Stem Cell Clinic

Cell Design Labs Appoints Roger Sidhu, MD as Chief Medical Officer – GlobeNewswire (press release)

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August 01, 2017 08:00 ET | Source: Cell Design Labs

EMERYVILLE, Calif., Aug. 01, 2017 (GLOBE NEWSWIRE) -- Cell Design Labs, Inc. today announced the appointment of Roger Sidhu, M.D., to the newly created position of Chief Medical Officer. Dr. Sidhu will be responsible for the design and development of Cell Design Labs clinical programs as well as providing insight into therapeutic applications for its proprietary CAR-T and adoptive T cell therapies (TCR-T) for the treatment of cancer and other complex diseases. In this new role, Dr. Sidhu will report to Brian Atwood, Chief Executive Officer of Cell Design Labs.

Roger brings extensive experience as he was a leader in the development of Amgens deep hematology/oncology portfolio, said Brian Atwood, Co-Founder, President and Chief Executive Officer of Cell Design Labs. His broad clinical knowledge and established track record will be instrumental in guiding the clinical development of our innovative cell therapies, particularly as we look toward the application of our proprietary synNotch and THROTTLE Switch technology platforms in liquid and solid tumors.

The science and vision of Cell Design Labs management team is quite compelling, said Dr. Sidhu. The opportunity to create next-generation customized cell therapies represents a new era in medicine as this powerful technology platform may play a major role in developing more effective and safer therapeutics for patients with cancer, autoimmune and infectious diseases.

Dr. Sidhu comes to Cell Design Labs from Amgen, where he most recently held the position of Global Product General Manager. In that role, he was responsible for strategy, development and commercialization of Amgens portfolio of early-stage immuno-oncology molecules with a focus on solid tumors. He directed programs across multiple platform technologies including CAR-T cell therapies, antibodies, vaccines and bispecific T-cell engagers (BiTEs). Prior to serving as Global Product General Manager, he held escalating positions within Amgens hematology/oncology department where he provided therapeutic area leadership for a portfolio of hematology/oncology therapeutics including Vectibix, Imlygic, Blincyto, Kyprolis, rilotumumab, trebaninib, Neupogen/Neulasta, Aranesp, Nplate and XGEVA. He has extensive experience leading global product specific partnerships and collaborations. Importantly, he led successful regulatory filings for oncology therapeutics resulting in marketing approval from both the U.S. Food and Drug Administration and the European Medicines Agency. He received his B.S. in Biochemistry from the University of Alberta in Alberta, Canada, his M.D. from Queens University in Ontario, Canada and completed a medical oncology fellowship at the British Columbia Cancer Agency in British Columbia, Canada. He is an author on numerous publications and presentations.

About Cell Design Labs, Inc. Cell Design Labs is a biotherapeutics company pioneering breakthrough science to develop disruptive cell-based therapies. Based on innovative research from Dr. Wendell Lims lab at UC San Francisco, Cell Design Labs leverages the power of the bodys immune system to develop smart, living therapies with the capability to treat our most challenging diseases with unprecedented power, precision, safety and durability. Using its proprietary technology platform for custom cell engineering, Cell Design Labs will develop its own portfolio of anticancer therapies as well as create partnerships with leading oncology companies. Initially focused on cancer, including both hematologic and solid tumors, this broad technology may also have applications in other complex diseases such as autoimmune and degenerative disorders. To learn more about Cell Design Labs, please visit our web site at: http://www.celldesignlabs.com.

synNotch and THROTTLE Switch are trademarks of Cell Design Labs, Inc.

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Cell Design Labs Appoints Roger Sidhu, MD as Chief Medical Officer - GlobeNewswire (press release)

New cancer therapy in clinical trial at Nebraska Medical Center has … – Omaha World-Herald

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By the time scans showed that his B-cell non-Hodgkin lymphoma was coming back last fall, James Olson had run through many of his treatment options.

In early January, his doctor recommended that the Kansas City, Missouri, man travel to the Nebraska Medical Center in Omaha to see whether he was a candidate for a new type of therapy still in clinical trials.

In May, Olson, 69, received an infusion of his own immune cells, which had been removed from his body and modified to recognize and attack the cancer. Known as CAR-T or chimeric antigen receptor T-cell therapy, it represents a new way of targeting some cancers beyond that of traditional treatments.

About 10 weeks later, his scans are good and hes got the stamina to mow his lawn and do some house painting. Hes enjoying the little pleasures of life, even seasonal chores like installing a window air conditioning unit at his home.

His doctors at the medical center, meanwhile, hope theyll soon be able to offer CAR-T to more patients.

The trial that Olson participated in still is underway, and the medical center continues to accept new patients. Another version of the treatment has shown so much promise that its been fast-tracked by the Food and Drug Administration and could receive conditional approval late this fall. The medical center is set to participate in an expanded trial for that treatment, possibly as soon as this month.

Recently, an expert panel unanimously endorsed a version of CAR-T for children and young adults with recurring acute lymphoblastic leukemia. If the FDA clears the drug, medical center doctors hope to offer the treatment to young adults up to age 25. Theyd also like to see new trials with that drug or others for older adults with recurring ALL, as the leukemia is known.

