StemCell Therapy

Regenerative injection therapy for tendons, ligaments, muscles and spine conditions.

About Regenerative Injection Therapies (RIT).

Regenerative injections broadly deals with the use of biologic materials to enhance the body's own repair mechanisms to help heal previously non-reparable tissues. The goal of these non-surgical procedures is to help heal the source of pain, not to simply mask it. The exact mechanism is evolving, but science points toward enhancing and stimulating healing and stabilizing factors of the local tissues.

Regenerative injection treatments offer a viable alternative for individuals considering elective orthopedic surgery or joint replacement due to arthritis or injury. Patients experience very little down time and they typically avoid the long, painful rehabilitation periods that can follow surgery. Since 2014, Regenerative Spine & Musculoskeletal Medicine has provided state of the art regenerative cellular therapies to help patients find relief from pain without invasive surgeries.

The Procedures:

Prolotherapy:

This treatment involves injecting a proliferant (usually dextrose) into weakened or injured joints, ligaments, or tendons. With a precise injection of a mild irritant solution directly on the site of injury, prolotherapy creates a mild, controlled inflammation that stimulates the bodys natural healing mechanism to lay down new tissue on the weakened area. Additional treatments repeat the process, allowing a gradual build-up of tissue to help restore strength to the area and relieve pain. Injection sessions are done 3-6 weeks apart, and usually a series of 3 injection sessions is done and then the response is assessed. The average number of treatment sessions is between 3 and 6.

Perineural Injections:

Peri-neural injections involves injecting diluted dextrose solutions superficially along the pathway of chronically inflamed nerves. They can be used for any part of the body where nerve pain exists. After the first treatment, pain relief may initially last for a period of four hours to four days. Repeated treatments (usually 6-8 sessions) are necessary, given every 1-3 weeks.

Platelet Rich Plasma Therapy (PRP):

During PRP therapy, a small vial of your own blood is drawn and placed in a centrifuge to separate the platelet-rich plasma from other blood components. This highly concentrated platelet-rich layer contains growth factors and a variety of cells. Growth factors stimulate local cells for tissue repair and remodeling. Your PRP is injected into and around the area of injury. Several injections may be done at the injured site at one time to fully treat the area. Many times only one injection is needed. If there is an incomplete response to treatment additional injections may be advised.

Cell Therapy:

Stem cells(MSCs) are readily available and can be harvested from your bone marrow through a needle. Once injected into an area of injury, MSCs secrete bioactive molecules to modulate repair and offer the potential to regenerate injured cartilage, ligament, tendons, or muscle. MSCs can be thought of as the manager of your bodys innate healing potential. Many times only one injection is needed. If there is an incomplete response to treatment additional injections may be advised.

Lipoaspirate (Fat) Graft:

Lipo aspirate therapy is a gentle process that uses your body's own fat tissue to cushion and support areas of injury or damage as your body heals itself. The fat is taken from the stomach, flank or thigh areas using a local anesthetic. It is especially effective for areas where there are soft tissue defects such as tears or arthritis. This type of injection is used in collaboration with PRP or bone marrow aspirate cell injections, which deliver growth factors to the injured area.

Alpha 2 Macroglobulin (A2M):

A2M is a naturally occurring molecule found in your blood that acts as a powerful protector against cartilage breakdown and progression of arthritis. A small vial of your own blood is drawn and placed in a centrifuge to separate the blood components, then is injected. A2M attaches to and removes the destructive enzymes that damage cartilage cells in the joint. The A2M is soothing to the joint and acts like a natural anti-inflammatory.

What parts of the body can benefit from regenerative treatments?

Spinal Injections:

Spinal procedures can be performed with dextrose, platelet/growth factors, or cellular therapy for those who wish to avoid the effects of steroids. Epidural nerve blocks, spine ligaments, facet joint, sacroiliac joint and intervertebral disc injections with platelets/growth factors may be performed. The injection is performed in the same manner as conventional spine injections with the use of x-ray guidance to ensure accurate placement of the treatment.

Joint, tendon, ligament, muscle Injections:

Musculoskeletal injections can be performed with dextrose, platelet/growth factors, or cellular therapy for those who wish to avoid the effects of steroids. Whenever appropriate the injection is performed with the use of x-ray or ultrasound guidance along with full safety and sterile precautions.

What conditions can benefit from regenerative injections?

Will insurance cover my Regenerative Injection?

Insurance companies will not pay for the cost of the Regenerative treatment. The cost of your injection can be discussed after your visit once you and the provider have decided on the most appropriate treatment option for you.

What sets Regenerative Spine & Musculoskeletal Medicine apart from others?

As the popularity of RIT grows, other medical professionals are beginning to perform these procedures, with great variation in training and background. Rene S. Melfi, M.D. is a physician specializing in non-surgical spine, orthopedic and musculoskeletal performance and function. With three national board certifications and Fellowship training in interventional spine and musculoskeletal medicine, Dr. Melfi has been performing spine and orthopedic injections since 2002. Dr. Melfi is also certified in Integrative Medicine and Acupuncture, and offers suggestions to enhance your results with recommendations for proper nutrition and supplements.

