Disease-specific human embryonic stem cell lines placed on NIH registry

Sep. 24, 2013 Scientists from King's College London have announced that 16 human embryonic stem (hES) cell lines have been approved by the US National Institutes of Health (NIH) and placed on their Stem Cell Registry, making them freely available for federally-funded research in the USA. The stem cell lines, which carry genes for a variety of hereditary disorders such as Huntington's disease, spinal muscular dystrophy and cystic fibrosis, are considered to be ideal research tools for designing models to understand disease progression, and ultimately in helping scientists develop new treatments for patients.

King's is now one of the five biggest providers of disease-specific human embryonic stem cells lines on the NIH Registry, and the largest from the UK. The development is a significant milestone for King's and keeps the university at the forefront of global research into regenerative medicine.

Embryonic stem cell lines are grown from frozen embryos donated by patients undergoing preimplantation genetic diagnosis (PGD) in conjunction with IVF treatment. Unlike 'adult' stem cells, embryonic stem cells can differentiate into any type of cell within the body and are considered to be more useful for stem cell-based therapies. Disease-specific stem cell lines are created from embryos found to be affected with genetic disorders and therefore not suitable for implantation, but offer huge potential for research into disease development.

King's has already developed eight clinical-grade and more than 30 research-grade stem cell lines, which were approved by the UK Stem Cell Steering Committee to be deposited with the UK Stem Cell Bank (UKSCB) and distributed worldwide.

The sixteen lines of stem cells on the NIH Registry carry genes for various hereditary disorders including Duchenne Muscular Dystrophy, Huntington's disease, cystic fibrosis, and rarer conditions such as Von Hippel-Lindau Syndrome, Wiskott-Aldrich syndrome, spinal muscular atrophy, myotonic dystrophy and neurofibromatosis.

'Major contribution to global stem cell research'

Professor Peter Braude, Emeritus Professor of Obstetrics and Gynaecology, King's College London; and former director of the Stem Cell Programme and the Pre-Implantation Genetic Diagnosis Programme, Guy's and St Thomas' NHS Foundation Trust, said: 'We are delighted that the NIH has found our lines useful and their procurement and consents in line with the strict guidelines that they have set. This achievement is the culmination of over ten years of painstaking research and consistent belief in the scientific usefulness of these very special cells to improve our understanding of genetic disease processes.

'This is a huge milestone for King's, and will allow us to make a major contribution to global stem cell research by having these stem cell lines available to scientists in the USA.

'These research-grade stem cell lines are essential not only to address basic questions in development and disease, but to test and implement technical improvements in culture conditions that might affect hES cell viability and pluripotency.'

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Disease-specific human embryonic stem cell lines placed on NIH registry

Stem cell guidelines inadequate, docs say

MANILA, PhilippinesThe new Food and Drug Administration (FDA) guidelines regulating stem cell therapy in the Philippines are sorely inadequate and grossly misleading, according to a group of doctors.

The Philippine College of Physicians (PCP), the umbrella organization of Filipino doctors specializing in internal medicine, said it was disappointed with the FDA and Department of Health for failing to decisively act on the dangers posed by unregulated stem cell therapy in the country.

The recent guidelines released by the FDA fell short and will not stop the proliferation of stem cell therapy for ailments that were not subjected to scientific study or clinical trials, PCP president Prescilla Limpin said in a statement

We will not back down from our earlier call and we will not stop until stem cell therapy undergoes scientific studies to prove its safety, quality and efficacy on the ailments it has been propagated. We will not allow its promotion and use to helpless and unknowing patients and their desperate families, said Dr. Prescilla Caguioa, the PCP president.

The FDA guidelines require that all stem cell and cellular-based treatments offered in the country should first pass the agencys standards for safety, efficacy and quality.

Beginning Sept. 1, 2013, all unregistered stem cell products would be considered as illegal and in violation of the law, the FDA said.

However, Maricar Limpin, the head of the PCP advocacy committee, warned that the FDA guidelines might be used by unscrupulous people to continue offering unproven steam cell therapies to the public.

She noted that the FDA rules cited hematopoietic (pertaining to the formation and development of blood cells) stem cell transplantation; corneal resurfacing with limbal stem cells; and skin regeneration with epidermal stem cells as recognized standards of healthcare.

This is grossly misleading because the FDA gave recognition to these procedures but failed to specify the ailments or indications where these were proven to be safe and effective, Limpin said.

It is the responsibility of the government to inform the public that the effectiveness and safety of stem cell therapy are still unproven in heart, lung, neurologic, skin, rheumatologic, kidney and gastrointestinal diseases, diabetes mellitus, hypertension, autism, cancer, aging and aesthetics, HIV, AIDS and other conditions, she said.