These people need something else, and this may be it, said Dr. Matthew Lunning, a hematologist and oncologist with Nebraska Medicine.

The federal panels endorsement came at a time when a number of companies are racing to develop therapies based on the approach, which scientists first began to explore decades ago. If approved by the FDA, the Novartis product endorsed by the panel would become the first gene therapy approved in the United States. In addition to targeting relapsed lymphoma and leukemia, researchers also are beginning to study the therapy for solid tumors, the kind that start in organs or tissue. Leukemia and lymphoma are considered blood cancers.

Dr. Julie Vose, chief of hematology and oncology at Nebraska Medicine, said the therapy offers many bright spots in oncology.

We just have to learn how to use it in each specific disease and in each specific patient, she said, noting that the therapy is not a one-size-fits-all treatment as existing methods have been. We have to personalize that treatment.

But even with FDA approval, she said, the treatments potential side effects, which include fever and flu-like symptoms ranging from mild to extremely severe, mean it can only be done at specialized centers like the medical center. Indeed, one earlier trial was closed because some patients suffered serious complications.

Vose said trials in non-Hodgkin lymphoma all have produced good results, including the trial currently underway at the medical center and eight other sites nationwide.

Nationally, patients involved in the trial have had a complete remission rate of 60 percent after 30 days and 40 percent after 60 days. Officially, the condition is known as refractory diffuse large B-cell non-Hodgkin lymphoma, an aggressive disease that is among about 80 subtypes of non-Hodgkin lymphoma.

These were patients who had failed every other possible treatment, Vose said. And more than half had good response to the treatment.

Treatment for newly diagnosed non-Hodgkin lymphoma and acute lymphoblastic leukemia usually begins with chemotherapy. About 30 percent of non-Hodgkin lymphoma patients and roughly 40 percent of acute lymphoblastic leukemia patients relapse after chemo. The majority of those go on to have a blood or bone marrow transplant, from which about half will relapse.

Patients who relapse after the transplant, or those who arent candidates for a transplant, could be potential candidates for CAR-T therapy.

Unlike traditional gene therapy, however, CAR-T doesnt involve replacing disease-causing genes with healthy ones. Instead, technology is used to reprogram T cells, immune cells that normally help the body fight infection and cancer. In lymphoma patients, however, Vose said, T cells go haywire and dont properly fight cancer.

During treatment, the patients T cells are collected during an outpatient procedure and sent to a lab in California for processing. The patient then receives several days of intense chemotherapy. The modified T cells are returned to Omaha and put back into the patient, who is monitored at the hospital for seven to 10 days. The entire process takes about three weeks.

Olson, who drove to Omaha last week for a checkup, said he didnt really have any side effects from the procedure. I wondered if theyd given me a placebo, said Olson, who spent his working life in real estate and was diagnosed in 2010. He was well aware of the possible risks after reading and signing a 33-page consent form.

The next question, for patients and researchers alike, is how long the treatment will hold.

We dont know how long because this is such a new treatment, Vose said, but many of the patients (who) have been treated over the past year are doing well.

That question, like many in cancer treatment, comes with its own risks and benefits to balance. If half of the lymphoma is gone and it lasts years, Lunning said, thats better than a remission that lasts a month.

This report includes material from the Washington Post and Associated Press.

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New cancer therapy in clinical trial at Nebraska Medical Center has ... - Omaha World-Herald

ViaCyte Announces First Patients Implanted with PEC-Direct Islet Cell Replacement Therapy in International Clinical … – PR Newswire (press release)

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The first cohort of type 1 diabetes patients is receiving multiple small-format cell-filled devices called sentinels in order to evaluate safety and implant viability. These sentinel units will be removed at specific time points and examined histologically to provide early insight into the progression of engraftment and maturation into pancreatic islet cells including insulin-producing beta cells. A second cohort of up to 40 patients is expected to begin enrolling later this year to evaluate both safety and efficacy. The primary efficacy measurement in the trial will be the clinically relevant production of insulin, as measured by the insulin biomarker C-peptide, in a patient population that has little to no ability to produce endogenous insulin at the time of enrollment. Other important endpoints will be evaluated including injectable insulin usage and the incidence of hypoglycemic events. ViaCyte's goal is to demonstrate early evidence of efficacy in the first half of 2018 and definitive efficacy 6 to 12 months later.

"Islet transplants have been used to successfully treat patients with unstable, high-risk type 1 diabetes, but the procedure has limitations, including a very limited supply of donor organs and challenges in obtaining reliable and consistent islet preparations," said trial investigator James Shapiro, MD, PhD, FRCSC, Director of the Clinical Islet Transplant Program, University of Alberta. "An effective stem cell-derived islet replacement therapy would solve these issues and has the potential to help a greater number of people."

"Patients with high-risk type 1 diabetes complications, such as hypoglycemia unawareness, are at constant risk of life-threatening low blood glucose," said Jeremy Pettus, MD, investigator in the clinical trial and Assistant Professor of Medicine at UC San Diego. "The PEC-Direct islet cell replacement therapy is designed to help patients with the most urgent medical need."