Your procedure at Regenerative Spine & Musculoskeletal Medicine is carefully chosen based on review of the latest evidence based medicine. Image guidance with x-ray or ultrasound is used, when appropriate, to confirm accurate placement of cellular therapy to optimize your results.

Call today for your appointment and a premier experience in Regenerative Injection therapy in Central New York 315-701-4000.

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Syracuse Regenerative Medicine

Introduction

During the natural aging process of the human body, several organs and tissues undergo a large anabolic phase (during the first 3 decades of life) and they soon develop into a catabolic phase, which is slower and irreversible (from the 4th to the final decades of life).In the anabolic phase the skin is shiny, silky, has elasticity and a large turgor. There is a large volume of toned muscular mass.The catabolic phase starts in the fourth decade of life and acceleratesin many cases during the seventh decade . In this phase there is an absence of skin sheen and the appearance of wrinkles and senile spots (the dernal layer also starts to show signs of weakness, and this occurs because of the decrease of the proteins that make up the skins elastic system, such as collagen and glycosaminoglycan / GAG).Muscular mass loses its volume and tone progressively, causing the body to show visible signs of aging. Probably a high protein diet may be responsible for the final quality of our organs and tissues during the anabolic phase causing the body to be more resistant and durable. This high protein diet, when applied during the catabolic phase, can maintain a better skin quality and improved muscular mass.During the past 10 years, we have endeavored to understand the consequences of the different intrinsicand extrinsic processes that alter the harmony of the movements of the muscles of the lower third of the face.

The outline of the mouth is made from a complex muscular system, where the

muscle of the mouth actively links with the

muscles that tighten the angle of the mouth sideways,

acts in a secondary fashion in this muscular complex. One can easily see, by way of a systematic evaluation of these muscles, (movements such as :whistling, smiling, making a sad face, and pulling a face as if having a bitter taste in the mouth) .Each patient can present important asymmetrical and accented depressions, caused by the exaggerated contraction of some of these muscles.

Till today,these facial defects have been treated with facial implants (fillers) and some serious cases have been even treated using classical surgical procedures : Fillers as surgery didn t revolve the problems !

Our proposal is to demonstrate that, by way of a selective intramuscular injection, of an oily patented solution containing a mixture of Carbolic Acid with Peanut Oil Acid using endopeel technology created by inventors Dr.Alain Tenenbaum ( facial plastic surgeon) and Mauro Tiziani ( molecular biologist) , it is possible to decrease the force of one or more muscles, that are working harder and in disharmony with the other muscles in the complex muscular system around the mouth.

We believe that the mechanism that is developed, after the injection of the ,,Endopeel,, oily solution, is a selective pointed chemical reversible myolysis, limited within the injected area of the muscular mass. With preliminary tissue studies, we can see that this myolysis is totally reversible after 7 months.

We have acquired experience from more than 1000 clinical cases over the past 8 years. The majority of these patients were re-treated in the same muscles that were treated earlier. The average re-treatment period was 4-6 months, and usually, smaller doses of the patented oily solution were injected, due to the hyperfunction of the muscles movements being attenuated. The average dose per injection is about 0.05 ml and the distance between each point is approximatively 1.0 centimeter.

We found that this treatment is very efficacious as long as there is a clear and precise evaluation of the above mentioned muscle system.

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Endopeel Portal Main Website : Lifting,Tightening & Tissue ...

Regenerative medicine is a game-changer in the world of medicine. Treatments include: Stem Cell Therapy, PRP (Platelet Rich Plasma) Therapy and Amniotic Stem Cell Therapy (Amnion). Each custom treatment option may help to heal damaged tissues and organs, offering solutions and hope for people whose conditions have proven beyond repair previously.

I didnt know anything about PRP when I went to my appointment with Dr. Hall. I was able to do some research before I had anything done. The stem cells come from my own bone marrow. Stem cell treatment is fairly new, but shows positive results. I decided that it was something that could help me. I trust Dr. Hall. Dr. Hall removed the stem cells from my hip and injected them into my knees while I was in surgery under anesthesia.

I was in physical therapy after the surgery. Now Im back in the gym three days a week, exercising on the elliptical machine, weight training and in yoga classes. I walk five miles four or five days a week.

In six weeks, I was at 133 degrees range of motion, which was only 4 degrees behind my good leg. I attribute my advanced recovery to the outstanding hands of the DOC surgeon, the PRP/stem cell therapy, and Mike at ATI Physical Therapy.I attribute my advanced recovery to the outstanding hands of the DOC surgeon, the PRP/stem cell therapy, and Mike at ATI Physical Therapy.

If you are reading this testimonial and questioning whether the extra money spent on the PRP and stem cell therapy are worth it, I would highly recommend that you take out a loan if necessary in order to benefit from this healing therapy.

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Regenerative Medicine - directorthocare.com

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.

Replacement. Replacement involves using healthy cells, tissues or organs from a living or deceased donor to replace damaged ones. Organ transplants, such as heart and liver transplants, are good examples.

The center aims to expand opportunities for transplants by finding ways to overcome the ongoing donor shortage, the need for immunosuppression and challenges with organ rejection.

