Heart Stem Cells Show Promise

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From CBSnews.com

Can a human heart repair itself?  One heart is trying.

Heart attack patient Ken Milles is the first person ever to get an infusion of his own, laboratory-grown cardiac stem cells. Doctors at the Cedars-Sinai Heart Institute are trying to see if his own heart cells will fix the damaged area of his heart.

Milles is part of a 24-patient clinical trial, designed by Dr. Eduardo Marbán of Cedars-Sinai Heart Institute.

The trial procedure begins when healthy heart cells are collected from the patient’s heart. Next, the cells are off to the lab, where more stem cells are grown, along with complimentary heart cells. These cells then create complex cardiospheres which, Whitaker reported, can actually start beating in the petri dish. Then, doctors insert the lab-grown stem and support cells into the damaged area of the heart, with hopes that patients like Milles will benefit.

In Milles case, doctors hope to repair an area scarred by a heart attack.

If it works in humans as it has in animals, CBS News correspondent Bill Whitaker reports, the scarring caused by the heart attack, will begin to heal, the heart will grow new muscle, pump more blood — and perhaps give the patient a new lease on life.

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Scientists Find Differences in Embryonic Stem Cells and Reprogrammed Skin Cells

From Newswise.com

UCLA researchers have found that embryonic stem cells and skin cells reprogrammed into embryonic-like cells have inherent molecular differences, demonstrating for the first time that the two cell types are clearly distinguishable from one another.

The data from the study suggest that embryonic stem cells and the reprogrammed cells, known as induced pluripotent stem (iPS) cells, have overlapping but still distinct gene expression signatures. The differing signatures were evident regardless of where the cell lines were generated, the methods by which they were derived or the species from which they were isolated, said Bill Lowry, a researcher with the Broad Stem Cell Research Center and a study author.

“We need to keep in mind that iPS cells are not perfectly similar to embryonic stem cells,” said Lowry, an assistant professor of molecular, cell and developmental biology. “We’re not sure what this means with regard to the biology of pluripotent stem cells. At this point our analyses comprise just an observation. It could be biologically irrelevant, or it could be manifested as an advantage or a disadvantage.”

The study appears in the July 2, 2009 issue of the journal Cell Stem Cell.

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New York Becomes First State To Allow Payment For Donating Eggs For Stem Cell Research

From MedicalNewsToday.com

New York’s Empire State Stem Cell Board earlier this month decided to allow embryonic stem cell researchers who receive state funding to compensate women for donating their eggs for use in research, making New York the first state to enact such a policy, the Washington Post reports (Stein, Washington Post, 6/26). According to the New York Times, the New York state Legislature in 2007 allotted $600 million for an 11-year stem cell research plan (Nelson, New York Times, 6/26). Under the board’s decisions, researchers receiving the state funding may pay women up to $10,000 to compensate them for the time, discomfort and expenses associated with egg donation. David Hohn, vice chair of the board’s two committees that endorsed the decision, said that the board “could not distinguish ethically between the payment for in vitro fertilization, which is very well precedented, and the compensation for donation for research.” The board said researchers should follow the same guidelines as infertility clinics that receive donated eggs for infertile couples. Under those guidelines, payments exceeding $5,000 must be justified, and those exceeding $10,000 are considered excessive (Washington Post, 6/26). Robert Klitzman, director of the master’s degree program in bioethics at Columbia University and a member of the stem cell board’s ethics committee, said the payments will be carefully evaluated by an institutional review board (New York Times, 6/26).

The Post reports that the decision goes against policies in other states that offer funding for embryonic stem cell research, as well as against current guidelines from scientific organizations like the National Academy of Sciences (Washington Post, 6/26). NAS guidelines, for example, prohibit paying women for eggs used in stem cell research. Similarly, the internal guidelines for New York-based groups like Rockefeller University, Cornell University and the Sloan-Kettering Institute prohibit financial compensation for donated eggs. However, researchers say that efforts to recruit unpaid donors have been unsuccessful and that the board’s decision will give New York an advantage in stem cell research (New York Times, 6/26).