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Stem cell guidelines inadequate, docs say

Cease and desist order against stem cell ads sought

The Philippine College of Physicians (PCP) asked the Food and Drug Administration (FDA) to issue a cease and desist order with sanctions against all forms of advertisement on stem cell therapy until the government has come up with conclusive studies on its efficacy on diseases.

In a media briefing, the doctors said FDAs efforts in governing the use and practice of stem cell treatment in the country is not enough to stop those who offer them despite the absence of clear and conclusive clinical trials on it.

The recent guidelines released by the FDA fell short and will not stop the proliferation of storm cell therapy for ailments that were not subjected to scientific study or clinical trials. We will not back down from our earlier call and we will not stop until stem cell therapy undergoes scientific studies to prove its safety, quality and efficacy on the ailments it has been propagated. We will not allow its promotion and use to helpless and unknowing patients and their desperate families, Dr. Prescilla Caguioa, PCP president said.

Tony Leachon, PCP Vice President also urged the FDA to stop unaccredited health and commercial facilities to offer the treatment.

Recently, the FDA released an order asking health facilities offering stem cell therapy to file their application for accreditation until August 31. This follows a similar order in June where FDA issued circular no. 2013-0017 that required all human cells, tissues and cellular and tissue-based products to be registered as well.

As of August 31, FDA said only 47 medical institutions have applied for accreditation.

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Cease and desist order against stem cell ads sought

Complete 2012-13 Induced Pluripotent Stem Cell Industry Report (Updated)

Dublin, Sept. 24, 2013 (GLOBE NEWSWIRE) -- Research and Markets (http://www.researchandmarkets.com/research/qzbnvh/complete_201213) has announced the addition of the "Complete 2012-13 Induced Pluripotent Stem Cell Industry Report" report to their offering.

Stem cell research and experimentation has been in process for well over five decades, as stem cells have the unique ability to divide and replicate repeatedly. In addition, their unspecialized nature allows them to differentiate into a wide variety of specialized cell types. The possibilities arising from these characteristics has caused great commercial interest, with potential applications ranging from the use of stem cells in reversal or treatment of disease, to targeted cell therapy, tissue regeneration, pharmacological testing on cell-specific tissues, and more. Diseases such as Huntington's Chorea, Parkinson's Disease, and spinal cord injuries are examples of clinical applications in which stem cells could offer benefits in halting or even reversing damage.

Traditionally, scientists have worked with both embryonic and adult stem cells as research tools. While the appeal of embryonic cells has been their ability to differentiate into any type of cell, there has been significant ethical, moral and spiritual controversy surrounding their use for research purposes. Although some adult stem cells do have differentiation capacity, it is often limited nature, which creates narrow options for use. Thus, induced pluripotent stem cells represent a promising combination of adult and embryonic stem cell characteristics.

A distinctive feature of this report is an end-user survey of 293 researchers (181 U.S. / 112 International) that identify as having induced pluripotent stem cells as their core research focus. These survey findings reveal iPSC researcher needs, technical preferences, key factors influencing buying decisions, and more. They can be used to make effective product development decisions, create targeted marketing messages, and produce higher prospect-to-client conversion rates.

Remember, to benefit from this lucrative product market, you need to anticipate and serve the needs of your clients, or your competitors will.

Key Findings Include:

In summary, this is a must-read industry report for research supply companies to optimally position themselves to sell iPSC products. To profit from this lucrative and rapidly expanding market, you need to understand your key strengths relative to the competition, intelligently position your products to fill gaps in the market place, and take advantage crucial iPSC trends. Claim this report now to profit from this expanding market - or your competition will.

Table of Contents

I. ABSTRACT

II. BACKGROUND

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Complete 2012-13 Induced Pluripotent Stem Cell Industry Report (Updated)

Leading Stem Cell Clinic in California, TeleHealth, Now Offering 3 Different Stem Cell Therapy Treatments

Orange County, CA (PRWEB) September 23, 2013

The leading regenerative medicine clinic on the West Coast, TeleHealth, is now offering three different types of stem cell therapy injections. The California stem cell treatments are predominantly covered by insurance, and performed by Board Certified stem cell doctors. For more information and scheduling, call (888) 828-4575.

The stem cell treatments are excellent for joint arthritis, tendonitis, ligament injuries, and spinal arthritis along with degenerative disc disease. Initial research with small studies has shown regenerative medicine treatments are working well for degenerative conditions, such as the recent study out of the Hospital for Special Surgery.

One of the treatments offered is bone marrow derived stem cell injections. These are outpatient procedures that involve harvesting the patient's own bone marrow, processing it, and injecting into the area of concern at the same setting. These bone marrow stem cell injections have very low risk and the potential for helping regenerate damaged cartilage and soft tissue from such conditions as achilles tendonitis, rotator cuff tendonitis and tennis elbow.

