Category Archives: Regenerative Medicine

R3 Stem Cell Overview - Top Regenerative Medicine Clinics (844) GET-STEM
http://r3stemcell.com The top regenerative medicine clinics in the country are R3 Stem Cell Clinics. Stem Cell Therapy is offered for all musculoskeletal con...

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R3 Stem Cell Overview - Top Regenerative Medicine Clinics (844) GET-STEM - Video

Sweden Medical Forum, part 13 - Ms. Kristina Runeberg, Cellectis
Ms. Kristina Runeberg, Cellectis AB "Industrial platform for scale-up and differentiation of human pluripotent stem cells for Regerative Medicine" Find addit...

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Sweden Medical Forum, part 13 - Ms. Kristina Runeberg, Cellectis - Video

Course Description: Regenerative medicine focuses on harnessing the power of ones own stem cells and regenerative capabilities to restore function to damaged cells, tissues and organs. In April 2006, the U.S. Food and Drug Administrations (FDA) implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products (HCT/Ps) in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in the industry on how such therapies should be regulated by FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

This 2-day interactive seminar on FDA regulations of regenerative medicine will cover:

-How FDA is currently regulating regenerative therapies and products intended for both human and veterinary use. -The distinction being made between human regenerative products and their regulation as drugs, biologics, devices, and combination products. -The New Drug Application (NDA) and the Biologic License Application (BLA) review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements. -The option for obtaining designation and approval as Orphan Drug Product. -Designing and conducting appropriate clinical trials to support the approval of regenerative therapies. -FDAs regulation of some regenerative medicine products and accessories as Medical Devices. -The Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) being applied by FDA to human regenerative products. -The labeling and marketing of regenerative products and therapies. -The potential for enforcement action and recommendations for mitigating that risk. -The current regulation of veterinary cellular treatments including autologous, allogeneic and xenogeneic cellular products in the United States.

Learning Objectives: Participants who attend this course on FDA regulation of regenerative medicines will leave with a comprehensive understanding of:

-How FDA regulates regenerative treatments and therapies? -The HCT/P Criteria and Minimal Manipulation Standard. -The Drug and Biological Approval Process. -Regenerative Products as Medical Devices. -How to Design Appropriate Clinical Trials? -Applicable cGMPs and cGLPs. -Marketing Exclusivity and Patent Restoration. -Product Labeling, Marketing and Advertising. -FDA and other Federal Agency Enforcement Action. -The Regulation of Veterinary Regenerative Medicine. -The New Animal Drug Application (NADA) Process. -Veterinary User Fees and Waivers.

Who will benefit: This course is designed for professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

-Senior quality managers -Quality professionals -Regulatory professionals -Compliance professionals -Production supervisors -Manufacturing engineers -Production engineers -Design engineers -Labelers and Private Labelers -Contract Manufacturers -Importers and Custom Agents -U.S. Agents of Foreign Corporations -Process owners -Quality engineers -Quality auditors -Document control specialists -Record retention specialists -Medical affairs -Legal Professionals -Financial Advisors and Institutional Investors -Consultants, Inspectors and cGMP Experts

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FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering, Etc.

Transcript Stephen J. Russell, M.D., Ph.D. Deputy Director Regenerative Medicine Translation

Stephen J. Russell, M.D., Ph.D.: Regenerative medicine is a very broad, new approach to medicine which uses the advances in stem cell technology, primarily, to advance clinical care. And what that really converts into is that instead of treating chronic diseases with drugs that have a short-term effect, and that need to be continued long term as a consequence, we can think in terms of regenerative medicine of solutions to problems.

If you think about what kind of illnesses people get, most of them are a consequence of degeneration or aging. I mean, as you go through life things stop working properly, so, you know, your eyesight begins to fail, your hearing begins to fail, you start to get problems with your joints, your muscles become weak, your heart begins to fail, your liver, your kidneys, everything, as you get older, is more likely to stop functioning correctly. And regeneration is the exact opposite of this degenerative process. I mean, the whole idea is to try and restore organs and prevent the deterioration.