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Hysterectomies Could Be Source of Stem Cells

Researchers eye tissues that are normally discarded after surgery

From health.usnews.com

Fallopian tubes removed from fertile women of child-bearing age during hysterectomies or other procedures might prove to be a new source of highly sought-after stem cells.

Researchers from the University of Sao Paulo in Brazil found that human fallopian tubes are rich in mesenchymal stem cells. The team isolated and grew these cells in a laboratory and differentiated them into muscle, fat, cartilage and bone cell lines without producing problems in the cell chromosomes, according to a report in the Journal of Translational Medicine.

“In addition to providing an additional potential source for regenerative medicine, these findings might contribute to reproductive science as a whole,” study leader Tatiana Jazedje, of the university’s Human Genome Research Center, said in a news release from the journal’s publisher.

Past studies have also shown success with isolating and differentiating mesenchymal stem cells harvested from umbilical cords, dental pulp and body fat.

Together, these findings are of great interest, the researchers said. “Moreover, the use of human tissue fragments that are usually discarded in surgical procedures does not pose ethical problems,” Jazedje said.

Next Big Market: Adult Stem Cell Drugs and Therapies

Written by M.E.Garza, Biomedreports.com

According to a new report in Fortune Magazine, marketable therapies emerging from work in the (less controversial) adult stem space could be the next multi-billion dollar market.

Research on adult stem cells has generated a great deal of excitement. Adult stem cells have already been used successfully with patients: to treat cartilage defects in children; restore vision to patients who were legally blind; relieve systemic lupus, multiple sclerosis, and rheumatoid arthritis; and to serve as an aid in numerous cancer treatments.

Scientists have found adult stem cells in many more tissues than they once thought possible. This finding has led researchers and clinicians to ask whether adult stem cells could be used for transplants. In fact, adult hematopoietic, or blood-forming, stem cells from bone marrow have been used in transplants for 40 years. Scientists now have evidence that stem cells exist in the brain and the heart. If the differentiation of adult stem cells can be controlled in the laboratory, these cells may become the basis of transplantation-based therapies. These Adult stem cells can be harvested from many areas of the body, including the bone marrow, fat and peripheral blood. Once the cells have been harvested, they are sent to the lab where they are purified and assessed for quality before being reintroduced back in the patient. Since the stem cells come from the patient there is no possibility for rejection and they are used in transplants to treat diseases, such as cancers like leukemia.

According to various studies, stem cells isolated from a patient (i.e. from the bone marrow or fat) have the ability to become different cell types (i.e. nerve cells, liver cells, heart cells and cartilage cells). Studies have also shown that these are capable of “homing in” on and repairing damaged tissue. Researchers feel they are far closer to commercializing drugs based on adult stem cells than any product based on embryonic stem cells. In fact, many clinics outside of North America already tout stem cell based treatments to treat chronic diseases for which there are inadequate standard therapies. These clinics currently accept patients with Diabetes Type 2, Autoimmune Diseases, Multiple Sclerosis, Degenerative Joint Disease, Autoimmune Diseases as well as Rheumatoid Arthritis and Osteoarthritis. Unfortunately, patients seeking those treatments in other countries most often run the risk of parting with their money and being disappointed with the results.

Back in the states, Robin Young, a medical industry analyst from RRY Publications, estimates that gross sales of adult cellular therapies will be well over $100 million this year. By 2018, he says stem cell therapy revenues could grow to $8.2 billion.

“Adult derived cells are the ones that have been studied for the past 10 to 15 years and are ready for prime time,” says Debra Grega, the executive director of the Center for Stem Cell and Regenerative Medicine at Case Western Reserve University. “Large pharmaceutical companies are now wanting to get into the adult stem cell therapeutic area. That indicates to me that there is enough safety and enough efficacy that they are willing to put money in.”

Pharmaceutical giant Pfizer (NYSE:PFE)  announced in November that it would invest up to $100 million in regenerative research, which would include both adult and embryonic stem cell research, over a three to five year period.

The overall stem cell market, however, is still quite small. The California-based outfit Geron (NASDAQ:GERN) dominates the embryonic stem cell market, and is perhaps 10 years away from commercializing a spinal cord treatment based on its research.

