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The principal special feature of genetics research is that the result of the study applies not only to the proband but also influences her lineage both in the past and in the future. For example genetic studies demonstrated Thomas Jefferson's sexual relationship with his slave Sally Hemings and defined their descendants to this day. As we all know from television, genetic studies can be done from any tissue fragment that contains DNA so that studies of surgical specimens, biopsy materials, hair, epithelium and blood samples can all be utilized for extensive genetic studies.

Some DNA is more medically valuable than other. Samples from isolated populations in which a particular disorder is prevalent have a much greater probability of yielding the causal gene(s) because they have fewer genome variations than in the general population. Once isolated, the genetic material associated with the disorder has a good chance of yielding novel diagnostic and/or therapeutic approaches for the disorder.

A persistent question is whether the providers of the genetic material have any rights to the products created from their genetic material. These days, most consent forms are written explicitly to exclude intellectual property rights from the subjects. As might be imagined, this smacks of exploitation in the developing world. Negotiation of a monetary return to the community has sometimes been concluded. Important and lucrative products have been derived from individuals' genomes without their receiving royalties or other compensation. However, the knowledge, technical expertise, and capital needed to make a useful product from a blood or tissue sample come from the company not the donor.

Truly informed consent remains a problem with research subjects from both developed and developing countries. The sample providers may not understand the implications of genetic research for their families and their community. They surely don't understand the many uses to which their genetic material may be applied. They may not be aware that their genes may be used for pharmacogenetics. They are not likely to be fully cognizant of the forensic uses to which their genetic material might be put as our privacy rights continue to be eroded. They are putting their trust in the research establishment and the regulatory controls effected by the IRB managing grant or contract. Contributors to repositories may not be fully aware of the fact that they are trusting scientifically-oriented review boards to determine how their genetic material will be used long into the future. While anonymization is of great help, in the future, the genome itself may serve to identify the person, especially if they are in more than one repository.

Informed consents for genetic studies using CLIA-approved tests are usually designed to give the subjects the option of finding out their susceptibilities or not. Subjects are told they will not get any feedback from tests that are in the developmental stages because the reliability of such tests is not known.

In developed countries they might not perceive possible implications for stigmatization and for health and life insurability. Lack of health insurability affects Americans the most because every other developed country has a national health program. In those countries genetic information about disease risks motivates the system to preventive measures. In the U.S., revealing genetic information may exclude individuals from health insurance or make them join undesirable assigned risk pools. Thus knowing her susceptibilities may put a burden on the patient/subject to reveal what could be considered to be a preexisting condition. In fact, the rapidly increasing availability and declining costs of genetic information represent among the strongest arguments for a comprehensive health insurance program in the U.S.

Patenting genetic material for development as medical tools raises the question of commoditization. Individuals from many countries but especially developing countries feel that their genome is an important component of their selves or souls. Just as some groups feel that they lose something if a photograph is taken of them, many feel that they may be compromised by genetic studies and the patenting of their individuality. In some environments, communities express the belief that there is no such thing as informed consent for genetic studies because the individual is speaking for his ancestors and descendants.

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StephanieJWShoop1, StephanieMarlow2, DavidBChurch3, KateEnglish4, PaulDMcGreevy5, AnnelieseJStell3, PeterCThomson5, DanGONeill2 and DavidCBrodbelt2

Canine Genetics and Epidemiology20152:1

DOI: 10.1186/2052-6687-2-1

Shoop et al.; licensee BioMed Central.2015

Received: 25June2014

Accepted: 18November2014

Published: 26January2015

Mast cell tumour (MCT) appears to be a frequent tumour type in dogs, though there is little published in relation to its frequency in dogs in the UK. The current study aimed to investigate prevalence and risk factors for MCTs in dogs attending English primary-care veterinary practices.

Electronic patient records from practices participating in the VetCompass animal surveillance project between July 2007 and June 2013 were searched for MCT diagnosis. Various search terms and standard diagnostic terms (VeNom codes) identified records containing MCT diagnoses, which were evaluated against clinical criteria for inclusion to the study. MCT prevalence for the entire dataset and specific breed types were calculated. Descriptive statistics characterised MCT cases and multivariable logistic regression methods evaluated risk factors for association with MCT (P<0.05).

Within a population of 168,636 dogs, 453 had MCT, yielding a prevalence of 0.27% (95% confidence interval (CI) 0.24% - 0.29%). The highest breed type specific prevalences were for the Boxer at 1.95% (95% CI 1.40% - 2.51%), Golden Retriever at 1.39% (0.98% - 1.81%) and Weimaraner at 0.85% (95% CI 0.17% to 1.53%). Age, insurance status, neuter status, weight and breed type were associated with MCT diagnosis. Of dogs of specific breed type, the Boxer, Pug and Staffordshire Bull Terrier showed greater odds of MCT diagnosis compared with crossbred dogs. Conversely, the German Shepherd Dog, Border Collie, West Highland White Terrier, Springer Spaniel and Cocker Spaniel had reduced odds of MCT diagnosis compared with crossbred dogs. No association was found between MCT diagnosis and sex.

This study highlights a clinically significant prevalence of MCT and identifies specific breed types with predisposition to MCT, potentially aiding veterinarian awareness and facilitating diagnosis.

Confidence interval

Electronic patient record

Mast cell tumour

Veterinary nomenclature.

Mast cell tumour (MCT) is the most common skin tumour type in dogs, but little is known about its frequency in the general dog population nor its frequency in particular dog breeds in the UK. This study has investigated the frequency of the disease, and possible risk factors associated with the development of MCT.

This has been conducted by analysing the large number of electronic patient health records contained within the VetCompass animal surveillance project collected between July 2007 and June 2013.

Data were available on a population of 168,636 dogs and within this 453 (0.27%) had MCT. The breeds with the highest breed specific prevalences were Boxer, Golden Retriever and Weimaraner. Conversely, some breeds appeared to be protected.

Age, insurance status, neuter status, weight and breed type were associated with MCT diagnosis. No association was found between MCT diagnosis and gender.

Such information helps to increase awareness of this condition, particularly in certain breeds, to owners and veterinarians.

Mast cell tumours (MCTs) are a frequent tumour type in dogs [1], accounting for 7-21% of cutaneous tumours diagnosed [14]. Dobson and others (2002) reported the incidence of MCT in English dogs as 129 in 100,000 dogs per year [5]; however, this study was limited to insured animals and thus may generalise poorly to the wider population of dogs in England. MCTs occur primarily in the dermis and subcutaneous tissues and can be confirmed in 92-96% of cases through fine needle aspirate (FNA) cytology [6]. Histopathology allows description of the degree of MCT malignancy and clinical grading [6] using two grading systems. Using the Patnaik system, MCTs are categorised into three grades (I, II & III), the third being more clinically important because tumours of this grade are often more aggressive and may metastasise [7]. The more recently proposed Kiupel two tier system categorises MCTs into high or low-grade in order to increase concordance among veterinary pathologists [8].

