Ethical Guidelines on Lab-Grown Embryos Beg for Revamping … – Scientific American

For nearly 40 years scientists have observed their self-imposed ban on doing research on human embryos in the lab beyond the first two weeks after fertilization. Their initial reasoning was somewhat arbitrary: 14 days is when a band of cells known as a primitive streak, which will ultimately give rise to adult tissues, forms in an embryo. It is also roughly the last time a human embryo can divide and create more than one person, and a few days before the nervous system begins to develop. But the so-called 14-day rule has held up all this time partly because scientists could not get an embryo to grow that long outside its mother's body.

Researchers in the U.K. and U.S. recently succeeded for the first time in growing embryos in the lab for nearly two weeks before terminating them, showing that the so-called 14-day rule is no longer a scientific limitationalthough it remains a cultural one. Now, a group of Harvard University scientists has published a paper arguing that it is time to reconsider the 14-day rule because of advances in synthetic biology.

The U.S. has no law against growing embryos beyond two weeksas long as the research is not funded with federal dollars. But most scientific journals will not publish studies that violate the 14-day rule, and the International Society for Stem Cell Research requires its members to agree to the rule in order to qualify for membership.

The guideline, first proposed in the months after Louise Brown became the first baby to be born via in vitro fertilization in 1978, assumes that development always follows a linear path: a fertilized egg forms an embryo, which grows and develops each day. But thanks to advances in synthetic biology, the scientists warn in the new paper that researchers will someday be able to skip such developmental stepscreating humanlike collections of organs that do not have to go through these early embryonic stages of development. We can get so distracted by the apparent issues with embryos that we might miss issues more likely to have a huge impact on society and commercial and governmental policies, says George Church, the Harvard Medical School synthetic biologist and geneticist who is the senior author of the article, published Tuesday in eLife.

Church says he does not think any team is working to make an advanced-stage human embryo in a lab. But his own work suggests the 14-day rule does not provide adequate guidance for synthetic biologists, who take an engineering approach to understanding and manipulating life. Six years ago, for instance, researchers in his lab tried to grow human stem cells on an embryonic scaffold to see if the cells would develop into various organs. That particular attempt didn't work, he says, but someday research on such synthetic human entities with embryolike features or SHEEFs, might succeed.

In addition, scientists in his lab and others are making primitive organoidsmini organs made to work like the kidney, lung, heart or even the brainthat could be used to test drugs or someday even replace failing body parts. It is not unreasonable, Church says, to envision a time when a scientist could create organoids from a number of different organs to see how a drug affects multiple organ systems or when someone could make a cluster of nerve cells in a dish capable of sensing what we call pain.

Now is the time to begin a public discussion on experiments such as these, Church argues, before it is scientifically viable and poses an ethical challenge to the 14-day rule.

Not surprisingly, these ideas have triggered some opposition among bioethicists. The Rev. Tadeusz Pacholczyk, a neuroscientist and director of education at the National Catholic Bioethics Center in Philadelphia, wrote via e-mail that any research on embryos or something like them is unethical, regardless of the 14-day rule. In cases of doubt, where one has a suspicion but not certainty that one might be engendering an embryonic human, such experiments should not be continued, he wrote.

Others, however, praised Church for starting the discussion before the science catches up with it. I think its a service to write a paper like this, says Josephine Johnston, director of research at the Hastings Center, a nonpartisan bioethics research institution. Not every scientist wants to draw attention to why their research may cross some boundaries.

The work of synthetic biologists poses particular ethical challenges in part because their models are getting more and more accurate, says Insoo Hyun, a bioethicist at the Case Western Reserve University School of Medicine. Now were getting into experiments that call into question some of our deepest beliefs philosophically about what it means to be human and what it means to deserve moral respect. Between synthetic biology and artificial intelligence a future might not be far off in which we have to ask whether something created in a lab is truly alive, Hyun says, conjuring up images of Mary Shelleys Frankenstein. Having a discussion ahead of time should help prevent decision-making based on gut instinct of what seems offensive versus well-reasoned arguments, Hyun notes.

The eLife paper comes at a busy time in bioethics. Earlier this month researchers at the University of Cambridge published a mouse study showing that they could create a natural-looking embryostarting not with eggs and sperm but with embryonic stem cells that can become any tissue in the body as well as trophoblast stem cells, which give rise to the placenta. If these results could be reproduced with human cells, it would pose some serious ethical questions.

And earlier this year the National Academy of Sciences and the National Academy of Medicine issued a report updating guidance on editing the human germ linecells that can pass on their genetic material to future generationswhich has long been another ethical line in the sand for researchers. Its expert committee concluded that it remains too risky to change an embryos genes for the sake of enhancing a persons abilities. The group did, however, articulate a set of criteria by which modifying the human germ line would someday be permissible for treating or preventing disease. Although they kept the door locked against such genetic modification, their conclusions allowed scientists to metaphorically knock on that door, says committee member Jeffrey Kahn, director of the Johns Hopkins Berman Institute of Bioethics. We didnt even think about knocking on the door before.

There is no international body in place to make or revise guidelines such as the 14-day rule. In the U.S. the National Academy of Sciences or a presidential commission on bioethics has traditionally made ethical recommendations about scientific research, with Congress sometimes blocking federal funding. Some other countries have standing committees, such as the U.K.s Human Fertilization and Embryology Authority, which regulate embryonic research. Synthetic biology falls between the cracks, though, with no one having such clear authority to regulate the work, Church and his colleagues wrote in the eLife paper.