The frontrunner in the adult stem cell space, according to Forbes, is Osiris Therapeutics, Inc.(NASDAQ:OSIR)- currently trading at $14.20 per share. Genzyme Corp. (NASDAQ:GENZ) has signed a partnership alliance with Osiris Therapeutics to develop two  late-stage adult stem cell treatments — Prochymal and Chondrogen — thought to be useful to treat a variety of diseases by controlling inflammation, promoting growth of new tissue and preventing scars. The deal will pay Osiris $130 million upfront ($75 million initially and the difference to be paid on July 1, 2009).  Assuming the drugs reach the marketplace, Genzyme will pay up to $1.25 billion in development, regulatory and sales milestone payments.

Osiris is focused on developing and marketing products to treat medical conditions in the inflammatory, orthopedic, and cardiovascular areas. Their principal biologic drug candidate, Prochymal, is being evaluated in Phase III clinical trials for three indications, including acute and steroid refractory Graft versus Host Disease (GvHD), Crohn’s disease and for the repair of gastrointestinal injury resulting from radiation exposure, and is the only stem cell therapeutic granted both Orphan Drug and Fast Track status by the United States Food and Drug Administration (FDA). Prochymal is also being developed for the repair of heart tissue following a heart attack, for protection of pancreatic islet cells in patients with type I diabetes, and for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The FDA could approve within a year which fights a painful illness called “graft-versus-host disease” which afflicts transplant recipients.  If they succeed, Osiris would be the first company to gain approval for a stem cell drug. Osiris will commercialize both drugs in the U.S. and Canada, and Genzyme will sell the drugs in all other countries.

Investors should be aware that there are only a limited number of stocks which are pure plays or semi-pure plays in the stem cell industry. Below are some of the companies working in the adult stem cell medicine space:

StemCells, Inc.(NASDAQ:STEM) – a company is engaged in the discovery and development of cell-based therapeutics to treat damage to, or degeneration of, major organ systems. Currently trading at $1.60 with a market cap of $164.09M.

Cytori Therapeutics Inc. (NASDAQ:CYTX) which develops, manufactures, and sells medical technologies to enable the practice of regenerative medicine. The Company’s commercial activities are focused on cosmetic and reconstructive surgery in Europe and Asia-Pacific, and stem and regenerative cell banking (cell preservation) in worldwide. Its product pipeline includes the development of new treatments for cardiovascular disease, spinal disc degeneration, gastrointestinal disorders, liver and renal disease and pelvic health conditions. They currently trade at $3.55 with a market cap of $121.02M.

Aastrom Biosciences, Inc.(NASDAQ:ASTM) engaged in the development of autologous cell products for the repair or regeneration of human tissue. The Company’s tissue repair cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries affecting vascular, bone, cardiac and neural tissues. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. Late last month, the company made headlines after temporarily suspending enrollment and patient treatment in its U.S. Phase II IMPACT-DCM clinical trial following a report that a patient died at home after being released from the hospital following treatment in the trial. The stock trades at $0.36 pps with a market cap of $58.44M.

ThermoGenesis Corp.(NASDAQ:KOOL) designs, manufactures and markets automated and semi-automated devices and single-use processing disposables that enable hospitals and blood banks to manufacture a therapeutic dose of stem cells, wound healing proteins or growth factors from a single unit of cord blood or the patient’s own blood in less than one hour. They currently trade at just under $0.70 and have a market cap of $37.02M.

Opexa Therapeutics, Inc. (Nasdaq:OPXA) is a biopharmaceutical company developing autologous cellular therapies with the potential to treat major illnesses, including multiple sclerosis (MS) and diabetes. The Company has a global license from Baylor College of Medicine (or Baylor) to an individualized T-cell therapeutic vaccine, Tovaxin, which is in clinical development for the treatment of MS. MS is the result of a person’s own T-cells attacking the myelin sheath that coats the nerve cells of the central nervous system (CNS). Shares currently trade under $0.60 with a market cap of $7.29M.

