Stem Cell Clinic

NYSCF scientists create personalized bone substitutes from skin cells

Public release date: 6-May-2013 [ | E-mail | Share ]

Contact: David McKeon dmckeon@nyscf.org 212-365-7440 New York Stem Cell Foundation

NEW YORK, NY (May 6, 2013) A team of New York Stem Cell Foundation (NYSCF) Research Institute scientists report today the generation of patient-specific bone substitutes from skin cells for repair of large bone defects. The study, led by Darja Marolt, PhD, a NYSCF-Helmsley Investigator and Giuseppe Maria de Peppo, PhD, a NYSCF Research Fellow, and published in the Proceedings of the National Academy of Sciences of the USA, represents a major advance in personalized reconstructive treatments for patients with bone defects resulting from disease or trauma.

This advance will facilitate the development of customizable, three-dimensional bone grafts on-demand, matched to fit the exact needs and immune profile of a patient. Taking skin cells, the NYSCF scientists utilized an advanced technique called "reprogramming" to revert adult cells into an embryonic-like state. These induced pluripotent stem (iPS) cells carry the same genetic information as the patient and they can become any of the body's cell types.

The NYSCF team guided these iPS cells to become bone-forming progenitors and seeded the cells onto a scaffold for three-dimensional bone formation. They then placed the constructs into a device called a bioreactor, which provides nutrients, removes waste, and stimulates maturation, mimicking a natural developmental environment.

"Bone is more than a hard mineral composite, it is an active organ that constantly remodels. Blood vessels shuttle important nutrients to healthy cells and remove waste; nerves provide connection to the brain; and, bone marrow cells form new blood and immune cells," said Marolt.

Previous studies have demonstrated the bone-forming potential from other cell sources, yet serious caveats for clinical translation remain. A patient's own bone marrow stem cells can form bone and cartilaginous tissue, not the underlying vasculature and nerve compartments; and, embryonic stem cell derived bone may prompt an immune rejection. The NYSCF scientists chose to work with iPS cells to overcome these limitations, comparing iPS sources with embryonic stem cells and bone marrow derived cells.

"No other research group has published work on creating fully-viable, functional, three-dimensional bone substitutes from human iPS cells. These results bring us closer to achieving our ultimate goal, to develop the most promising treatments for patients," said de Peppo.

While severity varies, bone defects and injuries are currently treated with bone grafts, taken either from another part of the patient's body or a donor bone bank, or with synthetic substitutes. None of these permit complex reconstruction, and they may elicit immune rejection or fail to integrate with surrounding connective tissues. For trauma patients, suffering from shrapnel wounds or vehicular injury, these traditional treatments provide limited functional and cosmetic improvement.

After a comprehensive in vitro analysis of the generated bone, the NYSCF team assessed stability when transplanted in an animal model to address a major concern for iPS-based cell therapies. Undifferentiated iPS cells can form teratomas, a type of tumor. The iPS cell-derived bone substitutes were implanted under the skin of immunocompromised mice. After 12 weeks, the explanted constructs matured and showed no malignancies but complete maturation of bone tissue, while blood vessel cells began to integrate along the grafts. These results indicate the stability of the bone substitutes.

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NYSCF scientists create personalized bone substitutes from skin cells

VistaGen Therapeutics and Duke University Publish Results on Production of Functional 3D Human Heart Tissue

SOUTH SAN FRANCISCO, CA--(Marketwired - May 7, 2013) - VistaGen Therapeutics, Inc. (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism assays, announced that its high-quality, human pluripotent stem cell-derived cardiomyocytes (heart cells) were used by collaboration partner Duke University to grow a revolutionary three-dimensional (3D) human heart muscle. An abstract of the original research article published in Biomaterials, an international journal covering the science and clinical application of biomaterials, can be found online at: http://www.sciencedirect.com/science/article/pii/S0142961213004705.

Researchers at Duke University combined VistaGen's human stem cell-derived heart cells with innovative tissue engineering and cardiac electrophysiology technologies to grow what is being called a "heart patch," which mimics the natural functions of native human heart tissue. This heart patch technology is being developed to aid in a better understanding of the biology critical to cardiac tissue engineering, for applications in regenerative cell therapy for heart disease, and as predictive in vitro assays for drug rescue and development.

H. Ralph Snodgrass, PhD, VistaGen's President and Chief Scientific Officer, stated, "The developed contractile forces and other functional properties of these cardiac tissues are remarkable and are significantly higher than any previous reports. The achievement of successfully growing a human heart muscle from cardiomyocytes derived from human pluripotent stem cells not only expands the scope of our drug rescue capabilities, but also reflects the advanced nature and potential of our collaboration with the skilled biomedical engineers at Duke Medical Center."

