AlloCure Begins Phase 2 Clinical Trial in Acute Kidney Injury
By NEVAGiles23
BURLINGTON, Mass.--(BUSINESS WIRE)--
AlloCure, Inc. today announced that it has initiated a phase 2 clinical trial of AC607, the companys mesenchymal stem cell therapy, as a potential treatment for acute kidney injury (AKI). The randomized, double-blind, placebo-controlled, multi-center trial, designated ACT-AKI (AC607 Trial in Acute Kidney Injury) (NCT01602328), will enroll 200 cardiac surgery subjects at leading tertiary care centers in the United States.
ACT-AKI follows the positive results from a phase 1 AC607 trial in cardiac surgery subjects, which showed an excellent safety profile and encouraging data on the incidence of AKI and hospital length of stay, said Robert M. Brenner, M.D., AlloCure President and Chief Executive Officer. We have worked closely with leaders in the field on the design of ACT-AKI, and trial initiation represents an important milestone for AlloCure and the patients we collectively serve.
AC607 is a promising therapeutic candidate for AKI, for which effective therapies are greatly needed, said Richard J. Glassock, M.D., Emeritus Professor of Medicine at the Geffen School of Medicine at the University of California, Los Angeles. The initiation of ACT-AKI represents a critical step in the development of an innovative therapy for this all-too-common, serious and costly medical condition, for which no approved treatments currently exist beyond supportive care.
About AC607
AC607 is a novel biologic therapy under development for the treatment of AKI. AC607 also possesses potential applications in other grievous illnesses. AC607 comprises allogeneic bone marrow-derived mesenchymal stem cells that are harvested from healthy adult donors and then expanded via a mature and state-of-the art manufacturing process. AC607 homes to the site of injury where it mediates powerful anti-inflammatory and organ repair processes via the secretion of beneficial paracrine factors, without differentiation and repopulation of the injured kidney. Importantly, AC607 avoids recognition by the hosts immune system, enabling administration in an off the shelf paradigm without the need for blood or tissue typing.
About AlloCure
AlloCure, Inc. is a privately held, clinical-stage biotechnology company focused on the treatment of kidney disease. The company is a leader in the AKI field and is pioneering the development of the first effective therapy for the treatment of AKI. The companys headquarters is located in Burlington, MA. For more information about AlloCure, please visit the companys web site at http://www.allocure.com.
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AlloCure Begins Phase 2 Clinical Trial in Acute Kidney Injury
'Missing link' between stem cells and the immune system
By NEVAGiles23
ScienceDaily (Aug. 31, 2012) UCLA researchers have discovered a type of cell that is the "missing link" between bone marrow stem cells and all the cells of the human immune system, a finding that will lead to a greater understanding of how a healthy immune system is produced and how disease can lead to poor immune function.
The studies were done using human bone marrow, which contains all the stem cells that produce blood during postnatal life.
"We felt it was especially important to do these studies using human bone marrow as most research into the development of the immune system has used mouse bone marrow," said study senior author Dr. Gay Crooks, co-director of the Eli and Edythe Broad Center of Regenerative Medicine and a co-director of the Cancer and Stem Cell Biology program at UCLA's Jonsson Comprehensive Cancer Center. "The few studies with human tissue have mostly used umbilical cord blood, which does not reflect the immune system of postnatal life."
The research team was "intrigued to find this particular bone marrow cell because it opens up a lot of new possibilities in terms of understanding how human immunity is produced from stem cells throughout life," said Crooks, a professor of pathology and pediatrics.
Understanding the process of normal blood formation in human adults is a crucial step in shedding light on what goes wrong during the process that results in leukemias, or cancers of the blood.
The study appears Sept. 2 in the early online edition of Nature Immunology.
Before this study, researchers had a fairly good idea of how to find and study the blood stem cells of the bone marrow. The stem cells live forever, reproduce themselves and give rise to all the cells of the blood. In the process, the stem cells divide and produce intermediate stages of development called progenitors, which make various blood lineages like red blood cells or platelets. Crooks was most interested in the creation of the progenitors that form the entire immune system, which consists of many different cells called lymphocytes, each with a specialized function to fight infection.
"Like the stem cells, the progenitor cells are also very rare, so before we can study them we needed to find the needle in the haystack." said Lisa Kohn, a member of the UCLA Medical Scientist Training Program and first author in the paper.