The PEC-Direct product candidate is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or severe hypoglycemic episodes. It is estimated that about 140,000 people in Canada and the US have such high-risk type 1 diabetes. In addition to providing an unlimited supply of cells for implantation, the PEC-Direct approach has other potential advantages relative to cadaver islet transplants such as delivering a more consistent product preparation under quality-controlled cGMP conditions, and a more straightforward and safe mode of delivery.

The clinical trial is being supported in part by JDRF, the leading global organization funding type 1 diabetes research. "JDRF remains dedicated to accelerating the delivery of beta cell replacement therapies to the T1D community, and we commend ViaCyte in its announcement of the first patients to be implanted with the PEC-Direct islet cell replacement therapy," said Derek Rapp, JDRF President and Chief Executive Officer. "JDRF is excited to support this clinical development given its potential to help those people with type 1 diabetes that need it the most those at high risk of life-threatening acute complications. JDRF and ViaCyte share a continuing commitment to realizing the potential of beta cell replacement strategies to deliver insulin independence without immune suppression for people living with type 1 diabetes, and ultimately, at JDRF we hope this will move us forward in fulfilling our vision of a world without type 1 diabetes."

"There are limited treatment options for patients with high-risk type 1 diabetes to manage life-threatening hypoglycemic episodes," said Paul Laikind, PhD, President and Chief Executive Officer of ViaCyte. "We believe that the PEC-Direct product candidate has the potential to transform the lives of these patients and we are excited to move closer to that goal with the initiation of clinical evaluation announced today. This also represents a step towards a broader application of the technology. We remain fully committed to developing a functional cure for all patients with insulin-requiring diabetes. To that end, we are hard at work on next-generation approaches as well, and expect the work with PEC-Direct to further advance our knowledge and drive progress."

In addition to JDRF, the California Institute for Regenerative Medicine (CIRM)'s Alpha Clinic, the Sanford Stem Cell Clinical Center, the JDRF Canadian Clinical Trials Network (CCTN), the Stem Cell Network, and Alberta Innovates Health Solutions (AIHS) are all providing support for the trial.

About the PEC-Direct Product Candidate The PEC-Direct product candidate delivers stem cell-derived pancreatic progenitor cells, called PEC-01 cells, in a device designed to allow direct vascularization of the cells in the device. After implantation, these cells are expected to become mature human islet tissue including well-regulated beta cells producing insulin on demand. The direct vascularization of the implanted cells is expected to allow for robust and consistent engraftment but will necessitate the use of maintenance immune suppression therapy.

About ViaCyte ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte's product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in a durable and retrievable cell delivery device. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two products in clinical development. The PEC-Direct product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit http://www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

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ViaCyte Announces First Patients Implanted with PEC-Direct Islet Cell Replacement Therapy in International Clinical ... - PR Newswire (press release)

3D printed brain-like tissue made from stem cells offers hope to address neurological disorders – Genetic Literacy Project

By Embryonic Stem Cells

Scientists in Australia have used a 3D printer to create nerve cells found in the brain using a special bio-ink made from stem cells.

The research takes us a step closer to making replacement brain tissue derived from a patients own skin or blood cells to help treat conditions such as brain injury, Parkinsons disease, epilepsy and schizophrenia.

The bio-ink is made of human induced pluripotent stem cells (iPSC), which have the same power as embryonic stem cells to turn into any cell in the body, and possibly form replacement body tissues and even whole organs.

3D printing with bio-ink (ABC News)

[Jeremy Crookfrom the University of Wollongong stated]many neuropsychiatric disorders result from an imbalance of key chemicals called neurotransmittersFor example, he said, defective serotonin and GABA-producing nerve cells are implicated in schizophrenia and epilepsy[Thus] the team used 3D printing to make neurones involved in producing GABA and serotonin.

Apart from providing customized transplants, 3D printed tissue could be useful for medical research.

For example, tissue from a patient with epilepsy or schizophrenia could be created, specifically to study their particular version of the condition.

You can compare how neuronal networks form differently compared to healthy patient, said Dr Crook.

[Read the full study here]

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:Scientists create 3D-printed brain-like tissue from stem cells

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3D printed brain-like tissue made from stem cells offers hope to address neurological disorders - Genetic Literacy Project

Controversial milestone: Scientists genetically modify human embryos for first time, reports say – The San Diego Union-Tribune

By Embryonic Stem Cells

A team of researchers that includes a scientist from the Salk Institute in La Jolla has created the first genetically modified human embryos, the MIT Technology Review reported this week.

If the achievement is true the scientists in question have neither confirmed nor disputed the account it could mark a milestone in preventing transmission of genetic diseases instead of just treating them.

It would also rev up debate about the safety and ethics of genetically changing human beings, including what laws exist to safeguard patients and what constitutes a medically legitimate genetic modification.

The technology could be used to alter people for nonmedical purposes such as making them taller, giving them a specific eye shape or switching out their black hair for a shade of blonde decisions that could be seen as fundamentally upending the definition of human nature.

The Technology Review story said the scientists harnessed the gene-editing method called CRISPR, a milestone in its own right, to modify one-celled embryos and allow them to develop for a few days. Other news organizations have published their own articles about this purported accomplishment, including the well-respected biomedical website Stat.

Prominent biologist Shoukhrat Mitalipov of Oregon Health & Science University was the lead researcher on the study, according to the Technology Review and Stat stories. Both reports said he declined to comment.

