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Judges side with FDA in rejecting stem cell device

By Stem Cell Treatment

WASHINGTON (AP) -- A federal appeals court has sided with the Food and Drug Administration in a case brought by medical device maker Cytori, ruling that the agency was correct to reject fast-track approval for two company devices used to process adult stem cells.

Cytori Therapeutics Inc. makes the Celution and StemSource devices which separate adult stem cells from fat tissue using a combination of spinning motions and chemical reactions. The company is studying the technology for a variety of medical uses, including breast reconstruction, burn healing and treating damaged heart tissue. The technology has even been adopted by some plastic surgeons, who claim adult stem cells can be injected into the face, breast and other areas to create a younger look.

Medical devices cannot be marketed in the U.S. without prior approval by the FDA.

Cytori asked the FDA in 2011 to approve the Celution and StemSource devices using a fast-track pathway reserved for devices that are similar to products already on the market. Cytori argued that its technology is similar to that used to process cells from blood and bone marrow.

The FDA rejected that argument and told the company it would need to apply through a more rigorous process that involves large studies with human participants.

A three-judge panel backed that decision in a ruling issued Friday.

"FDA concluded and explained that fat is not blood and that the difference matters. A court is ill-equipped to second-guess that kind of agency scientific judgment," states the opinion, written by Judge Brett Kavanaugh. "After careful review, we find FDA's assessment both reasonable and reasonably explained."

The ruling was signed by fellow Judges Janice Rogers Brown and David Sentelle of the U.S. Court of Appeals for the District of Columbia.

The judges noted that the study Cytori submitted to the FDA for approval included only 12 patients, too small for regulators to evaluate the safety and effectiveness of the technology.

Cytori downplayed the significance of the ruling Friday in an interview with The Associated Press, saying the company had effectively abandoned the shortcut approval pathway, known as the 510k process.

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Judges side with FDA in rejecting stem cell device

Cytori Loses Bid to Overturn FDA Bar on Stem – Cell Devices

By Stem Cell Treatment

Cytori Therapeutics Inc. (CYTX), a biotechnology company developing experimental burn treatment therapies, lost a U.S. appeals court bid to overturn the Food and Drug Administrations initial rejection of two medical devices that use fat as a source of stem-cell therapy.

The U.S. Court of Appeals in Washington upheld the FDAs decision that two devices submitted by Cytori for approval required more extensive testing before they could be released safely on the market.

The devices, called Celution and StemSource, arent substantially equivalent to currently marketed devices, which rely on blood or marrow cells, U.S. Circuit Judge Brett Kavanaugh wrote today in the 12-page opinion.

The FDA reasonably concluded and reasonably explained that the Celution and StemSource did not meet either the intended use requirement or the technological characteristics requirement for a substantial equivalence determination, Kavanaugh said in a ruling joined by circuit judges Janice Rogers Brown and David Sentelle.

In order to win approval for new medical devices through a more streamlined premarket notification process, the devices have to be similar to others already on the market and have similar uses, Kavanaugh said.

Cytori shares fell as much as 3 percent on the news before recovering to $2.77 in New York trading, unchanged from yesterdays close.

Cytoris experimental therapy takes adipose tissue, or body fat, from a patient and through its device separates the adult stem and regenerative cells. The San Diego, California-based company last year won a $4.7 million U.S. government contract to develop a stem cell therapy to treat burns caused by thermal or radioactive bombs.

Testing the technology in a clinical trial and getting approval may take five years, Chief Executive Officer Christopher Calhoun said in an interview with Bloomberg Television Sept. 28. The company is testing its therapy for other soft tissue damage, as well as cardiovascular disease, Calhoun said.

To contact the reporter on this story: Sara Forden in Washington at sforden@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

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Cytori Loses Bid to Overturn FDA Bar on Stem - Cell Devices

Catholic Church gives blessing to stem cell research

By Stem Cell Treatment

In the past 20 years, stem cell research has been thrust into the medical spotlight as celebrities like Michael J. Fox and Christopher Reeve have advocated for it. Also, numerous studies have shown stem cell therapies have successfully treated a plethora of diseases.

