Category Archives: Stell Cell Research


Using stem cells to create an endless supply of blood – CNN

"This technology gives us that particular dream, or at least it brings us a lot closer," said Klein.

To ramp up production, the UK researchers infected stem cells with cervical cancer genes. By inserting cancer genes from human papilloma virus (HPV) into bone marrow cells, Frayne and her colleagues were able to create the first adult red blood cells that could multiply an infinite number of times. These cells are referred to as "immortal."

As the red blood cells mature, they spit out the nucleus -- the core that houses their DNA -- giving the cells a signature round, dimpled shape. Frayne and her colleagues filtered those cells from the rest, so the final batch did not contain the active cancer genes.

Frayne said that a small number of these stem cells can be found in a simple blood draw, too; there's no need to do an invasive biopsy of the bone. Since her team completed the study last year, she said, they have already created two new immortal cell lines this way.

But his cells didn't eject the nucleus well enough, and fetal blood cells have too tight a grip on oxygen; they are less likely to drop off the oxygen where it needs to go. Eventually, though, he abandoned the research because "it's not really commercially viable."

Many others have attempted to create blood in the lab, using stem cells from umbilical cords and other sources. But these stem cells fizzle out and stop dividing at a certain point.

"It's almost like they desperately want to carry on differentiating" into mature cells, Frayne said.

Frayne said that the first human trials will begin in England later this year, though they will not be using the immortal cells from her new study. Making the new cells under industry standards, Frayne said, could take at least several more years.

But where Lanza really expects to see this technology is on the battlefield.

Lanza, who met with DARPA officials about his own blood cell research in the past, said that the military wants to use lab-grown blood "for patients who have massive blood loss, particularly in the battlefield, where a soldier is blown up by a bomb and there isn't time for blood typing."

"I think the goal ultimately is to put this on the back of a Humvee," he said.

That research, however, met the same obstacles other scientists faced in the past, Klein said.

"They were not able to make sufficient amounts blood at any kind of reasonable cost," said Klein, who also serves on the FDA Blood Products Advisory Committee. Though familiar with the DARPA research, he was not involved in evaluating its products.

"To make big huge vats of it would be outside of our ability in a research lab," she said. "We'd have to have company interest."

A hospital in the US might pay hundreds to thousands of dollars to purchase and test a unit of donated blood, and it may charge far more to transfuse it to patients. Producing a pint of blood using her method, Frayne said, would likely be several times more expensive than buying bags from blood donors in the UK.

But Frayne is optimistic that costs will come down. She hopes that lab-grown cells will be shown to last longer, and therefore doctors might need to use less blood less frequently. That's because stem cells can be collected while they're young, Frayne said, while human blood has cells of all different ages. Many donated blood cells die not long after transfusion.

That aside, Klein said that lowering the cost to $1,000 to $2,000 per unit of blood would make these cells worth the price for a small subset of patients who have rare blood types or need regular transfusions. For the typical hospital patient, however, it would probably not be very practical or cost-effective, he said.

But it is their willingness to invest money in the research, Klein said, that may have led to the British team's success where the US and other countries have faltered.

"They have put a great deal of financial muscle behind doing this on a national basis, which we simply haven't seen in the United States," he said, adding that perhaps there was an element of "healthy skepticism (in the US) that maybe it will never in our lifetime be practical."

"I don't share that skepticism," he said.

But what about the rogue red cell that slips through the filter with its cancer genes still intact? Lanza calls these cells "escapees."

"When you're dealing with such huge numbers of cells," said Lanza, "there may be a few of these cells that would slip in."

Frayne said that these cells are highly unlikely to cause any form of blood cancer. The cancer genes are only switched on by a certain antibiotic, and by the time the cells are collected, any remaining nuclei are no longer working. Before blood transfusion, radiation can also be used to destroy any leftover DNA without affecting normal cells, she said.

Still, Frayne said, "These are all really good points to be raising, and they need to be looked at."

But none of these concerns have slowed a deluge of requests to use her cells, Frayne said, though perhaps not from whom you'd expect. It's not blood banks hoping to capitalize on a new, if untested, method. In fact, it's other researchers who, until now, have not had an unlimited way to study diseases like malaria, which infect red blood cells. "That's where all my requests are coming from," she said.