At BioMedReports, we will continue to explore this potentially bountiful market within the healthcare sector in coming weeks, as it sounds like investors would greatly benefit from insight into the current marketplace.

“From a Wall Street perspective, adult stem cells are a much better investment,” said Stephen Dunn of Dawson James Securities.”

Placentas could be an important source of stem cells to fight disease

By Sandy Kleffman, Contra Costa Times

The human placenta could be an important source of stem cells for curing leukemia, sickle cell disease and other blood-related disorders, a new study reveals.

These stem cells appear to have distinct advantages over the techniques currently used to fight such diseases, and they may one day provide an alternative treatment for people who cannot find matching bone marrow donors, researchers said.

Scientists at Children’s Hospital Oakland obtained placentas from consenting women who had cesarean sections at Alta Bates Summit Medical Center in Berkeley.

They found that the placentas contained large numbers of blood-producing stem cells, which they were able to remove and grow in a cell culture.

“Yes, the potential is there,” said senior scientist Frans Kuypers. “Yes, you can get them out, and yes, they’re viable.”

One big advantage of such stem cells is that they do not require the perfect match needed for those who have bone marrow transplants, Kuypers said, because they do not trigger the same strong immune system response.

Today, scientists often seek to cure people who have leukemia and other blood-related disorders by giving them stem cell-rich bone marrow from donors who have closely matched tissue types. The transplanted bone marrow makes healthy blood cells to replace the faulty ones.

But if the donor has a different tissue type, the recipient’s body will not recognize the new cells and will attack them, leading to what is known as graft-versus-host disease.

The placental stem cells, like umbilical cord blood, “are much more tolerant with respect to matching,” Kuypers said.

The findings, which will appear in the July issue of Experimental Biology and Medicine, could represent especially good news for African-Americans, Asians and multiracial individuals, who often have difficulty obtaining compatible bone marrow donors.

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Stem cells put to test as treatment for diabetes

By Elizabeth Simpson, elizabeth.simpson@pilotonline.com, The Virginian-Pilot

Sarah Piscitelli had barely gotten used to the idea she had an incurable disease – diabetes – before she was sitting in a Norfolk clinic having an experimental solution infused into her vein.

Was the liquid – in an opaque IV bag so she couldn’t see it – a potent mixture of stem cells or a powerless placebo?

She won’t find out for two years, but what she does know is she’s part of a clinical trial that has the potential to change lives.

The 23-year-old Virginia Beach woman was older than the norm when she was diagnosed in February with Type 1 diabetes, the less common variety usually diagnosed in childhood.

The timing of Piscitelli’s diagnosis placed her in a position to enroll in a national clinical trial to see whether infusions of stem cells can kick-start her body’s ability to make insulin.

She’s one of 60 people across the country who will test the idea. If successful, it could eventually change the lives of people in the early stages of the disease. Some 30,000 a year are diagnosed with Type 1.

She received her third and last infusion at an Eastern Virginia Medical School clinic Friday. The amount of insulin she’s had to use each day since the first dose in April has dropped.

But here’s the rub:

Neither she nor the researchers will know whether she’s getting the real deal or a placebo until the end of the two-year study.

Does she need less insulin because she’s in the so-called “honeymoon” period that new diabetics often experience after starting insulin?

Or are stem cells doing the hoped-for job of rejuvenating her pancreas?

“My mom tells me to pretend it’s the real thing,” she said, “because positive thinking itself can help.”

The study is being conducted by a Maryland company called Osiris Therapeutics that is developing stem-cell therapy to treat ailments such as Crohn’s disease, arthritis and heart disease.

The injectable solution the company is testing – Prochymal – is made of stem cells from bone marrow donated by adults, not human embryos.

The Strelitz Diabetes Center at EVMS is one of 20 sites recruiting volunteers with Type 1 diabetes for the trial.

Dayna Buskirk, director of clinical development for Osiris Therapeutics, would not reveal how many of the 60 are enrolled so far, nor how much the study costs.

However, the Juvenile Diabetes Research Foundation has seen enough promise in the idea that it donated $2 million to the effort last June.

Typically, if such a trial shows good results, it would be followed by another phase that would involve a larger number of people at even more clinical sites.