Previous work had found a fairly mature type of lymphocyte progenitor with a limited ability to differentiate, but the new work describes a more primitive type of progenitor primed to produce the entire immune system, Kohn said
Once the lymphoid primed progenitor had been identified, Crooks and her team studied how gene expression changed during the earliest stages of its production from stem cells.
See the rest here:
'Missing link' between stem cells and the immune system
UCLA researchers discover missing link between stem cells and immune system
By daniellenierenberg
Public release date: 2-Sep-2012 [ | E-mail | Share ]
Contact: Kim Irwin kirwin@mednet.ucla.edu 310-206-2805 University of California - Los Angeles Health Sciences
UCLA researchers have discovered a type of cell that is the "missing link" between bone marrow stem cells and all the cells of the human immune system, a finding that will lead to a greater understanding of how a healthy immune system is produced and how disease can lead to poor immune function.
The studies were done using human bone marrow, which contains all the stem cells that produce blood during postnatal life.
"We felt it was especially important to do these studies using human bone marrow as most research into the development of the immune system has used mouse bone marrow," said study senior author Dr. Gay Crooks, co-director of the Eli and Edythe Broad Center of Regenerative Medicine and a co-director of the Cancer and Stem Cell Biology program at UCLA's Jonsson Comprehensive Cancer Center. "The few studies with human tissue have mostly used umbilical cord blood, which does not reflect the immune system of postnatal life."
The research team was "intrigued to find this particular bone marrow cell because it opens up a lot of new possibilities in terms of understanding how human immunity is produced from stem cells throughout life," said Crooks, a professor of pathology and pediatrics.
Understanding the process of normal blood formation in human adults is a crucial step in shedding light on what goes wrong during the process that results in leukemias, or cancers of the blood.
The study appears Sept. 2 in the early online edition of Nature Immunology.
Before this study, researchers had a fairly good idea of how to find and study the blood stem cells of the bone marrow. The stem cells live forever, reproduce themselves and give rise to all the cells of the blood. In the process, the stem cells divide and produce intermediate stages of development called progenitors, which make various blood lineages like red blood cells or platelets. Crooks was most interested in the creation of the progenitors that form the entire immune system, which consists of many different cells called lymphocytes, each with a specialized function to fight infection.
"Like the stem cells, the progenitor cells are also very rare, so before we can study them we needed to find the needle in the haystack." said Lisa Kohn, a member of the UCLA Medical Scientist Training Program and first author in the paper.
See the rest here:
UCLA researchers discover missing link between stem cells and immune system
Annabelle Rama to undergo stem cell treatment to improve health
By raymumme
YAHOO:
Talent manager Annabelle Rama will fly to Germany in September to undergo therapy - stem cell therapy, that is. This has been a promise made by her son Richard Gutierrez who's footing the bill. "Early this year pa lang ay napagplanuhan na 'yung pagpapa-stem cell ng nanay ko at prinomise ko sa kanya na pag-iipunan ko, prinomise ko sa kanya na ako ang magti-treat sa kanya," Richard said on the first episode of "H.O.T. TV," Aug. 5.
He noted, "'Yung mom ko hindi mahilig 'yan na pumunta sa mga doctor, hindi mahilig magpa-check-up."
Looking forward
This early, Annabelle is already excited about her trip and the upcoming treatment.
"Kaya ako excited pumunta kasi unang-una mataas ang aking sugar, mataas ang aking cholesterol, tapos me problema pa ako sa high blood, blood pressure ko. Siguro nga kailangan kong pumunta ng Germany," she said, noting that the condition of her friends, talent manager Lolit Solis and actress Lorna Tolentino, have improved tremendously after going through stem cell therapy.
"Nakita ko ang mukha ni Lolis pumuputi ang mukha niya, eh at saka mukha siyang fresh na fresh. Lalo na si LT, nakita ko rin siya. Mukhang gumanda naman siya. Basta lahat ng kaibigan kong galing doon, nakakausap ko, sabi nila ay talagang gumaling daw sila. 'Yung kanilang napi-feel na mabigat sa katawan dahil sa sakit nila ay nawawala lahat," she said.
Exorbitant fees?
Annabelle had already inquired about the fees of stem cell procedure in the country and she feels it's exorbitant.
