Category Archives: Stem Cells

Stem cells have long been used to treat blood cancers and some immune diseases. But some doctors are offering stem cell treatments for diseases still under clinical trial. Photograph: Mauricio Lima/AFP/Getty Images

Medical and legal experts from around the world have united to call for more stringent regulation of stem cell therapies to prevent people pursuing unproven and potentially deadly treatments overseas.

In a perspective piece for the US journal Science Translational Medicine, 15 experts from countries including the UK, the US, Canada, Belgium, Italy and Japan wrote that national efforts alone would not be enough to counter an industry offering unproven treatments to vulnerable patients.

Stem cell-based interventions are classified under diverse and potentially incompatible national regulatory frameworks, the authors wrote.

Approaches for international regulation not only need to develop consistent rules over the commercialisation of medical practices and products but also need to give them teeth by developing cross-border partnerships for compliance.

Stem cells found in bone marrow and umbilical cord blood have long been used to successfully treat blood cancers including leukaemia and some immune diseases. But those are among the few proven treatments. Legitimate and ethics-approved clinical trials by academic centres are also occurring, exploring the potential of stem cells to treat a wider range of diseases.

But some doctors are directly offering to the general public stem cell treatments for diseases still under clinical trial or for which no evidence exists and for which the safety and efficacy is as yet unproven.

Deaths as a result of stem cell treatments have already occurred. In 2013 Sheila Drysdale died in a New South Wales nursing home after undergoing an unproven liposuction stem-cell therapy at a western Sydney clinic. Following Drysldales death, her doctor, Ralph Bright, gave a statement to police in which he claimed that stem-cell treatment could improve comorbidities and that stem cells could move from joints to other parts of the body to improve disease in distant sites including lungs and brain, vision, mentation and pain.

In his report into Drysdales death, the coroner Hugh Dillon wrote that he could not say what motivated Dr Bright to perform this unproven, dubious procedure on Sheila Drysdale.

But regardless of his motivation, Dr Brights performance as a medical practitioner was, for the reasons outlined above, poor and resulted in Sheila Drysdales death.

The Medical Council of NSW investigated Bright and placed a number of restrictions on his right to practice. Bright is still authorised to practise stem cell therapy for patients with osteoarthritis or who are taking part in research studies approved by an ethics committee. He is also still allowed to treat patients returning for remaining injections of stored cells.

In 2013 a Queensland woman, Kellie van Meurs, died when she travelled to Russia to undergo stem-cell treatment for a rare neurological disorder. She died of a heart attack as a result.

Australias drug regulator, the Therapeutic Goods Administration, last year sought feedback on the regulation of autologous stem-cell therapies but is yet to publish those submissions. A TGA spokeswoman said the Administration was still examining the options for changes to the legislation to reflect public and industry views. The TGA currently considers autologous treatments, which involve treating someone with their own tissue or cells, to be a therapeutic good and, therefore, does not regulate them. Stem cells used for medical practice and therapeutic purposes are covered by different regulatory frameworks.

Associate Professor Megan Munsie, a University of Melbourne stem cell scientist and a co-author of the paper, said: The idea that stem cells are magical holds court in the community, along with this idea the advances in treatment are being held up by red tape.

Unethical health practitioners exploited this, she said, along with the vulnerability of patients with difficult-to-treat or incurable conditions.

There is a precedent for international regulation of this industry because regulations already exist around drugs the way they are manufactured, she said.

This could be extended to the regulation to the stem cell and tissue-based therapies. This international stance would then force or encourage stronger local regulations.

There have been successful efforts by scientists to push back against unscrupulous doctors. In Italy scientists and regulators highlighted the unproven yet government-subsidised treatments being offered by the entrepreneur Davide Vannoni and fought to stop him. He was convicted of criminal charges but the sentence was later suspended.

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Stem cell therapies: medical experts call for strict international rules - The Guardian

Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth. In addition, in many tissues they serve as a sort of internal repair system, dividing essentially without limit to replenish other cells as long as the person or animal is still alive. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.

Stem cells are distinguished from other cell types by two important characteristics. First, they are unspecialized cells capable of renewing themselves through cell division, sometimes after long periods of inactivity. Second, under certain physiologic or experimental conditions, they can be induced to become tissue- or organ-specific cells with special functions. In some organs, such as the gut and bone marrow, stem cells regularly divide to repair and replace worn out or damaged tissues. In other organs, however, such as the pancreas and the heart, stem cells only divide under special conditions.

