Test predicts response to treatment for complication of leukemia stem cell treatment

(New York City) A new test may reveal which patients will respond to treatment for graft versus host disease (GVHD), an often life-threatening complication of stem cell transplants (SCT) used to treat leukemia and other blood disorders, according to a study led by researchers at the Icahn School of Medicine at Mount Sinai and published online today in the journal Lancet Haematology and in print in the January issue.

Patients with fatal blood cancers like leukemia often require allogenic stem cell SCT to survive. Donor stem cells are transplanted to a recipient, but not without the risk of developing GVHD, a life-threatening complication and major cause of death after SCT. The disease, which can be mild to severe, occurs when the transplanted donor cells (known as the graft) attack the patient (referred to as the host). Symptom severity, however, does not accurately define how patients will respond to treatment and patients are often treated alike with high-dose steroids. Although SCT cures cancer in 50 percent of the patients, 25 percent die from relapsed cancer and there remaining go into remission but later succumb to effects of GVHD.

"High dose steroids is the only proven treatment for GVHD," said James L. M. Ferrara, MD, DSc, Ward-Coleman Chair in Cancer Medicine Professor at the Icahn School of Medicine at Mount Sinai, Director of Hematologic Malignancies Translational Research Center at Tisch Cancer Institute at Mount Sinai. "Those with low-risk GVHD are often over-treated and face significant side-effects from treatment. Patients with high risk GVHD are undertreated and the GVHD progresses, often with fatal consequences. Our goal is to provide the right treatment for each patient. We hope to identify those patients at higher risk and design an aggressive intervention while tailoring a less-aggressive approach for those with low-risk."

Dr. Ferrara, along with a multi-center team of researchers, developed and tested this new scoring system using almost 500 patient blood samples with newly diagnosed GVHD in varying grades from two different centers. They used three validated biomarkers TNFR1, ST2 and Reg3 to create an algorithm that calculated the probability of non-relapse mortality (usually caused by GVHD) that provided three distinct risk scores to predict the patient's response to GVHD treatment.

The acid test was to evaluate the algorithm in a validation set of 300 additional patients from twenty different SCT centers throughout the US. The algorithm worked perfectly, and the cumulative incidence of non-relapse mortality significantly increased as the GVHD score increased, and so the response rate to primary GVHD treatment decreased.

"This new scoring system will help identify patient who may not respond to standard treatments, and may require an experimental and more aggressive approach," said Dr. Ferrara. "And it will also help guide treatment for patients with lower-risk GVHD who may be over-treated. This will allow us to personalize treatment at the onset of the disease. Future algorithms will prove increasingly useful to develop precision medicine for all SCT patients."

In order to capitalize on this discovery, Dr. Ferrara has created the Mount Sinai Acute GVHD International Consortium (MAGIC) which consists of a group of ten SCT centers in the US and Europe who will collaborate to use this new scoring system to test new treatments for acute GVHD. Dr. Ferrara and colleagues have also written a protocol to treat high-risk GVHD that has been approved by the FDA.

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Co-collaborators included University of Michigan, University of Regensburg, and the Blood and Marrow Clinical Trials Network.

The study was supported by grants from the National Cancer Institute; the National Heart, Lung, and Blood Institute, the National Institute of Allergy and Infectious Diseases, the Doris Duke Charitable Fund, the American Cancer Society, and the Judith Devries Fund.

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Test predicts response to treatment for complication of leukemia stem cell treatment

Test Predicts Response to Early Treatment for Dangerous Complication of Stem Cells Transplants Used in Leukemia Patients

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Newswise (New York City) A new test may reveal which patients will respond to treatment for graft versus host disease (GVHD), an often life-threatening complication of stem cell transplants (SCT) used to treat leukemia and other blood disorders, according to a study led by researchers at the Icahn School of Medicine at Mount Sinai and published online today in the journal Lancet Haematology and in print in the January issue.

Patients with fatal blood cancers like leukemia often require allogenic stem cell SCT to survive. Donor stem cells are transplanted to a recipient, but not without the risk of developing GVHD, a life-threatening complication and major cause of death after SCT. The disease, which can be mild to severe, occurs when the transplanted donor cells (known as the graft) attack the patient (referred to as the host). Symptom severity, however, does not accurately define how patients will respond to treatment and patients are often treated alike with high-dose steroids. Although SCT cures cancer in 50 percent of the patients, 25 percent die from relapsed cancer and there remaining go into remission but later succumb to effects of GVHD.

