Vampire facials sound like a totally modern sci-fi development, but people have thought that drinking or slathering on blood can heal and renew for millennia. Pliny the Elder, nearly 2,000 years ago, wrote, [e]pileptic patients are in the habit of drinking the blood even of gladiators, draughts teeming with life. Elizabeth Bthory, a noblewoman from early modern Hungary, was said to have murdered virgins and then bathed in their blood in order to retain her youth. (Its worthwhile to note that King Louis XV and Marie Antoinette were also accused of bathing in their subjects blood.) In the stories, Bthory literally soaks up the youth of virgins via contact with their blood.

We think topically applied and ingested blood, bones, organs, and cells are magical sources of life force, health, and youth that somehow surpass the efficacy of less gory, more common ingredients.

The tales of blood baths seem spurious to say the least, and apparently theyre not backed up by primary evidence. But the fact that people have been passing the stories along for centuries tells us something about how we think. Even now, we seem to really dig the idea of applying or consuming human cells for the purpose of absorbing beauty and health from them. Vampire facelifts and Dr. Barbara Sturms MC1 cream make use of plasma from ones own blood drawn and separated in-office to supposedly renew skin. We think topically applied and ingested blood, bones, organs, and cells are magical sources of life force, health, and youth that somehow surpass the efficacy of less gory, more common ingredients.

Ingredients associated with conception, birth, and nursing seem to particularly excite us. Semen facials inadvisable and groan-worthy seem to make the rounds again when clicks are needed. In Korea, the brand Isa Knox uses recombinant human placenta protein (rHPP-8TM) in the Tervina line, supplied by the CHA Placenta Institute (part of the CHA Global Medical Network that includes a university medical school and institutes for stem cell and cosmetics research).

In the case of human stem cell skincare, companies have slapped a veneer of science on our old magical beliefs to ratchet up prices and expectations.

The idea of human ingredients is so seductive that people pay extra for them even when theyre not actually in the products. A Korean beauty product nicknamed mothers milk, Eureque Muru Mor Cream, contains no human milk, just baby powder fragrance and animal milk extracts that are supposed to be similar to human breast milk. If youre looking for the real deal, check out Mud Facial Bar, which offers an ethically sourced, $10 breast milk add-on for its facials.

In the case of human stem cell skincare, companies have slapped a veneer of science on our old magical beliefs to ratchet up prices and expectations. Stem cells here Im talking about pluripotent human stem cells can be manipulated to become any cell type in the human body under the right conditions and divide essentially without limit to replenish other cells as long as the person or animal is still alive according to the National Institutes of Health.

The twist is that stem cell skincare brands such as Lifeline Skin Care dont actually use whole, live human stem cells in their products. An actual stem cell would need to be kept alive in a skin cream, and that would certainly be challenging to accomplish, according to cosmetic chemist Kelly Dobos. Lifelines parent company, International Stem Cell Corporation, extracts human growth factors from stem cells by stimulating unfertilized eggs. Its the growth factors which stimulate cell growth, differentiation, healing, and proliferation that end up bottled, not the whole stem cells.

There really isn't any concrete, unbiased research to support the use of epidermal growth factors (EGF).

I asked Stephen Alain Ko, cosmetic chemist and blogger at kindofstephen, whether applying growth factors to skin makes sense. He wrote via email, [t]here really isn't any concrete, unbiased research to support the use of epidermal growth factors (EGF) on healthy human skin, and there is also a concern that EGF can also be involved in certain cancer growth as well. Ko noted that Oprah-recommended SkinMedicas TNS Essential Serum ($281 for one ounce) faces a California class action lawsuit claiming the company failed to disclose cancer risks associated with applying human growth factors to skin.

When asked about Skinmedicas TNS Essential Serum, Dobos wrote, [a]t $281 for one ounce and questionable science backing the ingredient claims, I would opt for a less expensive skin care product. Skincare companies dont need to make extravagant claims about the power of stem cell-derived ingredients, or even use whole human stem cells in their products; simply mentioning stem cell taps into long-held beliefs about the power of wearing and consuming human cells and our wallets.

Link:
Would You Slather Blood and Breast Milk on Your Face? - Racked

Fox17

Be The Match registry seeking blood and bone marrow donors Fox17 A blood and marrow transplant replaces abnormal blood-forming stem cells with healthy cells. These are commonly used to treat blood cancers or other kinds of blood diseases that decrease the number of healthy blood cells in the body. Dr. Stephanie ...

More:
Be The Match registry seeking blood and bone marrow donors - Fox17

An adult stem cell center established by the Kansas Legislature in 2013 is almost ready for its first clinical trial.

Buddhadeb Dawn, executive director of the Midwest Stem Cell Therapy Center, told legislators Tuesday that the trial will focus on treating graft-versus-host disease and will begin after final approvals from the U.S. Food and Drug Administration.

Our goal was to do this (trial) in January, but we got delayed because of different things, Dawn said during a hearing of the House Health and Human Services Committee. So we are now hoping to start it perhaps in summer.

Based at the University of Kansas Medical Center in Kansas City, the stem cell center has analyzed trials done elsewhere and hosted a clinical trial sponsored by a biotech company that uses modified stem cells from bone marrow to treat stroke.

But the graft-versus-host disease trial would be the first homegrown one.

Graft-versus-host disease is a potential complication when a patient receives a transplant of tissue, like an organ or bone marrow, from another person.

The disease occurs when transplanted tissue fights the patients natural immune system, potentially damaging the liver, skin or other areas. Its a rare illness, with about 20,000 cases in the United States each year.

Rep. Randy Powell, a Republican from Olathe, said the trial was a welcome and exciting development. He said his wife is at risk for the illness following treatment for leukemia.

I know that graft-versus-host is a big thing, Powell said. I think my wife still has an annual checkup where they keep their eye out (to make sure) thats not sticking its head up and causing issues.

Dawn said the center would like to take the next step and move into clinical trials using adult stem cells to treat things like joint ailments, diabetes and amyotrophic lateral sclerosis, also known as Lou Gehrigs disease.

But the regulatory process takes time.

Wed like to be able to offer a portfolio of different disease conditions that adult stem cells can benefit, Dawn said. Im hoping that within the next five years we would at least have some FDA approval for treatment with adult stem cells for other conditions.

Dawn said successful trials could lead to more private investment dollars so we are self-sustaining at some point in the future.

The centers reliance on state funds has been a point of contention for fiscally conservative legislators in the past. Most of the facilitys budget still comes from the states payment, which was reduced by about $28,000 to $754,500 last year.

Thats far less than what stem cell research facilities in other states receive.

Doug Girod, executive vice president of the KU medical center, said that given the budget, Dawn and his small team have done remarkable work.

We could be 10 times bigger than we are and doing 10 times as much if we had the resources, Girod said. But I think were maximizing every opportunity we can with what we have right now.

The center was spearheaded by socially conservative legislators, including Sen. Mary Pilcher-Cook, to showcase adult stem cell research as an alternative to using stem cells derived from human embryos.

About $56,000 of its annual budget goes to educating the public about the differences between embryonic stem cells and adult cells and hosting an annual conference about advances in adult stem cell treatment.

Rep. John Wilson, a Democrat from Lawrence, said he initially was skeptical about the facility because he thought the Legislature was inserting itself into a religious or philosophical fight. But he said his attitude has changed.

Im glad that despite my opposition to it the state has gone forward with funding some really terrific research, Wilson said. My concern now is how do we take it to the next level so all of this hasnt been for nothing.

Andy Marso is a reporter for KMUW's Kansas News Service, a collaboration of KMUW, Kansas Public Radio and KCUR covering health, education and politics in Kansas. You can reach him on Twitter@andymarso.

Read the original:
Kansas Stem Cell Center Close To First Clinical Trial - KMUW

An adult stem cell center established by the Kansas Legislature in 2013 is almost ready for its first clinical trial.

Buddhadeb Dawn, executive director of the Midwest Stem Cell Therapy Center, told legislators Tuesday that the trial will focus on treating graft-versus-host disease and will begin after final approvals from the U.S. Food and Drug Administration.

Our goal was to do this (trial) in January, but we got delayed because of different things, Dawn said during a hearing of the House Health and Human Services Committee. So we are now hoping to start it perhaps in summer.

Based at the University of Kansas Medical Center in Kansas City, the stem cell center has analyzed trials done elsewhere and hosted a clinical trial sponsored by a biotech company that uses modified stem cells from bone marrow to treat stroke.

But the graft-versus-host disease trial would be the first homegrown one.

Download the Midwest Stem Cell Therapy Center annual update to legislators.

Graft-versus-host disease is a potential complication when a patient receives a transplant of tissue, like an organ or bone marrow, from another person.

The disease occurs when transplanted tissue fights the patients natural immune system, potentially damaging the liver, skin or other areas. Its a rare illness, with about 20,000 cases in the United States each year.

Rep. Randy Powell, a Republican from Olathe, said the trial was a welcome and exciting development. He said his wife is at risk for the illness following treatment for leukemia.

I know that graft-versus-host is a big thing, Powell said. I think my wife still has an annual checkup where they keep their eye out (to make sure) thats not sticking its head up and causing issues.