Regenerative medicine holds the promise of definitive, affordable health care solutions that heal the body from within.

Stem cells have the ability to develop through a process called differentiation into many different types of cells, such as skin cells, brain cells, lung cells and so on. Stem cells are a key component of regenerative medicine, as they open the door to new clinical applications.

Regenerative medicine teams are studying a variety of stem cells, including adult and embryonic stem cells. Also being studied are various types of progenitor cells, such as those found in umbilical cord blood, and bioengineered cells called induced pluripotent stem cells. Each type has unique qualities, with some being more versatile than others.

Many of the regenerative therapies under development in the Center for Regenerative Medicine begin with the particular patient's own cells. For example, a patient's own skin cells may be collected, reprogrammed in a laboratory to give them certain characteristics, and delivered back to the patient to treat his or her disease.

Stem cells and their use in regenerative medicine have been in the media a lot lately. But what exactly does it mean? Physicians and researchers in the Center for Regenerative Medicine say it has to do with developing completely new ways to treat and manage chronic diseases such as diabetes, heart failure, and degenerative nerve, bone and joint conditions.

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About Regenerative Medicine - Center for Regenerative ...

Regenerative medicine seeks to replace tissue or organs that have been damaged by disease, trauma, or congenital issues, vs. the current clinical strategy that focuses primarily on treating the symptoms. The tools used to realize these outcomes are tissue engineering, cellular therapies, and medical devices and artificial organs.

Combinations of these approaches can amplify our natural healing process in the places it is needed most, or take over the function of a permanently damaged organ. Regenerative medicine is a relatively new field that brings together experts in biology, chemistry, computer science, engineering, genetics, medicine, robotics, and other fields to find solutions to some of the most challenging medical problems faced by humankind.

When injured or invaded by disease, our bodies have the innate response to heal and defend. What if it was possible to harness the power of the body to heal and then accelerate it in a clinically relevant way? What if we could help the body heal better?

The promising field of Regenerative Medicine is working to restore structure and function of damaged tissues and organs. It is also working to create solutions for organs that become permanently damaged. The goal of this approach is to find a way to cure previously untreatable injuries and diseases.

1. Tissue Engineering and BiomaterialsTissue engineering is a strategy where biologically compatible scaffolds are implanted in the body at the site where new tissue is to be formed. If the scaffold is in the geometric shape of the tissue that needs to be generated, and the scaffold attracts cells the outcome is new tissue in the shape desired. If the newly forming tissue is subjected to exercise as it forms, the outcome can be new functional engineered issue.

Millions of patients have been treated with some form of tissue engineered devices, yet the field is in its infancy. The primary success stories have been with soft tissue regeneration. To learn more about some of the promising studies and clinical trials involving tissue engineering,click here.

2. Cellular TherapiesMany millions of adult stem cells are found in every human. Our body uses stem cells as one way of repairing itself. Studies have illustrated that if adult stem cells are harvested and then injected at the site of diseased or damaged tissue, reconstruction of the tissue is feasible under the right circumstances. These cells can be collected from blood, fat, bone marrow, dental pulp, skeletal muscle and other sources. Cord blood provides yet another source of adult stem cells. Scientists and clinicians are developing and refining their ability to prepare harvested stem cells to be injected into patients to repair diseased or damaged tissue.

To learn more about some of the promising studies and clinical trials involving cellular therapies,click here.

3. Medical Devices and Artificial OrgansIn cases where an organ fails, the predominant clinical strategy is to transplant a replacement organ from a donor. The principal challenges are the availability of donor organs, and the requirement that the donor take immunosuppression drugswhich have side effects. Further, there are many instances where the time to find a suitable donor organ requires an interim strategy to support or supplement the function of the failing organ until a transplantable organ is found. Using circulatory support as an example, there are technologies in various stages of maturity, initially using ventricular assist devices (VADs) as a bridge to a heart transplant, and now there are VADs that are used for long-term circulatory support (destination therapy).

Scientists and clinicians around the world are developing and evaluation devices to supplement or to replace the function of many organ systems including the heart, lung, liver and kidney.

To learn more about some of the promising studies and clinical trials involving medical devices and artificial organs, click here.

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What Is Regenerative Medicine? | Regenerative Medicine at ...

New Video Series - Watch Now

Scroll down to get an inside look into the lab and hear directly from our scientists about their projects aimed at helping patients with conditions such as diabetes, lung disease, hemophilia A and gastrointestinal disorders.

An International Leader in Regenerative Medicine

The Wake Forest Institute for Regenerative Medicine (WFIRM) is a leader in translating scientific discovery into clinical therapies. Physicians and scientists at WFIRM were the first in the world to engineer laboratory-grown organs that were successfully implanted into humans. Today, this interdisciplinary team is working to engineer more than 30 different replacement tissues and organs and to develop healing cell therapies - all with the goal to cure, rather than merely treat, disease.

The Next Evolution of Medical Treatments

Regenerative medicine has been called the "next evolution of medical treatments," by the U.S. Department of Health and Human Services. With its potential to heal, this new field of science is expected to revolutionize health care. It is our mission at WFIRM to improve patients' lives by developing regenerative medicine therapies and support technologies.