"Kasi sa Piipinas may pinagtatanungan na ako, umabot ng mga four million pesos 'yung naitanong ko kaya parang na-discourage akong magpagamot kasi nga ganoon kamahal."
Read the rest here:
Annabelle Rama to undergo stem cell treatment to improve health
Genetic Engineering: A Food Fix? – Forbes
By Dr. Matthew Watson
Forbes | Genetic Engineering: A Food Fix? Forbes Genetic engineering, in the short term, then would save us the pollution, expense and growing weed resistance caused by pesticides. But in the long term, these weeds (and perhaps the insects as well) will also become resistant to the genetically ... |
Source:
http://news.google.com/news?q=genetic-engineering&output=rss
Elk Run Biotechnology Center is a Slow Process – KAALtv.com
By Dr. Matthew Watson
KAALtv.com | Elk Run Biotechnology Center is a Slow Process KAALtv.com (ABC 6 News) -- It's a project years in the making, but many are now wondering what is going on with the Biotechnology Center in Pine Island. It's a sign that carries much more than a name of a yet to be developed technology campus. Promises of high ... |
Source:
http://news.google.com/news?q=biotechnology&output=rss
Are some cell counts too good to be true? Why some companies’ product data may mislead.
By Dr. Matthew Watson
Cell therapies present unique challenges when complying with this paradigm for several reasons only two of which I will mention here. Firstly, it is not possible to achieve the level of product purification as one might with other therapeutic products. Secondly, the product characterization is at a cellular rather than molecular level.
Autologous cell therapies present another set of unique challenge in this paradigm because of the notable patient-to-patient variability where the patient is also the donor of the raw material. This often means there is a wider tolerance of heterogeneity in the product but it still must be within what has been proven to the regulatory agency as a safe and effective range.
In cases where an autologous cell therapy is centrally manufactured, they are most often subjected to product release testing similar to that described above. One notable difference, particularly for fresh products, is that the products may be shipped to the clinic and even administered before the full panel of test results are obtained. This wold be considered highly unusual (if ever acceptable) with other types of products but is tolerated because of the time-sensitivity of these products and their high safety profile.
In the case of autologous cell therapy products produced at the bedside there is often not the same kind of product release discipline. Often the regulatory agencies deal with the product consistency and specification compliance issue by ensuring that the cell processing device used point-of-care is validated to ensure the cellular product output is always within a specified range shown to be clinically safe and effective.
The Varying Degree of Product Characterization/Specification of Autologous GTP Cell Therapy Products
However - and now I get to the point of this blog post - for cell-based products, procedures and/or devices/kits which are not mandated to be formally approved by a regulatory agency before they can be commercially marketed, there is no product specification rigor. Compliance with the Good Tissue Practice regulations and guidance is deemed to ensure safety. In the United States, cell-based products which are deemed to be "minimally manipulated" and intended for "homologous use" are typically allowed to go straight to market with no formal approval. Safety and clinical data is not required but is practically necessary to support physician adoption and, where applicable, reimbursement.
This means that for these products there is a great deal of variability in terms of how much rigor companies apply in characterizing their product and then ensuring that each batch complies with the specifications they themselves have determined to be safe and effective. Again, where such products are manufactured in a centralized facility the likelihood of some release testing is greater. However, those companies relying on a point-of-care processing kit or device business model that has not been deemed to require formal market approval, rarely (if ever) include product release testing.
The common criticism of these companies is that they simply do not know what they are injecting into patients because of the combination of the patient-to-patient donor variability, the lack of any disciplined product characterization or dosing studies, and the absence of any product release testing.
This criticism is not equally levied at all autologous GTP products or companies - even those relying on point-of-care processing. Of course some companies care and do a lot to try to ensure their product is well-characterized and that each batch complies with product specifications. This may involve the use of product release tests but can also involve the combination of pre-market research into the product characterization, safety, and dosing along with validation of the device/kit output. In this way a company can say that within a very small margin, the output will be within the product specifications the company knows is safe and efficacious.
However, in a rush to get their device/kit to market some companies appear to care very little about the cell product characterization, validation of the output of their device/kit, or tying this data to optimal dose.
More concerning are those companies that appear to provide such data but it is wrong or meaningless. What follows appears to potentially be a case study of precisely this problem.