I see regenerative medicine as the new surgery. I mean if you go back over Mayo Clinic's history, we were built on the brilliance of the Mayo brothers' surgery. We're seeing some real opportunity in certain specific areas that we're focusing on at this point in time. One of those is diabetes. I mean we do know that if we transplant a pancreas or if we transplant islets, the part of the pancreas that produces insulin and senses glucose, we can cure diabetes. There simply are not enough pancreas transplants available or islets available to be able to serve the need of the population because diabetes is common. So that's where regenerative medicine comes in as a way to generate islets from other cell types, generate islets from the patient's own skin cells or whatever, and so we really see that as a major opportunity.

Though great progress has been made in medicine, current evidence-based and palliative treatments are increasingly unable to keep pace with patients' needs, especially given our aging population. There are few effective ways to treat the root causes of many diseases, injuries and congenital conditions. In many cases, clinicians can only manage patients' symptoms using medications or devices.

Regenerative medicine is a game-changing area of medicine with the potential to fully heal damaged tissues and organs, offering solutions and hope for people who have conditions that today are beyond repair.

Regenerative medicine itself isn't new the first bone marrow and solid-organ transplants were done decades ago. But advances in developmental and cell biology, immunology, and other fields have unlocked new opportunities to refine existing regenerative therapies and develop novel ones.

The Center for Regenerative Medicine takes three interrelated approaches:

Rejuvenation. Rejuvenation means boosting the body's natural ability to heal itself. Though after a cut your skin heals within a few days, other organs don't repair themselves as readily.

But cells in the body once thought to be no longer able to divide (terminally differentiated) including the highly specialized cells constituting the heart, lungs and nerves have been shown to be able to remodel and possess some ability to self-heal. Teams within the center are studying how to enhance self-healing processes.

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About Regenerative Medicine - Mayo Clinic Research

11 WebOps 1
This company provides a service whereby stem cell biopsies can be stored fresh from the operating table in a specially deigned canister which maintains an in...

By: Global Alliance for Regenerative Medicine, Roatan, Honduras

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11 WebOps 1 - Video

San Diego, CA (PRWEB) March 10, 2014

Histogen Aesthetics, a subsidiary of regenerative medicine company Histogen, Inc. focused on skin care and cosmeceuticals, announced today that the Company has acquired the CellCeuticals Biomedical Skin Treatments line of skincare products.

Histogen Aesthetics will continue sales of the eleven existing CellCeuticals Biomedical Skin Treatments skincare products, while bringing new innovation to the line through the addition of a unique regenerative medicine technology, working to improve skin aging at a cellular level.

We have long admired the science, clinical data and elegant formulas behind the CellCeuticals line, and see it as an ideal fit for our recently revitalized aesthetics subsidiary, said Dr. Gail K. Naughton, CEO and Chairman of Histogen, Inc. We are very excited to begin infusing unique cell-signaling factors into the CellCeuticals regimen, to truly transform skin one cell at a time.

Dr. Naughton has spent more than 30 years in tissue engineering and regenerative medicine, and holds over 100 patents in the field. She founded Histogen in 2007, focused on developing therapies that work to stimulate the stem cells in the body to regenerate tissues and organs. Through this work, she has also seen how different compositions of human proteins can have cosmetic benefits, particularly in anti-aging and rejuvenation.

I am pleased that the CellCeuticals Biomedical Skin Treatments will evolve, and see Histogen Aesthetics as an excellent home for this innovative product line, said Paul Scott Premo, co-founder of CellCeuticals Skin Care, Inc. I believe the addition of this regenerative medicine technology will be the opportunity to introduce a new generation of products that are the vanguard of regenerative skin care.

The CellCeuticals system is made up of eleven distinctive products including the Extremely Gentle Skin Cleanser, CellGenesis Regenerative Skin Treatment, and PhotoDefense Color Radiance SPF55+ with proprietary and patented PhotoPlex technology. The line is currently available at retailers including QVC.com, Dermstore.com, and Nordstrom.com, as well as http://www.cellceuticalskincare.com.