Klein, Lanza and Frayne all said lab-grown blood cells are not meant to replace blood donors. To fill a national blood service, or even a single hospital, will require another major leap in the research.

"They're not going to put the Red Cross out of business," said Lanza. "Volunteer blood donations are always going to be the first line of defense -- but with this technology, you have a safety net."

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Using stem cells to create an endless supply of blood - CNN

Does the Catholic Church Oppose All Stem-Cell Research?

Important Questions

The Catholic Church is concerned with the protection of all innocent human life, as Pope Paul VI's landmark encyclical, Humanae vitae (1968), made clear. Scientific research is important, but it can never come at the expense of the weakest among us.

Stem cells are a special type of cell that can easily divide to create new cells; pluripotent stem cells, which are the subject of most research, can create new cells of various types. Over the last several years, scientists have been optimistic about the possibility of using stem cells to treat a wide range of diseases and other health problems, because stem cells could potentially regenerate damaged tissues and organs.

While news reports and political debates often use the term stem-cell research to discuss all scientific research involving stem cells, the truth is that there are a number of different types of stem cells that are being studied. For example, adult stem cells are often drawn from bone marrow, while umbilical-cord stem cells are taken from the blood that remains in the umbilical cord after birth.

Most recently, stem cells have been found in the amniotic fluid that surrounds a baby in the womb.

There is no controversy about research involving all of these types of stem cells. In fact, the Catholic Church has publicly supported adult and umbilical-cord stem-cell research, and Church leaders were among the first to applaud the discovery of amniotic stem cells and to call for further research.

The Church has consistently opposed research on embryonic stem cells, however. For several years now, many scientists have called for greater research on embryonic stem cells, because they believe that embryonic stem cells exhibit greater pluripotency (the ability to divide into different types of cells) than, say, adult stem cells.

The public debate around stem-cell research has focused entirely on embryonic stem-cell research (ESCR). The failure to distinguish between ESCR and other forms of stem-cell research has muddied the debate.

Despite all of the media attention that has been devoted to ESCR, not a single therapeutic use has been developed with embryonic stem cells. In fact, every use of embryonic stem cells in other tissue has led to the creation of tumors.

The greatest advances in stem-cell research so far have come through adult stem-cell research: Dozens of therapeutic uses have been developed and are currently in use. And the discovery of amniotic stem cells may well provide scientists with all the advantages that they had hoped to derive from ESCR, but without any of the moral objections.

On August 25, 2000, the Pontifical Academy for Life released a document entitled Declaration on the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells, which summarizes the reasons why the Catholic Church opposes ESCR.

It doesnt matter whether scientific advances may be made through ESCR; the Church teaches that we can never do evil, even if good may come of it, and there is no way to obtain embryonic stem cells without destroying innocent human life.

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Does the Catholic Church Oppose All Stem-Cell Research?

Immortal Stem Cells Let Scientists Create an Unlimited Supply of Artificial Blood – ScienceAlert

Researchers have developed a line immortal stem cells that allow them to generate an unlimited supply of artificial red blood cells on demand.

If these artificial blood cells pass clinical trials, they'll be far more efficient for medical use than current red blood cell products, which have to be generated from donor blood - and would be a huge deal for patients with rare blood types, who often struggle to find matching blood donors.

The idea isn't for these immortal stem cells to replace blood donation altogether - when it comes to regular blood transfusions, donated blood still does the trick.

But it's a constant struggle to propagate red blood cells from donor blood. In the UK alone, 1.5 million units of blood need to be collected each year to meet the needs of patients, particularly those with rare blood types of conditions such as sickle-cell disease.

"Globally, there is a need for an alternative red cell product,"said lead researcher Jan Frayne from the University of Bristol in the UK.

"Cultured red blood cells have advantages over donor blood, such as reduced risk of infectious disease transmission."

In the past, researchers had attempted to turn donated stem cells straight into mature red blood cells - a technique that works, but is an incredibly inefficient process.

Each stem cell only makes around 50,000 red blood cells before it dies off, at which point the researchers need a new blood donation.

And while 50,000 might sound like a lot, put that into perspective, a typical bag of blood used in hospitals contains around 1 trillion red blood cells.

To overcome this, the University of Bristol team took a different approach - they turned adult stem cells into the world's first line of immortalised 'erythroid' stem cells -erythroid refers to the process that produces red blood cells.