The INCELL Study
This week I came across a fascinating white paper from Incell Corporation analyzing the output of adipose tissue processing kits of MediVet-America apparently demonstrating the inaccuracy of their cell counts (a common type of cell therapy product characterization) and calling into the question the cell count claims of Intellicell Biosciences (New York, NY) and Adistem (Hong Kong).
At the heart of the critique is the claim that the cell counting (product characterization) techniques employed by these companies counts as cells things (namely acellular micelles) which are not cells.
I encourage you to read the white paper in its entirety. They corresponding author told me to watch for one or more papers which they are preparing for submission to peer-reviewed publications shortly. Presumably these will rely on a larger data set and perhaps test other methodologies or technologies.
For the purposes of this blog, I've pulled what I believe are the most salient excerpts below:
Intrigued by the high cell numbers (5 to 20 million cells/gram) reported by kit/device manufacturers such as MediVet-America (Lexington, KY), Intellicell Biosciences (New York, NY), and Adistem, Ltd. (Hong Kong) in adipose stem cell therapy compared to other methods (e.g.,
Chung,Vidal, and Yoshimura), INCELL staff conducted a research study to investigate the high apparent yield of stem cells. This initial work was focused on SVF cells from the MediVet Kit, which is marketed to isolate adiposederived canine SVF and stem cells.
The cell yields reported for the Medivet Kits are five to more than ten times higher than the yields routinely obtained by INCELL from freshly harvested human or animal adipose tissue using our adipose tissue processing methods. These yields are also tenfold or higher than those reported in the literature by most academic researchers (Chung-canine, Vidal–equine, Yoshimura–human). Since these cell counts are used to support stem cell dosing recommendations and cell banking, it is important to better understand why the cell numbers are higher.
...
A comparative analytical study of three dog donors of adipose tissue was designed to evaluate the cell yields using the MediVet Kit as an example of this class of isolation system. All kit procedures were followed as per the instructions provided. A brief overview of the different cell counting methods used, and the resultant cell counts, observations and explanations of the results observed, are described below
....
This study shows that incorrect counting of adipose derived SVF cells and the subset of regenerative stem cells can subsequently result in inaccurate dosing, both in direct therapeutic applications and in cryostorage of cells for future use. The DAPI-hemocytometer cell count (manual) was considered the most accurate, but there are various sources of technical difficulties that can lead to incorrect cell numbers. The nature of adipose tissue itself with variability in dissociation by enzymatic digestion can all contribute to the outcomes. Fat tissue has a propensity to form acellular micelles and oils upon tissue disruption. Processing methods or reagents (e.g., Solution E or lecithins) can generate micelles that may be erroneously counted as cells. Autofluorescence and dye trapping or uptake by the micelles can lead to very high inaccurate cell counts when automated cell counting is used.
In this study the most inaccurate counting came from the Cellometer. When used according to kitrecommended guidelines and on-site training provided by Nexelcom for counting cells by the MediVet procedure, the Cellometer overstated the DAPI-hemocytometer cell count by up to 20X or more. The Coulter Counter protocols also led to incorrect, high cell numbers. Although the cell counts were still a bit high, the authors recommend the NucleoCounter, or similar equipment, as more acceptable for automated counting. The manual hemocytometer-DAPI method is the most accurate, but requires a highly experienced cell biologist or technician to make accurate counts and is not suitable for routine clinical use....Other companies also have claims of very high cell numbers when their processes are used. Adistem, like MediVet, states they add an emulsifying agent to their kits to assist in cell release, and they also use a light activation system. Their kits were not tested in this study but it is possible that the high cell numbers reported by Adistem are also incorrect and result from the same problems highlighted in this paper for the MediVet procedure. Ultrasonic energy, which is commonly used to manufacture micellular liposome structures and to disrupt and lyse cells, is another potentially problematic procedure for counting and verifying viable, regenerative cells. Intellicell 3uses ultrasonic energy to release cells from adipose tissue, and it is possible that resultant micelles or cell fragments contribute to the higher than expected cell numbers. This assumption could be verified with additional studies.
In summary, the authors caution that great care must be taken when using kits and automated cell counting for stem cell dosing and cryobanking of cells intended for clinical use. Overestimated cell numbers would be a major confounding source of variation when efficacy of stem cells injected are compared as doses based on cell number and when cryostored cells are aliquoted for use based onspecific cell numbers as a treatment dose. Hopefully, this study will lead to more reproducible counting and processing methods being reported in the literature, more inter-study comparability of cell doses to clinical outcomes, more industry diligence to support claims, and more accurate counting for dosing stem cell therapies to patients....