About Histogen Aesthetics Histogen Aesthetics LLC, formed in 2008 as a subsidiary of Histogen, Inc., focuses on the development of innovative skin care products utilizing regenerative medicine technology. Histogen Aesthetics technology is based on the expertise of founder Dr. Gail K. Naughton, in which fibroblasts are grown under unique conditions, producing a complex of naturally-secreted proteins and synergistic bio-products known to stimulate skin cells to regenerate and rejuvenate tissues. In 2014, Histogen Aesthetics acquired CellCeuticals Biomedical Skin Treatments, a line of scientifically-proven products that reactivate cells to help aging skin perform and look healthier and younger. For more information, visit http://www.cellceuticalskincare.com.

About Histogen Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process is also being researched for oncology applications, and in orthopedics through joint venture PUR Biologics, LLC. For more information, please visit http://www.histogen.com.

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Histogen Aesthetics Acquires CellCeuticals Biomedical Skin Treatments

An intern at UC Davis Institute for Regenerative Cures
Each summer, 10 high school students are invited to work alongside scientists and research technicians in UC Davis stem cell laboratories. The program, done ...

By: UC Davis Health System

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An intern at UC Davis Institute for Regenerative Cures - Video

Gladstone Institutes

Joint Gladstone-UCSF study highlights novel reprogramming method; offers new hope for treating liver failure

SAN FRANCISCO, CAFebruary 23, 2014 The power of regenerative medicine now allows scientists to transform skin cells into cells that closely resemble heart cells, pancreas cells and even neurons. However, a method to generate cells that are fully maturea crucial prerequisite for life-saving therapieshas proven far more difficult. But now, scientists at the Gladstone Institutes and the University of California, San Francisco (UCSF), have made an important breakthrough: they have discovered a way to transform skin cells into mature, fully functioning liver cells that flourish on their own, even after being transplanted into laboratory animals modified to mimic liver failure.

In previous studies on liver-cell reprogramming, scientists had difficulty getting stem cell-derived liver cells to survive once being transplanted into existing liver tissue. But the Gladstone-UCSF team figured out a way to solve this problem. Writing in the latest issue of the journal Nature, researchers in the laboratories of Gladstone Senior Investigator Sheng Ding, PhD, and UCSF Associate Professor Holger Willenbring, MD, PhD, reveal a new cellular reprogramming method that transforms human skin cells into liver cells that are virtually indistinguishable from the cells that make up native liver tissue.

These results offer new hope for the millions of people suffering from, or at risk of developing, liver failurean increasingly common condition that results in progressive and irreversible loss of liver function. At present, the only option is a costly liver transplant. So, scientists have long looked to stem cell technology as a potential alternative. But thus far they have come up largely empty-handed.

Earlier studies tried to reprogram skin cells back into a pluripotent, stem cell-like state in order to then grow liver cells, explained Dr. Ding, one of the papers senior authors, who is also a professor of pharmaceutical chemistry at UCSF, with which Gladstone is affiliated. However, generating these so-called induced pluripotent stem cells, or iPS cells, and then transforming them into liver cells wasnt always resulting in complete transformation. So we thought that, rather than taking these skin cells all the way back to a pluripotent, stem cell-like state, perhaps we could take them to an intermediate phase.

This research, which was performed jointly at the Roddenberry Center for Stem Cell Research at Gladstone and the Broad Center of Regeneration Medicine and Stem Cell Research at UCSF, involved using a cocktail of reprogramming genes and chemical compounds to transform human skin cells into cells that resembled the endoderm. Endoderm cells are cells that eventually mature into many of the bodys major organsincluding the liver.

Instead of taking the skin cells back to the beginning, we took them only part way, creating endoderm-like cells, added Gladstone and CIRM Postdoctoral Scholar Saiyong Zhu, PhD, one of the papers lead authors. This step allowed us to generate a large reservoir of cells that could more readily be coaxed into becoming liver cells.

Next, the researchers discovered a set of genes and compounds that can transform these cells into functioning liver cells. And after just a few weeks, the team began to notice a transformation.

The cells began to take on the shape of liver cells, and even started to perform regular liver-cell functions, said UCSF Postdoctoral Scholar Milad Rezvani, MD, the papers other lead author. They werent fully mature cells yetbut they were on their way.

