Time to shine

A Clarenville couple is hoping their ordeal with leukemia is over after receiving a stem cell transplant from an anonymous donor from Halifax.

In 2008, Janice Davidson was diagnosed with Acute Myeloid Leukemia and immediately underwent an aggressive series of treatments.

The first time around her cancer was put into remission quite quickly.

She was cancer for free for almost two years when it came back in 2011.

The next step in the treatment process was to do a stem cell transplant using Janice's own stem cells instead of a donor's.

In layman's terms, it is a process in which stem cells are taken out and then put back in the patient after they are put in remission.

Janice's husband, Ian Davidson, says she had a difficult time with the process but came through the ordeal and was cancer free for another year and a half.

Then the cancer came back again.

"This time, our only option was the stem cells of a donor, because her system is clearly broken. Janice didn't have a match in her own family, only 25 per cent of people find matches within their own family so it's not as high as you would think," says Davidson.

It's much more desirable to have a match in the family because there are more genetic markers that are similar and it reduces the risk of a phenomenon called graft-versus-host disease, a complication associated with stem cell or bone marrow transplant. When the body recognizes that it's not its original cells, the body can attack itself. It can be very mild or it can be life threatening.

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Time to shine

Ottawa research team leading study that allows heart to heal itself

OTTAWA A team of cardiac researchers led by Ottawa scientists has launched groundbreaking clinical trials of a stem cell therapy that helps the heart heal itself.

About 70,000 Canadians have a heart attack each year. While many patients return to health after treatment, others suffer from scarring, which affects the chance of long-term survival.

Scar tissue leads to stretching of the heart and that leads to consequences, including heart failure and early death, says Dr. Duncan Stewart, the CEO and scientific director of the Ottawa Hospital Research Institute and the trials lead principal investigator.

This trial enlists stem cells and their amazing ability to help organs regenerate. The first study participant is Harriet Garrow, 68, who had a heart attack on July 2 at home in Cornwall.

After her heart stopped beating, Garrow was resuscitated by paramedics and taken to a hospital in Cornwall, then transferred to the University of Ottawa Heart Institute.

She received all available heart attack therapies, including opening up a blocked artery with a balloon catheter, but her heart had still had extensive damage. She agreed to the experimental therapy and had an infusion on July 25.

Like all the participants, Garrow doesnt know if she received stem cells, lab-enhanced stem cells or a placebo. But she notes that on Sunday she walked up the 13 stairs in her home for the first time since her heart attack.

I feel good, she says. Not quite back to normal, but better than last week.

In about a dozen studies on about 2,000 patients, stem cells have already been proven to have modest but promising benefits. The problem is heart attack patients stem cells dont have the same healing powers as those from young, healthy patients, says Stewart.

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Ottawa research team leading study that allows heart to heal itself

America Stem Cell, Inc. Receives FDA Clearance for Its Multi-Center Nationwide Trial

SAN ANTONIO--(BUSINESS WIRE)--

America Stem Cell, Inc. (ASC) announced today it has received clearance from FDA for its Phase I/IIa nationwide multi-center dual-umbilical cord transplantation study evaluating ASC-101 in patients with hematologic malignancies and myelodysplastic syndrome.

ASC-101 is currently undergoing evaluation in a single-center study at The University of Texas MD Anderson Cancer. To date, 12 patients have been enrolled in the study with 9 patients evaluable. On the basis of data obtained in the single-center study, FDA has given approval to proceed with a multi-center trial.

Enhancing umbilical cord stem cell engraftment into bone marrow in the dual cord transplant setting will improve clinical outcomes for patients with serious, life-threatening cancers and other disorders for which hematopoietic stem cell transplant is prescribed, said, Dr. Elizabeth Shpall, MD, Medical Director, Cell Therapy Laboratory and Director, Cord Blood Bank at M.D. Anderson Cancer Center and Study Chair on the ASC-101 Phase I/IIa clinical trial. Dr. Shpall has submitted an abstract to the upcoming American Society of Hematology (ASH) meeting in December describing the clinical results to date with ASC-101.