Chung D, Hayashi K, Toupadakis A, et al. Osteogenic proliferation and differentiation of canine bone marrow and adipose tissue derived mesenchymal stromal cells and the influence of hypoxia. Res Vet Sci, 2010; 92(1):66-75. Vidal MA, Kilroy GE, Lopez MJ, Johnson JR, Moore RM, Gimble JM. Characterization of equine adipose tissue-derived stromal cells: adipogenic and osteogenic capacity and comparison with bone marrow-derived mesenchymal stromal cells. Vet Surg, 2007; 36:613–622. Yoshimura K, Shigeura T, Matsumoto D, et al: Characterization of freshly isolated and cultured cells derived from the fatty and fluid portions of liposuction aspirate. J Cell Phys, 2006; 205:64-76.
California Stem Cell Agency: A New Board Member and a New Vacancy
By Dr. Matthew Watson
The chairs are shifting a tad on the
governing board of the $3 billion California stem cell agency as a
French immigrant is added, a Latino leaves and a veteran patient
advocate is reappointed.
Coming on board for next week's meeting
is Anne-Marie Duliege, chief medical officer of Affymax Inc., of
Palo Alto, a publicly traded biopharmaceutical company that deals
with kidney disease. Leaving is David Serrano Sewell, who has been
named to the state Medical Board by Gov. Jerry Brown. Reappointed is
Jeff Sheehy, an HIV/AIDs patient advocate who may be the most public face
of patient advocates on the stem cell agency.
Anne-Marie Duliege Affymax Photo |
State Controller John Chiang appointed
Duliege to the CIRM post, saying,
“Dr. Duliege brings
first-hand knowledge of what is required to take a drug from research
phase through FDA approval.”
the Bioscience Forum in South San Francisco called “Beating the
Odds,” a discussion of Affymax's first commercial product.
According to information posted by the group, Duliege led the way by
shepherding it through a 10-month gauntlet at the FDA.
2007. Her prior positions included time at Chiron and Genentech. She
is a practicing physician, working part-time, and received her
medical degree from Paris Medical School.
stem cell agency. Ted Love, one of the initial members of the CIRM board, also sits on the Affymax board of directors. Indeed, Duliege fills the seat
vacated by Love when he resigned from the CIRM board. The position must be
filled by an officer of a California life science company.
David Serrano Sewell CIRM Photo |
Serrano Sewell, who has also served on
the CIRM board since its inception, is apparently resigning to accept
an appointment to the board that regulates
California physicians. Apparently – because the stem cell agency
has not confirmed that he is leaving, although this morning it placed a resolution honoring him on the agenda for next week's meeting. That almost invariably means a board member is departing.
city of San Francisco, was one of 10 patient advocate members on the
29-member board. Sewell was apppointed by the California lieutenant
governor. His seat will remain vacant until the current lieutenant
governor, Gavin Newsom, makes an appointment, who must also be a patient advocate.
Jeff Sheehy CIRM Photo |
Sheehy was reappointed recently by
state Senate President Pro Tem Darrell Steinberg. Sheehy is a
communications manager at UC San Francisco and a nationally known
HIV/AIDS advocate. He is co-chairman of CIRM's Science Subcommittee
and vice chairman of the grants review group. Sheehy leads the
discussion of grant applications when they come before the full board
in public session.
Eugene Washington, dean of the UCLA medical school, is a member of
the board but never attends the meetings. Instead he sends a
surrogate. Serrano Sewell's departure brings the number of Hispanics
to three, co-vice chairman Art Torres, Francisco Prieto and Marcy
Feit. No Asians sit on the board.
Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Bob Klein, "Lobbying" and Reader Reaction
By Dr. Matthew Watson
A robust discussion has arisen
concerning Bob Klein and his appearance last month before the
governing board of the $3 billion California stem cell agency, a body
that he once chaired and an enterprise that he once oversaw.
was manipulated and whether he was engaged in so-called “revolving
door” activity – the practice of former government officials,
such as Klein, becoming paid representatives of enterprises that were
involved with their former agency.
interesting questions that we will discuss on the California Stem
Cell Report during the next few days.
of those who commented for the delay in posting their remarks.)
Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Nearly $6 Million Sought: Four Scientists Seek to Overturn Rejection by CIRM Reviewers
By Dr. Matthew Watson
Four researchers are appealing
rejection of their proposals to win millions of dollars from the
California stem cell agency just as the agency is moving to curb such
reconsideration efforts by scientists.
agency calls its basic biology round. The agency's governing board
meets next Wednesday and Thursday to hand out as much as $35 million
to as many as 25 scientists competing for the research dollars.
round. One upshot has been a proposal that would tighten the review process. That plan also comes before directors next week.
applications were given scientific scores that exceeded those of some
proposals that were approved by reviewers. The lower scoring
proposals were given the go-ahead on the basis of “programmatic
review,” which one CIRM document says is designed to allow
“consideration of issues beyond scientific merit, such as disease
representation and societal impact.”
as extraordinary petitions – were filed by Michael Teitell of UCLA,
Deborah Lieu of UC Davis, Tony Hunter of Salk and Hanna Mikkola, also
of UCLA. In all, their applications seek nearly $6 million from CIRM.
said she was “relatively inexperienced.” Lieu's appeal said she
has “24 publications with over 6 years of experience in the
differentiation of cardiac muscle cells from human pluripotent stem
cells, 12 publications (3 co-corresponding author) on human
pluripotent stem cells and their cardiac derivatives, and 3
publications on the engineering of pacemaker cells” in addition to
other related professional experience.
application received a score of 68, ranking it above two other grants
approved by reviewers and equal to a third also approved by
reviewers.
reviewers did not have access to. Mikkola's application for $1.4 million
received a score of 65, which ranks it above one grant approved by
reviewers.
Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Stem Cell Agency Moving to Curb Free-Wheeling Appeals by Researchers
By Dr. Matthew Watson
The $3 billion California stem cell
agency on Tuesday released details of proposed, major changes in how
scientists are allowed to appeal decisions when their
applications for millions of dollars are rejected by grant reviewers.
would formalize ad hoc procedures that have emerged over the last
several years. The plan would also make it clearer exactly what can
and cannot be done or expected under the agency's appeal process,
which is poorly understood by at least some researchers.
on at the CIRM board meeting next Wednesday and Tuesday, is heavily
nuanced, dealing with such matters as “supplemental information,”
an “additional analysis option,” “criteria for material dispute
of fact,” “criteria for material new information” – not to
mention the old standby – “extraordinary petition.”
distinction between an “appeal” and an “extraordinary
petition.” However, it is a distinction without a difference except
to those in thrall of bureaucratic jargon. Both are appeals. Their
purpose is to provide a method for overturning reviewers' decision under certain conditions.
only four business days prior to next week's governing board meeting
– a little late to generate thoughtful comment and constructive
suggestions from those most likely to be affected by the changes –
the 500 or so recipients of $1.6 billion in CIRM funding. Before final action on the changes, the board may well want to send out the proposal to all of its grant recipients and ask them for written comment that could then be considered at a public meeting of its Science Subcommittee.
the appeal process for more than four years, including the
presentations at its public meetings by scientists. Ironically, the
first such public appearance was made by Bert Lubin, who is now a member of the CIRM
board and CEO of Childrens Hospital in Oakland, Ca..
wrote at the time, the pitch by Lubin, who was unsuccessful,
disturbed some board members. Gerald Levey, then dean of the UCLA
medical school and a member of the board, said,
"I don't think we can run a board
this way. If we do, it would be chaos."
Nature as saying that his rejected application did not come from “the
in crowd” of stem cell researchers or organization.
“So a project that was really going
to go into patients was essentially triaged.”
the appeal process also uses language that obfuscates exactly what
researchers can do under state law. The document says that scientists
“may” make oral and written comments to the board, which is a
state government entity. In fact, state law makes it clear that
researchers as well as any member of the public have the “right”
to comment. The board legally cannot prevent them from speaking or
making comments. And the board, to its credit, has always allowed
ample public comment even when it slows the board's work.
Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
USC Researchers Appeal Rejection of $20 Million Proposal
By Dr. Matthew Watson
Researchers from the University of
Southern California are making a pitch to overturn rejection of their
$20 million grant application by reviewers in one of the signature
commercialization rounds of the California stem cell agency.
