Tag: adult stem cells

Bioethics News

Patient’s own menstrual blood stem cells used to treat Asherman’s syndrome

Infertility treatment.”The best option for endometrial regeneration in patients with Asherman’s syndrome.”

Asherman’s syndrome is an acquired uterine abnormality characterised by the presence of intrauterine adhesions, and which clinically causes infertility, recurrent miscarriages and menstrual changes. Its prevalence ranges between 2% and 22% of infertile women.

Several surgical and medical treatments have been proposed, but outcomes have been unsatisfactory. Now, a study published in Human Reproduction has proposed treating the condition with adult stem cells obtained from the patient’s own menstrual blood.

To date, seven infertile women with Asherman’s syndrome have been treated. All patients were of reproductive age (33.7 ± 1.5 years) and had suffered infertility for 4.8 ± 1.2 years.

Menstrual blood stem cells. The blood stem cells obtained on day 2 of menstruation were transplanted to the uterus, followed by hormone stimulation.

Another successful cell therapy with no ethical difficulties

Endometrial thickening and return to its normal morphology were observed in all patients. One patient became pregnant spontaneously; four others underwent embryo transfer and two of these became pregnant.

The findings of this study suggest that transplantation of adult stem cells obtained from the patient’s own menstrual blood may be one of the best options for endometrial regeneration in patients with Asherman’s syndrome.

This practice — from a bioethical point of view — merits a favourable assessment, since adult stem cells are used which, as we know, present no ethical difficulties for use.

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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

First cell gene therapy to treat “Bubble boy” disease has been legalised in Europe

Last July, an article was published in medical journal Blood, which described the success of a cell gene therapy modality to treat the immunodeficiency caused by adenosine deaminase deficiency – “Bubble boy” disease. This is a disease that alters purine metabolism, leading to an accumulation of metabolites that are toxic for lymphocyte development. As a result, the immune defences of these patients are much weakened, so they often suffer serious infections. It can also be associated with cognitive and hearing deficits.

Now, a group of researchers from Ospedale San Raffaele, Milan (Italy) and the Telethon Foundation, in collaboration with pharmaceutical giant GSK, have developed their product “Strimvelis”, which is the first gene therapy to use genetically modified stem cells. It is also the first product approved by the European Commission to treat the aforementioned immunodeficiency.

The medication is generated from a gene modification of the patient’s own stem cells. The defect that causes the disease is corrected in the cells, which are then injected into the patient via intravenous infusion so that they can henceforth colonise their bone marrow.

As they are genetically modified cells from the patient himself, and not from a third party, the risk of graft-versus-host disease is drastically reduced, which is clearly an unquestionable medical advantage.

Authorisation was obtained from the European Commission after assessing Strimvelis in 18 children, in whom a 3-year survival rate of 100% was found. This opens a promising path for application of this medication in patients with adenosine deaminase deficiency.

From an ethical point of view, there is no difficulty in the use of Strimvelis, provided that the necessary requisites for implementing a new cell therapy are met since the genetic modification is performed in the patient’s own adult stem cells.

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 Deadly Business of an Unregulated Global Stem Cell Market

Guest Post: The deadly business of an unregulated global stem cell industry

Tereza Hendl and Tamra Lysaght

In our paper, we report on the case of a 75-year old Australian woman who died in December 2013 from complications of an autologous stem cell procedure. This case was tragic and worth reporting to the medical ethics community because her death was entirely avoidable and the result of a pernicious global problem – doctors exploiting regulatory systems in order to sell unproven and unjustified stem cell interventions.

The patient at the centre of this case, Sheila Drysdale, underwent a liposuction procedure administered by cosmetic surgeon, Dr Ralph Bright, at his private Sydney clinic. Dr Bright did not perform this procedure for cosmetic reasons, but rather to ‘treat’ her advanced dementia with adipose (fat) derived stem cells. Mrs Drysdale died within ten hours of the surgery. Following an inquest into her death, the New South Wales Deputy Coroner stated that the utilisation of stem cells to ‘treat’ dementia was “highly questionable” and displayed “some of the hallmarks of ‘quack’ medicine,” particularly owing to the lack of scientific evidence supporting such ’therapy.’ The Coroner, thus, called for a more rigorous regulation of ‘innovative’ medical procedures in Australia that would protect vulnerable patients. Sadly, the relevant regulatory authorities have done very little to bring about any justice for Mrs Drysdale, or to address the systemic problems in Australia’s legislative framework that allows medical professionals to offer unproven stem cell-based interventions to patients without any accountability.

This case came to our attention as part of the work being done on an Australian Research Council funded Linkage Project “Regulating autologous stem cell therapies in Australia.”

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

Equipoise and Caution Regarding “Ethical” Stem-Cell Therapy

You may have seen one of the many news reports this week about an “adult” stem cell treatment gone bad.  In it, doctors, not working in regulated industry or in the bounds of a clinical trial, injected stem cells derived from a person’s fatty tissue into the eyeballs of three people in an attempt to treat a vision-destroying condition called macular degeneration—and all three lost what remaining vision they had.  T

In a separate experience, two people received “reprogrammed” stem cells, also called “induced pleuripotent stem cells” or “iPSCs,” for the same condition, and they did not appear harmed, and may have been showing early signs of improvement, one year later.  In this second case, the cells are described as having undergone rigorous quality testing before being injected into the patients’ eyeballs.

The two cases are described in this week’s New England Journal of Medicine.  The links above are to those reports; subscription may be required to read them.  NEJM makes some of its editorials and perspective pieces generally available, other articles not.  Two such articles, one from FDA and one from a physician at Boston Childrens’ Hospital, address these cases.  In both opinion articles, the authors argue that careful regulation and quality control of stem cell studies is critical to their ethical testing.