"We have many challenges to meet, but are optimistic about the ability of the field to have a significant impact on human health. We believe regenerative medicine promises to be one of the most pervasive influences on public health in the modern era."-Anthony Atala, MD, Director

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Wake Forest Institute for Regenerative Medicine (WFIRM ...

STEM CELL TECHNOLOGY

Advanced Regenerative Medicine is using breakthrough technology in order to provide relief from osteoarthritisspecifically in the knee, hip, and shoulder joints. But what is regenerative medicine, and how is it being used to help patients avoid invasive joint replacement surgeries?

Regenerative medicine is changing the game in terms of how the body repairs and heals itself. This is especially beneficial to our senior population, who frequently experience pain from osteoarthritis in the hip, knees, and shoulders.

What is regenerative medicine? This medical treatment method is changing the way that medical professionals get to the root cause of injury, disease, osteoarthritis, and more. It is focused on rejuvenating the bodys ability to heal itself naturallywhich eliminates the need for surgery.

Regeneration delivers specific types of cells to diseased tissues or organs. The end goal is to help the tissue restore itself and return to its original functioning capabilities. This is achieved by using stem cell therapy.

Stem cells are a critical key to regenerative medicine. These cells are able to develop into another type of cell in the body, which helps tissues and organs rebuild and repair themselves. The idea behind regenerative medicine from ARM is to help a patients body heal on its own, while reducing risks and inconveniences associated with traditional joint replacement.

Regenerative medicine can help patients regain full range of motion of hip, knee, and shoulder joints. Furthermore, they will experience substantially reduced levels of pain. This approach is minimally invasive and can be conducted on an outpatient basis.

ARM uses cutting-edge technology to extract adipose-derived stem cells from adipose tissue. This enables ARM to eliminate the use of foreign enzymes and chemicals, which makes the process safer.

If youre unsure if regenerative medicine and stem cell therapy is right for you, our helpful staff can help guide you through the process and make the best decision for your needs. To learn more about stem cell procedures and regenerative medicine, contact Advanced Regenerative Medicine today.

Dr. Mark R. LoDico, a pioneer in the field of pain medicine, believes that no one should have to live with the frustration of chronic pain. Board Certified in both Anesthesiology and Pain Medicine, he founded Advanced Pain Medicine in 2001, uniquely committing the practice to finding specific, ongoing solutions to specific pain.

Link:
What is Stem Cell Regenerative Medicine? | Advanced ...

ORTHOPAEDIC MEDICINE SPECIALTIES FOR PAIN TREATMENTOrthopaedic medicine is a specialty devoted to the evaluation, diagnosis and non-operative treatment for pain caused by musculoskeletal diseases to aid in pain management. Diagnostic modalities include a comprehensive history, a detailed and specific physical examination, radiologic evaluations and local anesthetic blocks for pain treatment. Therapeutic modalities for pain management encompass manipulations, corticosteroid or proliferant injections with and without fluoroscopic guidance, therapeutic exercise and use of pharmaceutical, nutriceutical, herbal and/or homeopathic based pain treatment.

The evolution began in 1741 when Nicholas Andre, at that time a Professor of Medicine at the University of Paris, coined the word orthopaedic. He published a book with the same title. The etymology of orthopaedic is based on two greek roots: orthos and paedia which translate to straight and rearing of children respectively. His illustration of a staff that is used to straighten a growing tree is known world wide.

For more than two centuries orthopaedists were physicians or surgeons concerned with musculoskeletal deformities: scoliosis, infections of bones and joints, poliomyelitis and congenital defects such as Erbs palsy, clubfoot and hip dislocations. Until the 20th century most orthopaedic treatments were manipulations and mechanical support with braces and plaster casts.

The American Orthopaedic Association was founded in 1887. The separation of orthopaedic surgery from general surgery took place in 1934 with the establishment of a separate board. According to the late Dr. Cyriax, orthopaedic medicine was established in 1929. The American Association of Orthopaedic Medicine was founded in 1982.

The accumulation of knowledge remains constant. The evolution of pain management continues.

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Home - Vermont Regenerative Medicine

CTI was named the winner of the Vision Award category, which was awarded to the organization for inspiringand deliveringnew thinking to the marketplace and for showcasingNorthern Kentucky as an area of thoughtful, innovative industry leaders.

"We're honored to be recognized by the Northern Kentucky Chamber of Commerce with this award for CTI's continued successes and innovations," according to Timothy J. Schroeder, Founder and CEO.

CTI Clinical Trial and Consulting Services (CTI), a global, privately held, full-service contract research organization announces the acquisition of Eurotrials, a full-service contract research organization, with more than 20 years of experience, and strong local expertise in Europe and Latin America.

CTI is extremely happy to partner with Bexion on the development of this novel therapy in patients who desperately need alternative treatments, stated William Aronstein, PhD, MD, FACP, Vice President, Medical Affairs at CTI. They are an innovative organization with very strong regional ties the drug was initially developed and licensed at a local hospital, early funding has predominantly come from the region, and the management and board have strong local connections.