Dawn said the center would like to take the next step and move into clinical trials using adult stem cells to treat things like joint ailments, diabetes and amyotrophic lateral sclerosis, also known as Lou Gehrigs disease.

But the regulatory process takes time.

Wed like to be able to offer a portfolio of different disease conditions that adult stem cells can benefit, Dawn said. Im hoping that within the next five years we would at least have some FDA approval for treatment with adult stem cells for other conditions.

Dawn said successful trials could lead to more private investment dollars so we are self-sustaining at some point in the future.

The centers reliance on state funds has been a point of contention for fiscally conservative legislators in the past. Most of the facilitys budget still comes from the states payment, which was reduced by about $28,000 to $754,500 last year.

Were maximizing every opportunity we can with what we have right now.

Thats far less than what stem cell research facilities in other states receive.

Doug Girod, executive vice president of the KU medical center, said that given the budget, Dawn and his small team have done remarkable work.

We could be 10 times bigger than we are and doing 10 times as much if we had the resources, Girod said. But I think were maximizing every opportunity we can with what we have right now.

The center was spearheaded by socially conservative legislators, including Sen. Mary Pilcher-Cook, to showcase adult stem cell research as an alternative to using stem cells derived from human embryos.

About $56,000 of its annual budget goes to educating the public about the differences between embryonic stem cells and adult cells and hosting an annual conference about advances in adult stem cell treatment.

Rep. John Wilson, a Democrat from Lawrence, said he initially was skeptical about the facility because he thought the Legislature was inserting itself into a religious or philosophical fight. But he said his attitude has changed.

Im glad that despite my opposition to it the state has gone forward with funding some really terrific research, Wilson said. My concern now is how do we take it to the next level so all of this hasnt been for nothing.

Andy Marso is a reporter for the Kansas News Service, a collaboration of KCUR, Kansas Public Radio and KMUW covering health, education and politics in Kansas. You can reach him on Twitter@andymarso. Kansas News Service stories and photos may be republished at no cost with proper attribution and a link back to kcur.org.

The rest is here:
Kansas Stem Cell Center Close To First Clinical Trial - KCUR

A team of scientists has developed a new safety index for a common group of chemotherapy drugs, by using a stem cell model to screen such therapies for their potential to damage patients hearts.

The study, published in Science Translational Medicine, was co-authored by Paul Burridge, PhD, assistant professor of Pharmacology.

Tyrosine kinase inhibitors (TKIs), a class of chemotherapy drugs, have become increasingly important in treating many types of cancer. But almost all TKIs are also associated with cardiovascular side effects ranging from arrhythmias to heart failure and there has not yet been an effective tool to predict this cardiotoxicity.

In the current study, the scientists demonstrated that human-induced pluripotent stem cells can be used to model how TKIs might affect the hearts of patients receiving chemotherapy.

To do so, the scientists took stem cells from both a control group and patients with cancer and reprogrammed them to become cardiomyocytes, or heart muscle cells. Using high-throughput screening, they then evaluated how the heart cells responded to treatment with 21 different FDA-approved TKIs, looking at factors like cell survival, signaling and alterations in their ability to beat properly.

With the stem-cell data, the scientists were able to create a cardiac safety index, which ranks the TKIs on their likelihood of inflicting heart damage. That index correlates with the toxicity that has been observed in patients clinically a validation that suggests the screening system might be a powerful tool in predicting toxicity before therapies are ever administered to patients.

Future research could establish even more specific predictions, by comparing the genomes of patients who might experience a certain drug side effect, such as atherosclerosis, with those who dont. Long-term, what my lab is interested in is taking a patients whole genome and, based on the work weve done in the past, being able to predict whether a patient will have an adverse drug event, said Burridge, also a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. This is the whole idea of pharmacogenomics, or precision medicine: Everyone is going to have a different response to a drug, and that response good or bad is already encoded in all of us.

In the study, the scientists also discovered that administering insulin or insulin-like growth factor 1 alongside TKIs seemed to protect against some of the heart damage associated with the drugs. While its still early, this is the first step toward opening up a whole new field of identifying cardioprotectants to reduce the toxicity of these drugs, Burridge said.

The research was supported by the National Institutes of Health (NIH) grants K99/R00 HL121177, 14BGIA20480329, R01 HL132875, R01 HL130020, R01 HL128170, R01 HL123968, and R24 HL117756; the NIH Directors Pioneer Award; the American Heart Association Predoctoral Fellowship; the American Heart Association Beginning Grant-in-Aid; American Heart Association Grant-in-Aid; the American Heart Association Established Investigator Award; the National Science Foundation Graduate Research Fellowship; the Endowed Faculty Scholar Award of the Lucile Packard Foundation for Children and Child Health Research Institute at Stanford and Burroughs Wellcome Foundation Innovation in Regulatory Science.

See the original post here:
Using Stem Cells to Predict Toxicity of Chemotherapy Drugs - ScienceBlog.com (blog)

A U.S. biotech company is preparing to start experiments using stem cells to try to stimulate 20 brain-dead patients back to life. And no, this isn't an elevator pitch for a sci-fi horror film.

The Mind Unleashed reports the company Bioquark will be trying to use stem cells to regrow and stimulate neurons to bring the patients back from brain death. It works like this: They implant stem cells in the patient's brain while also infusing the spinal cord with chemicals typically used to try and wake up coma patients. Then, hopefully, brain activity is essentially 'jump-started.' The technique is untested, so these experiments will go a long way toward proving (or disproving) the viability of the process.

Bioquark CEO Ira Pastor said they hope to see some results within 2-3 months after treatment begins, with the long-term goal being to develop techniques for brain-dead patients to eventually be able to make a full recovery. Which is certainly a heady, and ethically tricky, goal. You know, and also kind of scary. Ambitious and potentially live-saving, but still a little freaky.

What do you think of the technique? Is this going to revolutionize brain recovery or be the first step toward the T-virus?

(via The Mind Unleashed)

Here is the original post:
Scientists moving ahead with research to resurrect the dead with stem cells - Blastr

Abby West first decided to become a bone-marrow donor when she was a young journalist covering a bone-marrow drive. Little did she know that nearly two decades later, shed be called upon to try to help save someones life.

The newspaper I had joined had a reporter who had passed away of sickle cell anemia, and I had become aware of the need for African-Americans to join the registry, West, a senior editor at Yahoo Celebrity, tells Yahoo Beauty about her decision to sign up with Be The Match. I was covering a bone-marrow drive for African-Americans, and it seemed like the right thing to do. West says she simply got her cheek swabbed which yields a sample of cells that doctors use to compare specific protein markers with those of patients who need a bone-marrow transplants and then went about her life.

But in June 2014 17 years later she received an email from Be the Match, a registry of the National Marrow Donation Program, saying that her bone marrow was a potential match for someone in need. She called the organization to learn more. You get a sense of urgency, need, and what is expected of you, she says. To make sure she was a healthy donor, West needed to fill out forms, and once it was determined she met all of the donor criteria, she moved on to a physical examination.

(Photo courtesy Abby West)

West says she underwent seven weeks of blood testing and prep work before she donated bone marrow. Part of the process was making a decision about whether she would do a surgical bone-marrow donation, in which a person is put under general or local anesthesia and liquid marrow is taken from the back of the pelvic bone, or a nonsurgical peripheral blood stem cell (PBSC) harvest, in which blood is drawn from one arm into a machine, where it is spun and the stem cells are extracted. The remaining blood is then returned to the persons body via the other arm. West chose the latter option, and started receiving Neupogen shots, which increased her bodys production of stem cells. It puts your stem cells on overdrive, she explains.

West says the message from Be the Match was always clear: It was her body and she could change her mind at any point. However, she says, they request that if youre going to change your mind, you do so before you begin the shots. Heres why: At this point, the patient she would be donating to was starting chemotherapy in anticipation of receiving her stem cells. You get the sense that someones life is in the balance and theres no turning back only moving forward, she says. You need to understand the commitment to potentially saving someones life.

West says the shots werent painful, but she did experience some flu-like symptoms. You feel a little achy, she says. Your body is becoming laden with stem cells. Its uncomfortable, but not painful. A nurse came to Wests office to give her the shots, but donors can also go to clinics to get them, or do them on their own. They try to make it as seamless and painless as possible, she says, noting that the shots made her feel moretired than usual. I wasnt on my gym grind that week, she says.

The day of the donation, West reported to a blood donation center at 7 a.m., along with a friend to keep her company, and sat in a chair for about eight hours while her blood was drawn, spun, and returned to her body. When you have to go to the bathroom, you just stop, unhook, go the bathroom, and hook back up again, she says. It wasnt a hardship I cant complain about it. It was eight hours of sitting and talking. West says the process was mildly uncomfortable, but she knew that in about 48 hours, someone was going to have a life-saving operation. Afterwards, she felt tired and went to sleep for a little while. I did it on Friday and was back at work on Monday, but I would have been fine to go to work the next day, she says.