And now, with the release of The Healing Cell: How the Greatest Revolution in Medical History Is Changing Your Life, the Catholic Church has given its stamp of approval on adult stem cell research by discussing the many ways these therapies work for the greater good. In fact, Pope Emeritus Benedict XVI wrote the books introduction, which was co-authored by Dr. Robin Smith and Monsignor Tomasz Trafny, along with Max Gomez.

Stem cell therapy isnt anything new. Using bone marrow transplants to treat leukemia, which started more than 40 years ago, is essentially the same procedure. Through this process, doctors extract stem cells from the bone marrow and transplant them into the body to replace damaged cells caused by blood and bone marrow cancers. Sometimes cancer patients use autologous cells cells harvested from their own body and sometimes they use donated cells from another persons bone marrow.

Ethical concerns

Smith said when celebrities began speaking out on behalf of embryonic super cells, thats when the real buzz started.

Embryonic stem cells can become anything, any organ, Smith said. You have to destroy the embryo to get the cells, unless its from a stillborn fetus. Its hard to control that in a lab. So thats a little different from an adult stem cell, which is more mature. They exist in our bodies throughout our lifetime and go on to create just one or two specific things. All these clinical trials are looking at what cells should come from and where, in order to be treated.

Embryonic stem cells are derived from unused embryos initially intended for in vitro fertilization. However, because of the sheer number of embryos actually created and stored, there are many ultimately slated for destruction.

The ethical concerns come from whether or not to use embryonic stem cells for research. Some people and organizations, including the Catholic Church, feel even though these cells come from blastocysts, it is still destroying human life.

Scientists often counter-argue that if these embryos are going to be destroyed anyway why not put them to use for research and medicinal treatment?

Smith noted that currently, there are 4,300 adult stem cell trials, and only 26 embryonic stem cell trials.

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Catholic Church gives blessing to stem cell research

DOH restricts hospitals amid stem- cell therapy craze

By Uncategorized

The Department of Health (DOH) has restricted hospitals and other facilities from using genetically-altered cells and tissues of human in carrying out stem-cell therapy and treatments in the country. Health secretary Enrique Ona added that their department also prohibits the use of umbilical cord, fat-derived human stem cells, and live animal stem cells for the conduct of the procedure locally.

Related story: Foundation seeks to help people on the verge of suicide On Wednesday, DOH released Administrative Order (AO) 2013-0012 which seeks to ensure the safety of people who want to undergo human stem cell and cell-based therapies.

The AO also prohibits for human treatment and research the creation of human embryos and their derivatives, the use of aborted human fetal stem cells and their derivatives, and plant parts labeled as stem cells, the order stated. Ona hopes AO will make effective and ethical stem cell modalities and practices that will be at par with emerging international and global standards on the very complex nature of this therapy.

Also read: Genetically modified crops threaten organic agriculture He explained the AO also hopes to prevent the introduction, transmission, and spread of communicable diseases by ensuring a minimum quality of service and staff qualification rendered by hospitals and other health facilities capable of utilizing human stem cell preparations and cell-based therapies. These guidelines will classify which stem cell preparations and therapies will be registered and allowed with certain restrictions, Ona said in a statement. Preparations that will be allowed include those with adult human stem cells, human umbilical cord stem cells, and human organ-specific cells, he noted.

Related story: Fresh food make up most of Pinoys' shopping basket, says study He explained that health facilities utilizing stem cell preparations and cell-based or cellular therapies will be mandated to comply with the guidelines set by DOHs Bioethics Advisory Board. The Borad, Ona notes, will ensure that ethical and professional standards are upheld and that contentious scientific, ethical and legal issues are addressed. He said charges and complaints shall be addressed to the DOH Bureau of Health Facilities & Services and the Philippine Food and Drug Agency. Stem cell therapy and treatments are medical procedures where doctors replace malignant cells with healthier cells in an effort to cure or address ailments like cancer. Some facilities also use the procedure for cosmetic purposes, targeting components of the skin like collagen to make patients look younger and healthy.