Results of the peer-reviewed study are expected to be published soon in a scientific journal, Oregon Health & Science spokesman Erik Robinson said Thursday. He declined to specify what the study discovered.

The Technology Review story also said Jun Wu of the Salk Institute for Biological Studies took part in the research. On Thursday, the institute declined to discuss the study.

Mitalipov gained fame in 2013 for spearheading development of the first human embryonic stem cells genetically matched to specific living individuals. The method he and some colleagues employed, called somatic cell nuclear transfer, was originally used two decades ago to create Dolly the cloned sheep.

Those researchers had taken a nucleus from a donor cell in a sheep and transferred it into a sheep egg cell that had had its own nucleus removed. The combination cell acted like a normal fertilized egg, producing Dolly. That sheep had the DNA of the donor cell, so it was a nearly exact clone of the sheep where the donor cell was taken from.

Growing a creature in this way is called reproductive cloning, and the U.S. government bans such procedures on people. Mitalipov and colleagues performed what is called therapeutic cloning: They used the process to cultivate human embryonic stem cells, which are likewise genetically matched to the donor nucleus.

In theory, these stem cells could be grown into replacement tissues to repair disease or injury in the person with the matching DNA. Genetically matching the stem cells to a particular patient lowers the risk that tissue transplants would be rejected by the persons immune system.

Wu and other Salk researchers in the lab of Juan Carlos Izpisa Belmonte have collaborated with Mitalipov to explore somatic cell nuclear transfer as a therapy for mitochondrial diseases. Mitochondria are organelles that make most of the energy cells use and perform other vital functions. They carry their own DNA.

The scientists generated human stem cells in the lab, repaired mitochondrial defects and found that they were able to restore certain desired functions in cells.

They took human skin cells and inserted their nuclei into human egg cells with healthy mitochondria that had their own nuclei removed. Those manipulated egg cells were then grown until they produced embryonic stem cells, free of the defective mitochondria.

The United Kingdom has approved a method that resembles reproductive cloning to prevent inheritance of mitochondrial diseases. This process involves replacing the nucleus of an egg cell from a donor with healthy mitochondria with that from the egg cell of the mother-to-be with diseased mitochondria.

Whether the reports this week about genetically modified human embryos are true, the capability of genetically engineering human embryos is fast approaching, said a bioethicist and a stem cell researcher who have examined the issue.

But having the capability doesnt mean it should be done, said Michael Kalichman, co-founding director of the the Center for Ethics in Science and Technology at UC San Diego.

Kalichman said society isnt ready for genetically modifying humans, and that its time for the public to start paying attention to what has been considered a futuristic scientific issue.

The strongest argument for genetic modification is to stop diseases, he said. The strongest argument against the technology is that it might cause unanticipated problems.

Paul Knoepfler, a stem cell researcher at UC Davis, said no matter how much effort is spent to ensure patient safety, there are no guarantees.

The bottom line is that well never really know until someone tries it, Knoepfler said. Potential harm might not emerge until adulthood or even until the genetically altered people have their own children, he added.

The other big thing is, I am not really convinced we can draw a clear line between doing this for only medical purposes versus (cosmetic) traits, he said.

Finally, its not clear why genetically editing human embryos would even be needed to prevent transmission of a genetic disease, Knoepfler said.

We already have an existing technology which is basically embryo screening, he said. Multiple embryos can be generated through in vitro fertilization to find one that doesnt have the disease.

That would be much safer than actually doing an edit, he said.

Stem cells could treat mitochondrial disease

Oregon scientists make embryos with 2 women, 1 man

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Controversial milestone: Scientists genetically modify human embryos for first time, reports say - The San Diego Union-Tribune

Scientists create 3D-printed brain-like tissue from stem cells – ABC Online

By Embryonic Stem Cells

Scientists in Australia have used a 3D printer to create nerve cells found in the brain using a special bio-ink made from stem cells.

The research takes us a step closer to making replacement brain tissue derived from a patient's own skin or blood cells to help treat conditions such as brain injury, Parkinson's disease, epilepsy and schizophrenia.

The bio-ink is made of human induced pluripotent stem cells (iPSC), which have the same power as embryonic stem cells to turn into any cell in the body, and possibly form replacement body tissues and even whole organs.

Jeremy Crook, who led the research, said the ability to customise brain tissue from a person's own body tissue was better for transplantation.

"That circumvents issues of immune rejection, which is common in organ transplantation," said Dr Crook, from the University of Wollongong and ARC Centre of Excellence for Electromaterials Science.

"It's personalised medicine."

Dr Crook said many neuropsychiatric disorders result from an imbalance of key chemicals called neurotransmitters, which are produced by specific nerve cells in the brain.

For example, he said, defective serotonin and GABA-producing nerve cells are implicated in schizophrenia and epilepsy while defective dopamine-producing cells are implicated in Parkinson's disease.

The team used 3D printing to make neurones involved in producing GABA and serotonin, as well as support cells called neuroglia, they reported in the journal Advanced Healthcare Material.

In the future, they plan to print neurones that produce dopamine.

"We might want to make a tissue that specifically generates that neurotransmitter for grafting into the brain of a Parkinson's patient," said Dr Crook.