They've called the cell line Bristol Erythroid Line Adult or BEL-A cells.

To create these 'immortal' cells, they effectively trapped the adult stem cells in an early stage of development, which means they can divide and create red blood cells forever without dying, which avoids the need for repeat donations.

"Previous approaches to producing red blood cells have relied on various sources of stem cells which can only presently produce very limited quantities," said Frayne.

"We have demonstrated a feasible way to sustainably manufacture red cells for clinical use," she told the BBC. "We've grown litres of it."

If immortal stem cells soundfamiliarto you, that's because there's another famous line of immortal stem cells used in labs around the world, known as HeLa, which was taken from the tissue of a woman called Henrietta Lacks without her knowledge.

Lacks was an African American woman who had a cancerous tumour biopsied in 1951,and never knew those cells were turned into the immortal HeLa cell line, which has played a crucial role in key milestones such as the development of the polio vaccine, as well asmajor cancer studies, and continues to be used today.

These BEL-A immortal stem cells, on the other hand, were specifically selected from voluntarily donated blood products with the sole aim of generating adult human blood cells.

If their red blood cell products pass clinical trials, they could prove just as revolutionary and useful as Lacks' cells did.

"Scientists have been working for years on how to manufacture red blood cells to offer an alternative to donated blood to treat patients," Dave Anstee, director of the UK's National Institute of Health Research Blood and Transplant Research Unit in Red Cell products, which collaborated on the research, announced in a press statement.

"The patients who stand to potentially benefit most are those with complex and life-limiting conditions like sickle cell disease and thalassemia, which can require multiple transfusions of well-matched blood."

"The intention is not to replace blood donation but provide specialist treatment for specific patient groups,"he added.

"The first therapeutic use of a cultured red cell product is likely to be for patients with rare blood groups because suitable conventional red blood cell donations can be difficult to source."

The artificial red blood cells still need to undergo clinical trials in humans before we can say for sure that they're safe and effective.

But early safety trials based on previous manufacturing methods will begin by the end of this year. If that goes to plan, the researchers will trial the BEL-A cell products in patients shortly after that.

We'll be watching the progress closely.

The research has been published in Nature Communications.

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Immortal Stem Cells Let Scientists Create an Unlimited Supply of Artificial Blood - ScienceAlert

Stem cells shown to restore erection capability in men with erectile dysfunction – Science Daily


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Stem cells shown to restore erection capability in men with erectile dysfunction
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Stem cells shown to restore erection capability in men with erectile dysfunction - Science Daily

Potential of stem cell therapy to repair lung damage — ScienceDaily – Science Daily


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Potential of stem cell therapy to repair lung damage -- ScienceDaily
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A new study has found that stem cell therapy can reduce lung inflammation in an animal model of chronic obstructive pulmonary disease (COPD) and cystic ...
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Potential of stem cell therapy to repair lung damage -- ScienceDaily - Science Daily

Pioneering stem cell gene therapy cures infants with bubble baby disease – Medical Xpress

March 28, 2017 by Tiare Dunlap Evangelina Vaccaro (far right), who in 2012 received treatment developed by UCLAs Dr. Donald Kohn for bubble baby disease, with her family before her first day of school. Credit: Courtesy of the Vaccaro family

UCLA researchers have developed a stem cell gene therapy cure for babies born with adenosine deaminase-deficient severe combined immunodeficiency, a rare and life-threatening condition that can be fatal within the first year of life if left untreated.

In a phase 2 clinical trial led by Dr. Donald Kohn of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, all nine babies were cured. A 10th trial participant was a teenager at the time of treatment and showed no signs of immune system recovery. Kohn's treatment method, a stem cell gene therapy that safely restores immune systems in babies with the immunodeficiency using the child's own cells, has cured 30 out of 30 babies during the course of several clinical trials.

Adenosine deaminase-deficient severe combined immunodeficiency, also known as ADA-SCID or bubble baby disease, is caused by a genetic mutation that results in the lack of the adenosine deaminase enzyme, which is an important component of the immune system. Without the enzyme, immune cells are not able to fight infections. Children with the disease must remain isolated in clean and germ-free environments to avoid exposure to viruses and bacteria; even a minor cold could prove fatal.