There are likely to be many factors contributing to the development of MCT which may be genetically influenced [6]. Up to 40% of dogs with subcutaneous and cutaneous MCTs have been found to have mutations in a proto-oncogene, c-kit[6]. Other potential factors include neuter status, sex, age, weight, insurance status and specific breed types. Females [9], and particularly neutered females [10] have been associated with increased risk of MCT in some studies, although other studies failed to identify an association between sex and MCT [11, 12]. While the mean age at presentation of cutaneous MCTs has been reported at between 7.5 and 9years old [9], one study found poorly differentiated (grade III) tumours more common in younger dogs, although the study population consisted of only one breed, the Shar-Pei [13]. Likewise, while one study found no difference in pre-disposition to MCTs between dogs of specific breed types and mixed breed (crossbred) dogs overall [14], certain breed types have previously been associated with this condition. Most commonly, Boxers and Golden Retrievers [10, 15, 16] and other larger breed types have been associated with pre-disposition to MCT whereas smaller breed types are reported to be at lower risk of the condition [10]. Less commonly, breed types including Pugs [10, 17], Weimaraners [15, 16] and the mastiff and terrier phylogenetic clusters [10] have also been associated with having MCTs.

This study aimed to estimate the prevalence and explore risk-factors for the development of MCTs in dogs, using a large sample of animals attending primary-care veterinary practices in England. By identifying factors associated with a higher risk of developing MCTs, it was hoped to improve the index of suspicion for this disease and hence early recognition of this important condition.

The VetCompass system documented 168,636 dogs from a total of 94 veterinary practices within England between 28

June 2007 and 30

June 2013. Of these, 453 dogs met the clinical criteria for inclusion to the study and were classified as dogs presenting with MCT at a participating veterinary practice during the study period. Thus, the MCT prevalence was estimated at 0.27% (95% CI 0.24% to 0.29%) over the study period. Individual breed type MCT prevalences that exceeded this overall estimate included that of the Boxer at 1.95% (95% CI 1.40% to 2.41%), the Golden Retriever at 1.39% (95% CI 0.98% to 1.81%), the Weimaraner at 0.85% (95% CI 0.17% to 1.53%), the Labrador Retriever at 0.72% (95% CI 0.58% to 0.85%), the Staffordshire Bull Terrier at 0.51% (95% CI 0.39% to 0.62%) and the Pug at 0.50% (95% CI 0.13% to 0.88%). Individual breed-type MCT prevalences that fell below the overall estimate included the Springer Spaniel at 0.20% (95% CI 0.06% to 0.35%), the Jack Russell Terrier at 0.16% (95% CI 0.09% to 0.23%), the West Highland White Terrier at 0.07% (95% CI 0.00% to 0.15%), the Border Collie at 0.07% (95% CI 0.00% to 0.14%), the Cocker Spaniel at 0.06% (95% CI 0.00% to 0.12%), the Yorkshire Terrier at 0.04% (95% CI 0.00% to 0.09%) and the German Shepherd Dog at 0.02% (95% CI 0.00% to 0.05) (Table

A). Overall MCT prevalence for dogs of specific breed types was 0.29% (95% CI 0.26 0.32%) and overall crossbred prevalence was 0.18% (95% CI 0.14 0.22) (Table

B).

Breed-type specific prevalence of mast cell tumour (MCT) diagnosis with 95% confidence intervals (CI)

A) Specific breed types

Breed-type

Cases (n)

Total (n)

MCT prevalence (%)

95% CI (%)

Boxer

47

2406

1.95

1.40 - 2.51

Golden Retriever

43

3086

1.39

0.98 - 1.81

Weimaraner

6

705

0.85

0.17 - 1.53

Labrador Retriever

106

14781

0.72

0.58 - 0.85

Staffordshire Bull Terrier

72

14219

0.51

0.39 - 0.62

Pug

7

1391

0.50

0.13 - 0.88

Springer Spaniel

8

3906

0.20

0.06 - 0.35

Jack Russell Terrier

18

11333

0.16

0.09 - 0.23

West Highland White Terrier

3

4254

0.07

0.00 - 0.15

Border Collie

3

4501

0.07

0.00 - 0.14

Cocker Spaniel

4

6353

0.06

0.00 - 0.12

Yorkshire Terrier

2

5512

0.04

0.00 - 0.09

German Shepherd Dog

1

5993

0.02

0.00 - 0.05

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The potential therapeutic benefits of HESC research provide strong grounds in favor of the research. If looked at from a strictly consequentialist perspective, it's almost certainly the case that the potential health benefits from the research outweigh the loss of embryos involved and whatever suffering results from that loss for persons who want to protect embryos. However, most of those who oppose the research argue that the constraints against killing innocent persons to promote social utility apply to human embryos. Thus, as long as we accept non-consequentialist constraints on killing persons, those supporting HESC research must respond to the claim that those constraints apply to human embryos.

In its most basic form, the central argument supporting the claim that it is unethical to destroy human embryos goes as follows: It is morally impermissible to intentionally kill innocent human beings; the human embryo is an innocent human being; therefore it is morally impermissible to intentionally kill the human embryo. It is worth noting that this argument, if sound, would not suffice to show that all or even most HESC research is impermissible, since most investigators engaged in HESC research do not participate in the derivation of HESCs but instead use cell lines that researchers who performed the derivation have made available. To show that researchers who use but do not derive HESCs participate in an immoral activity, one would further need to establish their complicity in the destruction of embryos. We will consider this issue in section 2. But for the moment, let us address the argument that it is unethical to destroy human embryos.

A premise of the argument against killing embryos is that human embryos are human beings. The issue of when a human being begins to exist is, however, a contested one. The standard view of those who oppose HESC research is that a human being begins to exist with the emergence of the one-cell zygote at fertilization. At this stage, human embryos are said to be whole living member[s] of the species homo sapiens [which] possess the epigenetic primordia for self-directed growth into adulthood, with their determinateness and identity fully intact (George & Gomez-Lobo 2002, 258). This view is sometimes challenged on the grounds that monozygotic twinning is possible until around days 1415 of an embryo's development (Smith & Brogaard 2003). An individual who is an identical twin cannot be numerically identical to the one-cell zygote, since both twins bear the same relationship to the zygote, and numerical identity must satisfy transitivity. That is, if the zygote, A, divides into two genetically identical cell groups that give rise to identical twins B and C, B and C cannot be the same individual as A because they are not numerically identical with each other. This shows that not all persons can correctly assert that they began their life as a zygote. However, it does not follow that the zygote is not a human being, or that it has not individuated. This would follow only if one held that a condition of an entity's status as an individual human being is that it be impossible for it to cease to exist by dividing into two or more entities. But this seems implausible. Consider cases in which we imagine adult humans undergoing fission (for example, along the lines of Parfit's thought experiments, where each half of the brain is implanted into a different body) (Parfit 1984). The prospect of our going out of existence through fission does not pose a threat to our current status as distinct human persons. Likewise, one might argue, the fact that a zygote may divide does not create problems for the view that the zygote is a distinct human being.