The expansions in Taiwan and Japan are part of continued efforts to increase capacity for clinical research across Asia, according to Patrick Earley, Vice President, International. We have been working across Asia for a number of years, but felt like a more permanent presence in Taipei and Tokyo would further enhance relationships with local medical centers and biotechnology companies."

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CTI - CRO Specializing in Clinical Research and Consulting

Resource page

For the purposes of the information provided on this page we have adopted the definition of the term regenerative medicine that was used in the House of Lords Regenerative Medicine Report (see below). This was:

regenerative medicine is used to refer to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function. This includes cell therapies, tissue engineering, gene therapy and biomedical engineering techniques, as well as more traditional treatments involving pharmaceuticals, biologics and devices.

Each regulator has a clear remit and regulates distinct areas of the regenerative medicine process. However, we work closely together to provide effective advice and guidance to support establishments through the regulatory requirements. Each regulator has a core set of standards that apply depending on where you are in the process, from cell derivation to treatment. We are all focused on ensuring that the standards that are applied at one stage of the process do not act as a barrier at another.

The role of each of the regulators in regenerative medicine is set out below:

Health Research Authority (HRA) has a remit to provide an ethics opinion on clinical trials. Those involving gene therapy regenerative medicines are reviewed through the Gene Therapy Advisory Committee (GTAC). Other regenerative medicine studies may be reviewed by other appropriately flagged RECs. It also provides the Integrated Research Application System (IRAS) through which applications and approvals from GTAC/RECs and MHRA for clinical trials involving regenerative medicines can be made.

Human Fertilisation and Embryology Authority (HFEA)[external link] regulates the use of human embryos or human admixed (human-animal) embryos to derive stem cells for use in the treatment of patients.

Human Tissue Authority (HTA) [external link] remit includes regulation of organisations that remove, store and use of human tissue or cells; this includes where they are used as starting materials for Advanced Therapy Medicinal Products (ATMPs). Under the European Union Tissues and Cells Directives (EUTCD), it licenses establishments that remove, test, process, store, and distribute tissues or cells that will (or may) be used to treat patients.

Medicines and Healthcare products Regulatory Agency (MHRA)[external link] remit includes responsibility for granting the appropriate authorisation for the manufacturing site of ATMPs, which are prepared and used under the hospital exemption, and for ATMPs made and supplied under the specials scheme under the relevant provisions in medicines legislation. In the area of clinical trials, the MHRAs remit includes assessment of applications for clinical trial authorisation and the associated manufacturers licence for investigational ATMPs. The National Institute for Biological Standards and Control (NIBSC) [external link], which houses the UK National Stem Cell bank, is part of the MHRA.

Please refer to the Research Community area of the website for information about the approvals for research studies and how to apply to individual review bodies. Further information about GTAC is also provided on this site. Additionally the Stem Cell Toolkit [external link] provides regulatory routemaps that are specific to individual stem cell projects.

Department for the Environment Food and Rural Affairs (DEFRA) [external link] has an Advisory Committee on Releases to the Environment (ACRE) [external link], which advises government on requests for permission to release genetically modified organisms (GMO) into the environment. In 2013, this committee published advice on gene therapy clinical trial for heart disease.

Health and Safety Executive (HSE) [external link] has the Scientific Advisory Committee on Genetically Modified Organisms (Contained Use) SACGM (CU) [external link]. This committee provides technical and scientific advice to the UK Competent Authorities on all aspects of the human and environmental risks, and is responsible for maintaining guidance on the contained use of GMOs.

From 13 October 2014, the MHRAs Innovation Office is the portal for all regulatory queries concerning regenerative medicines. A one stop shop service provides a single point of access from the four regulators in the field, the Human Tissue Authority (HTA), the Human Fertilisation and Embryology Authority (HFEA), Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA), who will provide a co-ordinated single response service for free regulatory advice.

Any query relating to the regulation of regenerative medicines, including Advanced Therapeutic Medicinal Products (ATMPs) can be submitted to the MHRAs Innovation Office and will be answered by the relevant experts from the four regulatory bodies.

Individuals or companies who have regulatory questions concerning regenerative medicines and who are unsure which agency to direct their inquiry to, or have a query that impacts several regulators, should use the Innovation Office advice form.

The HRA and others work closely together and will continue to engage with those involved in regenerative medicine, including researchers, the British Society for Gene and Stem Cell Therapy [external link], and the Cell Therapy Catapult [external link] to help clarify the regulatory requirements that apply.

The HRA recently held a regenerative medicine event hosted by the Cell Therapy Catapult to look at changes and discuss issues with the sector, regulators and representative bodies. Additionally in 2012, the MHRA hosted an event on the regulation of regenerative medicine [external link].

As set out in the Government Response to the House of Lords Inquiry [external link] a Regenerative Medicine Expert Group (RMEG) is being established to develop an NHS regenerative medicine delivery readiness strategy and action plan. This group will build on existing initiatives so that the NHS is fully prepared to deliver these innovative treatments. The group will be supported by the Department of Health; members will be drawn from a number of groups and organisations, including the HRA. The remit of the Regenerative Medicine Expert Group will include a role to monitor the effect of regulation on the development of regenerative medicines in the UK.