There is a significant unmet medical need to improve stem cell engraftment into bone marrow for patients undergoing umbilical cord transplantation, and America Stem Cell is committed to filling that need, said Dr. Linda Paradiso, Chief Development Officer at ASC. ASC-101 is a novel enzyme treatment that will potentially transform hematopoietic stem cell transplantation by accelerating patient immune system and platelet recovery, reducing opportunistic infections and other co-morbidities, and improving patient survival.

ASC was founded with the vision to make stem cell transplants safer and more efficacious for patients undergoing cell therapy. The expansion of this trial using ASC-101 in cancer patients undergoing stem cell transplantation is a major step forward in advancing the ASC clinical pipeline, said Lynnet Koh-LeMaire, Chief Executive Officer/Founder of America Stem Cell.

America Stem Cell is commercializing breakthrough platform technologies and products that enable cell-based therapies and immunotherapies across a wide range of indications. ASCs technologies target homing and engraftment of therapeutic cells to sites of ischemia, inflammation and disease for improved clinical efficacy and patient outcomes. The most advanced product (ASC-101), manufactured at Florida Biologix, is currently in PhI/IIa clinical trials for cord blood transplantation. ASCs second wave of products will expand the platform technology to a broad range of cell types and diseases.

About America Stem Cell, Inc.

America Stem Cell is a privately-held biotechnology company based in San Antonio, TX, with offices in San Diego, CA, and is dedicated to the development and commercialization of enabling technologies to enhance and expand the therapeutic potential of stem cell therapies. The key technology platforms (ASC-101 and ASC-102) are designed to improve the homing and engraftment of stem cells to target organs and increase their therapeutic potential for patients in need of hematopoietic stem cell transplantation. Additionally, these technologies have the potential to enhance efficacy in stem cell treatment of inflammation from chemotherapy/radiation, solid tumors, autoimmune diseases, and ischemic diseases including myocardial infarction and stroke. ASC has partnerships and collaborations with Kyowa Hakko Kirin, Spectrum Health Innovations, Florida Biologix, various medical research institutions including The University of Texas M.D. Anderson Cancer Center, Oklahoma Medical Research Foundation, Fred Hutchinson Cancer Center, University of California San Diego, the Sanford-Burnham Institute, Indiana University, Juvenile Diabetes Research Foundation, as well as corporate partnerships. For additional information, please contact Lynnet Koh at 760-612-6277, or view http://www.americastemcell.com.

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America Stem Cell, Inc. Receives FDA Clearance for Its Multi-Center Nationwide Trial

Youthful stem cells from bone can heal the heart, Temple scientists report

Public release date: 4-Sep-2013 [ | E-mail | Share ]

Contact: Jeremy Walter Jeremy.Walter@tuhs.temple.edu 215-707-7882 Temple University Health System

(Philadelphia, PA) - Many people who survive a heart attack find themselves back in the hospital with a failing heart just years later. And the outcome often is unfavorable, owing to limited treatment options. But scientists at Temple University School of Medicine's Cardiovascular Research Center (CVRC) recently found hope in an unlikely source stem cells in cortical, or compact, bone. In a new study, they show that when it comes to the regeneration of heart tissue, these novel bone-derived cells do a better job than the heart's own stem cells.

According to the study's senior investigator, Steven R. Houser, Ph.D., FAHA, Chairperson of Temple's Department of Physiology and Director of the CVRC, it is early days for cortical bone-derived stem cells (CBSCs). Nonetheless, his team's findings, featured on the cover of the August 16th issue of Circulation Research, have considerable implications for stem cell therapy for the heart.

A major challenge in the treatment of heart attack is early intervention, which is key to reducing the chances for long-term complications, such as heart failure. When it comes to stem cells, Houser said, "The strategy is to inject the cells right after [a heart attack]." Currently, though, that approach works only in animal studies. To make it work in humans, Houser explained, "we need cells right off the rack and ready to go clinically."