There are, however, other grounds on which some have sought to reject that the early human embryo is a human being. According to one view, the cells that comprise the early embryo are a bundle of homogeneous cells that exist in the same membrane but do not form a human organism because the cells do not function in a coordinated way to regulate and preserve a single life (Smith & Brogaard 2003, McMahan 2002). While each of the cells is alive, they only become parts of a human organism when there is substantial cell differentiation and coordination, which occurs around day-16 after fertilization. Thus, on this account, disaggregating the cells of the 5-day embryo to derive HESCs does not entail the destruction of a human being.

This account is subject to dispute on empirical grounds. That there is some intercellular coordination in the zygote is revealed by the fact that the development of the early embryo requires that some cells become part of the trophoblast while others become part of the inner cell mass. Without some coordination between the cells, there would be nothing to prevent all cells from differentiating in the same direction (Damschen, Gomez-Lobo and Schonecker 2006). The question remains, though, whether this degree of cellular interaction is sufficient to render the early human embryo a human being. Just how much intercellular coordination must exist for a group of cells to constitute a human organism cannot be resolved by scientific facts about the embryo, but is instead an open metaphysical question (McMahan 2007a).

Suppose that the 5-day human embryo is a human being. On the standard argument against HESC research, membership in the species Homo sapiens confers on the embryo a right not to be killed. This view is grounded in the assumption that human beings have the same moral status (at least with respect to possessing this right) at all stages of their lives.

Some accept that the human embryo is a human being but argue that the human embryo does not have the moral status requisite for a right to life. There is reason to think that species membership is not the property that determines a being's moral status. We have all been presented with the relevant thought experiments, courtesy of Disney, Orwell, Kafka, and countless science fiction works. The results seem clear: we regard mice, pigs, insects, aliens, and so on, as having the moral status of persons in those possible worlds in which they exhibit the psychological and cognitive traits that we normally associate with mature human beings. This suggests that it is some higher-order mental capacity (or capacities) that grounds the right to life. While there is no consensus about the capacities that are necessary for the right to life, some of the capacities that have been proposed include reasoning, self-awareness, and agency (Kuhse & Singer 1992, Tooley 1983, Warren 1973).

The main difficulty for those who appeal to such mental capacities as the touchstone for the right to life is that early human infants lack these capacities, and do so to a greater degree than many of the nonhuman animals that most deem it acceptable to kill (Marquis 2002). This presents a challenge for those who hold that the non-consequentialist constraints on killing human children and adults apply to early human infants. Some reject that these constraints apply to infants, and allow that there may be circumstances where it is permissible to sacrifice infants for the greater good (McMahan 2007b). Others argue that, while infants do not have the intrinsic properties that ground a right to life, we should nonetheless treat them as if they have a right to life in order to promote love and concern towards them, as these attitudes have good consequences for the persons they will become (Benn 1973, Strong 1997).

Some claim that we can reconcile the ascription of a right to life to all humans with the view that higher order mental capacities ground the right to life by distinguishing between two senses of mental capacities: immediately exercisable capacities and basic natural capacities. (George and Gomez-Lobo 2002, 260). According to this view, an individual's immediately exercisable capacity for higher mental functions is the actualization of natural capacities for higher mental functions that exist at the embryonic stage of life. Human embryos have a rational nature, but that nature is not fully realized until individuals are able to exercise their capacity to reason. The difference between these types of capacity is said to be a difference between degrees of development along a continuum. There is merely a quantitative difference between the mental capacities of embryos, fetuses, infants, children, and adults (as well as among infants, children, and adults). And this difference, so the argument runs, cannot justify treating some of these individuals with moral respect while denying it to others.

Given that a human embryo cannot reason at all, the claim that it has a rational nature has struck some as tantamount to asserting that it has the potential to become an individual that can engage in reasoning (Sagan & Singer 2007). But an entity's having this potential does not logically entail that it has the same status as beings that have realized some or all of their potential (Feinberg 1986). Moreover, with the advent of cloning technologies, the range of entities that we can now identify as potential persons arguably creates problems for those who place great moral weight on the embryo's potential. A single somatic cell or HESC can in principle (though not yet in practice) develop into a mature human being under the right conditionsthat is, where the cell's nucleus is transferred into an enucleated egg, the new egg is electrically stimulated to create an embryo, and the embryo is transferred to a woman's uterus and brought to term. If the basis for protecting embryos is that they have the potential to become reasoning beings, then, some argue, we have reason to ascribe a high moral status to the trillions of cells that share this potential and to assist as many of these cells as we reasonably can to realize their potential (Sagan & Singer 2007, Savulescu 1999). Because this is a stance that we can expect nearly everyone to reject, it's not clear that opponents of HESC research can effectively ground their position in the human embryo's potential.

One response to this line of argument has been to claim that embryos possess a kind of potential that somatic cells and HESCs lack. An embryo has potential in the sense of having an active disposition and intrinsic power to develop into a mature human being (Lee & George 2006). An embryo can mature on its own in the absence of interference with its development. A somatic cell, on the other hand, does not have the inherent capacity or disposition to grow into a mature human being. However, some question whether this distinction is viable, especially in the HESC research context. While it is true that somatic cells can realize their potential only with the assistance of outside interventions, an embryo's development also requires that numerous conditions external to it are satisfied. In the case of embryos that are naturally conceived, they must implant, receive nourishment, and avoid exposure to dangerous substances in utero. In the case of spare embryos created through in vitro fertilizationwhich are presently the source of HESCs for researchthe embryos must be thawed and transferred to a willing woman's uterus. Given the role that external factorsincluding technological interventionsplay in an embryo's realizing its potential, one can question whether there is a morally relevant distinction between an embryo's and somatic cell's potential and thus raise doubts about potentiality as a foundation for the right to life (Devolder & Harris 2007).

Some grant that human embryos lack the properties essential to a right to life, but hold that they possess an intrinsic value that calls for a measure of respect and places at least some moral constraints on their use: The life of a single human organism commands respect and protection no matter in what form or shape, because of the complex creative investment it represents and because of our wonder at the divine or evolutionary processes that produce new lives from old ones. (Dworkin l992, 84). There are, however, divergent views about the level of respect embryos command and what limits exist on their use. Some opponents of HESC research hold that the treatment of human embryos as mere research tools always fails to manifest proper respect for them. Other opponents take a less absolutist view. Some, for example, deem embryos less valuable than more mature human beings but argue that the benefits of HESC research are too speculative to warrant the destruction of embryos, and that the benefits might, in any case, be achieved through the use of noncontroversial sources of stem cells (e.g., adult stem cells) (Holm 2003).