High dose steroids is the only proven treatment for GVHD, said James L. M. Ferrara, MD, DSc, Ward-Coleman Chair in Cancer Medicine Professor at the Icahn School of Medicine at Mount Sinai, Director of Hematologic Malignancies Translational Research Center at Tisch Cancer Institute at Mount Sinai. Those with low-risk GVHD are often over-treated and face significant side-effects from treatment. Patients with high risk GVHD are undertreated and the GVHD progresses, often with fatal consequences. Our goal is to provide the right treatment for each patient. We hope to identify those patients at higher risk and design an aggressive intervention while tailoring a less-aggressive approach for those with low-risk.

Dr. Ferrara, along with a multi-center team of researchers, developed and tested this new scoring system using almost 500 patient blood samples with newly diagnosed GVHD in varying grades from two different centers. They used three validated biomarkers TNFR1, ST2 and Reg3 to create an algorithm that calculated the probability of non-relapse mortality (usually caused by GVHD) that provided three distinct risk scores to predict the patients response to GVHD treatment.

The acid test was to evaluate the algorithm in a validation set of 300 additional patients from twenty different SCT centers throughout the US. The algorithm worked perfectly, and the cumulative incidence of non-relapse mortality significantly increased as the GVHD score increased, and so the response rate to primary GVHD treatment decreased.

This new scoring system will help identify patient who may not respond to standard treatments, and may require an experimental and more aggressive approach, said Dr. Ferrara. And it will also help guide treatment for patients with lower-risk GVHD who may be over-treated. This will allow us to personalize treatment at the onset of the disease. Future algorithms will prove increasingly useful to develop precision medicine for all SCT patients.

In order to capitalize on this discovery, Dr. Ferrara has created the Mount Sinai Acute GVHD International Consortium (MAGIC) which consists of a group of ten SCT centers in the US and Europe who will collaborate to use this new scoring system to test new treatments for acute GVHD. Dr. Ferrara and colleagues have also written a protocol to treat high-risk GVHD that has been approved by the FDA.

Co-collaborators included University of Michigan, University of Regensburg, and the Blood and Marrow Clinical Trials Network.

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Test Predicts Response to Early Treatment for Dangerous Complication of Stem Cells Transplants Used in Leukemia Patients

Cost of Stem Cell Treatment in Europe l Placid Answers – Video

Cost of Stem Cell Treatment in Europe l Placid Answers
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Cost of Stem Cell Treatment in Europe l Placid Answers - Video

Family: Experimental stem-cell treatment does wonders for Gordie Howe

Updated DEC 19, 2014 6:19p ET

Call it a Christmas miracle. That's pretty much the way Gordie Howe's family is describing his extraordinary recovery -- thanks to an experimental stem-cell treatment -- from a series of strokes that appeared to threaten the 86-year-old hockey legend's life only a few weeks ago.

"This is truly a Christmas miracle," said Dr. Murray Howe, a Toledo physician and one of Gordie's four children. "I would not have believed it if I hadn't seen it with my own eyes. "

Howe, gravely ill at the time, underwent the treatment on Dec. 8 in San Diego.

"As a family, we are thrilled that Dad's quality of life has greatly improved, and his progress has exceeded our greatest expectations," the Howe family said Friday in a news release in which it thanked a legion of fans praying for its father's recovery. "Once again, we cannot emphasize how much you have fueled Mr. Hockey's recovery, and we thank everyone for their continued prayers and support."

The neural stem cells were injected into the spinal canal on Day 1 and mesenchymal stem cells by intravenous infusion on Day 2, according to the release.

"His response was truly miraculous," the family said. "At the end of Day 1, he was walking with minimal effort for the first time since his stroke. By Day 2, he was conversing comfortably with family and staff at the clinic. On the third day, he walked to his seat on the plane under his own power."

Just five days later, Howe was walking unaided and even taking part in daily household chores, according to the release.

When tested, his ability to name items has gone from less than 25 percent before the procedure to 85 percent today, the release said.

"His physical therapists have been astonished," the family said. "Although his short-term memory, strength, endurance and coordination have plenty of room for improvement, we are hopeful that he will continue to improve in the months to come."

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Family: Experimental stem-cell treatment does wonders for Gordie Howe

Gordie Howe's condition improves after stem-cell treatment

Hockey legendGordie Howehas made strides in his recovery from a stroke after underdoing adult stem-cell treatment earlier this month inMexico.

The 86-year-old Howe had a significant stroke in October and his family said in an update on Friday that he has shown significant improvement since participating in a clinical trial.