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DOH restricts hospitals amid stem- cell therapy craze

Cell Therapy Shows Promise For Advanced Leukemia In Adults

By Uncategorized

Editor's Choice Academic Journal Main Category: Lymphoma / Leukemia / Myeloma Also Included In: Stem Cell Research Article Date: 21 Mar 2013 - 12:00 PDT

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Similar immune-system therapy has proven effective in children with this cancer as well as in adults with a similar type of leukemia, however, this is the first time this specific therapy has worked in adults.

The findings of the current study were based on five patients with acute lymphoblastic leukemia (ALL). T cells were extracted from the patient and modified to express a receptor for protein on other immune cells - called B cells - that are found in both cancerous and healthy tissues.

ALL is a cancer of the blood and bone marrow which progresses quickly - if left untreated, patients sometimes die within weeks. The first treatment is generally three phases of chemotherapy drugs.

For most patients, this puts the cancer in remission. However, it often comes back. The second treatment agenda is usually another round of chemotherapy followed by a bone marrow transplant.

The authors point out that when the cancer returns, it is often immune to many chemotherapy drugs. Therefore, Dr. Renier Brentjens, an oncologist at Memorial Sloan-Kettering Cancer Center in New York City, and his colleagues set out to test a different approach.

The five participating patients received infusions of their altered T cells after undergoing standard chemotherapy. All five patients saw a total remission - for one patient this occured within just eight days, according to the researchers.

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Cell Therapy Shows Promise For Advanced Leukemia In Adults

Cell Therapy For Aggressive Leukemia Uses Patient’s Own T Cells, Has Very Promising Results

By Uncategorized

Leukemia is never an easy disease to beat back, but adults with relapsed B cell acute lymphoblastic leukemia, or B-ALL, have especially grim prospects. This particular kind of blood cancer progresses quickly, and has only a 30 to 40 percent cure rate in adults. Chemotherapy drugs can sometimes clear out the cancer the first time around, but some patients relapse, requiring another round of chemotherapy, then a bone marrow transplant. But this second round can sometimes fail because the recurring leukemia proves resistant to the drugs.

Now, in a paper published Wednesday in the journal Science Translational Medicine, scientists have successfully treated B-ALL patients by inserting new genetic material into some of their T cells. The cell therapy allows the patients immune system to find and destroy the places where the blood cancer is hiding out.

In one case, the treatment cleared up a patients leukemia in a little more than a week.

We had hoped, but couldnt have predicted that the response would be so profound and rapid, Memorial Sloan-Kettering Cancer Center researcher Renier J. Brentjens told the New York Times.

Brentjens and his colleagues treated five B-ALL patients with some of their own T cells, which were genetically programmed to recognize a particular protein on the surface of B cells, the immune system cells that are affected by this kind of leukemia. The reengineered T cells then lay waste to all of the patients B cells, healthy and cancerous alike (the loss of healthy B cells can be treated later).

Were creating living drugs, senior author Michel Sadelain told the New York Times. Its an exciting story thats just beginning.

Still, the treatment is far from 100 percent perfect. Three of the five patients in the study have been in remission for anywhere between five months and two years. Another patient died of a blood clot after going in to remission, and another relapsed again possibly because a steroid treatment meant to control a side effect of the cell therapy may have wiped out the souped-up T cells before they could attack the B cells. The three survivors may yet relapse again.

And there are risks associated with the cell therapy. The T cells offensive onslaught can create whats called a cytokine storm, a potentially fatal immune chain reaction that usually induces an extremely high fever.

"This is very early in development," University of Pennsylvania researcher David Porter, who was not involved with the study, told US News & World Report. "We are just starting to learn about the short-term side effects, and we don't know about the long-term effectiveness or safety."

At the moment, this kind of cell therapy is being used as a lead-in to a bone marrow transplant. But in the future, doctors may be able to just use immunotherapy by itself.

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Cell Therapy For Aggressive Leukemia Uses Patient's Own T Cells, Has Very Promising Results

New nano-‘tracking devices’ allow doctors to visualize stem cells inside hearts

By Stem Cell Treatment

Heart stem cell therapy after a major heart attack holds the promise of helping to repair severely damaged cells by encouraging the growth of new ones. However, the process which involves infusing healthy stem cells into the heart to replace the damaged tissue has had limited success in clinical trials.