"VistaGen's human cardiomyocytes produced engineered cardiac tissues that exhibited structural and functional properties superior to those previously reported," said Dr. Nenad Bursac, Associate Professor in the Departments of Cardiology and Biomedical Engineering at Duke University. "This is the closest man-made approximation of natural human heart muscle to date."

Achieving this capability represents a significant breakthrough in heart cell-based therapies and in testing new medicines for potential heart toxicity and potential therapeutic benefits impacting heart disease. The following are among several key development points from the study:

The original research article also will be published in print in Biomaterials.

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue, predictive toxicology and drug metabolism screening. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, with modern medicinal chemistry to generate novel, safer chemical variants (Drug Rescue Variants) of once-promising small molecule drug candidates. These are drug candidates discontinued by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories, after substantial investment in discovery and development, due to heart or liver toxicity or metabolism issues. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.

VistaGen's small molecule prodrug candidate, AV-101, has completed Phase 1 development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects millions of people worldwide.

Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen.

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VistaGen Therapeutics and Duke University Publish Results on Production of Functional 3D Human Heart Tissue

Dr. Ernesto Gutierrez is Named President of World Stem Cells Clinic, a Stem Cell Research and Stem Cell Treatment …

Tampa, FL (PRWEB) May 04, 2013

World Stem Cells Clinic in Cancun is pleased to announce the appointment of Dr. Ernesto Gutierrez to the position of President of their medical lab and treatment center. Dr. Gutierrez brings experience and intensity to his new position at World Stem Cells Clinic and promises he and his team of experts will provide the best medical care available in the world to improve their patients quality of life.

Dr. Ernesto Gutierrez is an extensively educated physician. He is a graduate from the Universidad Anhuac Norte, School of Medicine in Mexico City and additionally holds a Post-Graduate Degree in Aesthetic and Anti-Aging Medicine from the Instituto Mexicano de Medicina Antienvejecimiento y Esttica, Guadalajara, Mexico. He holds active membership of both the Mexican College of Aesthetic and Anti-Aging Medicine and the Age Management Medicine Group. Dr. Gutierrez has spent considerable time in additional training in the US, with rotations in both Florida and Nevada for two specialty organizations and is certified in Age Management Medicine by the Cenegenics Education and Research Foundation part of Cenegenics Medical Institute in Las Vegas, Nevada. His bilingual English and Spanish skills, both in medical and conversational applications, are excellent. Dr. Gutierrez is the perfect addition to the team given his thorough understanding of both the North and South American medical systems.

Dr. Ernesto Gutierrez explains how the clinic and laboratory at World Stem Cells Clinic in Cancun were designed, built and are operated under the stringent guidelines as established by The International Cellular Medical Society (ICMS) and the US Food and Drug Administrations Good Tissue Practice (cGTP) regulations for pharmaceutical, biologics and clinical laboratories. The strict adherence to these established guidelines and policies guarantees the highest quality of clinical care and stem cell treatment safety for the patient. At World Stem Cells Clinic they continually strive to improve the patients outcomes with breakthrough research and by creating new cells and protocols.

Both the US patient management team at World Stem Cells, LLC (http://worldstemcells.com/) and their Cancun patient management team at World Stem Cells Clinic (http://worldstemcellsclinic.com/) offer medical information on the stem cell treatments provided by the doctors, help patients arrange transportation to Cancun and within the city, hotels, medical records procurement, and basically ensure that their every need is met.

Dr. Gutierrez says, "we will treat you like family!"

Working under the guidelines set forth by ICMS, World Stem Cells Clinic (http://worldstemcellsclinic.com/) provides Stem Cell Treatment for Ankylosing Spondylitis, Autism, Cerebral Palsy, Charcot-Marie-Tooth Disease (CMT), Crohns Diseases, COPD, Fuchs disease, Guillain-Barre Syndrome, Hashimotos Thryroiditis, ITP, Kidney Diseases, Macular Degeneration, Lupus (SLE), Multiple Sclerosis, PAD, Parkinsons disease, Rheumatoid Arthritis, Scleroderma, Stroke, Ulcerative Colitis at its contract Clinics, GLP laboratory, doctors and hospitals in the beautiful resort area of Cancun. They endeavor to provide the best care possible at a competitive price while providing documentation of all treatments that can be used to provide better future care and scientific data to the medical industry. World Stem Cells Clinic is participating in ICMS (International Cellular Medical Society) Stem Cell Reimplantation Registry. They provide Stem Cell Treatments to patients in need.

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Dr. Ernesto Gutierrez is Named President of World Stem Cells Clinic, a Stem Cell Research and Stem Cell Treatment ...