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Scientists Transform Skin Cells Into Functioning Liver Cells

Los Angeles, CA (PRWEB) February 22, 2014

At MetroMD Institute, a study reveals Growth Hormone Therapy, alternatively known as HGH Therapy, improves short stature in children. In 2003, growth hormone therapy was approved in United States for children with idiopathic short stature with a height at or higher than 2.25 standard deviations. Over the period of a decade, many breakthroughs have occurred; HGH Therapy is one of them. HGH is an essential hormone that declines with advancing age and disrupts the functioning of the human body. Some of the visible symptoms of lower HGH levels include body fatigue, lower energy levels, low libido, weathered skin, prominent aging, and so forth. MetroMD treats a myriad of patients who request HGH injections to regain the low energy levels and building vitality; the therapy is FDA approved and helps people to feel healthy and energetic.

Children who have deficient HGH levels are best served by Sermorelin; this hormone serves as a best regenerative medicine that produces excellent HGH Therapy results, says Alex Martin, Medical Director at MetroMD. Doctors enunciated that the therapy is administered with an once-a-day injection that can be used for a multitude of benefits as to improve the texture of hair, nail, libido enhancement, raise energy levels, boost immunity, and improve lean body mass. To determine who can be the right candidate for the aforesaid therapy, patients have to undergo proper body examinations and lab testing. X-rays of bone growth plates of children determines the requirement for Sermorelin therapy. To know more about HGH therapy browse through http://www.metromd.net

About Metro MetroMD is a Los Angeles based Research Institute of Regenerative Medicine. The institute deals in latest treatment technologies and a leading provider of HGH Therapy. Thousands of patients are benefited with Stem Cell, PRP therapy to combat aging, sports and non-healing injuries without having the need to go for surgical invasive procedure. Dr.Alex Martin is a Medical Doctor at the Institute and recommends the use of Human Growth Hormone and Stem Cell Therapy for men and women of all ages.

Contact: MetroMD Institute of Regenerative Medicine 7080 Hollywood Blvd, Suite 804 Los Angeles, CA 90028 (323) 285-5300 http://www.metromd.net

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MetroMD Recommends the Use of HGH Therapy to Treat Short Stature of Children

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6-Feb-2014

Contact: Laura Coverson laura.coverson@cshs.org 310-423-5215 Cedars-Sinai Medical Center

LOS ANGELES (Feb. 6, 2014) A Cedars-Sinai research team led by Paul W. Noble, MD, chair of the Department of Medicine and director of the Women's Guild Lung Institute, has been awarded $628,816 by California's stem cell agency to develop a treatment for idiopathic pulmonary fibrosis, a deadly disease that destroys the lungs and damages other vital organs.

The illness, which has no cure and few effective treatments, thickens and hardens lung tissue, leaving the organs badly scarred. Patients with idiopathic pulmonary fibrosis have great difficulty breathing and the chronic reduction in oxygen damages vital organs. The cause of the disease is not clearly understood and many people live only three to five years after diagnosis.

"Lung fibrosis occurs when the lung is unable to repair itself properly after injury or infection," said Noble. "Some people are more susceptible to developing fibrosis, and we currently don't understand why the normal repair and renewal of lung cells stops occurring in these patients."

The two-year study will build upon preliminary research completed at Cedars-Sinai by Noble and physician researcher Dianhua Jiang, MD, PhD. They uncovered important clues to the precise way normal lung stem cell repair occurs and how a cure might be developed.

"Currently, there is no therapy for idiopathic pulmonary fibrosis approved by the Food and Drug Administration. The only effective therapy is lung transplantation, which we do here at Cedars-Sinai," said Noble. "But if successful, our research will result in a completely novel approach to the treatment of lung diseases, allowing for the renewal and repair of the patient's cells."

This phase of Noble's research will involve the study of laboratory mice and human tissue to further identify the exact mechanisms necessary for stem cells to repair damage to the lungs.

"Funding these awards highlights our commitment to advancing the field with the most cutting-edge approaches and to help deepen our understanding of every aspect of stem cells, to help us find new treatments, and even cures for the deadliest diseases," said Jonathan Thomas, PhD, JD, chair of the governing Board of the California Institute for Regenerative Medicine.

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Director of Women's Guild Lung Institute awarded grant to study treatment for lung disease