Tag: cell lines

Bioethics News

The biological status of the early human embryo. When does human life begins?

“Those who argue that that embryo can be destroyed with impunity will have to prove that this newly created life is not human. And no-one, to the best of our knowledge, has yet been able to do so.”

Introduction

In order to determine the nature of the human embryo, we need to know its biological, anthropological, philosophical, and even its legal reality. In our opinion, however, the anthropological, philosophical and legal reality of the embryo — the basis of its human rights — must be built upon its biological reality (see also HERE).

Consequently, one of the most widely debated topics in the field of bioethics is to determine when human life begins, and particularly to define the biological status of the human embryo, particularly the early embryo, i.e. from impregnation of the egg by the sperm until its implantation in the maternal endometrium.

Irrespective of this, though, this need to define when human life begins is also due to the fact that during the early stages of human life — approximately during its first 14 days — this young embryo is subject to extensive and diverse threats that, in many cases, lead to its destruction (see HERE).

These threats affect embryos created naturally, mainly through the use of drugs or technical procedures used in the control of human fertility that act via an anti-implantation mechanism, especially intrauterine devices (as DIU); this is also the case of drugs used in emergency contraception, such as levonorgestrel or ulipristal-based drugs (see HERE), because both act via an anti-implantation mechanism in 50% of cases.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

The biological status of the early human embryo. When does human life begins?

“Those who argue that that embryo can be destroyed with impunity will have to prove that this newly created life is not human. And no-one, to the best of our knowledge, has yet been able to do so.”

Introduction

In order to determine the nature of the human embryo, we need to know its biological, anthropological, philosophical, and even its legal reality. In our opinion, however, the anthropological, philosophical and legal reality of the embryo — the basis of its human rights — must be built upon its biological reality (see also HERE).

Consequently, one of the most widely debated topics in the field of bioethics is to determine when human life begins, and particularly to define the biological status of the human embryo, particularly the early embryo, i.e. from impregnation of the egg by the sperm until its implantation in the maternal endometrium.

Irrespective of this, though, this need to define when human life begins (see our article  is also due to the fact that during the early stages of human life — approximately during its first 14 days — this young embryo is subject to extensive and diverse threats that, in many cases, lead to its destruction (see HERE).

These threats affect embryos created naturally, mainly through the use of drugs or technical procedures used in the control of human fertility that act via an anti-implantation mechanism, especially intrauterine devices (as DIU); this is also the case of drugs used in emergency contraception, such as levonorgestrel or ulipristal-based drugs (see HERE), because both act via an anti-implantation mechanism in most of the time.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Ten years since the discovery of iPS cells. The current state of their clinical application

Photo Neurons derived from human iPS cells Stem Cells Australia

Background

Few biomedical discoveries in recent decades have raised so many expectations as the achievement of adult reprogrammed cells or induced pluripotent stem (iPS) cells.1

Pluripotent cells are obtained from adult cells from various tissues that, after genetic reprogramming, can dedifferentiate to a pluripotency state similar to that of embryonic cells, which allows for subsequent differentiation into different cell strains.2,3

In our opinion, this discovery is relevant not only to biomedical issues but also to ethical ones, given that iPS cells could replace human embryonic stem cells (see HERE) – whose use raises numerous ethical problems – in biomedical experimentation and in clinical practice. However, after the last 10 years, the use of iPS cells has still not been clarified. A number of expectations have been met, but other mainly clinical expectations are still far from being achieved.

Current research limitations with iPS cells

There is a notable low efficacy in the techniques employed for obtaining a sufficient proportion of iPS cells, which represents a difficulty in its clinical application.4  Another limitation is the incomplete reprogramming, which depends on the type of cell employed,5 and the problems of mutagenesis resulting from inserting exogenous transcription-factor coding genes, which can cause tumors in the employed cells used.6 Recent studies aim to mitigate this effect.7 A clinical trial for treating macular degeneration with retinal pigment epithelium cells derived from autologously obtained iPS cells has recently been halted.8 After an initially successful experience with the first treated patient, the genetic sequencing of the iPS cells obtained from the second patient revealed mutations in 3 different genes, one of which was classified as oncogene in the Catalogue of Somatic Mutations in Cancer.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Stem cell research. The two sides of the coin

Science facing market

The “heads” of stem cell research

Stem cells today represent a great hope for the future of regenerative medicine due to their ability to differentiate into cell lines of almost any tissue, making them a promising therapeutic option for many diseases.

These pluripotent cells are found in embryonic and also in adult tissues. Their isolation and culture in specific media may lead to the development of tissues that are useful in regenerative therapies for conditions such as heart disease, myelopathies, diabetes, nerve injuries, retinopathies, etc. After their isolation, they are injected directly into the tissues to be regenerated, so that the stem cells differentiate into cells of these same tissues.