Many, if not most, who support the use of human embryos for HESC research would likely agree with opponents of the research that there are some circumstances where the use of human embryos would display a lack of appropriate respect for human life, for example, were they to be offered for consumption to contestants in a reality TV competition or destroyed for the production of cosmetics. But proponents of the research hold that the value of human embryos is not great enough to constrain the pursuit of research that may yield significant therapeutic benefits. Supporters of the research also frequently question whether most opponents of the research are consistent in their ascription of a high value to human embryos, as opponents generally display little concern about the fact that many embryos created for fertility treatment are discarded.

When spare embryos exist after fertility treatment, the individuals for whom the embryos were created typically have the option of storing for them for future reproductive use, donating them to other infertile couples, donating them to research, or discarding them. Some argue that as long as the decision to donate embryos for research is made after the decision to discard them, it is morally permissible to use them in HESC research even if we assume that they have the moral status of persons. The claim takes two different forms. One is that it is morally permissible to kill an individual who is about to be killed by someone else where killing that individual will help others (Curzer, H. 2004). The other is that researchers who derive HESCs from embryos that were slated for destruction do not cause their death. Instead, the decision to discard the embryos causes their death; research just causes the manner of their death (Green 2002).

Both versions of the argument presume that the decision to discard spare embryos prior to the decision to donate them to research entails that donated embryos are doomed to destruction when researchers receive them. There are two arguments one might marshal against this presumption. First, one who wants to donate embryos to research might first elect to discard them only because doing so is a precondition for donating them. There could be cases in which one who chooses the discard option would have donated the embryos to other couples were the research donation option not available. The fact that a decision to discard embryos is made prior to the decision to donate the embryos thus does not establish that the embryos were doomed to destruction before the decision to donate them to research was made. Second, a researcher who receives embryos could choose to rescue them, whether by continuing to store them or by donating them to infertile couples. While this would violate the law, the fact that it is within a researcher's power to prevent the destruction of the embryos he or she receives poses problems for the claim that the decision to discard the embryos dooms them or causes their destruction.

Assume for the sake of argument that it is morally impermissible to destroy human embryos. It does not follow that all research with HESCs is impermissible, as it is sometimes permissible to benefit from moral wrongs. For example, there is nothing objectionable about transplant surgeons and patients benefiting from the organs of murder and drunken driving victims (Robertson 1988). If there are conditions under which a researcher may use HESCs without being complicit in the destruction of embryos, then those who oppose the destruction of embryos could support research with HESCs under certain circumstances.

Researchers using HESCs are clearly implicated in the destruction of embryos where they derive the cells themselves or enlist others to derive the cells. However, most investigators who conduct research with HESCs obtain them from an existing pool of cell lines and play no role in their derivation. One view is that we cannot assign causal or moral responsibility to investigators for the destruction of embryos from which the HESCs they use are derived where their research plans had no effect on whether the original immoral derivation occurred. (Robertson 1999). This view requires qualification. There may be cases in which HESCs are derived for the express purpose of making them widely available to HESC investigators. In such instances, it may be that no individual researcher's plans motivated the derivation of the cells. Nonetheless, one might argue that investigators who use these cells are complicit in the destruction of the embryos from which the cells were derived because they are participants in a research enterprise that creates a demand for HESCs. For these investigators to avoid the charge of complicity in the destruction of embryos, it must be the case that the researchers who derived the HESCs would have performed the derivation in the absence of external demand for the cells (Siegel 2004).

The issue about complicity goes beyond the question of an HESC researcher's role in the destruction of the particular human embryo(s) from which the cells he or she uses are derived. There is a further concern that research with existing HESCs will result in the future destruction of embryos: [I]f this research leads to possible treatments, private investment in such efforts will increase greatly and the demand for many thousands of cell lines with different genetic profiles will be difficult to resist. (U.S. Conference of Catholic Bishops 2001). This objection faces two difficulties. First, it appears to be too sweeping: research with adult stem cells and non-human animal stem cells, as well as general research in genetics, embryology, and cell biology could be implicated, since all of this research might advance our understanding of HESCs and result in increased demand for them. Yet, no one, including those who oppose HESC research, argues that we should not support these areas of research. Second, the claim about future demand for HESCs is speculative. Indeed, current HESC research could ultimately reduce or eliminate demand for the cells by providing insights into cell biology that enable the use of alternative sources of cells (Siegel 2004).

While it might thus be possible for a researcher to use HESCs without being morally responsible for the destruction of human embryos, that does not end the inquiry into complicity. Some argue that agents can be complicit in wrongful acts for which they are not morally responsible. One such form of complicity arises from an association with wrongdoing that symbolizes acquiescence in the wrongdoing (Burtchaell 1989). The failure to take appropriate measures to distance oneself from moral wrongs may give rise to metaphysical guilt, which produces a moral taint and for which shame is the appropriate response (May 1992). The following question thus arises: Assuming it is morally wrongful to destroy human embryos, are HESC researchers who are not morally responsible for the destruction of embryos complicit in the sense of symbolically aligning themselves with a wrongful act?

One response is that a researcher who benefits from the destruction of embryos need not sanction the act any more than the transplant surgeon who uses the organs of a murder or drunken driving victim sanctions the homicidal act (Curzer 2004). But this response is unlikely to be satisfactory to opponents of HESC research. There is arguably an important difference between the transplant case and HESC research insofar as the moral wrong associated with the latter (a) systematically devalues a particular class of human beings and (b) is largely socially accepted and legally permitted. Opponents of HESC research might suggest that the HESC research case is more analogous to the following kind of case: Imagine a society in which the practice of killing members of a particular racial or ethnic group is legally permitted and generally accepted. Suppose that biological materials obtained from these individuals subsequent to their deaths are made available for research uses. Could researchers use these materials while appropriately distancing themselves from the wrongful practice? Arguably, they could not. There is a heightened need to protest moral wrongs where those wrongs are socially and legally accepted. Attempts to benefit from the moral wrong in these circumstances may be incompatible with mounting a proper protest (Siegel 2003).

But even if we assume that HESC researchers cannot avoid the taint of metaphysical guilt, it is not clear that researchers who bear no moral responsibility for the destruction of embryos are morally obligated not to use HESCs. One might argue that there is a prima facie duty to avoid moral taint, but that this duty may be overridden for the sake of a noble cause.