CBSCs could be those cells. Stem cells are youthful by degrees, and CBSCs are considered some of the most pluripotent like human newborns, nave and ready to become anything. But while CBSCs and similarly pluripotent stem cells retain the ability to develop into any cell type needed by the body and sometimes bring their youthful energy to the aid of mature cells making them especially appealing for therapeutics they also have the potential to wander off course, possibly landing themselves in unintended tissues. Cardiac stem cells, on the other hand, are a little more capable and a little more set in their ways, like toddlers. While they may need some coaxing into action, they are more likely to stay in their resident tissue.

To figure out how CBSCs might behave in the heart in the first place, Houser's team, led by Temple graduate student Jason Duran, began by collecting the cells from mouse tibias. The particular mice used had been engineered with green fluorescent protein (GFP), which meant that the CBSCs carried a green marker to allow for their later identification. The cells were then expanded in petri dishes in the laboratory before being injected directly into the hearts of non-GFP mice that had suffered heart attacks. Some mice received cardiac stem cells instead of CBSCs.

In the following weeks, as the team monitored the progress of the mice, they found that the youthfulness of the CBSCs had prevailed. The cells had triggered the growth of new blood vessels in the injured tissue, and six weeks after injection, they had differentiated, or matured, into heart muscle cells. While generally smaller than native heart cells, the new cells had the same functional capabilities, and overall they had improved survival and heart function. Similar improvements were not observed in the subset of mice treated with cardiac stem cells. Nor was there evidence in those mice that the cardiac cells had undergone differentiation.

The findings challenge the general assumption that cardiac stem cells, because they reside in the heart, are the cells most capable of repairing damaged heart tissue. For that reason, according to Houser, the new paper likely will be controversial.

"What we did generates as many questions as it does answers," he said. "Cell therapy attempts to repopulate the heart with new heart cells. But which cells should be used, and when they should be put into the heart are among many unanswered questions."

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Youthful stem cells from bone can heal the heart, Temple scientists report

4 UCLA stem cell researchers receive CIRM Early Translational grants

Public release date: 3-Sep-2013 [ | E-mail | Share ]

Contact: Shaun Mason smason@mednet.ucla.edu 310-206-2805 University of California - Los Angeles

Four researchers from UCLA's Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research have received Early Translational Research Awards totaling approximately $13 million from the California Institute for Regenerative Medicine, the state's stem cell agency. The UCLA researchers received four of the 12 total awards; no other institution received more than one.

The Independent Citizens Oversight Committee, CIRM's governing body, announced at its Aug. 28 meeting in La Jolla, Calif., that grant recipients included Dr. Jerome Zack, professor of medicine and microbiology, immunology and molecular genetics; Dr. Robert Reiter, Bing Professor of Urologic Research; Dr. Donald Kohn, professor of pediatrics and microbiology, immunology and molecular genetics in the life sciences; and Dr. Gerald Lipshutz, associate professor-in-residence of surgery, urology and medicine.

The grants are part of CIRM's Early Translational Research Initiative, which aims to advance promising, innovative discoveries using stem cells. In this "early translation" phase, scientists are expected to do research that will result in the development of drugs or cellular therapies to be used in FDA-approved clinical trials, translating discoveries from the laboratory to the clinic as quickly as possible.

"Our CIRM grants highlight the excellence of the UCLA bench-to-bedside research program," said Dr. Owen Witte, director of the Broad Stem Cell Research Center.

Dr. Jerome Zack, who has dedicated his career to finding a cure for HIV/AIDS, received a grant of approximately $5.3 million. His team is working to engineer blood-producing stem cells that will create T-cells, the foot soldiers of the immune system, which recognize and attack HIV. The engineered T-cells are to be given to patients through a bone marrow transplant, a one-time treatment that will provide an inexhaustible source of immune system cells capable of eliminating HIV-infected cells. This treatment would serve as a functional HIV cure with minimal adverse effects, a great improvement over the current standard of care with expensive, regularly given drug cocktails.

Dr. Robert Reiter, a prominent prostate cancer researcher, received approximately $4 million for his research in developing a type of drug called a monoclonal antibody to target castration-resistant prostate cancer stem cells. Castration-resistant prostate cancer is an aggressive, recurrent form of the disease. This potentially transformative treatment for cancer patients could eliminate the cancer stem cells responsible for recurrent disease and lead to long-term remissions.