Lon Schneider will be taken up one week from tomorrow by the
governing board of the $3 billion state enterprise.
million disease team round that was considered last month during a
record-breaking outpouring of appeals and a day of emotion-filled
appearances by patients. CIRM directors adjourned their meeting
without completing action on a number of items, leaving open the possibility of additional appeals such as the one from USC.
received a score of 63 from reviewers. They said in a letter to
the board,
“We are submitting the petition at
this time as we are new to the CIRM ICOC(governing board) process and after listening
to the July 26 ICOC meeting deliberations now understand that the
petition process allows the ICOC to further consider our proposal.
We noted that the proposal scored one point above ours and another
two points below ours, each utilized the extraordinary petition
strategy to gain ICOC review which resulted in funding approval in
the former, and reconsideration in the latter instance.”
expressed by CIRM Director Oswald Steward, director of the Reeve Center at UC Irvine, at last month's board
meeting about fairness in the grant process. He said,
“I'm not really quire sure that all
of the applicants clearly understood that they could come back to us
to address the criticisms(of reviewers).”
Concerns about whether all applicants fully understand the appeal process have surfaced on a number of occasions over the last several years. The CIRM board, however, is generally reluctant to overturn negative recommendations by reviewers. It also almost never reverses positive recommendations.
make unspecified changes in the appeal process. No further details on
those changes have yet been released by the agency although the
meeting is just four business days away.
CIRM board, the scientists defended their scientific approach and
responded to criticism by reviewers, especially those related to
sedation. Reviewers expressed reservations about over-sedation, which
the researchers said were erroneous.
be making appeals during next week's board meeting.
Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Researcher Alert: Troubling CIRM Grant Appeal Process Up for Revision
By Dr. Matthew Watson
Directors of the California stem cell
agency next week are expected to make unspecified changes in how
scientists can appeal denials of their applications for millions of
dollars in research grants.
emotional meeting last month in which the CIRM governing board faced a record outpouring of appeals of negative decisions by grant
reviewers. The board is the ultimate arbiter on applications. While it almost never overturns positive decisions by reviewers, it sometimes
approves applications that they have rejected.
the appeal process are yet available for the meeting Sept. 5-6 in
Burlingame, Ca. All that is known at this point is the following item
from the board agenda: “consideration of modifications to the
extraordinary petition policy and adoption of additional
information policy.” Extraordinary petitions are the key vehicle
for appeals.
month's high stakes, $243 million round posed new challenges and
consumed so much time that the board was unable to complete action on
several items.
board sent five applications back for re-review. (See here, here and
here.) Some of those are expected to come up next week and others at
the end of October. The board agenda, however, did not specify which
applications would be considered next week. Nor did it specify how many additional appeals have been filed in the round that was up for
approval in July.
Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
UCLA Researchers Discover "Missing Link" Between Stem Cells and the Immune System
By Dr. Matthew Watson
Newswise UCLA researchers have discovered a type of cell that is the missing link between bone marrow stem cells and all the cells of the human immune system, a finding that will lead to a greater understanding of how a healthy immune system is produced and how disease can lead to poor immune function.
The studies were done using human bone marrow, which contains all the stem cells that produce blood during postnatal life.
We felt it was especially important to do these studies using human bone marrow as most research into the development of the immune system has used mouse bone marrow, said study senior author Dr. Gay Crooks, co-director of the Eli and Edythe Broad Center of Regenerative Medicine and a co-director of the Cancer and Stem Cell Biology program at UCLAs Jonsson Comprehensive Cancer Center. The few studies with human tissue have mostly used umbilical cord blood, which does not reflect the immune system of postnatal life.
The research team was intrigued to find this particular bone marrow cell because it opens up a lot of new possibilities in terms of understanding how human immunity is produced from stem cells throughout life, said Crooks, a professor of pathology and pediatrics.
Understanding the process of normal blood formation in human adults is a crucial step in shedding light on what goes wrong during the process that results in leukemias, or cancers of the blood.
The study appears Sept. 2 in the early online edition of Nature Immunology.
Before this study, researchers had a fairly good idea of how to find and study the blood stem cells of the bone marrow. The stem cells live forever, reproduce themselves and give rise to all the cells of the blood. In the process, the stem cells divide and produce intermediate stages of development called progenitors, which make various blood lineages like red blood cells or platelets. Crooks was most interested in the creation of the progenitors that form the entire immune system, which consists of many different cells called lymphocytes, each with a specialized function to fight infection.