A third way of obtaining pluripotent cells is that described by Yamanaka 10 years ago, a finding for which he was awarded the Nobel prize in Medicine. Starting from a differentiated adult cell, Yamanaka managed to find a way of “dedifferentiating” it so that it returned to its pluripotent state, to then “redifferentiate” it into a particular cell line with therapeutic utility. These are known as iPS or induced pluripotent stem cells.

Similarly, tissues that simulate the function of certain organs have been reproduced in vitro from stem cells, and could, in the future, be an alternative to current organ transplantation.

The current state of the clinical application of stem cells remains uncertain. Although successful outcomes have been reported in some fields, such as cardiology and haematology, many clinical trials and therapeutic applications have failed due to problems arising in the differentiation processes and the appearance of tumours.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Stem cells: unique biobank material?

Stem cells are perhaps not what first springs to mind as biobank material. Yet, even stem cells can be biobank material and there are biobanks that focus on stem cells. The use of this biobank material, however, has some unique features.

Stem cell researchers process not only data from human material. The material itself is “processed” and sometimes transplanted to research participants. Commercializing stem cell research moreover implies that cells derived from donated human tissue appear in products on a market. This gives rise to ethical and legal questions.

Does the law allow patenting cell lines derived from human donated material? Is buying and selling such material lawful? Another issue concerns research participants’ right to withdraw their consent at any time. Human embryonic stem cell research uses stem cells from donated spare embryos from IVF treatment. How far does embryo donors’ right to withdraw consent stretch? Must transplanted devices with matured cells be removed from research participants, if the embryo donor withdraws consent? Moreover, assuming that researchers share stem cell lines with companies, are these companies willing to invest in the development of stem cell products if embryo donors may withdraw their consent at any time?

Another difficulty is the purpose to which embryo donors are asked to consent. According to the law, human embryos can be donated only for research purposes (or to other IVF patients). Yet, medical research loses its meaning if results cannot be commercialized. It cannot then reach patients. It is important to inform donors about this broader context of embryo donation.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

The privacy debate over research with your blood and tissue

Many people don’t realize that their leftover tissue, blood or other samples – otherwise known as “biospecimens” – taken during a visit to the doctor or hospital might be stripped of identifying information and used in research without their consent.

This makes some people uncomfortable.

So when the federal government decided to revise its “Common Rule” regulations governing federally funded research involving humans for the first time in decades, the draft revision included a proposal to require consent for all research with biospecimens, whether they have identifying information accompanying them or not. The original regulations required a person’s consent for research with biospecimens only if they had information with them that made them identifiable.

But when the updated Common Rule was released on Jan. 18, there was no change to this part of the regulation.

Human research regulations need to keep up with major advances in technology. They also need to balance enabling scientific progress with attempting to ensure safety and privacy for human participants in research.

So why wasn’t the proposal requiring consent for all biospecimen research adopted, and how do the new regulations recognize people’s concern in what happens to pieces of themselves in the future?

Research with nonidentified biospecimens doesn’t require consent.
Blood vials via www.shutterstock.com

Why we need human biospecimens for research

Exciting new research projects, like the Precision Medicine Initiative (PMI), aim to personalize medical interventions and therapies for things like cancer care.

But knowing how to personalize treatment requires comparing data from thousands of biospecimens to discover the relationship between genetic variation, health behaviors and medical outcomes.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Is it true that there are vaccines produced using aborted fetuses?

pdfSome of the vaccines currently used to prevent diseases such as rubella, measles, rabies, poliomyelitis, hepatitis A, chickenpox or smallpox are produced using tissues from human abortions.

The vaccines consist of dead or attenuated live viruses that are introduced into the patient’s body to activate the body’s defences against that virus without becoming ill. Thus, if the patient subsequently enters into contact with the live virus, it will be unable infect him, since he has the necessary defences to cope with it, i.e. he is immunised.

To prepare the vaccines, the viruses must be cultured in cells in the laboratory. The ethical difficulty appears when these cells come from surgically-aborted human foetuse. Similarly, the viruses themselves can be obtained from aborted foetuses that have been infected with a particular virus. An article published in 2008 in Cuadernos de Bioetica includes detailed information on the different cells and viral strains originating from these sources.