More generally, the HRA is working in partnership with a range of organisations to improve the environment for research in the UK. Please refer to our projects and plans pages for more information.

During 2012-13, the House of Lords Science and Technology Committee held an inquiry into regenerative medicine in the UK. For more information about the inquiry, the resulting report and the HRAs responses please use the links below:

UK Stem Cell Toolkit [external link]This toolkit is intended to be a reference tool for those who wish to develop a programme of human stem cell research and manufacture, including clinical applications. It applies only to the regulation of human stem cells and their use in the laboratory and clinical settings. The toolkit provides regulatory routemaps that are specific to individual stem cell projects. It does this by using your responses to questions when you start using the toolkit.

Clinical Trials Toolkit [external link]This toolkit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. It provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials. The toolkit is primarily focused on Clinical Trials of Investigational Medicinal Products (CTIMPs) and the regulatory environment and requirements associated with these. However researchers and R&D staff working on trials in other areas will also find useful information and guidance of relevance to the wider trials environment.

Cell Therapy Catapult [external link]The Cell Therapy Catapult was established in 2012 to grow the UK cell therapy industry. It was set up to help businesses take innovative ideas through to commercialisation. The website has specific regulatory resource pages, which include an overview of the relevant regulations for cell therapy.

MHRA Innovation Office [external link]The MHRA Innovation Office helps organisations that are developing innovative medicines, medical devices or using novel manufacturing processes to navigate the regulatory processes in order to be able to progress their products or technologies. Examples of innovative products include Advanced Therapy Medicinal Products (ATMPs), nanotechnology, stratified medicines, novel drug/device combinations, and advanced manufacturing.

UK Regenerative Medicine Platform (UKRMP) [external link]The Medical Research Council (MRC), Biotechnology and Biological Sciences Research Council (BBSRC) and the Engineering and Physical Science Research Council (EPSRC) have established the UKRMP to address the challenges associated with translating scientific discoveries towards clinical impact.

UK Stem Cell Bank [external link]The UK Stem Cell Bank was established to provide a repository of human embryonic, foetal and adult stem cell lines as part of the UK governance for the use of human embryos for research. Its role is to provide quality controlled stocks of these cells that researchers worldwide can rely on to facilitate high quality and standardised research. It also prepares stocks of EUTCD-Grade cell lines for use as starting materials for the development of cellular therapies. The UK Stem Cell Bank is hosted by NIBSC [external link], which is part of the MHRA.

UK Trade & Investment (UKTI) Life Science Investment Organisation (LSIO) [external link]This dedicated unit within UKTI is intended to support overseas companies to invest and expand in the UK from the earliest research and development collaborations through to clinical trials, commercial operations and partnerships.

Knowledge Transfer Network (KTN) Regenerative Medicine Priority Area [external link]This is an official group within the Healthtechnologies and Medicine Knowledge Transfer Network (KTN). Knowledge Transfer Networks have been set up by the Technology Strategy Board (TSB) to facilitate collaboration and stimulate innovation by bringing together people from a range of organisations with a variety of expertise.

DEFRA Advisory Committee on Releases to the Environment (ACRE) [external link]

HSE Scientific Advisory Committee on Genetically Modified Organisms (Contained Use) (SACGM (CU) [external link].

MHRAs Clinical Trials, Biologicals and Vaccines Expert Advisory Group[external link]

Regenerative Medicine Expert Group [external link]

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Regenerative Medicine - Health Research Authority

Tuesday, September 5, 2017

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued alengthy statement on August 28, 2017on the FDAs new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.The short version is that the Agency will:

Step up enforcement against stem cell actors who claim that their unproven and unsafe products will address a serious disease, but instead put patients at significant risk. To that end, Dr. Gottlieb also announced the creation of an internal working group to identify and pursue such actors and clinics through whatever legally enforceable means are necessary to protect the public health.

Develop and advance a comprehensive policy framework that will more clearly describe the rules of the road for this new field, based on FDAs existing authority. The science-based policy would be aimed at accelerating the proper development of stem cell and other regenerative medicine products, and it is expected to be released Fall 2017. Dr. Gottlieb also noted that the Agency would be issuing a compliance policy that, with the exception of outliers potentially harming public health in a significant way right now, will give current product developers a very reasonable period of time to interact with the FDA in order to determine if they need to submit an application for marketing authorization. And we will also be developing a novel approach to FDA approval that we believe will allow very small product developers to gain all the benefits of FDA approval through a process that is minimally burdensome and less costly. The latter part of this statement clearly takes into account that individual clinicians working in academic hospitals and other venues to innovate in their respective specialties make up a large portion of regenerative medicine product developers, and putting in place an overly burdensome or expensive process would not be in the publics best interest.

The widely differing viewpoints about the appropriateness of FDA oversight of human cell and tissue-based products (HCT/Ps) and their potential risks and benefits were aired during a two-day public hearing in September 2016, as wereported on at the time. From the second prong of Dr. Gottliebs announcement, we would expect that the four draft HCT/P guidance documents debated during the public hearing may be revised or finalized, and they may also be supplemented with additional guidance to further clarify jurisdictional lines or procedural flexibility for very small product developers.