In a statement issued through theDetroit Red Wings, the family described the procedure and his recovery:

"Following the press coverage of our father's deteriorating medical condition, the Howe family was contacted in late November by Dr.Maynard Howe(CEO) andDave McGuigan(VP) ofStemedica Cell Technologies. McGuigan knew our family as a result of his previous employment with theDetroit Red Wings.

"Stemedica is abiotechnologycompany that manufactures allogeneic adultstem cellsin itsU.S. governmentlicensed,cGMP facilityinSan Diego,California. Although no relation, Dr. Howe and his brothers Drs. David and Roger are hockey players and bigGordie Howefans, having grown up inMinnesota. They wished to help our father by generously facilitating Dad's participation in a stem cell clinical trial at Novastem, a licensed distributor of Stemedica's products inMexico.

Novastem (www.novastem.mx) is currently conducting federally licensed andInstitutional Review Boardapproved clinical trials for several medical conditions, including stroke, using Stemedica's stem cell products. At the time, we were contacted, Mr. Hockey had been rapidly declining and was essentially bedridden with little ability to communicate or to eat on his own.

"After reviewing the information on Stemedica and Novastem, our family decided to give our father this opportunity. On December 8, Mr. Hockey underwent a two-day, non-surgical treatment at Novastem's medical facility. The treatment included neuralstem cellsinjected into the spinal canal on Day 1 and mesenchymalstem cellsby intravenous infusion on Day 2. His response was truly miraculous. At the end of Day 1, he was walking with minimal effort for the first time since his stroke. By Day 2, he was conversing comfortably with family and staff at the clinic.

"On the third day, he walked to his seat on the plane under his own power. By Day 5, he was walking unaided and taking part in helping out with daily household chores. When tested, his ability to name items has gone from less than 25 percent before the procedure to 85 percent today. His physical therapists have been astonished. Although his short-term memory, strength, endurance and coordination have plenty of room for improvement, we are hopeful that he will continue to improve in the months to come.

"As a family, we are thrilled that Dad's quality of life has greatly improved, and his progress has exceeded our greatest expectations. Once again, we cannot emphasize how much you have fueled Mr. Hockey's recovery and we thank everyone for their continued prayers and support."

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Gordie Howe's condition improves after stem-cell treatment

First stem-cell therapy approved for medical use in Europe

This treatment will only be allowed under carefully defined conditions, however, so that the outcomes can be carefully monitored to see if the treatment works and doesnt have any unexpected side-effects.

Stem cells can act as a repair system for the body.

Limbal stem cells are located in the eye at the border between the cornea the clear front part of the eye - and the sclera the white of the eye.

Physical or chemical burns can cause loss of these stem cells, resulting in limbal stem cell deficiency, LSCD, a condition that is estimated to affect about 3.3 out of 100,000 people in the European Union and around 650 people in Britain.

Symptoms include pain, sensitivity to light, inflammation, excessive blood vessel growth, clouding of the cornea, and eventually blindness.

In LSCD the limbal stem cells become so diminished that they eyes can no longer make new cells to repair damage.

The new treatment takes a small sample of the patients healthy cornea, removes the stem cells and grows them until there are sufficient numbers to put back into the eye. The cells themselves then repair the damage.

Moorfields Eye Hospital in London has successfully treated around 20 people with Holocar so far in trials.

Prof Chris Mason, from University College London, told the BBC: "This move would enable far more people to access it, you could now prescribe this."

The EMA decision to approve Holoclar will now be sent to the European Commission for market authorization. It will then be up to Nice to decide whether to approve the therapy for use on the NHS.

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First stem-cell therapy approved for medical use in Europe

Howe's Family Reports Rapid Improvement

Gordie Howe's family says the hockey great has made a dramatic improvement after he participated in a stem cell clinical trial.

The 86-year-old Howe had a serious stroke in late October, but in a statement released through the Detroit Red Wings on Friday, his family said his physical therapists have been "astonished" by his progress.

Executives from Stemedica Cell Technologies contacted the family and facilitated Howe's participation in the clinical trial. He had a two-day, non-surgical treatment earlier this month.

"The treatment included neural stem cells injected into the spinal canal on Day 1 and mesenchymal stem cells by intravenous infusion on Day 2," the family said. "His response was truly miraculous. At the end of Day 1 he was walking with minimal effort for the first time since his stroke. By Day 2 he was conversing comfortably with family and staff at the clinic."

The family says Howe has been able to help out with daily household chores, and when tested, his ability to name items has gone from less than 25 percent before the treatment to 85 percent.

"Although his short-term memory, strength, endurance and coordination have plenty of room for improvement, we are hopeful that he will continue to improve in the months to come," the family said. "As a family, we are thrilled that dad's quality of life has greatly improved, and his progress has exceeded our greatest expectations."