RNL BIO Co. Ltd. Files IND To Commence Phase II Clinical Trial Of RNL-JointStem For Osteoarthritis In The United States

GERMANTOWN, Md., May 2, 2013 /PRNewswire/ -- RNL BIO, a stem cell biotechnology company dedicated to the commercialization of autologous cell therapy products for a variety of degenerative, ischemic and other indications, has announced that it has filed an Investigational New Drug application (IND) with the Food and Drug Administration (FDA) to begin clinical trials with its adipose-derived stem cell product, termed RNL-JointStem, for the treatment of osteoarthritis (OA). Assuming approval of the IND by the Center for Biologics Evaluation and Research (CBER) at the FDA, RNL BIO plans to initiate its double-blinded, randomized, positive-control Phase II clinical trial during the third quarter of 2013 in Sugarland, Texas. Dr. Jason Dragoo of Stanford University and Dr. David Alan Fisher of Indiana University acted as reviewers and completed revision of the protocol now under evaluation by the FDA. Phase I and Phase II clinical trials of RNL-JointStem have already been completed under the authority of the Korean Food and Drug Administration (KFDA).

"We are excited about filing an IND for RNL-JointStem because it brings us closer to a clinical trial with RNL-JointStem in the United States," said Jeong-Chan Ra, CEO and Chairman of RNL BIO. "Our goal for this trial is to achieve global demonstration that RNL-JointStem is efficacious. If our trial is successful it can lead to a paradigm shift in the treatment of osteoarthritis, using stem cell products derived from a patient's own fat tissue." Among the key advantages demonstrated in previous trials of RNL-JointStem is that it is administered in a single injection, unlike the many invasive treatments currently used in the treatment of OA. "Treatments of this painful chronic condition should relieve pain, not add to it," said Dr. Ra. "We hope to confirm the efficacy of RNL-JointStem for cartilage regeneration, pain reduction and joint function improvement for OA patients, and that it will see market approval in due course."

The clinical trial will compare RNL-JointStem to existing modalities utilizing hyaluronic acid (HA). The patient population for this initial clinical trial will include patients diagnosed with osteoarthritis and whose clinicians judge that they meet candidacy requirements. The intended market for RNL-JointStem is patients under 60 years of age for whom there is no efficacious therapy at present.

About Osteoarthritis

Degenerative arthritis is the most common type of arthritis. It is estimated that 26.9 million Americans 25 years old or older have clinical degenerative arthritis of some joints, with a higher percentage of affliction in the older population. Its clinical manifestations include joint pain and impairment to movement, and surrounding tissues are often affected with local inflammation. The etiology of degenerative arthritis is not completely understood; however, injury, age, and genetics have been considered among the risk factors.

Degenerative arthritis is a progressively debilitating disease that affects mostly cartilage, with associated changes in bone. Cartilage has limited intrinsic healing and regenerative capacities.

Through this trial

Due to the increasing incidence of degenerative arthritis and the aging population coupled with inefficient therapeutic choices, novel cartilage repair strategies are in need. The market for a therapeutically efficacious product for this indication is estimated to be very large.

About an IND

An Investigational New Drug (IND) is a procedure for the authorization to perform a clinical trial in the United States. An IND is required whenever the performance of a clinical trial in the United States is intended. The IND includes information related to the quality, manufacture and control of the Investigational Medicinal Product, data from pre-clinical studies and clinical intent-to-use. An overall risk-benefit assessment, critical analyses of the pre-clinical data in relation to the potential risks and benefits of the proposed study are required to be part of the IND.

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RNL BIO Co. Ltd. Files IND To Commence Phase II Clinical Trial Of RNL-JointStem For Osteoarthritis In The United States

Stem cell discovery could aid research into new treatments

May 2, 2013 Scientists have made a fundamental discovery about how the properties of embryonic stem cells are controlled.

The study, which focuses on the process by which these cells renew and increase in number, could help research to find new treatments.

Researchers have found that a protein, which switches on genes to allow embryonic stem cells to self-renew, works better when the natural occurring level of the protein is reduced.

It was previously thought that once levels of this protein -- called Oct 4 -- were reduced the numbers of new stem cells being produced would also fall.

The finding will inform stem cell research, which is looking to find treatments for conditions including Parkinson's, motor neuron, liver and heart disease.

During embryonic development, cells that have the capacity to become any cell type in the body -- called pluripotent stem cells -- can either renew themselves by multiplying in number or differentiate to become cells found in different parts of the body, for instance skin or liver.

This need for pluripotent cells to increase in number is important so that there is a sufficient supply of them to be differentiated into other cell types.

Scientists at the Medical Research Council Centre for Regenerative Medicine at the University of Edinburgh found that when there were lower levels of Oct 4, the protein bound much more tightly to key parts of DNA in cells.

The strong attraction of Oct 4 to these sections of DNA enabled the efficient switching on of key genes that caused pluripotent stem cells to renew.

The findings could help to improve the way in which stem cells are cultured in the laboratory, providing a better understanding of the processes needed for cells to divide and multiply or to generate different cell types.

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Stem cell discovery could aid research into new treatments