Church says he has seen more problems arise from underregulation of science rather than overregulation, citing the death of three early gene therapy patients and earlier from the drug thalidomide, which was sold to prevent morning sickness but led to terrible birth defects. Church says he does not know where new boundaries should be drawn to contain future synthetic biology researchbut instead of a stop sign at the end of the research road, like the 14-day rule, his team imagines a perimeter fence to keep scientists from straying too far from an ethical path.

George Annas, director of Boston University School of Public Healths Center for Health Law, Ethics and Human Rights, says he is glad Church and colleagues are flagging this research, which might otherwise be overlooked. He also agrees that recent advances in stem cell science, genetics and synthetic biology suggest it is time to question whether the 14-day rule has outlived its usefulness: I think its a fair question, he says.

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Ethical Guidelines on Lab-Grown Embryos Beg for Revamping ... - Scientific American

Do Investors See Hidden Value in US Stem Cell Inc (OTCMKTS: USRM) – Street Register

US Stem Cell Inc (OTCMKTS: USRM) has enjoyed a prosperous 2017 as a whole so far, when you back up and look at the whole picture. This, a stock that was trading as low as .0019/share starting out in January, went on to fall just a hair shy of the six cent mark, at .0599. That was a run of more than 3,000% and it happened in two main thrusts within the first two months of the calendar year.

Each of those intense surges was followed by a period of sideways and consolidative trading, but each time, they have given way to further moves to the upside. Most recently, the stock came down to below the two-cent area, and has since run back over a nickel on the strength of some encouraging financials, including the first time in the companys history that it recorded a positive cash flow.

But is a solid financial filing worthy of the monumental increases that shares of US Stem Cell Inc (OTCMKTS: USRM) have seen in 2017? The company certainly didnt post 3,000% increases in any statistical category, so what gives? Why has the market dictated USRM surge so high in price this year?

The answer could lie in the extreme high potential of the market space in which the company operates. According to the world-renowned Mayo Clinic, regenerative medicine is a game-changing area of medicine with the potential to fully heal damaged tissues and organs, offering solutions and hope for people who have conditions that today are beyond repair. Regenerative medicine itself isnt new, but advances in developmental and cell biology, immunology, and other fields have unlocked new opportunities. According to some estimates, the global market valuation of the regenerative medicine/cell therapy industry could exceed $100B annually within the next five years.

USRM is working hard to make its mark on the regenerative medicine / cellular therapy industry by marketing cell based therapeutics that prevent, treat, or cure disease by repairing and replacing damaged or aged tissue, cells, and organs and restoring their normal function. The company holds the believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases, and ultimately lessen patient burdens and reducing the economic impact disease imposes upon society.

Its business includes three divisions (US Stem Cell Training, Vetbiologics, and US Stem Cell Clinic), the development of proprietary cell therapy products, as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic.

It is perhaps the extreme high potential of a USRM, and its operating space that leads many investors to see the hidden value in this company. The regenerative medicine business has some enormous players that already have a hold over the traditional medicine markets. That paints a target on smaller companies that are working diligently to develop viable regenerative treatments for a wide array of degenerative diseases. It would only take one key breakthrough to make USRM the subject of a buyout.

Perhaps the investment community senses this, and that may explain, at least partially, the meteoric rise of US Stem Cell Inc (OTCMKTS: USRM) in 2017. Were definitely going to want to keep a very close eye on any and all developments coming out of the USRM camp. Well be certain to relay any significant changes along to our readers. Stay up to date on USRM by signing up for our 100% free penny stock newsletter. It takes just a second to submit your email into the box below, so subscribe now!

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Do Investors See Hidden Value in US Stem Cell Inc (OTCMKTS: USRM) - Street Register

Scottish Universities Collaborate to Develop New Drugs for Tissue … – Technology Networks