Currently, there are two commonly used treatment options for children with ADA-SCID. They can be injected twice a week with the adenosine deaminase enzymea lifelong process that is very expensive and often does not return the immune system to optimal levels. Some children can receive a bone marrow transplant from a matched donor, such as a sibling, but bone marrow matches are rare and can result in the recipient's body rejecting the transplanted cells.

The researchers used a strategy that corrects the ADA-SCID mutation by genetically modifying each patient's own blood-forming stem cells, which can create all blood cell types. In the trial, blood stem cells removed from each child's bone marrow were corrected in the lab through insertion of the gene responsible for making the adenosine deaminase enzyme. Each child then received a transplant of their own corrected blood stem cells.

The clinical trial ran from 2009 to 2012 and treated 10 children with ADA-SCID and no available matched bone marrow donor. Three children were treated at the National Institutes of Health and seven were treated at UCLA. No children in the trial experienced complications from the treatment. Nine out of ten were babies and they all now have good immune system function and no longer need to be isolated. They are able to live normal lives, play outside, go to school, receive immunizations and, most importantly, heal from common sicknesses such as the cold or an ear infection. The teenager, who was not cured, continues to receive enzyme therapy.

The fact that the nine babies were cured and the teenager was not indicates that the gene therapy for ADA-SCID works best in the youngest patients, before their bodies lose the ability to restore the immune system.

The next step is to seek approval from the Food and Drug Administration for the gene therapy in the hopes that all children with ADA-SCID will be able to benefit from the treatment. Kohn and colleagues have also adapted the stem cell gene therapy approach to treat sickle cell disease and X-linked chronic granulomatous disease, an immunodeficiency disorder commonly referred to as X-linked CGD. Clinical trials providing stem cell gene therapy treatments for both diseases are currently ongoing.

Explore further: Stem cell researcher pioneers gene therapy cure for children with "Bubble Baby" disease

More information: Clinical efficacy of gene-modified stem cells in adenosine deaminasedeficient immunodeficiency. http://www.jci.org/articles/view/90367

UCLA stem cell researchers have pioneered a stem cell gene therapy cure for children born with adenosine deaminase (ADA)-deficient severe combined immunodeficiency (SCID), often called "Bubble Baby" disease, a life-threatening ...

For the last several decades, scientists worldwide have been seeking to harness the power of stem cells to develop therapies for human diseases and conditions. At UCLA's Broad Stem Cell Research Center, the potential to bring ...

New research published online today in Blood, the Journal of the American Society of Hematology (ASH), reports that children with "bubble boy disease" who undergo gene therapy have fewer infections and hospitalizations than ...

Gene therapy can safely rebuild the immune systems of older children and young adults with X-linked severe combined immunodeficiency (SCID-X1), a rare inherited disorder that primarily affects males, scientists from the National ...

Researchers have found that gene therapy using a modified delivery system, or vector, can restore the immune systems of children with X-linked severe combined immunodeficiency (SCID-X1), a rare, life-threatening inherited ...

Using a new cellular model, innovative gene therapy approaches for the hereditary immunodeficiency Chronic Granulomatous Disease can be tested faster and cost-effectively in the lab for their efficacy. A team of researchers ...

A new study published in Nature Communications and co-authored by Northwestern Medicine scientists shows how two proteins of the Ca2+ release-activated Ca2+ (CRAC) channel family interact with each other to control the flow ...

UCLA researchers have developed a stem cell gene therapy cure for babies born with adenosine deaminase-deficient severe combined immunodeficiency, a rare and life-threatening condition that can be fatal within the first year ...

Wellcome Trust Sanger Institute scientists and their collaborators have developed a new analysis tool that was able to show, for the first time, which genes were expressed by individual cells in different genetic versions ...

The liver is crucial for the detoxification of the human body. The exposure to toxins makes it particularly prone to drug-induced injury. Cholestasis, the impairment of bile flow, is therefore a common problem of drug development ...

Men unable to have an erection after prostate surgery enjoyed normal intercourse thanks to stem cell therapy, scientists are to report Saturday at a medical conference in London.

McMaster University researchers have discovered that while survivors of childhood brain tumours have a similar Body Mass Index (BMI) to healthy children with no cancer, they have more fat tissue overall, and especially around ...