Read More

Stem cells are regenerative, and there is no long-term harm to the donor, Muzzafar Qazilbash, MD professor of stem cell transplantation at the University of Texas MD Anderson Cancer Center explains to Yahoo Beauty.

Photo: Courtesy of Abby West

While there is a need for people of all races and ethnicities to donate bone marrow, there a special need for African-Americans to do so, Qazilbash says. African-Americans make up about 10 percent of the U.S. population, and only about 25 percent to 30 percent of people who could potentially benefit from a bone-marrow transplant have a perfectly matched sibling donor available, he says. The rest of the patients have to find matched, unrelated donors from the National Marrow Donor Program. However, the overwhelming majority of approximately 25 million volunteer donors registered with NMDP are people of Western and Northern European origins, and as a result it is very hard to find matching, unrelated matchingdonors for African-American patients, he says. Encouraging more people of African ancestry will increase the possibility of finding unrelated donors for African-American patients, which can be life saving.

Jack Jacoub, MD, medical oncologist and director of thoracic oncology at MemorialCare Cancer Institute at Orange Coast Memorial Medical Center in Fountain Valley, Calif., tells Yahoo Beauty while some ethnicities have very little genetic variability, there is a lot of genetic variability in the African-American population making the probability of having two genetically similar people less likely. Then you bring up the issue of how few African-American donors there are, and there is difficulty finding an adequate donor, he says.

Donor stem cellscan be used to treat life-threatening conditions such as leukemia and lymphoma, as well as sickle-cell anemia, Jacoub says. They can also help people with bone-marrow failure syndromes such as aplastic anemia a condition in which a persons body stops producing blood cells as well as help treat children born with severe immune system deficiencies, Qazilbash says.

West never received information about the person she donated bone marrow to, other than the fact that the patient was a man. She doesnt know how he fared after the donation, but learned that he struggled with graft-versus-host disease, a complication that can occur after a stem-cell or bone-marrow transplant. Its fairly common for people to have it and move forward, but Ive never found out how he ultimately ended up, she says.

West was so moved by her experience that she eventually joined the board of Be the Match, and now urges others tobecome bone-marrow donors. You always think about what you would want someone to do for you or your family member, she says, noting that shes still on the registry and would donate again if there was a need.

Of course, blood and needles are involved, which can scare some people off, but West says its worth it in the end. In order to do something heroic, you have to overcome some discomfort and some trepidations, she said.

To find out more about becoming a bone-marrow donor, please visit BeTheMatch.org.

Read more: Five Oscars Beauty Launches You Need to Know About Janelle Mone $750 Headband Led the Pack of Stunning Oscars Hair Accessories The $15 Product Behind Taraji P. Hensons Amazing Glow at 2017 Oscars

Lets keep in touch! Follow Yahoo Beauty on Facebook, Twitter, Instagram, and Pinterest.

See original here:
Exactly What It's Like to Donate Bone Marrow and Why More African-American Donors Are Needed, Stat - Yahoo Health

NEW DELHI: Private banking of umbilical cord blood is a big business running parallel to childbirth in big hospitals, but is it worth the cost? While companies offering the facility for a few thousand rupees claim it can be used to treat conditions ranging from cerebral palsy to diabetes, health experts and doctors disagree. They say stem cell transplantation for treatment is limited to hereditary or genetic conditions, specifically blood disorders.

In both cases, umbilical cord blood cannot be used to save the donor since it will have the same genetic abnormalities. Its usage for treating the donor's siblings, or other family members, is also rare, as the HLA (a protein) has to match and weight-to-cord-blood ratio with the recipient has to be just right.

The limitations notwithstanding, expecting mothers are flooded with offers to preserve the cord blood. Patients complain that most private hospitals and boutiques for childbirth allow marketing agents from stem cell banking facilities to freely solicit them. "I was inundated with calls from stem cell companies trying to convince me to go for umbilical cord preservation. On each visit to the hospital, representatives from these companies hound you," said Nutan Verma, who is expecting twins.

Geeta Sharma said she went through multiple presentations from executives of stem cell banking companies while waiting in hospital to deliver her baby. "They offered free genetic testing, lifelong storage and other benefits. I chose one of them offering to preserve umbilical cord for 21 years at Rs 50,000. The company representative told me that the contract can be renewed on expiry," she said.

Geeta Jotwani, deputy director general of Indian Council of Medical Research (ICMR), told TOI that private companies offering to preserve umbilical cord blood must be strictly regulated. "Soliciting of patients by selling fake hopes is wrong. There is no evidence of stem cell use from umbilical cord presently, except in blood disorders. Only those having family members with these disorders should store it," she said.

Jotwani said ICMR was working on guidelines for stem cell banking which would be made public soon. "Many private banks are storing cord tissue, dental pulp, menstrual blood and adipose tissue as well for which there is no scientific evidence of any use in treatment as yet," she added.

Dr S P Yadav, paediatric hematologist at Medanta Medicity, Gurgaon, said private stem cell banking companies claimed that umbilical cord blood could be used to treat spinal cord injury, cerebral palsy and even diabetes, though there is no such proven research. "Currently, only five medical conditions can be treated through cord blood stem cell transplant blood cancer, bone marrow failure, thalassaemia and sickle cell anaemia, immune system deficiency since birth and inborn errors of metabolism," he said. "The chances of cord blood being used in the family or by the donor are 0.01%. Still, if somebody wants to preserve it, they should be allowed to. The problem is when poor or middle class families are lured into doing so with false claims about preserved blood being a panacea for all diseases," said Yadav.

On average, private banking of stem cells derived from cord blood costs Rs 50,000 to Rs 70,000. Banks claim to freeze the cells in liquid nitrogen so that it can be used up to 20 years from the date of preservation.

Read the original:
Umbilical cord blood: Cord blood: Big business, small benefits ... - Times of India

As a devoted gran, Sipy Howard looks forward to watching her grandkids grow up.

In two years' time, the 65-year-old hopes to proudly look on as her youngest granddaughter, Sienna, goes off to school .

But devastatingly, she doesn't know if she'll be able to do so - because she urgently needs a bone marrow transplant to survive.

Sipy, a "warm and adoring" gran, was diagnosed with leukaemia on December 15 last year - which also happened to be her birthday.

Although she has been undergoing intense chemotherapy, she is in need of a bone marrow and stem cell transplant to save her life.

Now, her daughters, Emma, 34, Jolene, 32, and Sammy, 26, have launched a desperate online campaign to find a donor for her.

The heart-wrenching campaign, dubbed #SavingSipy , aims to encourage potential donors to sign up to the bone marrow register.

It stresses how simple it is to register as a donor online.

Sipy, married to husband Eli, told Mirror Online she is "moved" by the support she has received from her loved ones - as well as strangers.

"We really need as many people as possible to sign up to the register," said the mum of three, from Kenton, northwest London.

She added: "I want to see my grandchildren growing up and my youngest granddaughter going to school."

Sipy was devastated to be diagnosed with Acute Myeloid Leukemia, an aggressive blood cancer, on her 65th birthday.

Her daughters were also shocked by the diagnosis.

Emma said: "You can never prepare yourself for hearing that a loved one has cancer.

"You are suddenly filled with fear and a desperation you have never quite experienced.

"I felt like I had been hit by a car when my dad broke the news to me on my mum's birthday.

"Keeping yourself emotionally together each day becomes your only goal."

She added that her mum is currently "struggling through" her second, gruelling round of chemotherapy.

"It's the knowing that she needs us more than ever that keeps us going, keeps us fighting," she said.

"We won't give up on her and our goal of finding a match for her."

Sipy, described as "bubbly, always laughing and generally a bit nuts", is a gran to two-year-old Sienna and four-year-old Sofia.

A member of the Jewish community, she has an "open house policy" and "cares for everyone she meets", according to her family.

Her daughters are hoping that the community - specifically the Sephardi community - could help to save her life.

Sammy said: "One of the hardest things about the situation is knowing there may be someone in the world who is a match for my mum, but because they have not registered to be on the bone marrow register, they can't save her.

"This is why we are desperately trying to reach out to everyone we can and get our message across.

"We urgently need people to register now and unfortunately we don't have much time."

Jolene added: "Awareness is key."

The campaign is being supported by the charity DKMS, which aims to help blood cancer patients find matching donors.

For details of how to register as a donor online, you can visit the #SavingSipy Facebook page here or DKMS's website here .

See more here:
Adoring gran who will die without bone marrow transplant desperate to see granddaughter go to school - Mirror.co.uk

Miami Herald

Life after a heart attack: She's golfing. He's running. How they did it. Miami Herald The study in which Wilson enrolled injected millions of donor, bone-marrow stem cells into her heart. Stem cells extracted from bone marrow grow rapidly and help regulate the body to heal itself, Hare explained. After a heart attack, an area of the ...

View original post here:
Life after a heart attack: She's golfing. He's running. How they did it. - Miami Herald

The decade-old excitement surrounding the potential for autologous cell therapy to treat cardiovascular disease may have fizzled into futility for many clinicians. But according to a new European consensus document, its possible this technology will yet find a way into future practice .