In Type 1 diabetes, a person’s immune system attacks and destroys insulin-producing cells in the pancreas. Insulin controls blood sugar, and poorly controlled levels can lead to heart disease, stroke, blindness, amputations, kidney disease and nerve damage.

Stem cells have characteristics particularly promising in treating autoimmune diseases such as diabetes.

One, they have the ability to transform into any type of tissue without the body rejecting them, and two, they travel to sites of inflammation. Once they get there, they can prevent further damage and even repair tissue.

“They sense where in the body something is going wrong, and they move in to see what they can do,” said Dr. Aaron Vinik, the Strelitz center’s scientific director, who’s overseeing the local part of the study. “If they find inflammation, they can mend the process if it’s early enough. They’re like subterfuge cells. They get in under the tent flap, and the body doesn’t recognize them as foreign.”

The trick is to call in those cellular troops soon enough. If it’s too late, the insulin-producing cells have already been destroyed.

The study is looking for people who are within two to 16 weeks of diagnosis. The peak age for diagnosis of Type 1 diabetes is 14, but because of consent and safety issues for still-developing children, the researchers are restricting this phase of the trial to adults 18 to 30.

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Stem Cell Transplants Improve Survival for Some Leukemia Patients

By Carol Pearson, VOANews.com

Researchers say some leukemia patients can dramatically improve their survival rates if they have stem cell transplants. In fact, the researchers say the use of stem cells may result in a new standard treatment.

For two weeks Randall Burnham thought he had the flu. Instead it was a type of deadly leukemia.

“When I was diagnosed, I was actually so sick I didn’t really understand what was going on,” he said. “Afterwards, they said that I was within a couple of days of dying.”

Burnham was diagnosed with acute myeloid leukemia – a cancer of the blood and bone marrow that spreads so rapidly that unless a patient gets treatment, he usually has only a matter of months to live. Chemotherapy is used to put the patient into remission.

“In other words, the bone marrow and the blood have been restored to a normal looking state,” said Dr. John Koreth of the Dana Farber Cancer Institute in Boston, Massachusetts.

Dr. Koreth says chemotherapy does not kill every cancer cell. In some patients, the cancer recurs.

BURNHAM: “I noticed that a couple of days ago that I don’t feel as achey as I did before.”

KORETH: “Good.”

Dr. Koreth says a simple chromosome test shows whether the patient has a good, poor or intermediate chance of the acute myeloid leukemia returning.

For those with a good prognosis, chemotherapy alone may suffice. For patients with a poor outlook, chemotherapy plus a blood stem cell transplant from a donor is the usual treatment.

But there was no consensus on how to treat patients in the intermediate group who have almost a 50 percent chance of recurence.

“For intermediate risk, even the experts were stumped,” he added.

Dr. Koreth and other researchers analyzed data from two dozen studies. They noticed that healthy stem cells from a compatible donor helped boost the survival rates of patients who had intermediate risk. Randall Burnham found a good match.

“I had a sister with a perfect match to me,” explained Mr. Burnham. “And then a brother and another sister with slight deviations, so they took the sister that had the perfect match. So she was the one who donated the stem cells to me.”

Burnham has been in remission for two years after having the transplant. Dr. Koreth says the study may provide clear direction on how intermediate risk patients should be treated.

There are risks associated with the transplant procedure. Burnham takes extra precautions, such as wearing gloves and a mask, because he is more susceptible to infections and other side effects. But Dr. Koreth says the treatment’s benefits outweigh the risks.

The study has been published in The Journal of the American Medical Association.

ABMDR Opens Stem Cell Harvesting Center in Yerevan

From Asbarez.com

LOS ANGELES—The Armenian Bone Marrow Donor Registry (ABMDR) recently unveiled its Stem Cell Harvesting Center in Yerevan with a grand opening celebration. The much-anticipated event was attended by scores of ABMDR donors, sponsors, patients, physicians, and special guests including VivaCell-MTS general manager Ralph Yirikian, a major supporter of the registry; Archbishop Tatev Sargsyan, who conveyed a special commendation from His Holiness Karekin II, Catholicos of All Armenians; ABMDR Advisory Board member Nani Oskanian; a representative from Armenia’s Ministry of Health; and a group of supporters from Los Angeles who had traveled to Armenia to take part in the celebration.