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Pioneering stem cell gene therapy cures infants with bubble baby disease - Medical Xpress

BioStem Technologies, Inc. Announces Completion of 503b … – Yahoo Finance

OAKLAND PARK, FL--(Marketwired - Mar 24, 2017) - BioStem Technologies, Inc. ( OTC PINK : BSEM ) ("BSEM" or "the company"), an emerging International BioTech company, celebrated the opening of its new laboratory and corporate offices with a ribbon cutting ceremony hosted by the BioStem Technologies executive team. BSEM's Founder and CEO, Henry Van Vurst, commented, "With the recent regulation changes we amended our original facility design to comply with FDA 503b regulations, which caused an extension to our timeline, but I couldn't be prouder of this new state-of-the-art facility. Cutting the ribbon with Mayor Lamar Fisher (City of Pompano Beach) was a very proud moment for the entire BSEM team, and it is a testament to how far we have come since the Company's inception in 2014."

The facility is a showcase of quality that will enable BSEM to leverage its vertical integration strategy in the Health, Wellness and Biotechnology sectors. The lab will serve as the Quality, R&D, and Pharmaceutical Manufacturing Laboratory, not only for the Company's in-house operations, but also for its contract formulation and contract manufacturing services. The Company is in the process of finalizing its certifications for the ISO 8, 7, and 5 suites, as well as validation of the cGMP and cGLP areas. Corporate operations are expected to move to the new facility in Q2 2017, while the operations of Qualified Pharma Ingredients, one of the company's subsidiaries, will remain at its current location in Oakland Park, Florida.

About BioStem Technologies, Inc. ( OTC PINK : BSEM ): BioStem Technologies, Inc. ( OTC PINK : BSEM ) is in the business of regenerative medicine and antiaging strategies throughout the United States, Europe, and Mexico. The Company's mission is to conquer the effects of biological aging (and related acute disease), and its strategy is to discover, develop, produce, and deliver the most effective stem cell and wellness products in the world. The Company is comprised of a diverse group of scientists, physicians, and industry visionaries who are creating innovative products for helping customers live their best, feel their best, and be their best. The company operates six strategic business units -- BioStem Cell Therapy, BioStem Wellness, BioStem Pharmaceuticals, Qualified Pharma Ingredients, BioBlue, and BioStem International -- providing a diversified line of products and services that include: clinical stem cell therapy, stem cell R&D, state-of-the-art laboratory services, pharmaceuticals, nutraceuticals, cosmeceuticals, API repackaging, and medical tourism.

Forward-Looking Statements: Except for statements of historical fact, the matters discussed in this press release are forward looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "future," "plan" or "planned," "expects," believe" or "projected." These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing, exploiting and protecting proprietary technologies, intense competition and additional risks factors as discussed in reports filed by the company with OTC Markets.

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BioStem Technologies, Inc. Announces Completion of 503b ... - Yahoo Finance

Stem Cell Center epitomizes PPP – Kuwait Times

Opens mid-September; first of its kind in the Gulf

KUWAIT: An artists rendition of the Sheikha Salwa Sabah Al-Ahmad Center for Stem Cell and Umbilical Cord. (inset) Masharee Al-Khair board member and treasurer Abdul-Aziz Al-Jassar and KIPCO Deputy Chairman Faisal Al-Ayyar KUNA

KUWAIT: The private sector in Kuwait has come to play a major role in various fields of the economic scene, for the good of the entire society, within the concept of social responsibility of the business. This role has been in many cases fulfilled in partnership with the public sector. The Sheikha Salwa Sabah Al-Ahmad Center for Stem Cell and Umbilical Cord, which is currently under construction, offers a good model of the public-private partnership (PPP).

Once completed, the center would help scientists are in their research to explore how the cells can be used for a better quality of life for patients suffering from genetic diseases, for instance. Such efforts have already been fruitful, as discoveries in the field have raised hope for people with incurable diseases such as blood cancers, disorders of the immunity system and metabolism, to have a better standard of life through stem cell transplant.

12,000 square meters The center is being built on a total area of 12,000 square meters in Al-Sabah Health Zone, opposite to the Maternity Hospital. It includes a three-floor main building and one for utilities, in addition to external landscaping and parking. The facility also includes testing and research laboratories, blood and cord storage banks, research and medical libraries, as well as a lecture theater.