Cells used and vaccines produced using aborted fetuses

The most widely used foetal cells are WI-38 and MRC-5. The WI-38 cells were derived by Leonard Hayflick in 1962 from the lung of a 3-month female foetus [2].The initials WI refer to the Wistar Institute, a body of the University of Pennsylvania, Philadelphia, and number 38 to the foetus from which the cells were obtained. The MRC-5 cells were obtained in 1966 from the lungs of a 14-week male foetus [3].The initials MRC indicate Medical Research Council, a body from London. Other cells derived from surgically-aborted foetuses are: WI-1, WI-3, WI-11, WI-16, WI-18, WI-19, WI-23, WI-24, WI-25, WI-26, WI-27, WI-44, MRC-9, IMR-90, and R-17 (obtained from lung); WI-2, WI-12 and WI-20, (skin and muscle); WI-5 (muscle); WI-8 and WI-14, and WS1 (skin); WI-4, WI-9, WI-10, WI-13 and WI-15 (kidney); WI-6, WI-21 and WI-22 (heart); WI-7 (thymus and thyroids), WI-17 (liver); FHs74Int (small intestine); and PER.C6

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Is it true that there are vaccines produced using aborted foetuses?

pdfSome of the vaccines currently used to prevent diseases such as rubella, measles, rabies, poliomyelitis, hepatitis A, chickenpox or smallpox are produced using tissues from human abortions.

The vaccines consist of dead or attenuated live viruses that are introduced into the patient’s body to activate the body’s defences against that virus without becoming ill. Thus, if the patient subsequently enters into contact with the live virus, it will be unable infect him, since he has the necessary defences to cope with it, i.e. he is immunised.

To prepare the vaccines, the viruses must be cultured in cells in the laboratory. The ethical difficulty appears when these cells come from surgically-aborted human foetuse. Similarly, the viruses themselves can be obtained from aborted foetuses that have been infected with a particular virus. An article published in 2008 in Cuadernos de Bioetica includes detailed information on the different cells and viral strains originating from these sources.

Cells used and vaccines produced using aborted foetuses

The most widely used foetal cells are WI-38 and MRC-5. The WI-38 cells were derived by Leonard Hayflick in 1962 from the lung of a 3-month female foetus [2].The initials WI refer to the Wistar Institute, a body of the University of Pennsylvania, Philadelphia, and number 38 to the foetus from which the cells were obtained. The MRC-5 cells were obtained in 1966 from the lungs of a 14-week male foetus [3].The initials MRC indicate Medical Research Council, a body from London. Other cells derived from surgically-aborted foetuses are: WI-1, WI-3, WI-11, WI-16, WI-18, WI-19, WI-23, WI-24, WI-25, WI-26, WI-27, WI-44, MRC-9, IMR-90, and R-17 (obtained from lung); WI-2, WI-12 and WI-20, (skin and muscle); WI-5 (muscle); WI-8 and WI-14, and WS1 (skin); WI-4, WI-9, WI-10, WI-13 and WI-15 (kidney); WI-6, WI-21 and WI-22 (heart); WI-7 (thymus and thyroids), WI-17 (liver); FHs74Int (small intestine); and PER.C6

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Sperm and eggs grown in a Petri dish could revolutionise reproduction

The imminent arrival of eggs and sperm grown from skin cells makes legislative change imperative, three Ivy League professors argue in the journal Science Translational Medicine.

IVF was a game-changing technology, write Glenn Cohen, of Harvard Law School, George Q. Daley, of Harvard Medical School, and Eli Y. Adashi, of Brown University, but IVG – in vitro gametogenesis – could revolutionise reproduction.

Although at the moment IVG has only been successful in mice, it may only be a matter of time before scientists are able to make an ordinary skin cell revert to a pluripotent cell which can be grown into germ cell. This will provide scientists and IVF clinics with an “inexhaustible supply” of eggs and sperm.

That day is not around the corner. “Copious preclinical evidence of safety” will be needed. At the moment, “Whether human iPSCs have a propensity for genetic and epigenetic aberrations is unresolved.” But scientists in several countries are working feverishly on this. Sooner or later, it will happen – perhaps in countries where medical researchers are very lightly regulated, like Cyprus, China or the Dominican Republic.

Obviously, until IVG is successful, this essay about its social impact is merely speculative. But the legal horizon is very hazy, because such possibilities have never existed before. “Before the inevitable, society will be well advised to strike and maintain a vigorous public conversation on the ethical challenges of IVG,” they argue.

Cohen, Daley and Adashi list several uses for the IVG which could probably be used to lobby legislators.

1. Scientists will be able to study germline disease at the cellular and molecular levels.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Human Embryo Experiment Shows Progress Toward ‘Three-Parent’ Babies

December 1, 2016

(The Washington Post) – The technique used in swapping the genetic material was not immaculate: Some mutant DNA remained in the fertilized eggs and the ensuing replicating stem cell lines. In some of those stem cell lines the mitochondria reverted to the mother’s disease-carrying genetic code. That happened in about 10 to 15 percent of the stem cells, which was a surprise, because that hadn’t been seen in experiments with animal models. They concluded that, going forward, the donors of healthy mitochondrial DNA need to be carefully screened for compatibility with the mother’s mitochondrial DNA.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.