NewsMar 19, 2017 | Original Story from the National Phenotypic Screening Centre

Research teams based the Universities of Dundee and Edinburgh are looking to partner with the pharmaceutical industry to better understand the biological processes that could allow the development of new drugs to support tissue regeneration or repair. The National Phenotypic Screening Centre (NPSC) at the University of Dundee and the Medical Research Council (MRC) Centre for Regenerative Medicine (CRM) at the University of Edinburgh have signed a memorandum of understanding that commits them to work more closely together as they strive to translate novel biological discoveries into new stem cell therapies. Regenerative medicine therapies to treat a range of debilitating diseases (including blindness, liver disease, Parkinsons disease, arthritis and many others) are actively being developed around the world. Many of them are and are based on one of two approaches: implantation of stem-cell-derived cells or the use of drugs to selectively activate and mobilize the bodys own stem cells in order to replace damaged or diseased tissues. Understanding the stem cells in tissues and their supporting environment (the stem cell niche) is critical to both approaches. The UK Regenerative Medicine Platform funded Engineering and exploiting the stem cell niche Hub, led by the MRC Centre for Regenerative Medicine (CRM) at the University of Edinburgh, is dedicated to further understanding of the biology of stem cell niches and to exploit this knowledge therapeutically to improve organ regeneration through endogenous repair and cell transplantation. Finding new drugs which can activate endogenous regenerative pathways requires the development of cell-based assays that are able to reproduce thecomplexbehaviour (the phenotype) of the cells and tissues in patients. The National Phenotypic Screening Centre (NPSC) specialises in developing such complex assays so they can be systematically screened using large libraries of drug-like molecules to uncover agents that can alter cell and tissue behaviour. Close collaboration between thetwocentres, which together represent government investment amounting to around 35M, will allow novel biological discoveries from CRM to benefit from the expertise and industrial drug screening infrastructure provided by the NPSC, leading to the start-points for new therapies. An in-depth understanding of cell and tissue function will facilitate the search to find molecules that improve key tissue regeneration processes that could eventually be used as drugs for regenerative repair. Professor Stuart Forbes, Director of the Centre for Regenerative Medicine and co-director of the Niche Hub, said, Stem cell medicine is coming of age, this is a great opportunity for Scottish Universities to partner with industry to ensure we can translate excellent science to new therapies that can help patients with chronic disease. Dr Paul Andrews, Director of Operations at the NPSC, said, We are very excited to be able to sign this agreement which will help cement our growing relationship with the excellent scientists that are within the MRC Centre for Regenerative Medicine and the wider UK Regenerative Medicine Hub network. UKRMP DirectorDr Rob Buckle said, This MOU between the Niche Hub and NPSC extends the growth of the UKRMP by encouraging further interactions with the wider UK research community which will help to open up new opportunities and approaches to help deliver the great promise of regenerative medicine. This article has been republished from materials provided by the National Phenotypic Screening Centre. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Scottish Universities Collaborate to Develop New Drugs for Tissue ... - Technology Networks

Cancer killed Henrietta Lacks then made her immortal – Virginian-Pilot

Sonny Lacks is known for his smile. Wide and welcoming, it's a feature that others tell him he shares with his mother.

He wishes he knew that for himself, but he was only 4 when she died.

On a recent Monday afternoon, Sonny and his older brother, Lawrence, sat at a dining room table in Baltimore and examined sketches of what will be their mother's tombstone. They've never had enough money for one. Finally, after all these years, a gift will allow their mother to be remembered as they want her to be.

Lawrence looked at the images but said little. He doesn't like talking about the mother he lost when he was 16.

"Don't know why; I never could," he said, taking off his glasses and rubbing his moist eyes. "I just can't."

The course of their lives changed in 1951 when their mother visited what was then Johns Hopkins Hospital, just 20 minutes down the road from where her boys now live. It was there that doctors discovered her strange illness and removed mysterious cells from her body.

The sons are one legacy of Henrietta Lacks a poor woman from the tobacco fields of south-central Virginia. The other is this: Her cells are still multiplying ferociously nearly six decades after her death. They have led to medical miracles such as the vaccine for polio and have produced millions of dollars in revenue for others.

The family's great loss has become the world's great gain.

___

Henrietta Lacks, died in 1951 at 31, but millions have been helped by study of the cells that killed her.

Henrietta Lacks was born Loretta Pleasant on Aug. 1, 1920, in Roanoke. The boys aren't sure how she became Henrietta, which was shortened to Hennie after her mother's death when the girl was 4.

Hennie and her nine siblings were sent to live with aunts, uncles and cousins in the tiny farming town of Clover, about four hours west of Norfolk.

Hennie landed with her grandfather, who also was raising one of her first cousins, David. They lived in what was called the "home-house," a two-story cabin built of hand-hewn logs and pegs that once was the slave quarters of their ancestors.

It looks toward the family cemetery, where the white relatives Hennie's great-grandfather and great-uncles were plantation owners are buried behind a row of boxwoods. The bushes separate their resting places from those of the family's black members, many of whom are in unmarked graves in a meadow.

The hundreds of acres surrounding the home-house were, and still are, known as Lacks Town. Those living in nearly every dwelling dotting the tobacco fields were, and still are, kin.

Growing up, the cousins scared each other with tales about the cemetery and phantom dogs and pigs that roamed Lacks Town Road, which runs alongside the house and up a half-mile to where cousin Sadie Grinnan was born in 1928.

Sadie remembers Hennie as the most beautiful thing, with honey-colored skin, a round face and a smile that made boys act like fools.

Sadie said she was surprised when Hennie and David, who went by "Day," started acting like a couple; they'd been raised like brother and sister.

But Lawrence was born to them in 1935 and Elsie four years later. Elsie was as striking as her mother but was born different, what some called "deaf and dumb."

Hennie and Day married in 1941, and the family left their life of farming tobacco to join the flood of blacks making their way to Baltimore and Washington, D.C., where wartime prosperity awaited in the shipyards and steel mills.

They were headed, they thought, to an easier life.

Sadie moved to Baltimore in the mid-1940s and often caught the No. 26 trolley to Turner Station, where Hennie had settled in as a housewife in the brick apartments built for the workers swelling the waterfront.

But Hennie missed the country and often piled the kids onto a bus for trips back to Clover.

Whether in Virginia or Maryland, she loved being a mom. Sadie watched her braid Elsie's long, brown hair and fret about the way the girl ran wild and darted off if they weren't looking.

Hennie could be as strict as she was sweet. After Sonny came along in 1947 and Deborah two years later, Lawrence was in charge of hand-washing the babies' diapers. If they weren't clean enough, Mama made him do it again.

About the time their fifth child, Joe, was born in 1950, Hennie and Day decided it was best to put Elsie in Crownsville State Hospital, once known as The Hospital for the Negro Insane of Maryland.