In order to get the most benefit from heart stem cell treatment, it is essential for doctors to properly place the cells in the heart. But, once the stem cells are injected, its difficult to determine exactly where they wind up, and many scientists believe faulty placement is ultimately the culprit of the therapys disappointing results.

Now, that problem could be potentially solved with a new visualization technique developed by Dr. Sam Gambhir and fellow researchers at Stanford University School of Medicine in California. Their study, published in Science Translational Medicine, details the invention of silica nanoparticles, which can be injected inside stem cells, acting as tiny tracking devices that allow doctors to see the stem cells path inside the body.

According to the studys researchers, the most encouraging results from heart stem cell therapy have been seen after bypass surgery, which is done right after a patient has suffered a heart attack. If performed correctly, stem cell injections can encourage new cell proliferation and help increase blood flow up to 10 percent.

To get the most benefit, doctors have to find the perfect place in which the cells will do the most work.

The best place is the region (in the heart) between the damaged tissue and the healthy tissue, Jesse Jokerst, a postdoctoral fellow in the Stanford Molecular Imaging Scholars Program and one of the studys authors, told FoxNews.com. Thats where the most therapeutic benefit can occur. When placed there, the stem cells can take advantage of the blood flow in the healthy region, but can effect a change in the diseased region.

In order to determine where to place the cells, physicians currently take images of the heart through magnetic resonance imaging (MRI) one image before the injection to estimate placement, and a second image after the injection to see how the cells have developed. But the time period between the capture of those pictures leaves a lot to be desired, as the stem cells do not have a unique signature that allows doctors to differentiate between them and the normal heart cells.

Feeling somewhat blind, the doctors have many questions once the stem cells are injected. Did they reach their intended target? Did they remain at the heart wall? How many cells actually stayed and how many diffused or died? Inevitably, the doctors have to wait weeks following the stem cell injection to get their questions answered, by observing if heart function improved.

Making a stem cell 'movie'

Frustrated by those time constraints, the researchers realized all their questions could be answered a lot faster and much more accurately through ultrasound imaging.

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New nano-'tracking devices' allow doctors to visualize stem cells inside hearts

Cellular Biomedicine Group Marks the Launch of China Clinical Trial for TC-DC Therapy for Hepatocellular Carcinoma

By Stem Cell Treatment

PALO ALTO, Calif., March 21, 2013 /PRNewswire/ -- Cellular Biomedicine Group (CBMG) announced that in the first week of March 2013, the company launched a clinical trial for TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy for hepatocellular carcinoma (HCC), the most common type of liver cancer. The clinical trial, which is already in progress, is the result of collaboration between CBMG, California Stem Cell (CSC) and Shanghai's PLA 85 Hospital. It is the first immune cell clinical trial of its kind in China.

CBMG's joint venture with CSC grants CBMG an exclusive license from CSC to develop and market CSC's cancer (TC-DC) technology in Greater China. CBMG receives support from CSC's California-based team of scientists and medical professionals, including CSC's Dr. Hans Keirstead.

PLA 85 Hospital is a large general teaching hospital with 12 departments, located in Shanghai and has been granted Class A Hospital status at the Tertiary Level (the highest class). The hospital has over 600 beds with more than 200 professors and associate professors, including many well-known experts who are known for their pioneering work in the diagnosis and treatment of tumors. The principal Investigator of the trial and director of the Liver Disease Center of PLA 85 Hospital, Professor Chengwei Chen, commented, "When I heard of the success this treatment had in clinical trials for other cancers in the U.S., I was very excited at the prospect of the hope it could bring to the millions of patients in China suffering from HCC. I am happy to lead this endeavor to help as many people as we can." SaidDr. Steve Liu, Chairman of CBMG, "The launch of this trial is a major milestone for all of the physicians, scientists and other professionals at CBMG, CSC and PLA 85 Hospital who have contributed to this work."