On behalf of the Kuwait Projects Company (KIPCO) and the Group companies, the Masharee Al-Khair (projects for good) Charity Organization provided a KD 7 million ($23 million) donation for the Gulf regions first-ever center to be dedicated to stem cell research and the storage of umbilical cords.

In addition, the Advanced Technology Company (ATC), a member of the KIPCO Group, has pledged to provide state-of-the-art equipment for the centers specialized laboratories, cooling systems and stem cell storage facilities. ATCs contribution is valued at KD 1 million.

Once completed in mid-September 2017, the Sheikha Salwa Sabah Al-Ahmad Center for Stem Cell and Umbilical Cord will be handed over to the Ministry of Health. KIPCOs donation for the center has been prompted by its strong belief in the major role of the private sector in all vital sectors in Kuwait so as to cope with the accelerating scientific progress worldwide. It also offers a model example of PPP, for promoting medical services in the country.

Landmark achievement The center is the first of its kind in the Gulf region, and a landmark achievement in the health sector, said Faisal Al-Ayyar, KIPCO Deputy Chairman. He noted that KIPCO Group of companies allocate one percent of their annual profits for Masharee Al-Khair to offer support to social, health and educational scenes. Ayyar expressed hope that the day would come when storing stem cells would be as easy as ever, and treatment through them a first choice for incurable diseases, boasting KIPCOs philanthropic role.

Abdul-Aziz Al-Jassar, Masharee Al-Khairs board member and treasurer, said meanwhile that KIPCOs donation for the center was prompted by a strong belief in the vital role of the private sector supporting the governments development plans. We pin great hopes on the would-be center, that will no doubt play a major role for promoting medical research, Jassar said. Founded in 1975, KIPCO has since become one of the Middle East and North African (MENA) regions most successful companies. With holdings in sectors such as financial services, media, manufacturing and real estate, KIPCO Group comprises over 60 companies and employs over 12,000 people in 24 countries. KUNA

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Stem Cell Center epitomizes PPP - Kuwait Times

Stem cell treatments can go wrong – Jamaica Observer

Stem cells are the foundation of all our body cells before they differentiate to become specialised cells that grow into our tissues and organs, such as kidney cells, muscle cells, nerve cells, and so on.

They commonly come from two sources: The embryo (embryonic stem cells formed in early development after the human egg is fertilised by a sperm); and adult tissue (adult stem cells, such as those existing in bone marrow to later differentiate to form red blood cells, white blood cells and other components of the blood).

The use of human embryonic stems cells for treatment or research is often frowned upon by some people, as they regard the human embryo as a person that should not be discarded after such endeavours. Consequently, much scientific work has recently been focused on the use of adult stem cells.

THE USE OF STEM CELLS

Stem cells may be beneficial in treating diseases that are amenable to cell replacement. However, this is still a young science, and belief that a particular treatment helps two or three people does not convince the scientific community or the whole society that the treatment will work for everyone so afflicted.

Scientific proof comes from conducting clinical trials, the international gold standard often involving hundreds of people so afflicted and comparing them with an equivalent number of people not afflicted to determine whether a treatment really works for those who receive it.

Whilst many stem cell research projects are currently being conducted in various centres around the world to determine whether they produce benefits, and what may be the possible risks involved, there are also medical clinics that are using stem cells not in a registered research project, but rather in the actual treatment of affected people.

TREATMENT CAN CAUSE HARM

A recent report in the highly respected New England Journal of Medicine informed that three elderly women in Florida had been blinded by an unproven treatment.

They had signed up for a purported clinical trial in 2015 for which they had to pay US$5,000 each. Before surgery, the vision in their eyes varied from 20/30 to 20/200, but within one week after surgery, they experienced a variety of complications, including vision loss, detached retinas and bleeding into their eyes, resulting in total blindness.

The authors of the article from the Standard University School of Medicine sought to make patients, doctors and the various regulatory agencies aware of the risks of such a minimally regulated, patient-funded research. It stated that some clinics appeal to patients that are desperate for care and who hope that stem cells will be their answer, but as in the case of these women, some of these current enterprises are very dangerous.

At this particular clinic, fat cells were taken from the patients abdomens and processed to obtain stem cells which were then injected into their eyes. The patients reported that the entire process took less than one hour. The patients had both eyes treated at once, even though most doctors would opt for a conservative approach to observe how the first eye responds.