Like the stem cells, the progenitor cells are also very rare, so before we can study them we needed to find the needle in the haystack. said Lisa Kohn, a member of the UCLA Medical Scientist Training Program and first author in the paper.
Previous work had found a fairly mature type of lymphocyte progenitor with a limited ability to differentiate, but the new work describes a more primitive type of progenitor primed to produce the entire immune system, Kohn said
Once the lymphoid primed progenitor had been identified, Crooks and her team studied how gene expression changed during the earliest stages of its production from stem cells.
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UCLA Researchers Discover "Missing Link" Between Stem Cells and the Immune System
Press Release
By NEVAGiles23
Research and MarketsPosted on:31 Aug 12
Research and Markets (http://www.researchandmarkets.com/research/9fkkzb/cell_therapy_tec) has announced the addition of Jain PharmaBiotech's new report "Cell Therapy - Technologies, Markets and Companies" to their offering.
This report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.
Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.
Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.
Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.
Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.
The cell-based markets was analyzed for 2011, and projected to 2021. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.
The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 284 of these are profiled in part II of the report along with tabulation of 274 alliances. Of these companies, 154 are involved in stem cells. Profiles of 70 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 55 Tables and 11 Figures. The bibliography contains 1,050 selected references, which are cited in the text.
Key Topics Covered:
Read the rest here:
Press Release
Research and Markets: Cell Therapy – Technologies, Markets and Companies – Updated 2012 Report
By raymumme
DUBLIN--(BUSINESS WIRE)--
Research and Markets (http://www.researchandmarkets.com/research/9fkkzb/cell_therapy_tec) has announced the addition of Jain PharmaBiotech's new report "Cell Therapy - Technologies, Markets and Companies" to their offering.
This report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.
Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.
Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.
Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.
Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.
The cell-based markets was analyzed for 2011, and projected to 2021. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.
The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 284 of these are profiled in part II of the report along with tabulation of 274 alliances. Of these companies, 154 are involved in stem cells. Profiles of 70 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 55 Tables and 11 Figures. The bibliography contains 1,050 selected references, which are cited in the text.
Key Topics Covered:
The rest is here:
Research and Markets: Cell Therapy - Technologies, Markets and Companies - Updated 2012 Report
Genetic Engineering Turns Bacteria Into Car Fuel – Business Insider
By Dr. Matthew Watson
Business Insider | Genetic Engineering Turns Bacteria Into Car Fuel Business Insider A humble soil bacteria has become a genetically engineered factory capable of making fuel for cars. But the project still has to get out of the lab and scale up to industrial-size production. The MIT project aims to make transportation fuels 10 times ... |
Source:
http://news.google.com/news?q=genetic-engineering&output=rss
Alt Text: Cleaning Up the Olympics, Genetic-Engineering Style – Wired News
By Dr. Matthew Watson
Wired News | Alt Text: Cleaning Up the Olympics, Genetic-Engineering Style Wired News Here's the plan: We use genetic engineering to create a human being who is genetically average in every way, clone him — or her, we can flip a coin — and issue one Average Athlete Baby to each country to raise as they choose. Then, 18 years later ... |
Source:
http://news.google.com/news?q=genetic-engineering&output=rss
WWF: We’re all eating GM-based meat – The Local.de
By Dr. Matthew Watson
The Local.de | WWF: We're all eating GM-based meat The Local.de "Genetic engineering in meat, eggs or cheese is landing on our plates and we don't know it," warned WWF consultant Birgit Wilhelm. "Until now, food that comes from animals that have been fed with genetically modified feed does not have to be labelled." ... |
Source:
http://news.google.com/news?q=genetic-engineering&output=rss
Biotechnology is neat, kids! Monsanto sponsors coloring book – Examiner.com
By Dr. Matthew Watson
Examiner.com | Biotechnology is neat, kids! Monsanto sponsors coloring book Examiner.com “As you work through the puzzles in the book,” promises a new Monsanto sponsored coloring book, “you will learn about biotechnology and how it can help people live better lives in a healthier world.” The kid's book, created by Monsanto supported ... Trade Group Funded by Monsanto Creates Children's BookTruth-Out |
Source:
http://news.google.com/news?q=biotechnology&output=rss