"That's absolutely achievable."

To make the neurones, Dr Crook and colleagues used their bio-ink to print layers of a hatched pattern to create a 5 millimetre-sized cube.

They then "crosslinked" the cube into a firm jelly-like substance.

Growth factors and nutrients were then fed into the holes of this spongey "scaffold", encouraging the stem cells to grow and turn into neurons and support cells, linking up to form tissue.

Waste was also removed via the holes in the scaffold.

Dr Crook said once scaled up, blood vessels would be needed, but small transplants could be theoretically possible using the tissue developed so far.

Tissue engineer Makoto Nakamura from Toyama University in Japan said the study was "very impressive".

"This article indicates the good feasibility of 3D bioprinting with human iPS cells to engineer neural tissues," said Professor Nakamura, who recently wrote an overview on the use of 3D bioprinting in the journal Tissue Engineering.

But he said there were also risks with the technology.

A close up of the 'scaffold' made of 3D-printed induced pluripotent stem cells (iPSCs)

(Supplied: Gu et al/Advanced Healthcare Materials)

A close up of the 'scaffold' made of 3D-printed induced pluripotent stem cells (iPSCs)

Supplied: Gu et al/Advanced Healthcare Materials

One of the challenges of using iPSCs is that, like embryonic stem cells, they have the potential to develop into teratomas disturbing looking tumours that contain more than one type of tissue type (think toenails growing in brain tissue, or teeth growing in ovary tissue).

According to Professor Nakamura, it would be important to ensure all the stem cells had turned into nerve cells in the final transplanted material.

"Undesired tissue may grow if even only one immature [stem] cell contaminates [the tissue to be transplanted]," he said.

Dr Crook said the team was currently carrying out animal experiments to test if teratomas developed from the 3D printed nerve cells.

While this is a first step towards 3D printing of whole organs, Dr Crook said a whole functioning brain would be a much more complex task.

"That's a whole different scale. The tissue we print is uniform, and not made up of different regions like a brain," said Dr Crook.

Still, it is a goal the researchers are heading towards.

"We would like to get as close as possible to replicating the function of the brain on the bench," said research team member Professor Gordon Wallace.

Apart from providing customised transplants, 3D printed tissue could be useful for medical research.

For example, tissue from a patient with epilepsy or schizophrenia could be created, specifically to study their particular version of the condition.

"You can compare how neuronal networks form differently compared to healthy patient," said Dr Crook.

And the tissue could also be used to screen for effective drugs or electrical stimulation treatments.

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Scientists create 3D-printed brain-like tissue from stem cells - ABC Online

Stem cell research: the debate continues to rage – CosmicNovo.com (Science and Technology)

By Embryonic Stem Cells

The list of medical or scientific endeavours mired in controversy is fairly short, but stem cell research and related therapy are some of the most contentious issues in modern science. Simply, stem cell therapy involves the use of stem cells to treat or prevent a disease or condition, a form of this type of treatment involves bone marrow transplant which is a relatively common operation. Whilst this may not strike you as something worthy of debate, it is because it is the further research in stem cell therapy that has become a battleground of ideology and discussion.

There is research and case studies showing that stem cell therapy involving cells from the umbilical cord blood of infants as well embryonic stem cells from human embryos. Although the former is fairly innocuous, is the latter, which requires a human embryo that has caused controversy, as to harvest them, you must destroy the embryo.

Understandably, there is a lot of opposition to the use of human embryonic stem cells in research, often times based on a range of philosophical, moral, or religious objections, with most protesters worried of cloning embryos just to harvest these cells. Theology, philosophy and morality aside, the medical possibilities of embryonic stem cells are almost limitless.

Doctors have explained that due to the nature of these cells, they are more flexible and can be put to a far greater range of uses than other more conventional stem cells. They pertain that these cells could help treat an incredibly high amount of diseases and illnesses including but not limited to neurodegenerative diseases and conditions such as diabetes and heart disease.

Of course, this only adds to the mounting debate surrounding the use of these cells, further driving questions from a moral and philosophical viewpoint as to whether or not it is ethical to be using embryonic stem cells, despite the purported benefits. Although research continues into the use of these specific cells, and governments grapple with potential legal and medical ramifications, it is important to realize that there are several other stem cell opportunities that do not require the same controversial source.

Although there has been blowback on other forms of research in the sector namely the use of umbilical blood the use of bone marrow transplants and other such alternative continue to save lives daily. However, until society catches up with science and medicine, there will be a continued debate as to the ethics and morality of this type of research, its applications, and what it could open the door for.

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Stem cell research: the debate continues to rage - CosmicNovo.com (Science and Technology)

How to Become a Regenerative Stem Cell Doctor

By Stem Cell Doctors

Overview

A new frontier in medicine, regenerative medicine or stem cell therapy involves the study of or the application of stem cells as a form of healing. Stem cells are naturally reproduced in the body therefore they are a renewable source of medicine with enormous potential. Still a relatively new area of scientific study, it is unknown just how far and wide reaching the healing capabilities of this type of therapy will be, but the potential seems quite limitless. A medical student choosing to specialize in this field of study will likely witness and participate in many new and exciting developments as this type of medicine evolves.