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Howe's Family Reports Rapid Improvement

Howe shows steady progress following stem cell treatment

Saturday, 20 December 2014 12:07

LOS ANGELES: Detroit Red Wings legend Gordie Howe has made an "astonishing" recovery after receiving stem cell treatment earlier this month from a Mexico-based medical firm, the Howe family said on Friday.

The 86-year-old Hall of Famer, who suffers from severe dementia, has gone from being bedridden in a semi-comatose state to walking on his own and doing daily chores as he "shuffles" around his daughter's Texas home, the family said in a statement.

"We are thrilled that Dad's quality of life has greatly improved, and his progress has exceeded our greatest expectations," the family wrote.

Howe underwent two days of a stem cell clinical trial from Tijuana-based firm Novastem. Two days after the start of treatment Howe was talking to the nurses, the family said.

After three days he left the hospital and walked on his own to the airplane, and after five days he was "taking part in helping out with household chores."

The family said his treatment included injecting neural stem cells into the spinal canal.

"His response was truly miraculous. His short-term memory, strength, endurance and coordination have plenty of room for improvement. We are hopeful that he will continue to improve in the months to come."

Howe suffered a serious stroke on October 26 and because of his deteriorating condition he had to be hospitalized at the beginning of December.

Confined to his bed and unable to speak or communicate, Howe had to rely on the nurses and family to feed him. Doctors said at one point he was "unresponsive" for 30 minutes.

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Howe shows steady progress following stem cell treatment

Stem cells born out of indecision

PUBLIC RELEASE DATE:

18-Dec-2014

Contact: Joshua Brickman joshua.brickman@sund.ku.dk 45-51-68-04-38 University of Copenhagen - The Faculty of Health and Medical Sciences

This latest research by Joshua Brickman and his research team from Danish Stem Cell Center (Danstem) at the University of Copenhagen specifically found that inhibiting or blocking stem cells ability to make a specific decision, leads to better cell growth and could lead to defined ways to differentiate stem cells.

This research is the first comprehensive analysis of a pathway important for stem and cancer cell decisions known as Erk. As a result this work could contain clues to cancer treatment as well as helping to establish a platform to make stem cell treatments for gut related disorders like the pancreas or the liver.

The research results have just been published in Cell Reports.

Blocking choices

"If you block all the choices they can make, they stay in the stem cell state. If you only allow them one door to exit from the stem cell state, you should be able to make particular cell types more efficiently. So if you only leave one door open then it's the path of least resistance and when you give them a push they really go," says Professor Joshua Brickman.

As embryonic stem cells can become any cell type in the body, they have to make choices. Based on this research, it appears that blocking these choices is the key to making them grow as stem cells. In other words, if these choices are removed the cells simply reproduce more stem cells.

Embryonic stem cells

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Stem cells born out of indecision

Europe boosts stem cell patent rights

Cultures of ISCOs parthenogenetic stem cells, made from unfertilized human egg cells.

Stem cells produced by Carlsbad's International Stem Cell Corp. can be patented, a European court ruled Thursday. The decision allows the biotech company to get patents for its stem cells made from unfertilized, or parthenogenetic, human egg cells.

In related news, the company said Thursday it plans to apply by the end of the year to do a clinical trial of a Parkinson's treatment derived from its parthenogenetic cells.

The trial should begin in a couple of months, said Simon Craw, the company's executive vice president of business development. The company will need to raise about $5 million for the trial, he said.

International Stem Cell is developing these cells as an alternative to human embryonic stem cells, which many regard as morally wrong. Moreover, the parthenogenetic cells have a reduced tendency to cause immune reactions when transplanted, which could make them an attractive use for therapy.

The European Union forbids patents on the use of human embryos, the source of embryonic stem cells. Patent applications in the United Kingdom and other countries for parthenogenetic cells have been held up because dividing parthenogenetic cells resemble embryos.

However, the Court of Justice of the European Union in Luxembourg ruled that parthenogenetic cells are not embryos, so cells made from them are eligible for patenting. While the structures look like embryos, they stop growing in a few days and die.

"In todays judgment, the Court holds that, in order to be classified as a human embryo, a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being," the European court said in a press release. "Consequently, the mere fact that a parthenogenetically-activated human ovum commences a process of development is not sufficient for it to be regarded as a human embryo."

Shares of the company closed after the decision at 8 cents, up 1 cent for the day.

The decision is a great turning point in the legal struggle to patent parthenogenetic stem cells in Europe, Craw said.

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Europe boosts stem cell patent rights