It broke Hennie's heart, "but she would visit her all the time," Sadie said.

___

A statue of Jesus dominates the original entrance to Johns Hopkins Hospital in Baltimore. The tradition is for those passing to rub the foot or touch the robe. Members of the Lacks family say they remember rubbing the toe when they arrived with Henrietta Lacks for cervical cancer treatment in the early 1950s.

A few months later, Hennie shared a secret. She'd started bleeding even though it wasn't her time of the month. And one morning she took a bath and discovered something. She told Sadie: "I feel a lump."

Dr. Howard Jones was the gynecologist on duty Feb. 1, 1951, in the outpatient center at Johns Hopkins when Henrietta Lacks came in.

Jones, who with his wife would later found the Jones Institute for Reproductive Medicine in Norfolk, examined her and saw something so peculiar it would stay with him for decades: A glistening, smooth growth that resembled purple Jell-O.

It was about the size of a quarter at the lower right of her cervix, and it bled easily when touched.

Jones thought it might be an infection and tested Lacks for syphilis, but the results came back negative. He ordered a biopsy cutting away a small portion of the tissue and within 48 hours had the diagnosis: cancer.

When Lacks returned for treatment eight days later, a second doctor sliced off another sliver of her tumor. Following the practice of the day, Lacks was not told.

Radium capsules were packed around her cervix to kill the cancer cells, and she later was released from the hospital.

At home, Lacks didn't tell anyone about her illness.

She continued to take care of her babies, two still in diapers; visit Elsie when someone would drive her to Crownsville; and cook her husband his favorite foods, such as white pinto beans.

She regularly returned to Johns Hopkins for treatment, but the cancer cells were swarming faster than the radium could kill them. It was becoming difficult for her to hide the pain. Cousins would enter the house and hear her upstairs, wailing, "Oh, Lord, oh, Lord, I can't get no ease! Jesus, help me, Jesus!"

On Aug. 8, shortly after her 31st birthday, she was readmitted to Johns Hopkins for what would be the last time.

Just after midnight on Oct. 4, 1951, Henrietta Lacks died. Doctors performed an autopsy that revealed firm white lumps studding her body, her chest cavity, lungs, liver and kidney. Her bladder appeared to be one solid tumor.

The cells seemed uncontrollable.

Sonny's only memory of his mother is from her funeral in Clover.

She was buried in an unmarked grave near the home-house, and he remembers how rain poured from the sky, as though heaven were weeping for Hennie.

___

Lawrence Lacks, 75, the oldest son of Henrietta Lacks lives in Baltimore, where most of the Lacks family still lives. Lacks was a teenager when his mother died in 1951 of cervical cancer.

Back in Baltimore, cousins came to help the widowed Day, who was trying to pull shifts at the shipyard and manage his three youngest children. Visits to Elsie became rarer.

Lawrence helped out, but he soon left to join the Army. Two relatives, one the family would later describe as evil, moved in to care for his brothers and sister.

Sonny recalls being beaten for no reason and having little food, maybe a biscuit, each day. The cabinets were locked so the kids wouldn't try to get more.

As they grew older, the children spent summers in Clover, plucking and stringing tobacco as their mom had done. They kept the abuse to themselves. Stoic, like their mom.

After his Army stint, Lawrence returned to Baltimore, married and took in his brothers and sister when their dad became ill. Elsie died at Crownsville in 1955; the family learned years later that she had been abused and may have had holes drilled in her head during experiments.

No one in the family talked about Hennie. Lawrence and his father didn't want to, and the younger kids didn't ask. Part of the Clover upbringing was that children didn't bother grown-ups with a lot of questions.

Henrietta's children had children of their own, and they, too, didn't ask about Grandma. It was as though she hadn't existed.

Then, in the early 1970s, the family got a call.

Researchers wanted Sonny and other family members to give blood samples so more could be learned about their mother's genetic makeup. The family wanted to know why.

Part of their mother, they were told, was alive and growing more than 20 years after her death.

Tissue from their mother's second biopsy in 1951 had been given to Johns Hopkins researcher Dr. George Gey, who for years had been trying unsuccessfully to grow human cells outside the body in his search for a cancer cure.

Technicians expected Lacks' cells to do what previous samples had done: nothing, or perhaps live a few days then die. Instead, the cells multiplied in petri dishes, spreading and piling atop one another. Uncontrollable.

On the day Lacks died, Gey appeared on a television program called "Cancer Can Be Conquered." He held Lacks' cells in a bottle close to the camera and discussed his scientific breakthrough: the first human cell line ever grown.

Gey called the cells "HeLa" the first two letters of Henrietta Lacks' first and last names and gave samples to other researchers around the country. Cancer cells work enough like normal cells that doctors could test and probe them and unlock their secrets.

Jonas Salk at the University of Pittsburgh Medical School infected HeLa cells with the polio virus and studied the reaction. By 1955, he had created a vaccine that helped nearly eradicate the crippling disease.

Companies used HeLa to test cosmetics. Researchers put flasks of HeLa near atomic test sites to measure the effects of radiation on human cells. Scientists sent HeLa into space with white mice to determine what happened to human flesh at zero gravity. HeLa helped scientists discover genetic mapping.

The cells multiplied so rapidly that they often contaminated other laboratory samples. In the 1970s, Soviet researchers thought they had discovered a virus that caused cancer, but it turned out HeLa cells had permeated the Iron Curtain.