The second procedure offered is platelet rich plasma therapy. This procedure involves a simple blood draw from the patient, and the blood is centrifuged for approximately 15 minutes. This separates the blood into concentrated platelets and growth factors, which are then injected into the problem area. This material then calls in the body's stem cells to facilitate further repair. At times PRP is used in conjunction with bone marrow derived stem cell injections.

The third procedure utilized is fat derived stem cell injections, which has the same indications as bone marrow derived.

TeleHealth sees patients from a broad area of the west coast and offers Board Certified doctors providing treatment. To seek treatment with the premier stem cell therapy clinic, call (888) 828-4575.

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Leading Stem Cell Clinic in California, TeleHealth, Now Offering 3 Different Stem Cell Therapy Treatments

Bioheart Announces Agreement With Invitrx to License Adipose Derived Stem Cells

SUNRISE, FL--(Marketwired - Sep 23, 2013) - Bioheart, Inc. (OTCQB: BHRT), a biotech company focused on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage as well as severe peripheral vascular disease announces that it has entered into an agreement with Invitrx Therapeutics to license their adipose derived stem cell products.The license agreement term sheet for adipose derived cells is for use in all indications in both human and animal medicine.

Invitrx Therapeutics is a biotechnology company specializing in the culture and engineering of adult stem cells, innovative products and therapies that are used in aesthetics, wound closure, and healing, as well as, plastic and reconstructive surgery.The team at Invitrx has been working with adipose derived stem cells for over 10 years and this experience can contribute to the development and commercialization of AdipoCell (Bioheart's adipose stem cell product).

Bioheart has recently completed enrollment in the Phase I Angel Trial using adipose derived stem cells.Preliminary 3 month follow up results will be released later this quarter.

"Combining the experience and expertise of the team at Invitrx with the currently available Bioheart products will strengthen our program.We are looking forward to expanding the Angel trial and incorporating some of the newly licensed techniques," said Mike Tomas, CEO of Bioheart, Inc.

Habib Torfi, Chairman and CEO of Invitrx, said, "Invitrx Therapeutics is looking forward to join forces with Bioheart Inc. to help advance and expand the product lines and the existing clinical trials in the stem cell field."

About Bioheart, Inc

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues.Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

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Bioheart Announces Agreement With Invitrx to License Adipose Derived Stem Cells

Poway man in groundbreaking stem cell Parkinsion’s study

By Emily Sorensen

A Poway man is part of a groundbreaking study that could lead to new advances in the treatment of Parkinsons disease.

Michael Radunsky, a Poway resident, is one of eight Parkinsons patients participating in a special study at Scripps Clinic Movement Disorders Center, where cutting-edge stem cell research may lead to a viable long-term treatment for those afflicted with Parkinsons disease.

Michael Radunsky

I am proud to be a participant in this seminal research project, said Radunsky, who has been involved with the study for about a year and a half. The study involves harvesting the skin cells, or fibroblasts, from a Parkinsons patient, reprogramming these cells into induced pluripotent stem cells (iPSC), further reprogramming the iPSC into dopamine-producing neurons, and finally, implanting these neurons into the patients substantia nigra, a small element deep in the brain which contains neurons that normally produce dopamine. Dopamine is a neurotransmitter that is used to regulate motor activity. In Parkinsons patients, these neurons begin to die and do not produce enough dopamine, according to Radunsky.

The goal of the study is to have the newly implanted neurons replace the dying ones to regulate the motor functions of Parkinsons patients. Radunsky said that so far, his cells are on step two of the progress, waiting to be further reprogrammed into neurons.

A key factor in this study is that the stem cells are derived from a patients own skin cells and not from embryos or other willing or unwilling donors. The ethical issue of embryonic stem cell research and treatments is entirely eliminated by obtaining the stem cells directly from the patient without harm or the termination of a pregnancy, said Radunsky.

Radunsky, who lives in Poway with his wife, Stephanie, and their two young children, was diagnosed with Parkinsons about two years ago, in August of 2011. He works in the photonics industry for a company that builds lasers used for ultra-cold atom physics.

It was his neurologist, Dr. Melissa Houser, who got him involved in the study. Houser is the leading clinical physician in the study, and recommended that he be involved.

Radunsky said that in six to eight months, implantation surgeries will begin, and will be followed by careful observation to see the effects of implanting the new neurons. I will make myself available to the project for as long as is necessary, said Radunsky. This will undoubtedly mean years of follow up.

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Poway man in groundbreaking stem cell Parkinsion’s study