One of the problems the field has faced is that people got super excited 10 years ago because it was overhyped, and essentially . . . it led to the expectation that every time we presented [something] at clinical meetings, the field would move forward. And of course that wasnt the case, chair of the European Society of Cardiology stem cell task force and lead author Anthony Mathur, MD (St Bartholomews Hospital West Smithfield, London, England), told TCTMD.

The reason why I think people have run out of steam on this one is that theyve shared the 10-year journey with us. Anthony Mathur

Mathur contrasted the story of cell therapy to that of drug or device development, which is usually kept private until promising phase III data are available to support its routine use. What we've done is weve exposed the clinical and scientific community to a journey that in pharma we just wouldn't see as clinicians, he said. The reason why I think people have run out of steam on this one is that theyve shared the 10-year journey with us.

The document, which appeared online February 15, 2017, ahead of print in the European Heart Journal, was written as an update to a slightly more optimistic statement from the same task force published in 2006.

Of all of the recommendations that the original document made, very few have borne fruit. For example, the task force suggested the completion of a randomized trial for the use of autologous stem cells to treat acute MI patients presenting after more than 12 hours or who fail to respond to therapy. A trial such as this has not been undertaken and likely wont happen, given that primary angioplasty practice in Europe and the United States has revolutionized the treatment of acute MI and drastically lowered mortality, Mathur said. Any new method of treating acute MI will find it really tough to demonstrate an improvement unless its a complete game changer.

Since these patients may well develop heart failure, for which chronic cell therapy strategies are under development, research efforts should refocus there for now, the task force writes.

However, they stand by one 2006 recommendation for a randomized trial of autologous cells in acute MI patients presenting within 12 hours and treated with immediate revascularization. The ongoing phase III BAMI trial, undertaken by members of this task force including Mathur, will study just that but results are not expected for several years. Once these results are available, it will be time to either draw a line under it or ask for regulatory approval, but it's sort of pointless to keep rehashing the whole thing and going back asking the same question, Mathur said.

Careful But Hopeful

Looking back, Mathur said that the trajectory of cell therapy in cardiology has taught him to be self-critical and very careful about what we say, and to understand that it is okay to stop doing certain things that were once thought to be appropriate. Also, because those involved in translational research lack the tools that give us an evidence or an idea of the signal that we should expect in larger clinical trials, [a] lot of what weve come across is potentially unexpected. Unfortunately, it also means . . . weve probably disregarded areas of research based on the signals we haven't seen in smaller studies simply because, in a way, the tools we have arent sensitive enough to pick it up, he said.

If there is any biological signal found in a phase II study, Mathur stressed the importance of trying to complete a phase III study in order to unlock these unexpected kernels.

Far from being defeated, he said he is hopeful that cell therapy will pan out in some way for cardiac patients. Whether cell therapy worked or not, it's all about the amazing stories and how it changed people's lives seemingly for the better. So thats something thats difficult to drop, Mathur said. We have seen a signal for patients in heart failure in which there seems to be some sort of benefit. And some might say its purely psychological. Fine, but these people who were told there was nothing else that could be done got better.

The rest is here:
Less Acute MI, More HF: European Task Force Shifts Support for 'Overhyped' Cell Therapy Research - TCTMD

FOX31 Denver

Super Foods In Skin Care FOX31 Denver Fruit Stem Cells are advanced high potency juices that take the place of petroleum by-products and fillers for boosted beauty benefits. Apple Juice, a.k.a. Malic Acid is rich in vitamins, potent malic alpha-hydroxy acids, phytonutrients, flavonoids ...

Continue reading here:
Super Foods In Skin Care - FOX31 Denver

Science Daily

Researchers implicate suspect in heart disease linked to diabetes ... Science Daily Scientists have struggled to trace the specific biology behind diabetes-associated heart disease risk or find ways to intervene. Now, researchers have hunted ... and more »

The rest is here:
Researchers implicate suspect in heart disease linked to diabetes ... - Science Daily

TEMPE, Ariz. On the day he hoped would save his elbow, Garrett Richards laid face down on a table with his back exposed. A doctor guided a needle into the iliac crest of his pelvic bone and began to extract bone marrow. Richards was wide awake, the blessing of local anesthesia saving him from physical pain but not the anxiety that crept into his head: Is this really going to work?

Within a few minutes, the harvested marrow was hurried to a centrifuge, spun to separate the good stuff, mixed into a slurry of platelet-rich plasma and readied to inject into Richards damaged right elbow. Rather than the standard tear across his ulnar collateral ligament, Richards ran lengthwise along the middle of his UCL, a rare manifestation of an increasingly commonplace injury that almost always ends with Tommy John surgery. Not in this case. While he could have chosen that route, he wanted to explore first the efficacy of the aforementioned good stuff: stem cells.

Today, Garrett Richards is darting 98-mph fastballs again. I feel as good as I ever have throwing a baseball, he said Monday from Tempe Diablo Stadium, where the Los Angeles Angels, perhaps the most Tommy John-addled team in baseball, expect to break camp with Richards as their opening day starter. The 28-year-old is the latest player to turn to orthobiologics, the class of treatments that includes stem cells and PRP, in hopes of healing an injury. While clinical studies have shown great success with those who use orthobiologics, they are not yet a panacea for the pervasive elbow injuries in baseball for two reasons: They work only on partial ligament tears, like Richards, and medical studies have yet to validate their efficacy independent of other treatments run concurrently.

The lack of knowledge as to how orthobiologics work inside the body while the proteins in stem cells and platelets are believed to regrow damaged tissue, doctors have yet to isolate best practices for particular injuries speaks to the difficulties in true medical advances. Still, the desire of Richards and others to avoid surgery lends orthobiologics enough credence to warrant further studies.

I truly think this kind of treatment has significant potential, said Dr. Neal ElAttrache, a longtime orthopedic surgeon at the Kerlan-Jobe clinic in Los Angeles who introduced orthobiologics to Major League Baseball when he injected PRP into the elbow of Dodgers reliever Takashi Saito in 2008. Theres no question biologics are here to stay and biologic manipulation is the frontier of treatment in what were doing. The problem, as I see it, is that the marketing and clinical use has far exceeded the science behind it.

Translation: Once the use of PRP and stem cells found traction in the media, pro athletes and weekend warriors alike sought their use, even if the success stories skewed anecdotal. Bartolo Colon resurrected his career after a stem cell injection in 2010 and is still pitching today at 43. Others did so without the fanfare or publicity. Richards faced a choice after being diagnosed with a partially torn UCL last May: Undergo Tommy John surgery and, at earliest, return following the 2017 All-Star break or follow the advice of Dr. Steve Yoon, a partner of ElAttraches at Kerlan-Jobe, and try to salvage the ligament with stem cells.

Science, bro, Richards said. Im a believer now.

Two weeks before Richards began his treatment, teammate Andrew Heaney had looked to avoid Tommy John via stem cells. Richards figured theyd rehab together every step of the way and be back in time for the fall instructional league. Then at the end of June, a scan showed Heaneys elbow wasnt healing, and he would need reconstructive surgery. Already Tyler Skaggs had taken nearly two years to return from his 2014 surgery, and six weeks after Heaneys, starter Nick Tropeano went down. Like Heaney, he is expected to miss the 2017 season.

It made Richards recovery that much more imperative. His first checkup, six weeks in, showed regrowth in the torn area via ultrasound. By August, he started throwing, and come October, when instructional league was in full bloom, so too was Richards. He didnt hesitate to pump his fastball and rip off one of his spin-heavy breaking balls. As far as pure, raw stuff goes, few in baseball can match Richards.

Read More

He was convinced science was working, bro, though the skepticism about orthobiologics generally remains, and understandably so, in the medical community. In May 2013, a paper published in the American Journal of Sports Medicine found 30 of 34 overhand throwers with partial UCL tears who used PRP had returned to their previous level of competition. This was reason for celebration. If a player could avoid the 14-month-plus recovery from the surgery, better for him as well as the team.

Another study arrived in 2016 that didnt cast doubt on the value of orthobiologics so much as offer a different avenue: rest. The 28 players used everything from electrical stimulation, ultrasound, laser therapy, massage and other soft-tissue work. And when paired with rest, their return to previous level came in at 84 percent. It was almost exactly as effective as PRP.

This reinforced ElAttraches concern: Neither of those studies had a control group against which to measure, so the numbers, while impressive, could not isolate what helped and what didnt. This chicken-or-egg question struck ElAttrache just the same when Saito returned and went on to pitch five seasons.

Maybe it was the injection, ElAttrache said. Or maybe it was that we shut him down and let him heal.

Garrett Richards is darting 98-mph fastballs again after turning to orthobiologics. (Getty Images)

He doesnt know, and thats an important distinction as orthobiologics grows exponentially. In 2004, voters in California pledged to provide $3 billion for stem-cell research and create the California Institute of Regenerative Medicine. It remains a benefactor for an industry trying to find its place in the United States.