The revelation led to improvements in the way labs handle cells and cultures.

Other cell lines were being born, but HeLa cells had become the gold standard. They shipped and stored well, and were incredibly robust. Jones said most cells can duplicate themselves in a culture in 36 hours; HeLa doubles in 24. The chromosomes in most cells shorten with each duplication until the cells can't divide anymore. Not HeLa.

Doctors still aren't sure why. Jones, 99, said recently: "They are still that unique."

___

David Sonny Lacks, 62, right, and Lawrence Lacks, 75, both of Baltimore, talk about their mother, Henrietta Lacks, who died in 1951. Sonny doesnt remember his mother but is told he has her smile. Lawrence doesnt like to talk about her; she died when he was 16.

Over the years, the Lacks family became used to the occasional phone calls from reporters and researchers.

They told what little they knew to Rolling Stone and Jet magazines and to the BBC.

What family members couldn't get used to was what had happened to Hennie.

They were angry at Johns Hopkins because they felt the hospital removed her cells without her permission.

They were bewildered by all the scientific jargon and how researchers took their blood but did not follow up or explain the results, they said. None of the children have developed their mother's aggressive cancer.

They were enraged by biomedical companies that produced the cells like they were printing money and sold them for millions, while many in the family couldn't afford health insurance.

Cousin Sadie Grinnan, now Sadie Sturdivant, 81, lives in Nathalie, near Clover, and is bothered by it, too.

"These other people," she said, "are making billions and billions."

What was hardest for Hennie's children to deal with was that so many people knew so much about their mother, while they knew so little.

"That's what hurts," Sonny said.

Now, he's looking for closure. It began in earnest with the release earlier this year of Rebecca Skloot's book, "The Immortal Life of Henrietta Lacks."

The book recounts the family's struggle, the science and the ethical implications surrounding the use of the cells.

Sonny's sister Deborah had worked closely with the author but died last May from heart disease. Deborah, who was 59, went to her grave wanting to honor her mother.

Sonny now is determined to fulfill her wish.

___

Henrietta Lacks great-granddaughter Aiyana Rogers, 11, looks at a family photo and a book about Lacks at her grandmother's home in Baltimore on April 12, 2010. Aiyana says shes proud of her great-grandmother. I just like that the world knows her now, she says. And that she is the most important woman in the world.

The family is working with an attorney to get a handle on all things Henrietta. For example, Sonny recently heard that a group in New York is holding a Henrietta Lacks race, and he wondered how people could do that without the family's permission. He and his brothers don't have the time or know-how to answer those kinds of questions.

Lawrence, now 75, rehabilitates houses for a living. Sonny, 62, is a truck driver who often picks up his grandkids in the afternoons. He helps out his younger brother, Joe, who changed his name to Zakariyya Abdul Rahman and goes by Abdul. At 59, Abdul has problems with his legs and can't get around easily.

The family has pooled its money to buy headstones for their father, who died in 2002 and is buried in Baltimore, and for Elsie, whose body was relocated to a grave near her mother's in Clover.

The Morehouse School of Medicine in Atlanta has volunteered to pay for Hennie's tombstone, and Skloot will buy one for Deborah, who was buried in Baltimore. The author also has established a scholarship fund for the family.

In a ceremony in October, Johns Hopkins will honor the contributions of Henrietta Lacks and others who have participated in scientific research.

Administrators say they think the medical center's role in Lacks' story often has been misrepresented. Dr. Daniel Ford, director of the Institute for Clinical and Translational Research at Johns Hopkins, said the hospital's critics are applying modern rules to a different era.

Patient consent, now a medical standard, wasn't even considered in 1951. Ford noted that Lacks' tissue was given away by researcher Gey and that the hospital never patented HeLa cells or sold them commercially.

"Gey's whole goal was to find a human cell line that would reproduce," Ford said. "It would be a platform, a model that scientists could learn human cell function from."

Gey had no idea what would happen.

Over the years, HeLa cells have multiplied to the point that they could weigh more than 20 tons, or 400 times Lacks' adult body weight. According to the U.S. Patent and Trademark Office, there are close to 11,000 patents involving HeLa. The cells are so prevalent that they can be ordered by the vial on the Internet.

The family tries to concentrate on all the good that's come from them. On Memorial Day weekend in Lacks Town, they will install their mother's headstone, made of granite with a rose-colored tint that hints of flowers sweet, like Hennie, and growing, like her cells.

Her grandchildren came up with the words that will be carved into the stone:

"In loving memory of a phenomenal woman, wife and mother who touched the lives of many. Here lies Henrietta Lacks (HeLa). Her immortal cells will continue to help mankind forever."

Aiyana Rogers, one of Sonny's granddaughters, flopped down at the dining table in Baltimore where the Lacks brothers talked about the memorial. She brought out a family portrait and Skloot's book, which she has started to read.

Aiyana's intrigued by the science and by the cures, but mostly she's just proud of her great-grandmother.

"I just like that the world knows her now," the 11-year-old said, with a wide, welcoming smile. "And that she is the most important woman in the world."

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Cancer killed Henrietta Lacks then made her immortal - Virginian-Pilot

Parsley and other plants lend form to human stem cell scaffolds – Science Daily


Science Daily
Parsley and other plants lend form to human stem cell scaffolds
Science Daily
Writing March 20 in the journal Advanced Healthcare Materials, a team led by William Murphy, a professor of biomedical engineering and co-director of the UW-Madison Stem Cell and Regenerative Medicine Center, describes the use of a variety of plants to ...