Dr. Donald Kohn, whom CIRM president Alan Trounson acknowledged as a world leader in gene therapy, received approximately $1.8 million for his project to treat sickle cell disease, a genetic disorder in which red blood cells "sickle," causing pain crises and organ failure. Currently, the only effective treatment for sickle cell disease is a bone marrow transplant from a matched sibling donor. Kohn's team developed a gene editing technology to correct the sickle gene defect in the blood-forming stem cells. After collecting the patient's stem cells from the bone marrow, Kohn and his team will genetically modify the cells using the gene editing technology and transplant the corrected cells back into the patient. It is hoped that the new blood-forming stem cells will create healthy red blood cells that do not sickle, effectively curing the disease.

Dr. Gerald Lipshutz, a leading transplant surgeon, received approximately $1.8 million for his project to develop a treatment for a condition called arginase deficiency. This rare genetic disorder of the liver causes ammonia and an amino acid called arginine to accumulate gradually in the blood. The disease causes stiffness and muscle spasticity, slower than normal growth, developmental delay and eventually tremors, seizures and intellectual disability. Dr. Lipshutz and his team are seeking to develop a source of gene-corrected liver-like cells for treating patients with this disease. They will attempt to correct the genetic defect by using induced pluripotent stem cells (iPS cells) that they develop from the skin cells of patients. They then drive the iPS cells to become liver cells with the corrected gene and give the modified cells back to the patient. This treatment would eliminate the organ rejection problems of liver transplant, the current standard treatment, and could be used for other diseases besides arginase deficiency that are treatable with liver transplants.

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4 UCLA stem cell researchers receive CIRM Early Translational grants

Youthful stem cells from bone can heal the heart

Sep. 4, 2013 Many people who survive a heart attack find themselves back in the hospital with a failing heart just years later. And the outcome often is unfavorable, owing to limited treatment options. But scientists at Temple University School of Medicine's Cardiovascular Research Center (CVRC) recently found hope in an unlikely source -- stem cells in cortical, or compact, bone. In a new study, they show that when it comes to the regeneration of heart tissue, these novel bone-derived cells do a better job than the heart's own stem cells.

According to the study's senior investigator, Steven R. Houser, Ph.D., FAHA, Chairperson of Temple's Department of Physiology and Director of the CVRC, it is early days for cortical bone-derived stem cells (CBSCs). Nonetheless, his team's findings, featured on the cover of the August 16th issue of Circulation Research, have considerable implications for stem cell therapy for the heart.

A major challenge in the treatment of heart attack is early intervention, which is key to reducing the chances for long-term complications, such as heart failure. When it comes to stem cells, Houser said, "The strategy is to inject the cells right after [a heart attack]." Currently, though, that approach works only in animal studies. To make it work in humans, Houser explained, "we need cells right off the rack and ready to go clinically."

CBSCs could be those cells. Stem cells are youthful by degrees, and CBSCs are considered some of the most pluripotent -- like human newborns, nave and ready to become anything. But while CBSCs and similarly pluripotent stem cells retain the ability to develop into any cell type needed by the body and sometimes bring their youthful energy to the aid of mature cells -- making them especially appealing for therapeutics -- they also have the potential to wander off course, possibly landing themselves in unintended tissues. Cardiac stem cells, on the other hand, are a little more capable and a little more set in their ways, like toddlers. While they may need some coaxing into action, they are more likely to stay in their resident tissue.

To figure out how CBSCs might behave in the heart in the first place, Houser's team, led by Temple graduate student Jason Duran, began by collecting the cells from mouse tibias. The particular mice used had been engineered with green fluorescent protein (GFP), which meant that the CBSCs carried a green marker to allow for their later identification. The cells were then expanded in petri dishes in the laboratory before being injected directly into the hearts of non-GFP mice that had suffered heart attacks. Some mice received cardiac stem cells instead of CBSCs.