What is a Regenerative Stem Cell Doctor

A regenerative stem cell doctor is a specialist who uses stem cell therapy to treat patients. As this is still a comparatively new form of medicine, this type of doctor will likely be involved in research or clinical trials, discovering new treatments and their effects as well as preventative approaches based on cellular technology to treat currently unmanageable human diseases.

Stem cells generally fall under three categories:

A stem cell doctor may use this type of medical treatment with patients who suffer from autoimmune deficiencies or genetic blood diseases. It's also typical for stem cell doctors to focus on pharmaceutical product development in areas of systemic diseases, cardiac and vascular diseases, or orthopedic diseases of the spine or bone marrow transplantation outcomes.

A regenerative stem cell doctor may also be involved in cancer research through the use of stem cell medicine as an alternative to damaging treatments such as radiation and chemotherapy. Stem cell therapy is also currently being used to treat bone, skin and corneal diseases and injuries through tissue grafting.

Educational Requirements for Becoming a Regenerative Stem Cell Doctor

A doctoral or professional degree is the educational requirement for a Regenerative or Stem Cell Doctor

Falling under the category of medical scientist, a student wishing to become involved in the exciting field of cell-based regenerative medicine will find themselves at the forefront of the ground breaking evolution of medicine. Of course, the educational path to such an esteemed profession will require lifelong dedication to learning and continued research and may even require dual graduate degrees depending upon the student's individual goals; as well as a commitment to meeting challenges and the fortitude to deal with setbacks as this type of medicine evolves.

Step-by-Step Educational Path to Becoming a Regenerative Stem Cell Doctor

Bachelor's Degree

Holding an undergraduate degree from an accredited college is necessary in order to procure a place in medical school or to be accepted into a doctoral program. For those whose sights are set on eventually becoming a medical scientist and working in the field of regenerative stem cell medicine, it is ideal to begin with a strong background in biology, chemistry and biophysics. Majoring in life science, biology, microbiology or pre-med is a good starting point as well as taking writing classes as this field of study will require reporting, journaling and possibly public speaking at some point. Future medical students will need to take The Medical College Admissions Test (MCAT).

Volunteer

Volunteering is always a good idea and will make an impressive addition to any resume or application submitted towards attaining the candidate professional goals. Students interested in stem cell therapy may find volunteer opportunities at universities or laboratory environments as research assistants.

Internship

Students will gain hands on experience through an internship by working under the supervision of experienced stem cell researchers, assisting with current investigations, writing reports and sharpening other required skills in preparation for entering medical school or a doctoral program. Several internships can be applied toward college credit hours.

Masters Degree

A Master of Science Degree or a master's degree with a focusin stem cell biology and regenerative medicine will prepare the way for entry into medical or PhD programs. During this course of study the candidate will acquire an in depth understanding of how the body can naturally repair and restore damaged cells, tissues and organs through courses in cutting-edge biomedical sciences such as molecular, cellular, and developmental biology. These master's programs will also provide hands-on laboratory experience working with stem cells.

Doctoral Degree

Having a PhD in a biological sciences field is perhaps the final stepping stone to qualify for positions at the forefront of the exciting field of cell-based regenerative medicine. One must also obtain a doctorate in medicine if their intention is to administer stem cell treatments. Some schools offer dual degree programs and the candidate may pursue both MD and PhD degrees concurrently.

At this point the candidate learning how to become a stem cell doctor will evolve from education to application through translational science as they study and develop new therapies based on stem cell behavior. Future stem cell doctors will receive specialized training in subjects such as genetics and developmental biology, participate in laboratory-based stem cell courses, take advanced courses in stem cell biology and regenerative medicine, and gain experience through clinical rotations as well as producing original research in the form of a thesis or dissertation.

It is also typical during the doctoral degree program that a future doctor will focus on specialties such as law, business and/or engineering pertaining to stem cell research or focus on areas more relevant to physicians and surgeons.

Licensing

Medical students are required to pass the United States Medical License Exams (USMLE) and complete residency training as well as acquiring the appropriate state(s) licenses in order to practice medicine.

Post Graduate Residency

After becoming a licensed doctor, in order to practice medicine it is necessary to complete a residency program in the area of their chosen specialty. Doctors who wish to work in stem cell based therapies will most likely complete a residency in internal medicine and may want to focus on developing skills in oncology or hematology. However, research involving stem cell medicine bleeds over into many specialty domains.

Fellowship

Post-doctoral education and training may entail working with researchers and staff on projects involving gene therapy, organ engineering or microbial studies. The American Academy of Anti-Aging Medicine (A4M) is at the forefront of this area of education by being the world's first school to offer a Stem Cell Fellowship Program. Requirements include 5 modules of training and experience as well as completing the A4M Board Certification. More programs for this type of fellowship are being designed and implemented as awareness rises, advances continue, and more and more doctors and students are in need of resources specific to stem cell education and application.

Continuing Education

A select few graduates, post doctoral fellows and clinical fellows may be selected to participate in curriculum intended to develop leadership skills for applicants with the potential to become future independent scientists in stem cell research. The educational requirements for a future in stem cell medicine are never ending as the potential for new therapies continue to grow and evolve and new and exciting discoveries are made.