Multinational Contract Research Organization (CRO) CMIC-GCP has been contracted to manage the trial design and minimize delays.

Hepatocellular CarcinomaForty-five percent of the world's HCC patients are in China, with over 300,000 new patients diagnosed every year. Currently the therapies commonly offered to most patients are surgery and local chemotherapy, with a 2-year recurrence rate of 51% and median survival time of 13 months.

CBMG's research studies the effects of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy. Dr. William Cao, President of CBMG said, "In simplified terms, TC-DC therapy takes a sample of the patient's own dendritic, or immune cells and a sample of the patient's tumor stem cells and places them together in the lab. The dendritic cell will learn the characteristics of the tumor stem cells, and is reintroduced to the patient's body, where it can "train" the immune system to fight and destroy the tumor stem cells, which are the root cause of tumor recurrence and metastasis."

About Cellular Biomedicine GroupCellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative diseases and cancers. Our developmental stem cell, progenitor cell, and immune cell projects are the result of research and development by scientists and doctors fromChinaandthe United States. Our flagship GMP facility, consisting of eight independent cell production lines, is designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit: http://www.cellbiomedgroup.com

Forward-Looking StatementsStatements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include, but are not limited to, risk factors inherent in doing business. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," or "continue," or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.

Contact: Jeff Ramson Investor Relations ProActive Capital Group +1 646-863-6341

Sarah Kelly Director of Corporate Communications, CBMG +1 650 566 5064 sarah.kelly@cellbiomedgroup.com

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Cellular Biomedicine Group Marks the Launch of China Clinical Trial for TC-DC Therapy for Hepatocellular Carcinoma

New method developed to expand blood stem cells for bone marrow transplant

By Stem Cell Treatment

Mar. 21, 2013 More than 50,000 stem cell transplants are performed each year worldwide. A research team led by Weill Cornell Medical College investigators may have solved a major issue of expanding adult hematopoietic stem cells (HSCs) outside the human body for clinical use in bone marrow transplantation -- a critical step towards producing a large supply of blood stem cells needed to restore a healthy blood system.

In the journal Blood, Weill Cornell researchers and collaborators from Memorial-Sloan Kettering Cancer Center describe how they engineered a protein to amplify adult HSCs once they were extracted from the bone marrow of a donor. The engineered protein maintains the expanded HSCs in a stem-like state -- meaning, they will not differentiate into specialized blood cell types before they are transplanted in the recipient's bone marrow.

Finding a bone marrow donor match is challenging and the number of bone marrow cells from a single harvest procedure are often not sufficient for a transplant. Additional rounds of bone marrow harvest and clinical applications to mobilize blood stem cells are often required.

However, an expansion of healthy HSCs in the lab would mean that fewer stem cells need to be retrieved from donors. It also suggests that adult blood stem cells could be frozen and banked for future expansion and use -- which is not currently possible.

"Our work demonstrates that we can overcome a major technical hurdle in the expansion of adult blood stem cells, making it possible, for the first time, to produce them on an industrial scale," says the study's senior investigator, Dr. Pengbo Zhou, professor of pathology and laboratory medicine at Weill Cornell.

If the technology by Weill Cornell passes future testing hurdles, Dr. Zhou believes bone marrow banks could take a place alongside blood banks.

"The immediate goal is for us to see if we can take fewer blood stem cells from a donor and expand them for transplant. That way more people may be more likely to donate," Dr. Zhou says. "If many people donate, then we can type the cells before we freeze and bank them, so that we will know all the immune characteristics. The hope is that when a patient needs a bone marrow transplant to treat cancer or another disease, we can find the cells that match, expand them and use them."

Eventually, individuals may choose to bank their own marrow for potential future use, Dr. Zhou says. "Not only are a person's own blood stem cells the best therapy for many blood cancers, but they may also be useful for other purposes, such as to slow aging."

A Scrambled Destruction Signal

Bone marrow is the home of HSCs that produce all blood cells, including all types of immune cells. One treatment for patients with blood cancers produced by abnormal blood cells is to remove the unhealthy marrow and transplant healthy blood stem cells from a donor. Patients with some cancers may also need a bone marrow transplant when anticancer treatments damage the blood. Bone marrow transplantation can also be used to treat other disorders, such as immune deficiency disorders.