In the following weeks, as the team monitored the progress of the mice, they found that the youthfulness of the CBSCs had prevailed. The cells had triggered the growth of new blood vessels in the injured tissue, and six weeks after injection, they had differentiated, or matured, into heart muscle cells. While generally smaller than native heart cells, the new cells had the same functional capabilities, and overall they had improved survival and heart function. Similar improvements were not observed in the subset of mice treated with cardiac stem cells. Nor was there evidence in those mice that the cardiac cells had undergone differentiation.

The findings challenge the general assumption that cardiac stem cells, because they reside in the heart, are the cells most capable of repairing damaged heart tissue. For that reason, according to Houser, the new paper likely will be controversial.

"What we did generates as many questions as it does answers," he said. "Cell therapy attempts to repopulate the heart with new heart cells. But which cells should be used, and when they should be put into the heart are among many unanswered questions."

To address at least some of those questions, Houser's team plans next to investigate CBSCs in a large-animal heart attack model. If that study yields similar results as the first, the cells could be ushered into a small-scale clinical trial of human patients. In humans, CBSCs would be collected from bone using techniques akin to those employed for bone marrow aspiration, a much simpler process than that used to isolate cardiac stem cells. While the cells would originate from a different person, raising the risk of rejection by the patient's immune system, it may be possible to have them at the ready in hospital settings, allowing for their injection immediately after a heart attack.

The cell therapy work by Houser's team represents just one of several forms of heart therapy being explored at Temple's CVRC. According to Houser, "Temple has made a commitment to cardiovascular research, with a clinical enterprise focused on treating patients. We're trying anything and everything to repair the heart [safely]." Other avenues of research include gene therapy, drug therapy, and the use of novel biomaterials to more effectively deliver drugs.

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Youthful stem cells from bone can heal the heart

Abe Funds Stem Cells to Help Cure Japan Wasting Disease

Economic regeneration is the name of the game for Japanese Prime Minister Shinzo Abe, and cellular regeneration is one way to play it.

The government is pushing through bills to fast-track regulatory approval for cell-based products and set new research guidelines. Its also funding a $1.12 billion study of a type of stem cell free from ethical concerns over embryo harvesting that have dogged the science for more than a decade.

Abe aims to cement Japans leadership in a field of research that last year garnered the nations first Nobel Prize for medicine in a quarter of a century. Not only academic bragging rights are at stake: the government wants new industries to wean the worlds third-biggest economy from its dependence on autos and estimates stem cells potential to rejuvenate worn-out body parts or reverse degenerative diseases such as Alzheimers may yield $380 billion in sales by 2050.

Lawmakers will debate legislation as early as this month to make the approval process for cell therapies faster than in the U.S. and U.K. That marks a sea-change from the kind of conservative regime that held back Japanese scientists from research into cells derived from human embryos, said Alan Colman, executive director at Singapore Stem Cell Consortium.

They dont want to repeat that for the innovation Japan was totally responsible for, said Coleman, who helped pioneer cloning techniques that created Dolly the sheep in 1996. They are trying to reinvent themselves and show themselves to be progressive and sensible and not inhibitory.

Investor optimism at the prospects for Japans cell technology can be seen in some stocks. Japan Tissue Engineering Co. (7774), which makes cultured cartilage and skin tissue, has soared more than five-fold this year. ReproCell Inc. (4978), the first company licensed to make iPS cells, is almost three times higher than its initial public offering price in June.

In July, the Health Ministry gave the go-ahead for the worlds first clinical trial on humans with stem cells made using the Nobel Prize-winning technique of Shinya Yamanaka.

In an embryos early stages, stem cells are pluripotent, meaning they can become any type of tissue in the body. As the embryo develops, they begin to specialize, or differentiate, into building blocks for the bodys different structures.

Yamanaka showed how these later-stage cells in mice can be reprogrammed into what are termed induced pluripotent stem cells, or iPS cells.

While New York-based Pfizer Inc. (PFE) and Advanced Cell Technology Inc. (ACTC) of Marlborough, Massachusetts, are already conducting trials on humans, these use cells harvested from embryos. As well as sidestepping ethical issues this raises, the Japanese technique reduces risks that immune systems will reject implanted cells because they are taken from patients own bodies.

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Abe Funds Stem Cells to Help Cure Japan Wasting Disease