Across the world, stem cells have far greater potency. U.S. law prevents doctors from manipulating the cells in any way. They are extracted and put back into patients bodies as is. In Switzerland, for example, doctors will harvest stem cells, manipulate them to promote greater healing capacity and then inject them. At least one star pitcher this offseason sought a stem cell injection in the United States, according to sources, while another veteran traveled halfway across the world to Zurich, seeking the comparative lack of regulations just as Peyton Manning did in 2011 to help heal a neck injury that eventually needed surgery.

The future of orthobiologics domestically doesnt end with the FDA loosening rules on stem cell usage. Doctors see significant promise in stem cells from a babys umbilical cord or a mothers placenta, both of which can be frozen. Already theyre capable of harvesting stem cells from old patients and engineering the cells into an immature state. The possibilities going forward are endless.

For right now, theyre going to play themselves out in Anaheim. The danger zone for re-injury after using orthobiologics tends to fall between April and June, though Richards cant imagine falling prey again. In addition to the 13-week break from throwing he took over the summer, Richards spent 10 more weeks in the offseason letting it heal further.

During his down time, Richards studied his own delivery to find even the slightest inefficiencies. He had three numbers in mind. The first was 85. Thats the percent at which he said hell throw his fastball, though because of improved mechanics he expects it wont hinder his velocity. The second is 100. Thats the pitch limit the Angels will foist on Richards, and hes not one to fight. The third is 200. Thats the number of innings Richards wants to pitch this season. He did it in 2015 and sees no reason he cant again.

If he can throw 85 percent, keep his pitch count below 100 and get those 200 innings, it will play publicly as another validation of orthobiologics. Just the same, if Richards elbow gives out eventually, his association with stem cells could perhaps give those considering it pause. Richards pays no mind to this. He just wants to be great.

So much so, in fact, that its going to cost him. Inside the Angels clubhouse, a chart, labeled 1 through 13, is taped to the side of a locker. Its a list of shame with the price buying lunch for the entire team. Players, coaches, P.R. directors, even manager Mike Scioscia are on there. Next to No. 6, it read: G. Rich Ace. He had made the mistake of saying aloud what he believed to be true: that hes the ace of the Angels.

Fulfilling that depends on plenty of things, none as important as his elbow, and Richards knows that. Hell do everything he can to take care of it, to nurture it, to fight against its natural gift of velocity that puts him at such risk. To make sure that next time hes on a table in the doctors office, its not with his elbow opened up and another season lost.

More on Yahoo Sports: Tom Bradys missing jersey is worth a small fortune Bob Huggins says he fell to his knees because his defibrillator activated Kings GM Vlade Divac says he turned down abetter deal for DeMarcus Cousins Yoenis Cespedes is back with his amazing cars

Read more from the original source:
How baseball players are trying stem cells to avoid Tommy John - Yahoo Sports

The Register's editorial 5:32 p.m. CT Feb. 20, 2017

A tray of vials containing cerebral spinal fluid in Baltimore used to analyze both adult and fetal tissue in cancer research.(Photo: AP)

Among the threats to scientific advances are politicians who do not understand science. Unfortunately, too many of these politicians land jobs in the Iowa Legislature. They send a message this state is the last place a medical researcher should locate.

In 2002, lawmakers with an unfounded fear of scientists cloning babies passed a bill banning the creation of stem cells through a process called somatic cell nuclear transfer. Researchers useembryos, left over from in vitro fertilization, that would otherwise be discarded. After the vote banning the process, lawmakers were crying, hugging and carrying on about how life begins at conception.

Their emotion was pathetically misguided, as there was nothing pro-life about the measure. In fact, the law jeopardized life-saving research. It also prompted a cell biologist at the University of Iowa to pack up, move to Illinois and take her team and millions of federal dollars for cancer research with her.

Now here we go again. Lawmakers who apparently lack anunderstanding of laboratory research and the history of medical advancementsare pushing Senate File 52 in yet another effort to meddle in the work of real scientists. The bill, recently approved by a GOP-led Senate subcommittee,would ban acquiring, providing, receiving, otherwise transferring or using fetal tissue in this state. Fetal tissue, extracted during legal, voluntary abortions, can be discarded or used in medical research.

Lawmakers apparently would rather it be discarded. Committee chair Sen. Jake Chapman, R-Adel, said he didn't want to hinder research, but we also need to understand there is a moral responsibility, as well, to ensure that baby body parts arent being sold.

The same way no one was cloning babies in Iowa more than a decade ago, no one is selling "baby parts" today.

But inflammatory rhetoric is what people resortto when they don't want to acknowledge facts. Federal law already prohibits profiting from selling fetal tissue. Planned Parenthood of the Heartland says its Iowa affiliate does not even donate it. If the bill becomes law, anyone using fetal tissue namely researchers could land in the slammer for up to 10 years.

The Iowa Board of Regents registered opposition to the legislation, along with lobbyists representing the medical industry, churches and others. The board, which oversees state universities, requested an exemption that would allow research on certain fetal cells and proposed language to enable medical donations and permit the diagnosis of diseases.

Lawmakers did not immediately amend the bill, even thoughUI has been one of dozens of institutions across the country that has used fetal tissue in medical research. In recent years, the National Eye Institute provided the school more than $1 million for glaucoma research that used the tissue, according to data compiled by the Associated Press in 2015.

Fetal tissue has been successfully used for decades in medical research. It was critical in creating a vaccine for polio, a disease that crippled, paralyzed and sometimes killed its victims. Scientistsinfected fetal kidney cellsto produce mass quantities of the virus that were collected, purified and used for inoculations. They won a Nobel Prize for Medicine in 1954.

Research using human fetal cells shows promise in treatments for spinal cord injuries, eye disease, strokes and Parkinson's disease. But some Iowa lawmakers appear uninterested in saving and improvinglives.They are, however, interested in catering to theanti-abortion crowd with a bill that would not prevent a single abortion.

Read or Share this story: http://dmreg.co/2loAhlb

View post:
Editorial: Fetal tissue bill is anti-life, anti-science - DesMoinesRegister.com

A MAN who narrowly missed out on a heart transplant has become the first patient in Europe to receive a revolutionary new treatment on compassionate grounds.

Gordon Foster, 59, suffered the first of a number of heart attacks at 30, and was advised he would need a heart transplant.

But as his heart functionality was working at 17 per cent, he was not eligible for the transplant which requires functionality at below 16 per cent.

Gordon, a welder, was then made redundant and became depressed.

His poor health meant he became housebound and, at times, was unable to move from one room to the next.

But his life has now been transformed as he has become the first patient in Europe to undergo stem cell treatment to regenerate part of his heart muscle through the new Compassionate Treatment Programme at St Bartholomews Hospital in London.

The treatment meant Gordon was given injections to stimulate the growth of his own stem cells. Bone marrow was then taken and the stem cells extracted from it before being injected back into his heart to regenerate the muscle.

Within a week of the operation, Gordon no longer needed to use his stair lift, his daily tasks such as walking up the stairs and doing housework became easier and he was able to enjoy spending time with his wife and children.

Gordon, who lives in Bridlington, said: I will forever be thankful to the Heart Cells Foundation, and the work of the team at St Bartholomews Hospital, as without them I believe I wouldnt be here today and Im enjoying every moment I spend with my wife and children.

Not only has the stem cell treatment I received helped to improve my physical health, but it has also massively improved my mental health and I now live every day with hope for the future.

Professor Anthony Mathur, consultant at St Bartholomews Hospital, said: Gordons story proves just how important it is to offer cell therapy to those who have no other medical choice.

With more than a million people suffering with heart disease and failure in the UK, the need for treatment in this field has never been greater.

We hope to lead the way to the treatment ultimately being available to thousands of other patients through the NHS, so we can help people like Gordon to lead near normal lives again.

View original post here:
New start for stem cell heart op man, Gordon - The Press, York

OSAKA, Japan & LEUVEN, Belgium--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502) (Takeda) and TiGenix NV (Euronext Brussels and Nasdaq:TIG) (TiGenix) today announced new data from the Phase 3 ADMIRE-CD clinical trial, which indicated that investigational compound Cx601, a suspension of allogeneic expanded adipose-derived stem cells (eASC), maintained long-term remission of treatment refractory complex perianal fistulas in patients with Crohns disease over 52 weeks.1 Results were presented at the 12th Congress of the European Crohns and Colitis Organisation (ECCO).