THE NEED FOR THE REGULATION OF RESEARCH

The article stated that while there is a lot of well-founded evidence for the positive potential of stem cell treatment for many human diseases, such treatments should be conducted in a well-designed clinical trial based on pre-clinical research.

The treatment done for the women lacked nearly all the components of a properly designed clinical trial, including a hypothesis based on laboratory experiments, the involvement of a control group of people and a treatment group, the safe collection of data, the masking of clinical and patient groups, and plans for follow-up.

Clinics offering stem cell treatments exist in Jamaica, The Bahamas and Cuba. However, while both The Bahamas and Cuba have developed regulations that stipulate in law the conditions to be met for stem cell treatments and research within their jurisdictions, Jamaica has developed no such regulation.

THE MEDICAL ACT DOES NOT PROVIDE PROTECTION

The Medical Act of Jamaica was passed in 1976, but does not mention or provide any guidance or protection regarding research with human participants.

Its focus was to: Register medical practitioners; appoint examiners to conduct exams for people applying for registration, and ensure the maintenance of proper professional conduct by practitioners.An amendment in 2004 added the requirement of continuing medical education for practitioners.

Guyana and St Lucia are the only countries in the Caribbean that have joined the progressive countries who all have legislation governing research with human participants within their borders. Regulations should stipulate the requisite conditions, including that treatment and research be monitored by an appropriate ethics committee to meet all international standards.

Without this, vulnerable people seeking health benefits will unknowingly continue to subject themselves to risks of harm without the protection that proper regulations can provide.

Derrick Aarons MD, PhD is a consultant bioethicist/family physician, a specialist in ethical issues in medicine, the life sciences and research, and is the Ethicist at the Caribbean Public Health Agency (CARPHA). (The views expressed here are not written on behalf of CARPHA)

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Stem cell treatments can go wrong - Jamaica Observer

Stem cell agency founder eyes $5 billion in state funding – Capitol Weekly

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by DAVID JENSEN posted 03.24.2017

The man often called the father of the California stem cell agency all but said he is set to launch an effort to pump an additional $5 billion in state funding into the research effort, which is scheduled to run out of cash in about three years.

Robert Klein, a wealthy real estate investment banker, told a packed audience on Thursday at the City of Hope inthe Los Angeles area that a public opinion poll would be taken next fall in California to gauge support for a new bond measure to support the agency. He said that California has the opportunity and privilege to lift the human condition.

A revolution is underway, Klein said.

The agency has yet to produce a stem cell therapy for widespread public use despite the expectations raised by Kleins campaign 12 years ago.

Klein managed the 2004 campaign that created the stem cell agency, and he oversaw the writing of the 10,000-word initiative that placed the agencys spending outside of the control of the Legislature and governor. Klein spoke at a day-long symposium involving the states soon-to-be $40 million, Alpha stem cell clinic network, which is scheduled to grow from three to five sites later this year.

Researchers, business executives and patients praised the performance of the clinics which were initiated with support from the California Institute for Regenerative Medicine, as the Oakland-based agency is formally known.

Klein, who served as the agencys first chairman until 2011, praised its work. He also noted that California has 50 percent of the nations biotech infrastructure. He said the state has an historic opportunity to carry the current stem cell research forward.

Klein did not say specifically he would organize a new campaign for a bond measure for the agency. But he was more specific about the voter poll this fall and was optimistic about the future of the research in California. He said,:

This fall when the citizens of California are polled, Ibelieve they will say (the agencys) results are encouraging.

The agency has yet to produce a stem cell therapy for widespread public use despite the expectations raised by Kleins campaign 12 years ago.

Klein did not say who would fund the poll or how campaign funds would be raised. However, he has an organization called Americans for Cures, which had its origins in the campaign of 2004. That ballot measure effort cost $34 million.

A new bond measure would likely be mounted in the 2018 November general election, which would improve the likelihood of approval plus help to provide timely financial continuity for the agency. Eds Note:Eds Note: David Jensen is a retired newsman who has followed the affairs of the $3 billion California stem cell agency since 2005 via his blog, the California Stem Cell Report, where this story first appeared. He has published more than 4,000 items on California stem cell matters in the past 11 years.

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Stem cell agency founder eyes $5 billion in state funding - Capitol Weekly