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New method developed to expand blood stem cells for bone marrow transplant

International Stem Cell Corporation Announces Positive Stem Cell Data in Parkinson’s Disease

By Stem Cell Treatment

CARLSBAD, CA--(Marketwire - Mar 20, 2013) - International Stem Cell Corporation (ISCC) ( OTCQB : ISCO ) (www.internationalstemcell.com), a California-based biotechnology company focused on the therapeutic applications of human parthenogenetic stem cells today announced positive results demonstrating the safety and efficacy of stem cell engraftment in a primate model of Parkinson's disease. The results were presented during the American Academy of Neurology (AAN) 65th Annual Meeting, Scientific Platform Session: Parkinson's Disease Therapeutics on Wednesday, March 20, 2013 in San Diego.

"This pilot study represents a first essential step in bringing cell-based therapies for Parkinson's disease to clinical trials," commented co-author of the study Evan Y. Snyder, MD, PhD, Director of Stem Cells and Regenerative Biology Program at Sanford Burnham Medical Research Institute.

These placebo-controlled studies were designed to demonstrate the viability, fate and functional efficacy of the stem cell derived neural cells after implantation to the brain. Highly pure populations of neuronal cells were differentiated from human parthenogenetic stem cells (hpSC) according to the protocol developed by International Stem Cell Corporation and recently published in the Nature Publishing Group's Scientific Reports.

The studies employ MPTP-lesioned African Green monkeys and 6-OHDA-lesioned rats, the principle models used to study Parkinson's disease. The duration of the primate study was four months and the rodent study six months. In the non-human primate model, behavioral endpoints were assessed with parkinsonian scores. These scores, based on a standardized rating scale, were recorded by observers blinded to whether the primates were in the treatment or control group. Observations were done twice per day, five days per week. In the rodent model, behavioral improvement was assessed using the cylinder test, amphetamine and apomorphine induced rotation tests. Cell engraftment, viability and phenotype of the implanted cells were determined histologically at the end of the studies. Tumorigenicity and safety of the therapy was assessed at the end of both the rodent and primate studies by gross necropsy, and brain histology.

The primate study consisted of eight asymptomatic monkeys which have the pathology of the disease, low levels of dopamine induced by bilateral injections of the neurotoxin MPTP, and lack clinical symptoms. Four of the monkeys were transplanted with hpSC-derived neuronal cells, two monkeys sham transplanted with an equivalent volume of cell-less media thus serving as the placebo control group and two healthy monkeys serving as a positive control. Behavioral endpoints were recorded to evaluate possible adverse effects.

Subsequent to implantation of the neuronal cells, all monkeys in the treatment group had higher levels of dopamine in the brain compared with the control group. Additionally, the rats in the treatment group showed gradual improvements in motor symptoms consistent with cells survival, engraftment and dopamine release. No adverse events, including dyskinesia, deformations, tumors or overgrowth, were observed in the rat or monkey treatment groups. Overall, these results provide evidence to support the hypothesis that hpSC-derived neuronal cells can be safe and have a disease modifying effect. These results, although preliminary, are a strong indication that our approach to Parkinson's disease can succeed.

"These results are pivotal for our pre-clinical Parkinson's program showing, as they do, that the hpSC-derived neuronal cells can potentially ameliorate the behavioral symptoms without triggering dyskinesias. This data forms the foundation of our discussions with the FDA as we move towards our IND in 2013," said Dr. Ruslan Semechkin, Principal Investigator of this study, head of R&D for International Stem Cell Corporation and Member of the American Academy of Neurology.

These results will be presented and discussed at the 65th American Academy of Neurology Annual Meeting, one of the world's most important annual events for neurologists and neuroscience professionals and the largest such international meeting of its kind with more than 12,000 attendees at last year's meeting.

Location: San Diego Convention Center, 111 W Harbor Dr., San Diego, CA 92101

Session:Movement Disorders; Parkinson's Disease Therapeutics

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