Practicing physicians and surgeons who specialize in stem cell therapies should become certified by The American Board of Stem Cell Medicine and Surgery (ABSCMS). Visit their website for more information.

Understanding the Career Path

Work Environments

The tentacles of stem cell research are far reaching. There are worldwide opportunities for professionals in this field and as new developments occur and are found to be effective and receive government approval, the doors of opportunity will continue to open. Most regenerative stem cell doctors will work full time in office or laboratory environments working with samples, studying data and creating or studying reports.

The U.S. Department of Labor lists the top industries employing medical scientistsincluding

Many practicing physicians perform stem cell related therapies that have not yet been approved by the FDA. Below are a few scenarios in which a stem cell scientist or stem cell doctor may find employment.

Universities

Opportunities in stem cell research and development abound and someone applying for these positions will find many opportunities in universities to include laboratory research as well as academic positions. A typical day may include working on the development of new treatments, working with samples, recording detailed reports involving studies and results, as well as writing and submitting grant proposals to gain additional funding for programs. Academic positions may include classroom instruction through texts, seminars or hands on training with students or writing publications regarding new discoveries as stem cell research uncovers new and exciting possibilities.

Hospitals

Doctors or medical scientists working in hospitals or hospital laboratories may work with individuals or groups of patients, administering treatments and monitoring the results during clinical trials. Surgeons specializing in stem cell therapies may work in hospitals with patients suffering from very specific conditions such as cancer patients and those with blood diseases. They will be involved in procedures such as bone marrow transplantation or the implantation of stem cells into the body to treat blood disorders such as lymphoma, leukemia, or sickle cell anemia. They may also perform surgeries involving tissue grafting for skin or corneal diseases and injuries.

Pharmaceutical Companies

Pharmaceutical companies are becoming more and more involved with stem cells as drug therapies as new experimental avenues are opened. Stem cell specialists may work with these companies combining stem cells with other pharmaceutical compounds in experimentation processes for the development of new therapeutics.

Salary Expectations

The median annual salary a stem cell doctor (medical scientists, except epidemiologists) can expect to earn, according to the U.S. Bureau of Labor Statistics, was $76,980 as of May 2012 with the highest ranking positions being compensated at over $146,000 and the lower 10% bringing in less than $42,000 annually. O Net reports the median wage (2014) to be equivalent to $38.43 hourly or $79,930 annually. This field of employment is expected to grow by 13% between 2012 and 2022.

Growth is expected to be driven by natural causes such as population growth and the continued spreading of infectious diseases which provide an ever increasing need for development in this field of medicine which can improve overall human health and create new cures for illnesses.

While becoming a regenerative or stem cell doctor isn't specific to any one medical specialty at this point, an interest in this field leaves many options for the beginning medical student. It's due to the relatively new nature of this field of study that candidates have several career options to explore. This profession has the potential to change lives, discover cures and provide higher quality medical care for billions of people living across the globe.

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How to Become a Regenerative Stem Cell Doctor

A Doctor’s View: Media has responsibility to spare us misleading advertising – Duluth News Tribune

By Stem Cell Doctors

The United States and New Zealand are the only countries in the world that allow such direct-to-consumer advertising. This means pharmaceutical companies can advertise their products directly to you via any media, whether radio, television, or newspapers.

This practice of direct-to-consumer advertising at one time was very heavily regulated by the U.S. Food and Drug Administration. That changed in 1997 when regulations regarding the listing of side effects were eased. In the decade that followed, spending for pharmaceutical advertising increased from $11 billion to $30 billion and has continued to boom in the last decade.

Why? Because its effective. Numerous studies show that direct-to-consumer advertising leads to the increased prescribing of expensive patented medicines rather than their generic alternatives and also leads to the increased use of off-label medicines.

I spend a lot of my time as a primary-care doctor talking through advertisements seen by patients. Common topics include that shingles shot, low testosterone, caloric supplements and multivitamins, and, recently, Hepatitis C screenings. To be clear, I love when my patients are informed, and I very much enjoy these conversations when the facts are clear. The problem, however, is, oftentimes, these advertisements lead to confusion and misinformation.

In mid-July I had a patient call my office near the end of the work day. He was frantic. He needed to get ahold of me immediately. He was at a stem cell education seminar and needed to know in the next few minutes if he should pay the thousands of dollars being requested for therapies that he was being told may help with his and his wifes chronic diseases. I told him no.

The following day we were sitting in my office and he showed me a full-page article in the News Tribune titled, Stem Cell Centers: Cutting Edge Treatments, Amazing Results. I call it an article because nowhere on the page did I see it labeled as an advertisement. The article instructed the reader, in all capital letters, to stop living with chronic pain. It wondered if you are a candidate and beckoned readers to a free seminar.

Per my patient, the seminar was exactly what you would expect: a made-for-TV advertisement offering to harvest the patient's stem cells and reinject them into the patient for the low price of $4,000 per injection. But wait, if you buy two, theres a $500 savings.

The truth about stem cells is that, while promising, they are largely unproven. That is, there is some very preliminary basic science research suggesting that stem cells may some day be beneficial in clinical medicine, but there are still no clinical trials that have shown any benefit. Nonetheless, companies stand to make a lot of money selling these uncertain therapies. States such as California and Florida are so fraught with stem cell clinics the FDA is weighing crackdowns. To be very clear, I would never advise a patient to undergo this treatment.