To say this position is hard to argue with is a gross understatement.  I will confess that on this blog, in the past, I have wondered whether some use of “adult” or “somatic” stem cells is over-regulated, as, for example, when such cells are obtained from a woman’s fatty tissue, and reinjected into her in an attempt at breast reconstruction after surgery. 

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

Blast Off: Stem Cells from Mayo Clinic Physician’s Lab Launch into Space

February 20, 2017

(Eurekalert) – Consider it one physician’s giant leap for mankind. Today, the latest rocket launch from NASA’s Kennedy Space Center in Cape Canaveral, Florida, included a payload of several samples of donated adult stem cells from a research laboratory at Mayo Clinic’s Florida campus. The launch by SpaceX, an American aerospace manufacturer and space transport services company, is part of NASA’s commercial resupply missions to the International Space Station.

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

Leading Adult Stem Cell Researcher named Australian of the Year

A little over a decade ago Australia was fiercely debating the ethics of stem cell research.

Now one of the central figures of that debate, adult stem cell researcher Alan Mackay-Sim, has been named Australian of the Year.

Makay-Sim, who received the award at a ceremony in Canberra last week, was a pioneer in the use of stem cells for regenerative purposes. In 2002 he became the first scientist in the world to use olfactory ensheathing cells to bring about spinal regeneration in humans. The procedure was used by Polish researchers in 2012 to help a man paralysed from the chest down to walk again.

Yet Mackay-Sim was also embroiled in the Australian campaign against embryonic stem-cell research. In the early 2000s, IVF pioneer Alan Trounson — then director of a national stem cell research centre — was leading a campaign for a massive government funded embryonic stem cell research initiative. Mackay-Sim’s work was often used as evidence against funding the Trounson project.

Some see Mackay’s recent accolade as a vindication of adult stem-cell research, which at one point received significantly less funding than its alternative. Writing in The Australian, columnist Angela Shanahan remarked:

“By concentrating on the use of adult stem cells rather than ­embryonic stem cells, Mackay-Sim’s research bypassed the most contentious ethical debates, and, what is more, he did this with very limited funds. He and his team deserve full credit for that.”

Others say that Mackay-Sim’s award is encouragement and “hope” for all stem-cell researchers. Writing in The Conversation, University of Melbourne stem-cell researcher Melissa Little said:

“while innovation is recognised by the major parties as a key driver for future success, their commitment to research funding in this country isn’t in line with their innovation focus…to have the spotlight turned towards the potential of stem cell science and the researchers in this field also brings us “hope”.”

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

First Stem Cell Study Could Lead to Development of Therapy to Reduce Inflammation Caused by CF

February 1, 2017

(News-Medical) – A 39-year-old man with cystic fibrosis (CF) made history by becoming the first person to receive human adult stem cells in a new research study that researchers hope will someday lead to the development of a therapy to reduce the inflammation and infection caused by CF. The pioneering subject in the study is Bob Held from Alliance, Ohio, who on Jan. 26 received an infusion of cells called allogeneic human mesenchymal stem cells (hMSC), adult stem cells collected from the bone marrow of healthy volunteers. Mr. Held was diagnosed with CF when he was 16 months old.

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

Alan Mackay-Sim ‘Fudged’, But There Was No Compromised of Ethics

January 30, 2017

(The Australian) – Mackay-Sim has done very valuable work on the use of nasal stem cells in spinal cord injury. He was the pioneer in this country in the use of adult stem cells and proved that they were safe to use. By concentrating on the use of adult stem cells rather than ­embryonic stem cells, his research bypassed the most contentious ethical debates, and, what is more, he did this with very limited funds.

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

New breakthrough in the treatment of Crohn’s disease using cell therapy

Crohn’s disease treatment using cell therapy. In 2009, Spanish researchers (see HERE) proposed the use of mesenchymal stem cells for the treatment of fistulas in Crohn’s disease. The findings of the first phase 3 randomised, double-blind, placebo-controlled clinical trial, in which the authors assessed the safety and efficacy of treatment, have now been published in the Lancet (see HERE). The trial included 212 patients: 107 assigned to treatment and 105 in the placebo group. The results have been very encouraging, to the point where The Lancet dedicated a Comment, in which they said that “we regard the results of this phase 3 study as an opportunity to support the start of a new era in the treatment of fistulising Crohn’s disease“. A new potential use of adult stem cells, which as we know, offer no ethical difficulties for use.

Photo BioInformant

La entrada New breakthrough in the treatment of Crohn’s disease using cell therapy aparece primero en Observatorio de Bioética, UCV.

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

New breakthrough in the treatment of Crohn’s disease using cell therapy

Crohn’s disease treatment using cell therapy. In 2009, Spanish researchers (see HERE) proposed the use of mesenchymal stem cells for the treatment of fistulas in Crohn’s disease. The findings of the first phase 3 randomised, double-blind, placebo-controlled clinical trial, in which the authors assessed the safety and efficacy of treatment, have now been published in the Lancet (see HERE). The trial included 212 patients: 107 assigned to treatment and 105 in the placebo group. The results have been very encouraging, to the point where The Lancet dedicated a Comment, in which they said that “we regard the results of this phase 3 study as an opportunity to support the start of a new era in the treatment of fistulising Crohn’s disease“. A new potential use of adult stem cells, which as we know, offer no ethical difficulties for use.

Photo BioInformant

La entrada New breakthrough in the treatment of Crohn’s disease using cell therapy aparece primero en Observatorio de Bioética, UCV.

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.