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Parsley and other plants lend form to human stem cell scaffolds - Science Daily

Asterias Bio’s cell therapy continues to demonstrate treatment effect in spinal cord injury patients; shares ahead 12% – Seeking Alpha

Thinly traded micro cap Asterias Biotherapeutics (AST +12.4%) perks up on light volume in response to its update on its ongoing SciStar Phase 1/2a clinical trial assessing the 10M-cell dose of AST-OPC1 (oligodendrocyte progenitor cells) in patients with sub-acute C-5 to C-7 cervical spinal cord injury (SCI).

Data on the sixth and final patient in the AIS-A (complete injury, no motor function below the injury site) 10M cell cohort showed upper extremity motor function improvement at month 3 and further improvement in month 6. The results were consistent with the five previous patients. Upper extremity motor function is the most desirable functional improvement in the quadriplegic population.

CEO Steve Cartt says, "These results are quite encouraging, and suggest that there are meaningful improvements in the recovery of functional ability in patients treated with the 10 million cell dose of AST-OPC1 versus spontaneous recovery rates observed in a closely matched untreated patient population. We look forward to reporting additional efficacy and safety data for this cohort, as well as for the currently-enrolling AIS-A 20 million cell and AIS-B 10 million cell cohorts, later this year."

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Asterias Bio's cell therapy continues to demonstrate treatment effect in spinal cord injury patients; shares ahead 12% - Seeking Alpha

Okyanos Cell Therapy Brings Stem Cell Education to North Florida – PR Web (press release)

Tapestry Senior Living is Tallahasee's newest senior living and memory care facility, located at 2516 West Lakeshore Drive, Tallahassee, FL 32312.

Freeport, Grand Bahama (PRWEB) March 21, 2017

Okyanos Cell Therapy has announced Tallahassee, FL will be the next destination for a free educational seminar as part of their live events series, Stem Cell Therapy: The Next Phase in the Evolution of Medicine. As the Bahamas first fully licensed adult stem cell facility under the 2013 Stem Cell Research and Therapy Act, Okyanos maintains a mission to help no-option patients and those with serious, progressive conditions to return to a more normal life utilizing cell therapy. The Tallahasee event will take place at Tapestry Senior Living on Saturday, April 8, 2017 at 10:00am. Pre-registration is required. If you wish to attend or learn more, please email seminars(at)okyanos(dot)com.

With stem cells existing as somewhat of a buzzword in healthcare today, questions loom as to what the true potential of stem cell-based therapies is for conditions like Parkinsons Disease, osteoarthritis and heart failure. It is through their free live education series that Okyanos works to raise awareness and bring understanding on the potential of stem cell research and treatment, as well as the importance of patient safety and proper regulation.

Residents of Tapestry Senior Living of Tallahassee as well as members of the community are invited to attend this informative discussion on the functions of adult stem cells as well as clinical research and observations. Guests will hear from Moira T. Dolan, MD, who serves as a Patient Consultant at Okyanos. Dr. Dolan will provide an overview of how the stem cells present in body fat (adipose tissue) can be used to address chronic, degenerative conditions and help patients return to a more normal life.

My role at Okyanos and generally as a physician is to understand each of my patients individual challenges and needs, and to advocate for them as they make treatment choices, said Dr. Dolan, who is a diplomate of the American Board of Internal Medicine and holds certification with the American Board of Anti-Aging and Regenerative Medicine. Through our live events I enjoy the opportunity to discuss the promise of adult stem cell treatment for a wide range of conditions and share some of what we are seeing in our patients at Okyanos who have undergone our evidence-based treatment protocols.

We are very excited to have Okyanos at our facility for this event, said Mackenzie Hellstrom, Director of Sales and Marketing at Tapestry Senior Living. In Okyanos approach to personalized medicine and our emphasis on person-centered care, we saw an opportunity to work together and provide an enriching experience for our residents and the community with this information about adult stem cells.

For more information, please contact Okyanos by calling 855-OKYANOS (659-2667) or via email: seminars(at)okyanos(dot)com. Seating is limited for this event.

ABOUT OKYANOS CELL THERAPY: (OH KEY AH NOS)

Combining state-of-the art technologies delivered in the first cell therapy center of excellence in the world, Okyanos is a leading adult stem cell therapy provider. Okyanos Cell Therapy helps people living with chronic, degenerative diseases return to a more normal life through a treatment approach using fat-derived stem cells. Based in Freeport, Grand Bahama, Okyanos is fully licensed under the Bahamas Stem Cell Therapy and Research Act and adheres to U.S. surgical center standards. The literary name Okyanos, the Greek god of the river Okeanos, symbolizes restoration of blood flow. Learn more at http://www.okyanos.com.

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Okyanos Cell Therapy Brings Stem Cell Education to North Florida - PR Web (press release)

Blinded by science: Women go blind after stem-cell treatment at Florida clinic – Palm Beach Post (blog)

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Three women reportedly went blind after a stem cell treatment at a Florida clinic.

Whats more is that at least two of the women had gone to the clinic because it was listed as a macular degeneration study on a federal database.

Doctors call the incident an example of how risky such clinics can be.