Until recently, scientists primarily worked with two kinds of stem cells from animals and humans: embryonic stem cells and non-embryonic "somatic" or "adult" stem cells. The functions and characteristics of these cells will be explained in this document. Scientists discovered ways to derive embryonic stem cells from early mouse embryos more than 30 years ago, in 1981. The detailed study of the biology of mouse stem cells led to the discovery, in 1998, of a method to derive stem cells from human embryos and grow the cells in the laboratory. These cells are called human embryonic stem cells. The embryos used in these studies were created for reproductive purposes through in vitro fertilization procedures. When they were no longer needed for that purpose, they were donated for research with the informed consent of the donor. In 2006, researchers made another breakthrough by identifying conditions that would allow some specialized adult cells to be "reprogrammed" genetically to assume a stem cell-like state. This new type of stem cell, called induced pluripotent stem cells (iPSCs), will be discussed in a later section of this document.

Stem cells are important for living organisms for many reasons. In the 3- to 5-day-old embryo, called a blastocyst, the inner cells give rise to the entire body of the organism, including all of the many specialized cell types and organs such as the heart, lungs, skin, sperm, eggs and other tissues. In some adult tissues, such as bone marrow, muscle, and brain, discrete populations of adult stem cells generate replacements for cells that are lost through normal wear and tear, injury, or disease.

Given their unique regenerative abilities, stem cells offer new potentials for treating diseases such as diabetes, and heart disease. However, much work remains to be done in the laboratory and the clinic to understand how to use these cells for cell-based therapies to treat disease, which is also referred to as regenerative or reparative medicine.

Laboratory studies of stem cells enable scientists to learn about the cells essential properties and what makes them different from specialized cell types. Scientists are already using stem cells in the laboratory to screen new drugs and to develop model systems to study normal growth and identify the causes of birth defects.

Research on stem cells continues to advance knowledge about how an organism develops from a single cell and how healthy cells replace damaged cells in adult organisms. Stem cell research is one of the most fascinating areas of contemporary biology, but, as with many expanding fields of scientific inquiry, research on stem cells raises scientific questions as rapidly as it generates new discoveries.

I.Introduction|Next

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Stem Cell Basics I. | stemcells.nih.gov

StemCells, Inc. is engaged in clinical development of its proprietary HuCNS-SC (purified human neural stem cells) platform technology to treat disorders of the central nervous system (CNS). Learnmore

Spinal cord injury (SCI) is the second leading cause of paralysis in the U.S. Transplantation of HuCNS-SC cells holds much promise. Learnmore

StemCells, Inc. has been very professional. They have given me all the support that I need.

Phase I/II SCI Clinical Trial Patient Learnmore

StemCells, Inc. being controlled by a U.S. company, and the way they were following up with their patients, just made me feel safer.

Phase I/II SCI Clinical Trial Patient Learnmore

Age-related Macular Degeneration (AMD) is the leading cause of vision loss in developed countries. HuCNS-SC cells may be a viable therapy. Learnmore

I was not ready to give in and say I was going to be blind I was ready to be a pioneer.

Phase I/II AMD Clinical Trial Patient Learnmore

As a patient with a cervical SCI, you may be eligible to participate in a clinical research study called the Pathway Study. The study is evaluating human neural stem cell transplantation as a potential therapy for SCI.

Learn more about this clinical trial

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StemCells, Inc. : Groundbreaking Science. Breakthrough ...

Contemporary Examples

PLUS: Neurobiologist Maureen L. Condic fact-checks 11 stem cell arguments and asks, does research really need human embryos?

He has no regrets on banning the use of federal funds for most stem cell research.

Bush may have discouraged some of the best graduate students from going into the stem cell research field.

stem cell differentiation involves a plethora of regulatory factors and signals that are in a constant state of flux.

One of Obama's first acts must be to overturn Bush's ignorant ban on federal funding for stem cell research.

stem cell research, the bullet train, reversing global warming?

He also came out strongly in favor of stem cell research, again using a personal family story to underline his commitment.

British Dictionary definitions for stem cell Expand

(histology) an undifferentiated cell that gives rise to specialized cells, such as blood cells

stem cell in Medicine Expand

stem cell n. An unspecialized cell that gives rise to a specific specialized cell, such as a blood cell.

stem cell in Science Expand

stem cell in Culture Expand

A cell from which a variety of other cells can develop through the process of cellular differentiation. Stem cells can produce only a certain group of cells (as with skin stem cells) or any cell in the body (as with embryonic stem cells).