The ADMIRE-CD trial is a randomized, double-blind, controlled, Phase 3 trial, designed to investigate the efficacy and safety of the investigational compound Cx601 for the treatment of complex perianal fistulas in patients with Crohns disease.2 Patients were randomized to a single administration of Cx601 cells or placebo (control), both added to standard of care.1 A significantly greater proportion of patients in the Cx601 group versus the control group achieved clinical and radiological combined remission* (56.3% and 38.6%; p=0.010), and clinical remission (59.2% and 41.6%; p=0.013) at week 52 in the modified intention-to-treat population (mITT).1 Of those mITT patients who had shown combined remission at week 24, a greater number in the Cx601 group versus the control group reported no relapse at week 52 (75.0% and 55.9%).1 The rates and types of treatment related adverse events (non-serious and serious) and discontinuations due to adverse events were indicated to be similar in both groups (Cx601: 20.4%; control: 26.5%).1

Crohns disease is a chronic inflammatory disease of the gastrointestinal tract, which is thought to affect up to 1.6 million people in Europe.3 Complex perianal fistulas are a complication for people living with Crohns disease and there are limited treatment options. Recognizing the rare and debilitating nature of the disorder, and lack of treatment options, in 2009 the European Commission granted Cx601 orphan designation for the treatment of anal fistula. In March 2016, TiGenix announced that it submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Cx601, and a decision by the EMA is expected in 2017. Additionally, in September 2016 orphan drug status was received from the Swiss Agency for Therapeutic Products (Swissmedic) regarding Cx601 for the rare disease complex perianal fistulas in Crohns disease.4

Perianal fistulizing Crohns disease is difficult to treat with currently available therapies and often leads to pain, swelling, infection and incontinence, said Dr. Asit Parikh, Head of Takedas Gastroenterology Therapeutic Area Unit. Existing therapies are limited and associated with complications and a high failure rate. Cx601 may offer patients an alternative treatment option.

These data highlight that the efficacy and safety of a single administration of Cx601 were maintained during one year of follow up, said Dr. Marie Paule Richard, Chief Medical Officer at TiGenix. It is important to also note that the definition of combined remission used in the ADMIRE-CD study, which includes both clinical and radiological assessment by MRI, is more stringent than the criteria commonly used in previous large scale, randomized clinical trials evaluating perianal fistulas in Crohns disease, based only on clinical assessment.

A global pivotal Phase 3 trial for U.S. registration with Cx601 for the treatment of complex perianal fistulas is expected to be initiated by TiGenix in 2017. In the U.S., TiGenix intends to apply for fast track designation from the U.S. Food and Drug Administration (FDA), which would facilitate and expedite the development and review process in the U.S.

Takedas Commitment to Gastroenterology

Takeda is a global leader in gastroenterology. With expertise spanning more than 25 years, the companys dedication to innovation continues to evolve and have a lasting impact. ENTYVIO (vedolizumab) demonstrates Takedas global capabilities and expansion into the specialty care market in gastroenterology and biologics. Designed and developed specifically to target the gastrointestinal (GI) tract, ENTYVIO was launched in 2014 for the treatment of adults with moderate to severe ulcerative colitis and Crohns disease. TAKECAB (vonoprazan fumarate) is Takeda's potassium-competitive acid blocker and was launched in Japan in 2015. Takeda also markets motility agent AMITIZA (lubiprostone), which originally launched in 2006 for the treatment of chronic idiopathic constipation, and received subsequent approval to treat irritable bowel syndrome with constipation and opioid-induced constipation. Preceding these notable launches, Takeda pioneered gastroenterological breakthroughs in proton pump inhibitors beginning in the 1990s with lansoprazole.Through specialized and strategic in-house development, external partnerships, in-licensing and acquisitions, Takeda currently has a number of promising early stage GI assets in development, and remains committed to delivering innovative, therapeutic options for patients with gastrointestinal and liver diseases.

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company Limited is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

About TiGenix

TiGenix NV (Euronext Brussels and Nasdaq: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Our lead product candidate from the adipose-derived stem cell technology platform is Cx601, which is in registration with the EMA for the treatment of complex perianal fistulas in Crohns disease patients. Our adipose-derived stem cell product candidate Cx611 has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product candidate, AlloCSC-01, is currently in a Phase II clinical trial in acute myocardial infarction. In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. On July 4, 2016, TiGenix entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to develop and commercialize Cx601 for complex perianal fistulas outside the United States. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain).

About Cx601

Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) locally injected. Cx601 is an investigational compound being developed in Crohns disease for the treatment of complex perianal fistulas showing inadequate response to at least one conventional or biologic therapy including antibiotics, immunosuppressants, or anti-TNF agents. Crohns disease is a chronic inflammatory disease of the intestine and, as a complication of it, patients can suffer from complex perianal fistulas, for which there is currently no effective treatment. In 2009, the European Commission granted Cx601 orphan designation for the treatment of anal fistulas, recognizing the debilitating nature of the disease and the lack of treatment options. Cx601 has met the primary end-point in the Phase 3 ADMIRE-CD study, a randomized, double-blind, controlled trial run in Europe and Israel and designed to comply with the requirements laid down by the EMA. Madrid Network issued a soft loan to help finance this Phase 3 study, which was funded by the Secretary of State for Research, Development and Innovation (Ministry of Economy and Competitiveness) within the framework of the INNTEGRA plan. In this trial, patients were randomized to a single administration of Cx601 cells or placebo (control), both added to standard of care. The studys primary endpoint was combined remission, defined as clinical assessment at week 24 of closure of all treated external openings draining at baseline despite gentle finger compression, and absence of collections >2cm confirmed by MRI. In the ITT population (n=212), Cx601 achieved statistically significant superiority (p=0.024) on the primary endpoint with 50% combined remission at week 24 compared to 34% in the control arm. Efficacy results were robust and consistent across all statistical populations. Treatment emergent adverse events (non-serious and serious) and discontinuations due to adverse events were comparable between Cx601 and control arms. The 24-week results have been published by The Lancet, one of the most highly regarded and well known medical journals in the world. The Phase 3 study has completed a follow-up analysis at 52 weeks confirming its sustained efficacy and safety profile. Top line follow-up data showed that in the ITT population Cx601 achieved statistical superiority (p=0.012) with 54% combined remission at week 52 compared to 37% in the control arm. Long-term results also showed that, of patients with combined remission at week 24, a higher proportion of patients treated with Cx601 had no relapse at week 52 (75.0% vs. 55.9%). Based on the positive 24-weeks Phase 3 study results, TiGenix has submitted a Marketing Authorization Application to the EMA in early 2016. TiGenix is preparing to develop Cx601 in the U.S. after having reached an agreement with the FDA through a special protocol assessment procedure (SPA) in 2015. On July 4, 2016, TiGenix entered into a licensing agreement with Takeda, a pharmaceutical company leader in gastroenterology, whereby Takeda acquired an exclusive right to develop and commercialize Cx601 for complex perianal fistulas in Crohns patients outside of the U.S.

-Ends-

____________

* defined as clinical assessment of closure of all treated external openings draining at baseline, despite gentle finger compression, and absence of collections >2cm confirmed by MRI

References

1 Pans, J, Garca-Olmo, D, Van Assche, G, et al., Long-term efficacy and safety of Cx601, allogeneic expanded adipose-derived mesenchymal stem cells, for complex perianal fistulas in Crohns Disease: 52-week results of a phase III randomized controlled trial. ECCO 2017; Barcelona: Abstract OP009.

2 Clinicaltrials.gov. Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease (ADMIRE-CD). https://clinicaltrials.gov/ct2/show/NCT01541579?term=cx601&rank=2. Published February 2012. Accessed February 9, 2017.

3 Burisch, J, Jess, T, Martinato, M, et al., on behalf of ECCO EpiCom. The burden of inflammatory bowel disease in Europe. J Crohns Colitis. 2013; 7: 322-337.

4 Swissmedic. About us Collaboration National collaboration Patients and Users. Available at https://www.swissmedic.ch/ueber/01398/01400/03296/index.html?lang=en. Accessed February 9, 2017.

Original post:
Takeda and TiGenix Report New Data Highlighting Maintenance of ... - Business Wire (press release)

Science Daily

Your brain's got rhythm: Synthetic brain mimics Science Daily Salk scientists create synthetic brain systems called 'circuitoids' to better understand dysfunctional movements in Parkinson's, ALS and other diseases. Confocal microscope immunofluorescent image of a spinal cord neural circuit made entirely from stem ... and more »

Read the original here:
Your brain's got rhythm: Synthetic brain mimics - Science Daily

Seventy-year-old Peggy Agar has known since she was in her 40s that she and her 12 siblings might be at risk for familial cardiomyopathy, a genetic form of heart disease.

Her mother was diagnosed with it in 1987, and several of her brothers were also subsequently diagnosed with cardiomyopathy.

Given our family history, our family knew we had to be vigilant to keep our hearts as strong as possible, says Agar, who lives in Bloomfield.

But now thanks to the power of genetic testing at UConn Healths Pat and Jim Calhoun Cardiology Center, Agar and her family can determine which family members may be at risk.

Through a routine blood sample, Agars gene sequences were analyzed by Dr. Travis Hinson, a cardiovascular physician-scientist who is a new faculty member with a joint appointment at UConn Health and the Jackson Laboratory for Genomic Medicine.

Hinsons advanced genetic analysis revealed that Agar carries a gene mutation that causes dilated cardiomyopathy, a disease of the heart muscle that potentially leads to an enlarged, weakened heart and ultimately heart failure. He identified that Agar carries a mutation in the largest gene in the body called titin that leads to dilated cardiomyopathy in about 1 in 5 patients with a positive family history. In 2015, his laboratory published these findings in the journal Science, where he studied miniature beating human heart tissues engineered from stem cells from patients with conditions similar to Agars.

Hinson says knowing their genetic predisposition allows patients and families to understand why heart disease may continue to be prevalent generation after generation in their family.