News reports from The Associated Press, The New England Journal of Medicine and others say that a clinic the experimental procedure occurred was in Sunrise, Florida run by U.S. Stem Cell Inc.

Age-related macular degeneration can rob a person of their central vision.

The women were injected in their eyes with a cell preparation derived from her own fat tissue.

Ophthalmologist Dr. Thomas Albini of the University of Miami, who examined the women, said one woman is totally blind and the others legally blind. He said all suffered detached retinas.

These women had fairly functional vision prior to the procedure and were blinded by the next day, Albini said.

The clinics method hasnt been proven effective or tested for safety in people, he added.

Its very alarming to us as clinicians that somebody would do this to both eyes at the same time, said Albini.

Dr. Thomas Albini of the University of Miami.

Elizabeth Noble, one of the women said she was diagnosed with age-related macular degeneration that blurs the central vision. The former educator said she heard about the treatment at the clinic for a research study described on ClinicalTrials.gov, a website run by the National Institutes of Health.

The former educator said she heard about the treatment at the clinic for a research study described on ClinicalTrials.gov, a website run by the National Institutes of Health.

Its very easy to register studies on ClinicalTrials.gov and essentially use a government website as a marketing device, Leigh Turner, a bioethicist at the University of Minnesota, told BuzzFeed News.

Noble went to the clinic in June 2015 where staff took fat from around her belly button, extracted those cells and mixed them with Nobles blood plasma. They then injected it into both her eyes for $5,000, according to a story in Buzzfeed.

In an editorial accompanying the Journals report, stem cell expert Dr. George Daley, dean of Harvard Medical School, called the clinics treatment careless.

This report joins a small but growing medical literature highlighting the risks of such wanton misapplication of cellular therapy, he wrote. Providing such treatments for profit outside a proper research setting is a gross violation of professional and possibly legal standards, he said.

Buzzfeed reports this isnt the first time experimental procedures at a clinic have gone awry.

In 2010, for example, a woman with the autoimmune disease lupus died after her own bone marrow cells were injected into her kidneys at a clinic in Thailand.

In 2013, the Florida Department of Health revoked the medical license of Zannos Grekos over the death of a 69-year-old woman. He had extracted material from her bone marrow, filtered it, and then infused it into the arteries feeding her brain. The woman had a stroke.

Treatment for age-related macular generation is at the center of the Medicare fraud trial in West Palm Beach of Dr. Salomon Melgen, who happens also to be tied to a bribery scandal involving a U.S. senator.

Read The Palm Beach Posts coverage of the fascinating Melgen trial by clicking here.

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Blinded by science: Women go blind after stem-cell treatment at Florida clinic - Palm Beach Post (blog)

Three women blinded by unapproved stem-cell ‘treatment’ at South Florida clinic – Washington Post

Three women with macular degeneration became permanently blind after undergoing anunproven stem-cell treatment touted as a clinical trial at a South Florida clinic. Medical experts said the episode raises questions about whether the government and doctors are doing enough to protect patients from the dangers of unapproved therapies.

The episode, described Wednesday in an article in the New England Journal of Medicine, represents one of the most egregious examples of patient injury involving a stem-cell clinic. These facilities have sprung up by the hundreds across the country over the past several years. Many offer supposed experimental treatments for ailments ranging from hip problems to autism to ALS.

Of special concern, said Jeffrey Goldberg, professor of ophthalmology at the Stanford University School of Medicine and one of the authors of the report,was the clinic's ability to list its study on a comprehensive database of clinical trials called ClinicalTrials.gov, which is run by the National Institutes of Health. At least one of the patients and maybe more believed that she was taking part in a government-sanctioned study, he said.

Goldberg called the incident a wake-up call across the spectrum for patients, physicians and government regulators. Surely, he said, it's an opportunity for the FDA to increase patient safety for these unapproved clinical trials.

Thomas Albini, a University of Miami ophthalmologist and another one of the authors, said that he and his colleagues at the Bascom Palmer Eye Institute had treated two of the patients for severe complications in 2015, shortly after they had undergone the stem-cell procedures at a clinic in Sunrise, Fla. The severe complications included detached retinas, hemorrhages and vision loss.

It's a disaster, Albini said, noting that the patients, before the stem-cell treatments, had only moderate vision loss. Buyer beware:These stem-cell clinics that function in this very unregulated way are doing procedures that are not approved and they can be quite dangerous.

The NEJM article did not identify the clinic or the patients, but its listing on the ClinicalTrials.gov website shows the sponsor as Bioheart Inc., also known as U.S. Stem Cell Inc., and says that the study was withdrawn before patients were enrolled. The clinic still has other stem-cell studies listed on the site, including for chronic obstructive pulmonary disease and degenerative disc disease.

[Stem-cell clinics face new scrutiny from regulators]

Repeated calls to U.S. Stem Cell and to Kristin Comella, who is listed as the chief scientific officer, have not been returned. In a NPR story last year, Comella said that two of the clinic's patients had suffered detached retinas following treatments, prompting the clinic to stop doing eye procedures.

According to Florida court filings, two of the patients involved, ages 72 and 78 at the time,sued the clinic and some individuals involved in the procedures. Their attorney, Andrew Yaffa of Coral Gables, said that the case was resolved to the mutual satisfaction of the parties but that neither he nor his clients could comment beyond that.The third patient was an 88-year-old Oklahoma resident who sought medical help a week after the stem-cell procedure at the Dean McGee Eye Institute in Oklahoma City.