Most HESCs are derived from embryos that were created for infertility treatment but that were in excess of what the infertile individual(s) ultimately needed to achieve a pregnancy. The HESCs derived from these leftover embryos offer investigators a powerful tool for understanding the mechanisms controlling cell differentiation. However, there are scientific and therapeutic reasons not to rely entirely on leftover embryos. From a research standpoint, creating embryos through cloning technologies with cells that are known to have particular genetic mutations would allow researchers to study the underpinnings of genetic diseases in vitro. From a therapeutic standpoint, the HESCs obtained from leftover IVF embryos are not genetically diverse enough to address the problem of immune rejection by recipients of stem cell transplants. (Induced pluripotent stem cells may ultimately prove sufficient for these research and therapeutic ends, since the cells can (a) be selected for specific genetic mutations and (b) provide an exact genetic match for stem cell recipients.) At present, the best way to address the therapeutic problem is through the creation of a public stem cell bank that represents a genetically diverse pool of stem cell lines (Faden et al. 2003, Lott & Savulescu 2007). This kind of stem cell bank would require the creation of embryos from gamete donors who share the same HLA-types (i.e., similar versions of the genes that mediate immune recognition and rejection).

Each of these enterprises has its own set of ethical issues. In the case of research cloning, some raise concerns, for example, that the perfection of cloning techniques for research purposes will enable the pursuit of reproductive cloning, and that efforts to obtain the thousands of eggs required for the production of cloned embryos will result in the exploitation of women who provide the eggs (President's Council on Bioethics 2002, Norsigian 2005). With respect to stem cell banks, it is not practically possible to create a bank of HESCs that will provide a close immunological match for all recipients. This gives rise to the challenge of determining who will have biological access to stem cell therapies. We might construct the bank so that it provides matches for the greatest number of people in the population, gives everyone an equal chance of finding a match, or ensures that all ancestral/ethnic groups are fairly represented in the bank (Faden et al. 2003, Bok, Schill, & Faden 2004, Greene 2006).

There are, however, more general challenges to the creation of embryos for research and therapeutic purposes. Some argue that the creation of embryos for non-reproductive ends is morally problematic, regardless of whether they are created through cloning or in vitro fertilization. There are two related arguments that have been advanced to morally distinguish the creation of embryos for reproductive purposes from the creation of embryos for research and therapeutic purposes. First, each embryo created for procreative purposes is originally viewed as a potential child in the sense that each is a candidate for implantation and development into a mature human. In contrast, embryos created for research or therapies are viewed as mere tools from the outset (Annas, Caplan & Elias 1996, President's Council on Bioethics 2002). Second, while embryos created for research and therapy are produced with the intent to destroy them, the destruction of embryos created for reproduction is a foreseeable but unintended consequence of their creation (FitzPatrick 2003).

One response to the first argument has been to suggest that we could, under certain conditions, view all research embryos as potential children in the relevant sense. If all research embryos were included in a lottery in which some of them were donated to individuals for reproductive purposes, all research embryos would have a chance at developing into mature humans (Devander 2005). Since those who oppose creating embryos for research would likely maintain their opposition in the research embryo lottery case, it is arguably irrelevant whether embryos are viewed as potential children when they are created. Of course, research embryos in the lottery case would be viewed as both potential children and potential research tools. But this is also true in the case of embryos created for reproductive purposes where patients are open to donating spare embryos to research.

As to the second argument, the distinction between intending and merely foreseeing harms is one to which many people attach moral significance, and it is central to the Doctrine of Double Effect. But even if one holds that this is a morally significant distinction, it is not clear that it is felicitous to characterize the destruction of spare embryos as an unintended but foreseeable side-effect of creating embryos for fertility treatment. Fertility clinics do not merely foresee that some embryos will be destroyed, as they choose to offer patients the option of discarding embryos and carry out the disposal of embryos when patients request it. Patients who elect that their embryos be discarded also do not merely foresee the embryos' destruction; their election of that option manifests their intention that the embryos be destroyed. There is thus reason to doubt that there is a moral distinction between creating embryos for research and creating them for reproductive purposes, at least given current fertility clinic practices.

Recent scientific work suggests it is possible to derive gametes from human pluripotent stem cells. Researchers have generated sperm and eggs from mouse ESCs and iPSCs and have used these stem cell-derived gametes to produce offspring (Hayashi 2011; Hayashi 2012). While it may take several years before researchers succeed in deriving gametes from human stem cells, the research holds much promise for basic science and clinical application. For example, the research could provide important insights into the fundamental processes of gamete biology, assist in the understanding of genetic disorders, and provide otherwise infertile individuals a means of creating genetically related children. The ability to derive gametes from human stem cells could also reduce or eliminate the need for egg donors and thus help overcome concerns about exploitation of donors and the risks involved in egg retrieval. Nonetheless, the research gives rise to some controversial issues related to embryos, genetics, and assisted reproductive technologies (D. Mathews et al. 2009).

One issue arises from the fact that some research on stem cell-derived gametes requires the creation of embryos, regardless of whether one is using ESCs or iPSCs. To establish that a particular technique for deriving human gametes from stem cells produces functional sperm and eggs, it is necessary to demonstrate that the cells can produce an embryo. This entails the creation of embryos through in vitro fertilization. Since it would not be safe to implant embryos created during the early stages of the research, the likely disposition of the embryos is that they would be destroyed. In such instances, the research would implicate all of the moral issues surrounding the creation and destruction of embryos for research. However, the creation of embryos for research in this situation would not necessitate the destruction of the embryos, as it does when embryos are created to derive stem cell lines. One could in principle store them indefinitely rather than destroy them. This would still leave one subject to the objection that life is being created for instrumental purposes. But the force of the objection is questionable since it is not clear that this instrumental use is any more objectionable than the routine and widely accepted practice of creating excess IVF embryos in the reproductive context to increase the probability of generating a sufficient number of viable ones to produce a pregnancy.

Further issues emerge with the prospect of being able to produce large quantities of eggs from stem cells. As the capacity to identify disease and non-disease related alleles through preimplantation genetic diagnosis (PGD) expands, the ability to create large numbers of embryos would substantially increase the chances of finding an embryo that possesses most or all of the traits one wishes to select. This would be beneficial in preventing the birth of children with genetic diseases. But matters would become morally contentious if it were possible to select for non-disease characteristics, such as sexual orientation, height, superior intelligence, memory, and musical ability. One common argument against using PGD in this way is that it could devalue the lives of those who do not exhibit the chosen characteristics. Another concern is that employing PGD to select for non-disease traits would fail to acknowledge the giftedness of life by treating children as objects of our design or products of our will or instruments of our ambition rather accepting them as they are given to us (Sandel 2004, 56). There is additionally a concern about advances in genetics heightening inequalities where certain traits confer social and economic advantages and only the well-off have the resources to access the technology (Buchanan 1995). Of course, one can question whether the selection of non-disease traits would in fact lead to devaluing other characteristics, whether it would alter the nature of parental love, or whether it is distinct enough from currently permitted methods of gaining social and economic advantage to justify regulating the practice. Nonetheless, the capacity to produce human stem cell-derived gametes would make these issues more pressing.