In conjunction with the Commissioners statement, FDA also took specific enforcement action against two high-profile stem cell entities operating in California and Florida:

Supplies of smallpox vaccine, intended to be mixed with fat-derived stem cells and administered to patients as a treatment for cancer, were seized from San Diego-based company StemImmune Inc. Related to the Governments investigation into the unapproved stem cell treatment will be how the company obtained access to the smallpox vaccine in the first place, as it is not commercially available. FDAs announcement about the StemImmune action is availablehere.

A Warning Letter was issued to US Stem Cell Clinic in Florida related to its manufacture of an unapproved drug using fat-derived stem cells and deviations from good manufacturing practices for cell-based products. The Agency announcement about the US Stem Cell Clinic action, along with a link to the complete Warning letter, is availablehere.

US Stem Cell Clinic quicklysubmitted a response to FDA, which it has alsoposted on its website, and which challenges the legal basis for Agency action against a patients own body tissue. We will continue to monitor this case to see whether it progresses into a Federal judicial review of FDAs approach to regulating HCT/Ps.

Finally, as we previously reported, the December 2016 bipartisan 21st Century Cures Act (Cures Act) included a newaccelerated approval pathway for regenerative medicineproducts. FDA has begun implementing the Cures Act provisions under itsRegenerative Medicine Advanced Therapy (RMAT) Designation program. Commissioner Gottliebs recent statement also emphasized the relationship between realizing the promise of the Cures Acts RMAT Designation Program and the need to effectively police the growing marketplace of unproven stem cell treatments. His strongly worded August 28th statement ended with the following:

We must put in place the framework to separate the promising treatments from those products that pose significant risks or offer patients little to no chance of benefit. We will also continue to take steps to keep those who would exploit this promising area from harming patients and abusing the publics trust. We cant let a small number of unscrupulous actors poison the well for the good science that holds the promise of changing the contours of human illness and altering the trajectory of medicine and science.

We are hopeful that the Agency will follow these words with consistent enforcement actions (especially given how manyhundreds of self-named stem cell clinicscurrently operate in the U.S.), in order to enhance regulatory certainty and encourage investment in legitimate business enterprises. The House Energy and Commerce Committee has already confirmed that it will soon be examining the potential effect of unproven stem cell therapies on the broader regenerative medicine field, as part of its oversight of Cures Act implementation more generally. Of course, we will keep our readers posted on important developments regarding these issues.

1994-2017 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

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FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine ... - The National Law Review

Apex Sports and Regenerative Medicine, established by Dr. Daniel Savarino, recently opened its doors in Tinton Falls to meet the growing need for Sports Medicine services in Monmouth County. Dr. Savarino is here to answer your most pressing questions about Sports Medicine, musculoskeletal injury and the services offered at Apex Sports and Regenerative Medicine.

What kind of injuries do you treat?

Musculoskeletal injuries can happen to anyone, regardless of age, fitness level or whether or not you are an athlete. Sports medicine physicians treat injuries that affect mobility, flexibility and strength and help prevent movement-related injuries.

Musculoskeletal injuries can be acute or chronic. Acute injuriesoccur because of an impact, fall or trauma and might include a sprain, strain, dislocation or fracture. Acute injuries should be treated immediately. Chronic injuries develop over time, as a result of repetitive motion, or when you dramatically increase the duration, frequency or intensity of an activity. Chronic injuries can also occur when you do not warm up sufficiently before beginning an activity, or use improper technique and/or equipment. Chronic injuries include stress fractures, tendinopathy or shin splints. If left untreated, chronic injury will become more severe over time.

What exactly is a sports medicine specialist?

A sports medicine specialist is a physician who has received training in the prevention and non-surgical management of injuries, or an orthopedic surgeon with specialized sports medicine training. At Apex Sports and Regenerative Medicine we specialize in non-operative and regenerative treatments.

Over 90 percent of injuries treated by a sports medicine specialist are non-surgical, according to the American Medical Society for Sports Medicine. At Apex we offer cutting edge, minimally invasive procedures using ultrasound guidance, which result in less downtime than surgery, so youre able to resume your favorite activities more quickly. We also offer a wide range of regenerative treatments, like PRP, stem cell therapy and high dose laser therapy to help your body recover from injury.

What happens at a typical appointment?

To diagnose your injury and determine treatment, we will take a thorough history of your health background and activities, as well as a physical exam. We may also take X-rays or conduct imaging tests, depending on the nature and severity of the injury.

You dont have to be a competitive athlete to benefit from the care of a sports medicine doctor. Whether youre suffering from a musculoskeletal injury, hoping to alleviate pain and increase mobility so you can carry out daily activities, or youre an athlete hoping to improve your performance, a sports medicine physician can design and carry out a treatment plan to help you to stay active.

Do you accept my insurance?