Albini said the eye damage could have been the result of contamination during preparation of the stem cells. He also said it was possible that the stem cells could have changed into cells that are associated with scarring.Even if the solution had been prepared correctly, he said, there's no evidence that it could have helped restore the patients' vision.

Albini said the three patients paid $5,000 each for the stem-cell procedure, which involved conducting mini-liposuction procedures to remove fat from the abdominal area, isolating the stem cells from the fat and injecting those cells directly into eyes. Charging the patients was a red flag, he said, that this was not a traditional clinical trial. A second was treating both eyes at the same time, rather than seeing how one eye responded before treating the other.

[Huge NIH clinical-trials data base lacks key details.]

Age-related macular degeneration is the leading cause of vision loss in people older than 75 in the United States. While researchers are making tremendous progress using stem cells to treat the disease, the field requires careful study with meticulously designed trials, the authors of the paper said. The FDA has approved only a few stem-cell therapies, mostly for blood disorders.

The proliferation of stem-cell clinics there are more than 570 of them, according to a study published last year has ignited a fierce debate among physicians, patients and scientists about how they should be regulated.FDA rules allow the use of patients' own stem cells for treatments, without agency approval, but only if the procedures meet stringent conditions. The stem cells, for example, cannot be more than minimally manipulated and must be intended for the original function. That would not typically include using stem cells from fat to repair eye cells.

Albini said that the FDA had started an investigation into the case but a spokeswoman said the agency does not discuss potential or ongoing investigations. She added that consumers are encouraged to contact the FDA and state authorities to report any potentially illegal or harmful activity related to stem-cell-based products. The FDA has issued several drafts of guidance for the stem-cell industry to try to outline its thinking on the matter, but the documents have not been finalized, and many clinic operators oppose FDA regulation.

[Unregulated stem-cell clinics are proliferating across the United States.]

Paul Knoepfler, a stem-cell scientist at the University of California at Davis who is a frequent critic of the clinics, said he didn't understand why the FDA and the NIH have not moved more aggressively to ensure patient safety.

It's puzzling and concerning, he said. He said that allowing the clinics to list their trials on ClinicalTrials.gov is almost like a form of advertising for products that don't have FDA approval. That's really problematic.

In a statement, the NIH said that the information on ClinicalTrials.gov is provided by study sponsors and thatposting on the site doesn't reflect endorsement by the NIH, which doesn't independently verify the scientific validity of the trial. It also said that every study includes links to an NIH disclaimer. However, we agree that such caveats need to be clearer to all users and we will be adding a more prominent disclaimer in the future.

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Three women blinded by unapproved stem-cell 'treatment' at South Florida clinic - Washington Post

Stem cell therapy shows promise in treating spinal cord injuries, Canadian study – Cantech Letter

Spinal cord injuries are among the most dramatic and devastating of all injuries, in part because they stem from traumatic accidents but also because there are very few treatment options.

While medical advances have been made in the areas of injury management and improved long-term functioning, for those dealing with spinal cord injuries the sad truth is that researchers have yet to come up with a cure for paralysis.

Victims of spinal cord injuries are left facing a lifelong disability, one that comes not only with a range of personal burdens but which also extracts its toll on the healthcare system studies have shown that the lifetime economic burden of spinal cord injuries in Canada ranges between $1.5 to $3.0 million per individual.

Yet cell therapies represent one area of current research that appears likely to deliver positive results. According to a new study from researchers with the University Health Network and the University of Toronto, the neuroregenerative potential of this approach is promising.

Cell therapy, which in general refers to any procedure involving the implantation of cells, comes in different guises in spinal cord research, depending on the type of cells employed. Clinical research is already being performed using stem cells, which have the ability to self-renew and to differentiate into a variety of specialized cells, and glial cells, which support neural functioning.

The aim in both cases is to introduce the new cells so as to encourage regrowth of nerve fibres where they have been severed and thereby restore nerve function, a seemingly impossible task, since along with the structural damage caused by spinal cord injury comes a series of secondary events such as scarring and inflammation which, although normal bodily repair processes, can effectively impede the chances at regrowth and reconnection of neural networks.

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Reviewing the current state of affairs in spinal cord research, the researchers find that cell therapies, especially those that combine more than one approach, are showing promise but need further study and clinical trials. While combinatorial treatments using cell-coupling, trophic factors, biomaterials, and rehabilitation, may help to improve stem cell effectiveness among a heterogeneous patient population, there is still much research required to optimize their application, say the studys authors.

The researchers found that in early clinical trials, for example, cell therapies have shown modest improvements connected to functional recovery, yet they say that the results are encouraging and that even slight enhancements in sensation and function for those dealing with spinal cord injuries are often quite meaningful. It is clear that a lot remains to be understood in the translation of stem cell therapies, say the studys authors. However, given the significant strides in laboratory work, we should not lose sight of their potential.

The new research is published in the journal Expert Opinion on Biological Therapy.

The primary causes of spinal cord injuries are motor vehicle accidents and unintentional falls, each accounting for a little over 40 per cent of spinal cord injuries. According to Spinal Cord Injury Ontario, there are 1,500 new spinal cord injuries each year and a total of 86,000 Canadians currently living with spinal cord injuries.

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Stem cell therapy shows promise in treating spinal cord injuries, Canadian study - Cantech Letter