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Ethics of Stem Cell Research (Stanford Encyclopedia of ...

Dana-Farber Cancer Institute EDUCATIONAL TITLES

Dr. Brown's research laboratory focuses on elucidating the epigenetic factors underlying the action of steroid hormones. This work has important implications both for normal physiology and for the treatment of hormone dependent malignancies including breast and prostate cancer. He is recognized for three seminal discoveries. His lab opened the steroid receptor coregulator field, illuminated the dynamic nature of receptor and coregulator interaction with the genome and elucidated the importance of epigenetically determined distant cis-regulatory steroid receptor binding sites. His contributions have uniquely reformulated the understanding of steroid hormone action in normal physiology and in hormone-dependent cancer.

DF/HCC members that share similar concepts* with Myles Brown, MD but have yet to coauthor a publication with this researcher.

ARTHUR B. PARDEE, PH.D. Dana-Farber Cancer Institute

DENNIS C. SGROI, MD Massachusetts General Hospital

BREAST CANCER, CANCER GENETICS

IRENE KUTER, DPHIL, MD Massachusetts General Hospital

BREAST CANCER

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Myles Brown, MD - DF/HCC

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In choices of fictional books to read I gravitate toward sci-fi and fantasy. For example,in late 2014 and through the first few months of this year I read all the Game of Thrones books.

The first three of those were the best and I thought definitely better than the TV show, although its pretty good too even if a bit violent for my taste.

My reading lately has been leaning more towardbooks about human transformation of various kinds including non-fictional works.

This reading has come to constitute, I realized, a somewhat electric mix with the common thread of science (and in particular genetics and biology) fantasy becoming reality. I recommend these as thought-provoking reads.

See any patterns there?

This reading is in part inspired by research I was doing for my own new book GMO Sapiens, hopefully coming out in December. By the way GMO Sapiens is a mashup (or portmanteau) of Homo sapiens and GMO.

It is focused on human genetic modification and the very real possibility of designer babies on the horizon.

In the coming weeks and months I will be posting excerpts from the book. Stay tuned.

Theres a growing stream of stem cell good news of late.

Stem cell biotech, TiGenix, reported encouraging Phase 3 allogeneicresultson stem cells. Abig milestone. I cant wait to see the actual data. Its product, Cx601, has so far beensafe and effective forperianal fistulas inCrohns disease. See more from Alexey on this.

CIRM has fundedthe largest public stem cell bank in the world. Want to make a withdrawal?

Asterias reported some great news. Its AST OPC-1 product showed some signs of encouraging efficacy in the first three patients treated. They are hoping to expand the trial.

In about two weeks on September 16th, the first winner of the new Ogawa-Yamanaka Stem Cell Prize will be announced at Gladstone Institutes. This should be a very exciting event honoring a top stem cell translational innovator in the area of cellular reprogramming, who will also received a cash prize of $150,000. According to the organizers, The Prize was established through a generous gift from Hiro Ogawa to honor the memory of Betty Ogawa, who passed away in May 2014. It continues the philanthropic legacy she shared with her husband of 46 years. The prize also recognizesShinya Yamanaka too of course.

Any guesses on who will win? Let us knowin the comments. Any kind of recognition of achievement and innovation in stem cells is wonderful.

On that note, Im also starting to think about candidates for my own stem cell prize, the annual Stem Cell Person of the Year Award.Its not to the same scale with a $2,000 prize, but I fund it out of my own pocket. The focus is different too. My award goes to the person who has had the single strongest, most innovative impact in the stem cell world for a given year and has taken risks either scientifically or in the area of advocacy. Im looking for outside-the-box thinkers and doers.

Past winners have included super patient advocateRoman Reed,scientist and politicianElena Cattaneo(who went on to win the ISSCR Public Service Award), and this past year, pioneering stem cell translational scientistMasayo Takahashi. Dr. Takahashi might be a good bet to win the Ogawa-Yamanaka Prize this year.

Who should be nominated this year for the 2015 Stem Cell Person of the Year Award?

Its not too soon to let me know your thoughts even though nominations dont officially open quite yet. Last year we had more than two-dozen amazing nominees. The process includes an Internet vote to choose finalists and then I pick the winner from those, sometimes consulting privately with global stem cell scholars.

For the past few years post-publication peer review (PPPR) has grown in influence and one particular website, PubPeer, has become the primary go-to place specifically for bluntPPPR. The kind that happens in journal clubs in labs across the world. Comments on PubPeer have led to numerous serious corrections and retractions of flawed articles. Im most familiar with its role in the STAP cell case.

Both the founders of and most of the commenters on PubPeer have remained anonymous.

That is until today.

The founders of PubPeer have publicly identified themselves in a blog post and formed a new non-profit organization, The PubPeer Foundation.

PubPeer founders include Brandon Stell, George Smith and Richard Smith. Also with the founders on the PubPeer Foundation Board of Directors will be Boris Barbour and Gabor Brasnjo.

Who are these guys?

RetractionWatch (big HT to them) has an interesting interview with PubPeer founder Stell. I highly recommend reading it. Jennifer Couzin-Frankel over at Science also has a nice piece on this development.

Stell is a neuroscientist and Co-Team Leader at the Brain Physiology Lab in Paris, the source of his picture above.

I was trying to learn more about the other two founders, George Smith and Richard Smith. From Couzin-Frankels piece it appears that the brothers want to remain relatively out of the limelight, and their very common names may very well aid them in that. Couzin-Frankel does write that Richard was a grad student who briefly worked in Stells lab and George is a web developer.

As to the Foundation, RetractionWatch has a helpful quote from Stell on looking ahead:

What role do you hope PubPeer plays moving forward? What plans do you have for the Foundation?

We hope that the PubPeer Foundation will provide us with more opportunities to develop the site in ways that will help grow the community of post-publication peer reviewers and further encourage quality science.As more of us scientists become accustomed to commenting on papers, and as that becomes more of a part of the overall scientific process, I think well be able to finally up-end the backwards reward structure that is currently in place in science. Hopefully we can get to a point where the data are much more important to a scientists career than the journal that published them.

To form the PubPeer Foundation, the leaders could not remain anonymous. It seems like a good thing that the founders of PubPeer have identified themselves. They deserve a lot of credit for having had a transformative impact on how science corrects itself. Theyve also faced tough situations such as being sued by Fazlul Sarkar, a case that is still working its way through the legal system. Sarkar wants to know the identity of some anonymous PubPeer commenters. I predict that the PubPeer Foundation will now receive substantial financial support, which in part can be used to get legal assistancefor possible future challenges.