If you carry the cardiomyopathy gene, you have a 50 percent chance of passing it to your offspring, says Hinson. Now with the power of genetic testing, we can tell each family member definitely early in their life whether they carry the cardiomyopathy genetic mutation, and intervene early to try to prevent any symptoms of the disease before they occur.

Agar says the genetic test results will arm her familys younger and future generations with important knowledge.

Now our family can better safeguard ourselves and younger generations at an early age to take extra precautions when it comes to our heart health, she says. Because of the way this myopathy develops in our family, we have learned that it is very important when we seek medical care that the physicians we see are aware of this family history.

Another positive aspect of the testing is that family members who are found not to have the gene no longer need to worry about passing the gene on to their children.

Agar has received comprehensive treatment from a team of physicians at UConn Healths Calhoun Cardiology Center, including cardiologist Dr. Jason Ryan and electrophysiologist Dr. Christopher Pickett. Since she was first diagnosed with cardiomyopathy in 2009, she has been treated for its complications. These include atrial fibrillation, the most common form of arrhythmia, and ventricular tachycardia, life-threatening and chaotic heart beats that can cause premature or sudden death. To protect her heart against dangerous arrhythmias, Agar takes daily medication; has received cardioversions (which convert an arrhythmia to a normal rhythm) and an ablation procedure (the destruction of tinyparts of heart tissue with radio frequency waves that are triggering arrhythmia); and has an implantable cardio-defibrillator.

As a result of the personalized team approach among the cardiologists who care for her at the Calhoun Cardiology Center, Agars heart function has been nearly normalized. She is grateful to the entire team.

Ive been fortunate, she says. UConns cardiac health team and their staff have been very supportive. They are truly experts in their field and treat me in a very professional and personal manner. They welcome questions and listen to my concerns. They convey the feeling that they truly care about my well-being.

Cardiomyopathy is the most common cause of heart failure. While it can be a genetic condition, it can also be caused by a heart attack or unhealthy lifestyle.

Agar advises others who may have a recurring theme of heart trouble in their family to seek care and not ignore it. With appropriate treatment, she says, cardiac problems dont necessarily have to significantly impact your quality of life. Remember that you are in charge of your own health. Pay attention to the advice of your health care professionals and do those things that are necessary for good health.

To learn more about the Calhoun Cardiology Center at UConn Health, visit: health.uconn.edu/cardiology.

Read the rest here:
Cardiovascular Genetic Testing Empowers Patient, Family - UConn Today

While a number of companies have dabbled in this space, the following players are facilitating the development of iPS cell therapies: Cellular Dynamics International (CDI),Cynata Therapeutics, RIKEN, and Astellas (previously Ocata Therapeutics).

While each iPS cell therapy group is considered in detail below, Cellular Dynamics International (CDI) is featured first, because it dominates the iPSC industry. CDI also recently split into two business units, a Life Science Unit and a Therapeutics Unit, demonstrating a commercial strategy for its iPS cell therapy development.

Founded in 2004 and listed on NASDAQ in July 2013, Cellular Dynamics International (CDI) is headquartered in Madison, Wisconsin. The company is known for itsextremely robust patent portfolio containing more than 900 patents.

According to the company, CDI is the worlds largest producer of fully functional human cells derived from induced pluripotent stem (iPS) cells.[1] Their trademarked, iCell Cardiomyocytes, derived from iPSCs, are human cardiac cells used to aid drug discovery, improve the predictability of a drugs worth, and screen for toxicity. In addition, CDI provides: iCell Endothelial Cells for use in vascular-targeted drug discovery and tissue regeneration, iCell Hepatocytes, and iCell Neurons for pre-clinical drug discovery, toxicity testing, disease prediction, and cellular research.[2]

Induced pluripotent stem cells were first produced in 2006 from mouse cells and in 2007 from human cells, by Shinya Yamanaka at Kyoto University,[3] who also won the Nobel Prize in Medicine or Physiology for his work on iPSCs.[4] Yamanaka has ties toCellular Dynamics International as a member of the scientific advisory board of iPS Academia Japan. IPS Academia Japan was originally established to manage the patents and technology of Yamanakas work, and is now the distributor of several of Cellular Dynamics products, including iCell Neurons, iCell Cardiomyocytes, and iCell Endothelial Cells.[5]

Importantly, in 2010 Cellular Dynamics became the first foreign company to be granted rights to use Yamanakas iPSC patent portfolio.Not only has CDI licensed rights to Yamanakas patents, but it also has a license to use Otsu, Japan-based Takara Bios RetroNectin product, which it uses as a tool to produce its iCell and MyCell products.[6]

Furthermore, in February 2015, Cellular Dynamics International announcedit would be manufacturing cGMP HLA Superdonor stem cell lines that will support cellular therapy applications through genetic matching.[8] Currently, CDI has two HLA superdonor cell lines that provide a partial HLA match to approximately 19% of the population within the U.S., and it aims to expand its master stem cell bank by collecting more donor cell lines that will cover 95% of the U.S. population.[9]The HLA superdonor cell lines were manufactured using blood samples, and used to produce pluripotent iPSC lines, giving the cells the capacity to differentiate into nearly any cell within the human body.

On March 30, 2015, Fujifilm Holdings Corporation announced that it was acquiring CDI for $307 million, allowingCDI tocontinue to run its operations in Madison, Wisconsin, and Novato, California as a consolidated subsidiary of Fujifilm.[14] A key benefit of the merger is that CDIs technology platform enables the production of high-quality fully functioning iPSCs (and other human cells) on an industrial scale, while Fujifilm has developed highly-biocompatible recombinant peptidesthat can be shaped into a variety of forms for use as a cellular scaffoldin regenerative medicinewhen used in conjunction with CDIs products.[15]

Additionally, Fujifilm has been strengthening its presence in the regenerative medicine field over the past several years, including a recent A$4M equity stake in Cynata Therapeutics and anacquisition ofJapan Tissue Engineering Co. Ltd.in December 2014. Most commonly called J-TEC, Japan Tissue Engineering Co. Ltd. successfully launched the first two regenerative medicine products in the country of Japan.According toKaz Hirao, CEO of CDI, It is very important for CDI to get into the area of therapeutic products, and we can accelerate this by aligning it with strategic and technical resources present within J-TEC.

Kaz Hirao also states,For our Therapeutic businesses, we will aim to file investigational new drugs (INDs) with the U.S. FDA for the off-the-shelf iPSC-derived allogeneic therapeutic products. Currently, we are focusing on retinal diseases, heart disorders, Parkinsons disease, and cancers. For those four indicated areas, we would like to file several INDs within the next five years.

Finally, in September 2015, CDI againstrengthened its iPS cell therapycapacity by setting up a new venture, Opsis Therapeutics. Opsis is focused on discovering and developing novel medicines to treat retinal diseases and is apartnership with Dr. David Gamm, the pioneer of iPS cell-derived retinal differentiation and transplantation.

In summary, several key events indicate CDIs commitment to developing iPS cell therapeutics, including:

Australian stem cell company Cynata Therapeutics (ASX:CYP) is taking a unique approachby creating allogeneic iPSC derived mesenchyal stem cell (MSCs)on a commercial scale.Cynatas Cymerus technology utilizes iPSCs provided by Cellular Dynamics International, a Fujifilm company, as the starting material for generating mesenchymoangioblasts (MCAs), and subsequently, for manufacturing clinical-gradeMSCs.According to Cynatas Executive Chairman Stewart Washer who was interviewed by The Life Sciences Report, The Cymerus technology gets around the loss of potency with the unlimited iPS cellor induced pluripotent stem cellwhich is basically immortal.

OnJanuary 19, 2017, Fujifilm took anA$3.97 million (10%) strategic equity stakein Cynata, positioning the parties to collaborate on the further development and commercialisation of Cynatas lead Cymerus therapeutic MSC product CYP-001 for graft-versus-host disease (GvHD). (CYP-001 is the product designation unique to the GVHD indication). The Fujifilm partnership also includes potential future upfront and milestone payments in excess of A$60 million and double-digit royalties on CYP-001 product net sales for Cynata Therapeutics, as well as strategic relationship for potential future manufacture of CYP-001 and certain rights to other Cynata technology.

One of the key inventors of Cynatas technology is Igor Slukvin, MD, Ph.D., Scientific Founder of Cellular Dynamics International (CDI) and Cynata Therapeutics. Dr. Slukvin has released more than 70 publications about stem cell topics, including the landmark article in Cell describing the now patented Cymerus technique. Dr. Slukvins co-inventor is Dr. James Thomson, the first person to isolate an embryonic stem cell (ESC) and one of the first people to create a human induced pluripotent stem cell (hiPSC). Dr. James Thompson was theFounder of CDI in 2004.

There are three strategic connections between Cellular Dynamics International (CDI) and Cynata Therapeutics, which include:

Recently, Cynata received advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA) that its Phase I clinical trial application has been approved, titledAn Open-Label Phase 1 Study to Investigate the Safety and Efficacy of CYP-001 for the Treatment of Adults With Steroid-Resistant Acute Graft Versus Host Disease. It will be the worlds first clinical trial involving a therapeutic product derived from allogeneic (unrelated to the patient) induced pluripotent stem cells (iPSCs).