Physicians and medical societies, including the American Medical Association, have been calling for the FDA to crack down on direct-to-consumer advertising, as there is strong and mounting evidence that it leads to the increased costs of prescription medicines, the inappropriate off-label use of medicines, and, in some cases, the propagation of misinformation.

I suspect the FDA will make changes in the near future. In the meantime, our local news media has a responsibility here. There is an ethical and moral responsibility for the News Tribune to not let organizations like Stem Cell Centers prowl on our community.

The American Academy of Family Practice has recommendation guidelines for direct-to-consumer advertising: Advertisements must conform to applicable laws, including FDA and/or Federal Trade Commission guidelines (stem cell treatments are not FDA-approved); must be labeled as advertisements, unlike the ad in the News Tribune; should contain information that is accurate, balanced, objective, and complete, with no false or misleading statements; shouldnt promote unhealthy or unsafe practices; should mention risks if benefits are mentioned; and should not promote the use of products that have addictive or abuse potential.

Id urge the News Tribune to also insist that these advertisements recommend discussions with patients physicians. In the instance of Stem Cell Centers, my patient felt cornered and put on the spot for thousands of dollars.

Please, News Tribune, lets be partners in taking care of our communitys health.

Dr. Timothy Kufahl is a family physician in downtown Duluth.

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A Doctor's View: Media has responsibility to spare us misleading advertising - Duluth News Tribune

The curious case of ClinicalTrials.gov, where dubious stem cell therapies seem legit – Ars Technica

By Stem Cell Doctors

Earlier this year, doctors reported the case of three women who went blind after having stem cells derived from their own fat injected directly into their eyeballsa procedure for which they each paid $5,000. Piecing together how those women came to pay for such a treatment, the doctors noted that at least one of the patients was lured by a trial listing on ClinicalTrials.gova site run by the US National Institutes of Health to register clinical trials. Though none of the women was ever enrolled in the trialwhich never took place and has since been withdrawnit was enough to make the treatment seem like part of legitimate, regulated clinical research.

At least 18 ostensible trials listed on the site offer similar stem cell treatments that participants must pay to receiveunlike most trials, which compensate rather than charge participants for experimental treatments. These trials, sponsored by seven companies total, claim to be developing therapies for a wide range of conditions, like erectile dysfunction, type II diabetes, vision problems, Parkinsons disease, premature ovarian failure, and chronic obstructive pulmonary disease (COPD). However, these trials are largely not backed by preliminary research. None of them has Food and Drug Administration approvaleven though the agency has published a draft guidance that suggests these treatments are subject to FDA regulation. And some of the studies are only granted ethical approval by review boards with apparent conflicts of interest and histories of reprimands from medical boards and the FDA.

Some of these studies, I mean, theyre just so outrageous, article author Leigh Turner, a bioethicist at the University of Minnesota, told Ars. But, to hook patients, a listing on ClinicalTrails.gov is helpful to stem cell clinics, he explains. A key thing that these businesses need to do is they need to look legitimate, they need to look credible, he explains. Listing studies on ClinicalTrials.gov is in some respects really clever from a marketing perspectiveand really dangerous.

Theyre taking a federally funded websitesupporting clinical research, he said, and using it as a marketing platform.

In his article Wednesday, Turner argued that the NIH should tighten restrictions on registering studies on the site. Right now, registration is largely based on the honor system. Its up to study sponsors to accurately note whether their study is subject to FDA regulation.

Some of these studies, I mean, theyre just sooutrageous

Many of the stem cell clinics argue that their work is not regulated by the FDA because theytreat each patient with the patient's own stem cells, called autologous-derived stem cells. In many cases, tissue is harvested from a patientoften fat tissue collected using liposuctionthen the tissue is processed in some way to obtain stem cells, which get injected back into the patient to treat any of several conditions. This was the case for the three blinded patients who received treatment at a clinic called US Stem Cell (previously known as Bioheart, Inc.).

Autologous treatments are exempt from FDA regulation if the cells are no more than minimally manipulated before they go back into the patient, the FDA noted to Ars. But a draft guidance that the agency has not yet enforced states that processing and isolating stem cells from tissue, specifically fat tissue, is not exempt. According to the draft guidance, this procedure involves cells that are more than minimally manipulated, because it alters the original relevant characteristics of the human tissue.

In a comment to Ars, the FDA said that, once the guidance is finalized, it will be able to apply the proper oversight to these stem cell treatments. In the meantime, it said:

We recognize that there are a number of clinics operating, which do not register with FDA. Consumers are encouraged to contact FDA and the appropriate state authorities in their jurisdictions to report any potentially illegal or harmful activity related to stem cell based products. We also encourage patients and health care providers to report adverse events associated with cellular therapies to FDA.

For now, stem cell clinics are skirting FDA oversight. Without enforcement, the only barrier to registering on ClinicalTrails.gov is to have an IRBinstitutional review boardsign off. These boards provide ethical oversight of a clinical trial and must be registered with the FDA.

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The curious case of ClinicalTrials.gov, where dubious stem cell therapies seem legit - Ars Technica

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