PubPeer has grown quickly, now has a striking following with around 300,000 pageviews/month and contains 35,000 total comments.

I recently chatted with Sean Morrison, current President of ISSCR, on his goals for the Society, where the stem cell field stands today, top challenges, and the future.

What are your goals for your tenure as President of ISSCR?

SM:ISSCR is the international voice for research in the scientific community. Theres been less effort though amongst policy makers and the general public. I want to expand the reach beyond just the scientists. ISSCR will be building its capacity to participate in stem cell policy issues worldwide and also its capacity to communicate with the public.

Whats the plan to make this happen?

SM: A range of things. Beefing up ISSCR communications programs. Blogging, twitter and other efforts.

What are the main challenges & opportunities that ISSCR faces now?

SM:ISSCR has had steady and remarkable growth. It has grown and its scope has grown too. Managing the growth is a challenge. Prioritizing future opportunities. How can we have the most impact for the membership? How can we grow that impact? The annual meeting continues to grow. International ISSCR symposia have grown. Publishing activities have expanded including withCell Stem Cell and nowStem Cell Reports. We continue to expand those kinds of activities. There is a set of opportunities related to going beyond the science. Our mission is to improve human health through stem cells. We cant do that solely by meetings and publishing. Those are critical core activities, but theres more that we can do such as in industry. Reaching out to those stakeholders. Expanding the activities of the Global Advisory Council (philanthropists, Susan Lim, and Deepak), stem cell policy, and communication.

How can ISSCR bring in more industry people?

SM: I do think more involvement of industry is important. How best can we do that? I attended the Industry Committee meeting at ISSCR meeting in Stockholm, where we had that conversation. I really do hope that we can increase the attractiveness and value provided by the annual meeting to people in industry. We want people talking about exciting unpublished data. One difficulty comes up though in this regard: who from industry is willing to talk about unpublished data? Some people have shown up in the past and are not willing to talk about data. The program committee needs to address that.

Whats your view on the evolution of the IPSC subfield?

SM: Im excited about stem cells generally. We need all kinds of stem cell research to move forward. Historically weve not been very good at predicting which cell type will work. Im very excited about somatic stem cell research and pluripotent stem cells, both embryonic and IPSC. Look at the things going on at Shinyas institute. Theyve been bold at diverse ways that they can have impact. With each year that goes by, the more plausible scenarios arise for possible therapies using pluripotent stem cells.

The pioneering IPSC trial in Japan was put on hold. How serious is that?

SM: If youve been culturing cells, some of the time theres going to be mutations. The fact that they found the mutations says that the process that they have in place worked. Its not uncommon in clinical trials for things to go on hold. Its not unique to stem cell trials or IPSCs. I have every expectation that theyll get that back on track.

What are you most excited about with your own research?

SM: Were doing a lot of work to characterize the HSC niche. Weve now identified the cells that are sources of the key factors for stem cell maintenance. In many ways the hematopoietic system is a paradigm. This will allow us to understand at a single cell level how the niche works and look for novel growth factors. Each time we identify one of those it has the potential to provide new tools.

What do you see as the most important and exciting stem cell development or trend of 2015 so far?

SM: Were at an inflection point in terms of stem cell therapies moving into high-quality clinical trials. In 2008 when we were fighting the public policy battles about where the line should be drawn on ESC research. Also there were people making claims about difficult problems. I was skeptical at the time. I felt that a lot of the problems could be too biologically complicated for cell therapies to work. Yet the science has surged forward much more quickly. Theres really exciting preclinical data and actual clinical trials that are about to start or have started. Spinal cord. Macular degeneration. And others. Some people have spent 10-20 years trying to understand the biology. Parkinsons with Lorenz Studer. Cell therapy for heart disease with Chuck Murry. Its important for the general public to understand the timeframe and that some will fail. In the past some were just squirting cells into tissuessort of like buying a lottery ticket. People now understand the biology better. Now we have a rational chance of success.

The debate that is shaping up for CIRM is also very important now. Stem cell research is already delivering and theres opportunity looking ahead. More funding for CIRM makes sense and it would be a major setback to not do that, especially with declining federal funding. One thing that will distinguish the winning states from the losing states is who has the vision to keep the biomedical research enterprise going at the state level. The conversation changed with CIRMs birth. It became, How do we keep up with California?

The spread of stem cell clinics selling non-FDA approved offerings in the US has accelerated. What should ISSCR and individual stem cell scientists be doing to address this growing problem?

SM: Theres a lot that youve done and we appreciate that. Theres also a lot that ISSCR has done. We have our A CloserLook website. ISSCR has spoken out more on this topic than any other topic relevant to the general public. Although stem cell research has enormous promiseand this is the most exciting time that weve ever hadunfortunately most people in the general public dont understand how long it takes to go from the idea or proof of principle in a mouse to do it in humans. Sadly there are fraudulent people out there that are preying on patients. These are at best unproven and in many cases not even plausible therapies.

Where do you see the stem cell field in 5-10 years?

SM:We should be excited, but Im always wary of these kinds of predictions. If we look over the last 10 years theres been a lot of twists in the plot. Theres been both good news and bad news. Some things have surged forward more quickly and some things that we are most excited about now werent on our radar screens then. We dont really know where were going to be. But Im very optimistic. The thing that we have to remember that we always forget, even when we identify an idea that works, it takes a lot of years to get that to a patient. Look how long it took for bone marrow transplant to develop. We now talk about bone marrow transplant as an example but it took 14 years. We should bear in mind that even if some of the things now in clinical trials are correct, it could take years to develop them in a safe and efficient way.

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Knoepfler Lab Stem Cell Blog | Building innovative ...

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By offering unproven therapies, a Texas biotechnology firm has sparked a bitter debate about how stem cells should be regulated. David Cyranoski 13 February 2013 Ann McFarlane is losing faith. In the first half of 2012, the Houston resident received four infusions of adult stem cells grown from her own fat. McFarlane has multiple sclerosis (MS), and had heard that others with the inflammatory disease had experienced improvements in mobility and balance after treatment. The infusions which have cost her about US$32,000 so far didnt help, but she knew that there were no guarantees. It is McFarlanes experience with Celltex Therapeutics, the company that administered the cells, that bothers her. She was told

Filed under Headlines, Multiple Sclerosis, Stem Cell Regulation, Stem Cells, Texas, World News Tagged with Celltex Therapeutics, FDA, Leigh Turner, multiple sclerosis, Parkinson's, stem-cell tourism

Posted by admin on August 15, 2012 Leave a Comment

Former FDA Official Slams Regulation of Stem Cells as Exceeding Agency Authority Should the US Food and Drug Administration (FDA) have the authority to regulate cells derived fromand later put back intoa person? A recent opinion-editorial published in The Wall Street Journal by former FDA Associate Commissioner Scott Gottlieb and Coleen Klasmeier, head of FDA practice at the law firm Sidley Austin LLP, argues FDAs efforts to increase regulatory enforcement against stem cell manufacturers has the potential to backfire against the nascent and potentially promising industry. At issue, write Gottlieb and Klasmeierboth of whom have an admitted financial interest in stem cell therapiesis a recent court case decided in favor of FDA by the US