“The opening of the Stem Cell Harvesting Center was an extremely touching experience for every one of us,” said Dr. Sevak Avagyan, executive director of ABMDR Armenia. “While it was wonderful to be surrounded by so many friends, supporters, and colleagues, ultimately the most heartwarming sight was that of our patients and stem cell donors finding common ground in the new facility, where hope awaits those afflicted by life-threatening diseases.” Accordingly, Dr. Avagyan added, the honor of cutting the ribbon of the Stem Cell Harvesting Center was given to Mrs. Varduhi, the ABMDR’s latest bone marrow stem cell donor.

Zara in Post PCR loading (Small)Commenting on the opening of the center, Dr. Frieda Jordan, president of the ABMDR Board of Directors, said, “We’ve been working on this project for the past year, sparing no effort or resource for its realization.” After acquiring the facility, the ABMDR recruited top medical talent and began the arduous process of training personnel and securing medical machinery.

As Dr. Jordan explains, the project was made possible by a number of major corporate and individual donations, as well as grassroots support through the registry’s first-ever telethon, held on April 13 last year. With a total of $850,000 raised, the ABMDR was able to renovate the Stem Cell Harvesting Center site, equip it with state-of-the-art machinery, and continue to train personnel.

In 2006, the ABMDR’s HLA tissue-typing laboratory passed the inspection of the European Federation of Immunogenetics (EFI). In May this year, the laboratory passed the EFI’s second inspection “with flying colors,” paving the way for the future accreditation of the Stem Cell Harvesting Center itself.

The only one of its kind in the region, the ABMDR’s Stem Cell Harvesting Center can store and harvest stem cells provided by healthy bone marrow donors. The stem cells subsequently can be utilized in transplants for patients suffering from life-threatening blood-related diseases such as leukemia and other cancers. “It was absolutely critical to have a stem cell harvesting center in Armenia, since the majority of the ABMDR’s bone marrow stem cell donors are residents of the republic,” Dr. Jordan said. “Having this facility in the country means that local stem cell donors will be spared the often exorbitant expense and inconvenience of traveling abroad to donate their stem cells. The center is equipped with cutting-edge medical machinery that allows our staff to perform not only HLA tissue typing, stem cell harvesting, and cell storage, but autologous transplants as well. These latter procedures can be life-savers for cancer patients, as they restore the integrity and function of bone marrows damaged by chemotherapy.”

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Researchers plan trial for Lou Gehrig’s disease therapy

By Brooke Adams, The Salt Lake Tribune

The mice at the top of a column of stacked plastic bins at Q Therapeutics are shivering so hard they seem to be jumping.

Their nonstop shivering and seizures are caused by a genetic defect that robs the mice of the crucial myelin sheath that surrounds nerve cells and helps them send signals. Because of the defect, the mice are soon paralyzed and die prematurely.

It is a related problem — loss of this myelin sheath — that in humans causes the progressive loss of function in multiple sclerosis and several other diseases that can cause paralysis in humans.

And that’s why what has happened to the mice is so promising: After being treated with an adult stem cell therapy developed at Q Therapeutics, they are no longer shivering.

The product, called Q-Cells, also may be applicable to such neurodegenerative diseases as Parkinson’s, Alzheimer’s and amyotrophic lateral sclerosis, or ALS — better known as Lou Gehrig’s disease.

Now, the National Institutes of Health have awarded a $5 million grant to Q Therapeutics, the University of Utah’s Cell Therapy Facility and Johns Hopkins University School of Medicine, which as a team has had success in animal models of ALS.

The funding will help support work needed to get permission from the Food and Drug Administration to start human clinical trials at Johns Hopkins. If efforts to raise additional funds are successful, those trials would begin next year.

“This type of therapy can bring about a major change in modern health care,” said Deborah Eppstein, CEO of Q Therapeutics. “It’s not just a little step. It’s a pole vault change, a going to the moon change.”

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