Participants for Cynatas upcoming Phase I clinical trial will be adults who have undergone an allogeneic haematopoietic stem cell transplant (HSCT) to treat a haematological disorder and subsequently been diagnosed with steroid-resistant Grade II-IV GvHD.The primary objective of the trial is to assess safety and tolerability, while the secondary objective is to evaluate the efficacy of two infusions of CYP-001 in adults with steroid-resistant GvHD.

Using Professor Yamankas Nobel Prize winning achievement of ethically uncontentious iPSCs and CDIs high quality iPSCs as source material, Cynata has achieved two world firsts:

Cynata has also released promising pre-clinical data in Asthma, Myocardial Infarction (Heart Attack), andCritical Limb Ischemia.

There are four key advantages of Cynatas proprietary Cymerus MSC manufacturing platform.Because the proprietary Cymerus technology allows nearly unlimited production of MSCs from a single iPSC donor, there is batch-to-batch uniformity. Utilizing a consistent starting material allows for a standardized cell manufacturing process and a consistent cell therapy product. Unlike other companies involved with MSC manufacturing, Cynata does not require a constant stream of new donors in order to source fresh stem cells for its cell manufacturing process, nor does it require the massive expansion of MSCs necessitated by reliance on freshly isolated donations.

Finally, Cynata has achieved a cost-savings advantage through its uniqueapproach to MSCmanufacturing. Its proprietary Cymerus technology addresses a critical shortcoming in existing methods of production of MSCs for therapeutic use, which is the ability to achieve economic manufacture at commercial scale.

On June 22, 2016, RIKEN announced that it is resuming its retinal induced pluripotent stem cell (iPSC) study in partnership with Kyoto University.

2013 was the first time in which clinical research involving transplant of iPSCs into humans was initiated, led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB)in Kobe, Japan. Dr. Takahashi and her team wereinvestigating the safety of iPSC-derived cell sheets in patients with wet-type age-related macular degeneration. Althoughthe trial was initiated in 2013 and production of iPSCs from patients began at that time, it was not until August of 2014 that the first patient, a Japanese woman, was implanted with retinal tissue generated using iPSCs derived from her own skin cells.

A team of three eye specialists, led by Yasuo Kurimoto of the Kobe City Medical Center General Hospital, implanted a 1.3 by 3.0mm sheet of iPSC-derived retinal pigment epithelium cells into the patients retina.[196]Unfortunately, the study was suspended in 2015 due to safety concerns. As the lab prepared to treat the second trial participant, Yamanakas team identified two small genetic changes in the patients iPSCs and the retinal pigment epithelium (RPE) cells derived from them. Therefore, it is major news that theRIKEN Institute will now be resuming the worlds first clinical study involving the use of iPSC-derived cells in humans.

According to the Japan Times, this attempt at the clinical studywill involve allogeneic rather than autologous iPSC-derived cells for purposes of cost and time efficiency.Specifically,the researchers will be developing retinal tissues from iPS cells supplied by Kyoto Universitys Center for iPS Cell Research and Application, an institution headed by Nobel prize winner Shinya Yamanaka. To learn about this announcement, view this article fromAsahi Shimbun, aTokyo- based newspaper.

In November 2015 Astellas Pharma announced it was acquiring Ocata Therapeutics for $379M. Ocata Therapeutics is a biotechnology company that specializes in the development of cellular therapies, using both adult and human embryonic stem cells to develop patient-specific therapies. The companys main laboratory and GMP facility is in Marlborough, Massachusetts, and its corporate offices are in Santa Monica, California.

When a number of private companies began to explore the possibility of using artificially re-manufactured iPSCs for therapeutic purposes, one such company that was ready to capitalize on the breakthrough technology was Ocata Therapeutics, at the time called Advanced Cell Technology. In 2010, the company announced that it had discovered several problematic issues while conducting experiments for the purpose of applying for U.S. Food and Drug Administration approval to use iPSCs in therapeutic applications. Concerns such as premature cell death, mutation into cancer cells, and low proliferation rates were some of the problems that surfaced. [17]

As a result, the company shifted its induced pluripotent stem cell approach to producingiPS cell-derived human platelets, as one of the benefits of a platelet-based product is that platelets do not contain nuclei, and therefore, cannot divide or carry genetic information. While the companys Induced Pluripotent Stem Cell-Derived Human Platelet Program received a great deal of media coverage in late 2012, including being awarded the December 2012 honor of being named one of the 10 Ideas that Will Shape the Yearby New Scientist Magazine,[178] unfortunately the company did not succeed in moving the concept through to clinical testing in 2013.

Nonetheless, Astellas is clearly continuing to develop Ocatas pluripotent stem cell technologies involving embryonic stem cells (ESCs) and induced pluripotent stem cells (iPS cells). In a November 2015 presentation by Astellas President and CEO, Yoshihiko Hatanaka, he indicated that the company will aim to develop an Ophthalmic Disease Cell Therapy Franchise based around its embryonic stem cell (ESC) and induced pluripotent stem cell (iPS cell) technology. [19]

Footnotes [1] CellularDynamics.com (2014). About CDI. Available at: http://www.cellulardynamics.com/about/index.html. Web. 1 Apr. 2015. [2] Ibid. [3] Takahashi K, Yamanaka S (August 2006).Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors.Cell126(4): 66376. [4] 2012 Nobel Prize in Physiology or Medicine Press Release. Nobelprize.org. Nobel Media AB 2013. Web. 7 Feb 2014. Available at: http://www.nobelprize.org/nobel_prizes/medicine/laureates/2012/press.html. Web. 1 Apr. 2015. [5] Striklin, D (Jan 13, 2014). Three Companies Banking on Regenerative Medicine. Wall Street Cheat Sheet. Retrieved Feb 1, 2014 from, http://wallstcheatsheet.com/stocks/3-companies-banking-on-regenerative-medicine.html/?a=viewall. [6] Striklin, D (2014). Three Companies Banking on Regenerative Medicine. Wall Street Cheat Sheet [Online]. Available at: http://wallstcheatsheet.com/stocks/3-companies-banking-on-regenerative-medicine.html/?a=viewall. Web. 1 Apr. 2015. [7] Cellular Dynamics International (July 30, 2013). Cellular Dynamics International Announces Closing of Initial Public Offering [Press Release]. Retrieved from http://www.cellulardynamics.com/news/pr/2013_07_30.html. [8] Investors.cellulardynamics.com,. Cellular Dynamics Manufactures Cgmp HLA Superdonor Stem Cell Lines To Enable Cell Therapy With Genetic Matching (NASDAQ:ICEL). N.p., 2015. Web. 7 Mar. 2015. [9] Ibid. [10] Cellulardynamics.com,. Cellular Dynamics | Mycell Products. N.p., 2015. Web. 7 Mar. 2015. [11]Sirenko, O. et al. Multiparameter In Vitro Assessment Of Compound Effects On Cardiomyocyte Physiology Using Ipsc Cells.Journal of Biomolecular Screening18.1 (2012): 39-53. Web. 7 Mar. 2015. [12] Sciencedirect.com,. Prevention Of -Amyloid Induced Toxicity In Human Ips Cell-Derived Neurons By Inhibition Of Cyclin-Dependent Kinases And Associated Cell Cycle Events. N.p., 2015. Web. 7 Mar. 2015. [13] Sciencedirect.com,. HER2-Targeted Liposomal Doxorubicin Displays Enhanced Anti-Tumorigenic Effects Without Associated Cardiotoxicity. N.p., 2015. Web. 7 Mar. 2015. [14] Cellular Dynamics International, Inc. Fujifilm Holdings To Acquire Cellular Dynamics International, Inc.. GlobeNewswire News Room. N.p., 2015. Web. 7 Apr. 2015. [15] Ibid. [16]Cyranoski, David. Japanese Woman Is First Recipient Of Next-Generation Stem Cells. Nature (2014): n. pag. Web. 6 Mar. 2015. [17] Advanced Cell Technologies (Feb 11, 2011). Advanced Cell and Colleagues Report Therapeutic Cells Derived From iPS Cells Display Early Aging [Press Release]. Available at: http://www.advancedcell.com/news-and-media/press-releases/advanced-cell-and-colleagues-report-therapeutic-cells-derived-from-ips-cells-display-early-aging/. [18] Advanced Cell Technology (Dec 20, 2012). New Scientist Magazine Selects ACTs Induced Pluripotent Stem (iPS) Cell-Derived Human Platelet Program As One of 10 Ideas That Will Shape The Year [Press Release]. Available at: http://articles.latimes.com/2009/mar/06/science/sci-stemcell6. Web. 9 Apr. 2015. [19] Astellas Pharma (2015). Acquisition of Ocata Therapeutics New Step Forward in Ophthalmology with Cell Therapy Approach. Available at: https://www.astellas.com/en/corporate/news/pdf/151110_2_Eg.pdf. Web. 29 Jan. 2017.

Read the original post:
Market Players Developing iPS Cell Therapies