Posted by admin on July 26, 2012 Leave a Comment

Its official: stem cells are drugs. At least, thats the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies. Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice not regulated by the US government. But if the cells are subjected to more than minimal manipulation, the FDA maintains that the therapy becomes a drug, which must be specifically approved for use. It was on this basis that in 2008 the FDA began moves to shut downRegenerative Sciences,

Posted by admin on July 26, 2012 Leave a Comment

Animal trials of Mesoblasts (ASX:MSB) mesenchymal stem cells in rheumatoid arthritis (RA) have encouraged the company press on with an FDA application for a phase II trial. Mesoblast (ASX:MSB) is continuing to expand the applications for its off-the-shelf stem cell technology by pushing forward to conduct a phase II trial for rheumatoid arthritis (RA). This follows encouraging results from preclinical trials of its adult stem cells in animal models of RA. The company revealed that a single injection of its mesenchymal precursor cells (MPCs) was able to simultaneously inhibit multiple cytokines responsible for driving RA. The MPCs concomitantly affected T cells, monocytes and synoviocytes to shut down TNF-alpha, IL-6 and IL-I7 cytokine pathways in sheep

Posted by admin on July 10, 2012 Leave a Comment

New Therapy for Heart Attack Patients Approved by FDA for Clinical Trials San Francisco, CA A new approach using stem cells to repair the damage caused by heart attacks has been given approval for first-in-human use in clinical trials by the Food and Drug Administration. Funding for research that contributed to the potential therapy came from Californias stem cell agency, the California Institute for Regenerative Medicine (CIRM), through a Disease Team grant to Cedars-Sinai Heart Institute in Los Angeles. This is the first time that research by a CIRM-funded Disease Team has resulted in an Investigational New Drug (IND) approval from the FDA, a critical step in testing promising therapies in patients, says Ellen

Filed under Headlines, Heart Attacks, Heart Disease, Stem Cells Tagged with California Institute for Regenerative Medicine, Cardiosphere Derived Cells, CDCs, Cedars-Sinai Heart Institute, CIRM, Eduardo Marbn, Ellen Feigal, FDA, IND, Robert Quint

Posted by admin on May 27, 2012 Leave a Comment

FDA approved biologics license application (BLA) for cord blood hematopoietic progenitor cells, manufactured by Clinimmune Labs, University of Colorado Cord Blood Bank. This is a second licensed cord blood product in US, after Hemacord. Related Post FDA Okays 1st Cord Blood Product Recommend on FacebookTell a friend

Posted by admin on November 1, 2011 Leave a Comment

The FDA requires the use of a Good Manufacturing Practice (GMP) facility for taking stem cell-based therapies into clinical trials. This GMP facility is a clean-room laboratory that ensures the therapeutic products will be safe and contamination-free for patients. In Spring 2008, CIRM gave $272 million for the construction of twelve stem cell research facilities in California. The University of California, Davis was one of the recipients of this Major Facilities grant. Their $20 million award is supporting construction of the new Institute for Regenerative Cures. This 60,000 square foot building will include a state-of-the-art GMP facility. Jan Nolta is the director of the UC Davis stem cell program and Institute for Regenerative Cures. Gerhard

Posted by admin on October 25, 2011 Leave a Comment

Investigational or experimental drugs are new drugs that have not yet been approved by the FDA or approved drugs that have not yet been approved for a new use, and are in the process of being tested for safety and effectiveness. Patients may decide to seek access to investigational drugs for different reasons.Some patients with serious or life-threatening illnesses seek treatment with investigational drugs if FDA-approved therapies are not working or if their side effects are too severe.Others may have heard about promising early study results for a specific investigational drug, and they might want to learn more. Investigational drugs are available through two pathways designed to protect patients, because an investigational drug may pose

Posted by admin on October 22, 2011 Leave a Comment

AUSTIN, TexasDoctors at Heart Hospital of Austin and Austin Heart, one of the largest non-academic cardiovascular research departments in the United States, are working to identify patients for a clinical trial to investigate a therapy that would allow physicians to treat patients with severe Peripheral Arterial Disease (PAD) using adult stem cells harvested from a patients own body. The study will focus on patients with critical limb ischemia, a severe blockage in the arteries of the lower extremities that significantly reduces blood flow, a condition that often results in amputation. This groundbreaking research may open doors to new treatment strategies for a wide range of cardiovascular conditions and offer hope for patients with end-stage disease,

Posted by admin on October 22, 2011 Leave a Comment

Global regenerative medicine company Mesoblast Limited (ASX:MSB; OTC ADR: MBLTY) today announced that it has received clearance from the United States Food and Drug Administration (FDA) to begin a Phase 3 clinical trial for bone marrow regeneration in patients with blood cancers. FDA clearance was obtained within the 30-day minimum time period after Mesoblast filed its Phase 3 Investigational New Drug (IND) submission. The Phase 3 trial will aim to reproduce the positive pilot trial results seen at the University of Texas MD Anderson Cancer Center, where accelerated neutrophil and platelet recoveries, together with excellent 100-day patient survival and low GVHD rates, occurred in patients receiving partially mismatched hematopoietic cells from umbilical cord blood expanded

Filed under Blood, Cord Blood, Stem Cells, Texas, Texas Research, World News Tagged with allogeneic, bone marrow transplantation, FDA, hematopoietic stem cell, IND, Investigational New Drug, MD Anderson, mesenchymal precursor cells, Mesoblast, Orphan Drug Designation, Phase III, stem cell, The University of Texas, umbilical cord blood

Posted by admin on October 20, 2011 Leave a Comment

Harvest Technologies Announces FDA Approval of Its Pivotal Randomized, Controlled, Double Blind Multicenter IDE Trial Using Autologous Adult Stem Cells to Treat Patients With Non-Reconstructable Critical Limb Ischemia PLYMOUTH, Mass., March 22, 2011 /PRNewswire/ Harvest Technologies Corp. (www.harvesttech.com) announced today that the FDA has approved the company sponsored 210-patient IDE clinical trial to be conducted at twenty-five sites in the U.S. using the companys proprietary Bone Marrow Aspiration Concentrate (BMAC) System to treat patients with non-reconstructable Critical Limb Ischemia (CLI). Mark D. Iafrati, M.D. Chief of Vascular Surgery at Tufts Medical Center in Boston is the trials Principal Investigator. If the pivotal study confirms these findings this would be a dramatic affirmation of the

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FDA : Stem Cell Cite