. Currently, patients suffering from this disease have no
choice but to constantly monitor blood sugar levels and take insulin shots when those levels rise. Human embryonic stem cells
Just a decade ago, it would have been ludicrous to suggest that research in cellular and molecular biology might lead to the development
of a laboratory protocol for creating a substitute pancreas that could be implanted into diabetic patients. And yet, the results reported by
Emmanuel Baetge and his team at Novocell in the journal _Nature Biotechnology_ suggest that what was once a pipe-dream may soon
be a reality -- a long-lasting treatment for diabetes achieved through the use of embryonic stem cells.
Embryonic stem (ES) cells occur naturally within the one-week old human embryo. During normal development not many ES cells are
formed, and none stay "embryonic-like" very long. They grow and divide over a few weeks into a variety of more specialized cells that
eventually differentiate into every tissue and organ in the adult body. In 1998, however, James Thomson mastered the technology required
to isolate ES cells and keep them dividing indefinitely without differentiating in petri dishes. The promise and potential power of ES cell
technology lies with scientists uncovering specific molecular signals that would channel ES cells to develop into just a single tissue,
which could be used to treat a particular disease.
The key to the success of the Novocell team was not to go for the gold all at once, but to carefully mimic the natural step-by-step process
by which a subset of cells in a human embryo become gradually transformed into a pancreas. This process is driven by a timed sequence
of particular genes turning on and off. Baetge and his colleagues recapitulated the entire process in a petri dish, starting with isolated ES
cells and channeling them through a series of four intermediate stages, over a two-week period, prior to a final transformation into pancreatic
tissue that produces insulin in quantities similar to that produced in a healthy pancreas. Since none of the intermediate stages of pancreatic
development survive inside an adult body, the protocol appears absolutely dependent on starting with ES cells, rather than any conceivable adult cell.
The Novocell team is not yet home free. So far, they have produced fetal-like pancreatic tissue that is not responsive to changes in sugar levels.
The protocol must be extended one more stage to produce fully functional adult cells. Baetge is confident that this goal will be achieved within
the next year. If all goes as planned, he says, clinical trials could begin as early as 2009. At the end of their publication, Baetge and colleagues
write, "We are awed by the capacity of hES cells to recapitulate development ex vivo and are optimistic that these unique cells will ultimately
represent a renewable source of pancreatic beta-cells for people with diabetes."
In the brief time since human ES cells were first isolated, many opponents of the research have argued vociferously that the potential of this
line of research for creating novel therapies has been hyped by scientists. Indeed, even research supporters have been cowed into a hyper-cautious
mode, agreeing that it might be decades before the technology provides treatments for common diseases. The Novocell team ignored all of this
pessimism and got on with the job. In doing so, they showed that hype can flow both ways.
Lee Silver, Ph.D., is a professor of molecular biology and public affairs at Princeton and an ACSH Trustee. He was recently criticized by
fellow Princeton professor Robert P. George and bioethicist Patrick Lee, who object to embryonic stem cell research, on NationalReview.com,
and Silver wrote a response. A measure related to the divisive issue will be voted on in Missouri next week.
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