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Stem cell | Define Stem cell at Dictionary.com

Embryonic stem cells (ESCs) are stem cells derived from the undifferentiated inner mass cells of a human embryo.

Embryonic stem cells are pluripotent, meaning they are able to grow (i.e. differentiate) into all derivatives of the three primary germ layers: ectoderm, endoderm and mesoderm.

In other words, they can develop into each of the more than 200 cell types of the adult body as long as they are specified to do so.

Embryonic stem cells are distinguished by two distinctive properties: their pluripotency, and their ability to replicate indefinitely.

ES cells are pluripotent, that is, they are able to differentiate into all derivatives of the three primary germ layers: ectoderm, endoderm, and mesoderm.

These include each of the more than 220 cell types in the adult body.

Pluripotency distinguishes embryonic stem cells from adult stem cells found in adults; while embryonic stem cells can generate all cell types in the body, adult stem cells are multipotent and can produce only a limited number of cell types.

Additionally, under defined conditions, embryonic stem cells are capable of propagating themselves indefinitely.

This allows embryonic stem cells to be employed as useful tools for both research and regenerative medicine, because they can produce limitless numbers of themselves for continued research or clinical use.

Because of their plasticity and potentially unlimited capacity for self-renewal, ES cell therapies have been proposed for regenerative medicine and tissue replacement after injury or disease.

Diseases that could potentially be treated by pluripotent stem cells include a number of blood and immune-system related genetic diseases, cancers, and disorders; juvenile diabetes;

Parkinson's; blindness and spinal cord injuries.

Besides the ethical concerns of stem cell therapy, there is a technical problem of graft-versus-host disease associated with allogeneic stem cell transplantation.

However, these problems associated with histocompatibility may be solved using autologous donor adult stem cells, therapeutic cloning, stem cell banks or more recently by reprogramming of somatic cells with defined factors (e.g. induced pluripotent stem cells).

Other potential uses of embryonic stem cells include investigation of early human development, study of genetic disease and as in vitro systems for toxicology testing.

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Embryonic stem cell - Science Daily

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An injection of stem cells into the eye may soon slow or reverse the effects of early-stage age-related macular degeneration, according to new research from scientists at Cedars-Sinai. Currently, there is no treatment that slows the progression of the disease, which is the leading cause of vision loss in people over 65.

"This is the first study to show preservation of vision after a single injection of adult-derived human cells into a rat model with age-related macular degeneration," said Shaomei Wang, MD, PhD, lead author of the study published in the journal STEM CELLS and a research scientist in the Eye Program at the Cedars-Sinai Board of Governors Regenerative Medicine Institute.

The stem cell injection resulted in 130 days of preserved vision in laboratory rats, which roughly equates to 16 years in humans.

Age-related macular degeneration affects upward of 15 million Americans. It occurs when the small central portion of the retina, known as the macula, deteriorates. The retina is the light-sensing nerve tissue at the back of the eye. Macular degeneration may also be caused by environmental factors, aging and a genetic predisposition.

When animal models with macular degeneration were injected with induced neural progenitor stem cells, which derive from the more commonly known induced pluripotent stem cells, healthy cells began to migrate around the retina and formed a protective layer. This protective layer prevented ongoing degeneration of the vital retinal cells responsible for vision.

Cedars-Sinai researchers in the Induced Pluripotent Stem Cell (iPSC) Core, directed by Dhruv Sareen, PhD, with support from the David and Janet Polak Foundation Stem Cell Core Laboratory, first converted adult human skin cells into powerful induced pluripotent stem cells (iPSC), which can be expanded indefinitely and then made into any cell of the human body. In this study, these induced pluripotent stem cells were then directed toward a neural progenitor cell fate, known as induced neural progenitor stem cells, or iNPCs.

"These induced neural progenitor stem cells are a novel source of adult-derived cells which should have powerful effects on slowing down vision loss associated with macular degeneration," said Clive Svendsen, PhD, director of the Board of Governors Regenerative Medicine Institute and contributing author to the study. "Though additional pre-clinical data is needed, our institute is close to a time when we can offer adult stem cells as a promising source for personalized therapies for this and other human diseases."

Next steps include testing the efficacy and safety of the stem cell injection in preclinical animal studies to provide information for applying for an investigational new drug. From there, clinical trials will be designed to test potential benefit in patients with later-stage age-related macular degeneration.

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The above story is based on materials provided by Cedars-Sinai Medical Center. Note: Materials may be edited for content and length.

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Stem cell injection may soon reverse vision loss caused by age-related macular degeneration