Insurance carriers refer to Apex as an out-of-network facility. This does not mean that we do not accept your insurance, but rather, it means that we do not currently have a contract with your health insurance provider. However, if you have an insurance policy with out-of-network benefits (i.e., a PPO policy), you can be reimbursed for your visit. Our staff is happy to answer any questions about insurance and payment.

Apex Sports and Regenerative Medicine is located at 55 N. Gilbert St. suite 1101 in Tinton Falls and is open Monday-Friday. To learn more about the practice or to schedule an appointment with Dr. Savarino, please call the office at 732-385-APEX (2739) or visit our website at apexsportsnj.com.

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Meet Dr. Daniel Savarino - centraljersey.com

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Developments in Regenerative Medicine: FDA Announces Plans to ... - JD Supra (press release)

Posted Aug. 30, 2017

The AVMA House of Delegates passed a new policy July 21 on "Therapeutic Use of Stem Cells and Regenerative Medicine."

According to the policy: "Regenerative medicine is defined as the use of biological therapies including platelet rich-plasma, pluripotent stem cells, and multipotent stem cells to effect therapeutic benefit in disease states. While regenerative medicine holds promise of improvements in the treatment of a variety of diseases, many of which lack adequately effective treatments, questions remain. The AVMA supports the continued scientific development of these modalities while at the same time encouraging its members to employ caution with respect to their use.

"While data continue to accumulate suggesting therapeutic benefit from regenerative medicine, published peer-reviewed studies definitively documenting benefit are still lacking for many diseases. Nor has a scientific consensus for stem cell type, stem cell origin, dosage, transfer media, or method of administration been developed for each disease being treated. Despite these scientific insufficiencies, the adoption of regenerative medicine in the veterinary profession has grown rapidly. Unfortunately, some therapies being propounded and the processes and equipment being sold have outpaced the science which supports them. Veterinarians have few guidelines and limited resources for differentiating valid and effective therapies from ones which have insufficient data supporting the processes and/or therapies. Therefore, it is incumbent upon veterinarians engaged in regenerative therapies to be well versed in the emerging science of the field in order to successfully select the specific therapeutic protocols, processes, equipment, and vendors most likely to result in clinical benefit for their patients."

The policy lists nine considerations for use of regenerative medicine by veterinarians.

AVMA to deliberate on assistance animals, stem cells (June 1, 2017)

FDA finalizes guidance on cell-based products in animals (July 15, 2015)

Stem cells in theory & practice (Feb. 15, 2011)

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Policy addresses therapeutic use of stem cells, regenerative medicine - American Veterinary Medical Association

Valeria Canto-Soler at work in the lab at the Gates Center for Regenerative Medicine.

When Valeria Canto-Soler, Ph.D., was a biology student in Argentina, she dreamed of a career studying elephants and other African wildlife in their natural habitat.

But life took her on a different journey. In July, Canto-Soler joined the Department of Ophthalmology and the Gates Center for Regenerative Medicine as the Doni Solich Family Endowed Chair in Ocular Stem Cell Research.

I like to joke about it, she says. Instead of spending my life studying animals in the wilds of Africa, Im in a dark room sitting in front of a microscope.

After an international search, Canto-Soler also was named director of CellSight, the Ocular Stem Cell and Regeneration Research Program, in partnership with the Gates Center and the Department of Ophthalmology. She also will be an Associate Professor of Ophthalmology at the CU Anschutz School of Medicine.

This $10 million ocular stem cell and regeneration program initiative began with a $5 million grant from the Gates Frontiers Fund to research the potential for stem cells to treat age-related macular degeneration, the leading cause of blindness in people ages 50 and older.

I dreamed of launching a stem cell research program like this for years, she says. The leadership at both the Gates Center and the Department of Ophthalmology has the same vision that I have. Working together, we can make it happen.

Canto-Soler grew up in Mendoza, Argentina, a city on the eastern side of the Andes Mountains. Similar to Denver in that its nestled in the foothills, Mendozas close proximity to the mountains gave her the opportunity to hike, explore and marvel at the natural wildlife she encountered.

But when it came to a career choice, it was more difficult for her to decide how to direct her love of nature and biology. In contrast to the U.S., students in Argentina have to decide on a career early.

Its a very important decision and there are very few chances for you to change your mind after that, she says.

As a young biology student, Canto-Soler found herself drawn to the study of the human nervous system and how the sense organs work.

Year by year, I felt more and more fascinated by the biology of the human body, she says. In the last two years of biology school, I started to work in a lab studying the nervous system. That defined my future.

Canto-Soler earned a B.S. in Biology from the University of Cordoba School of Natural Sciences, Cordoba, Argentina in 1996. In 2002, she completed a Ph.D. in Biomedical Sciences at the Austral University School of Medicine in Buenos Aires.

After she earned her Ph.D., Canto-Soler had the opportunity to explore new vistas. She was accepted as a Fellow with the Retinal Degenerations Research Center in the Department of Ophthalmology at Johns Hopkins University School of Medicine in Baltimore. She worked with renowned scientist Ruben Adler, MD, at the Wilmer Eye Institute.

I was so excited the focus of his research was the development of the eye, Canto-Soler says. It was perfect for me.

She thought her fellowship would provide her the knowledge and experience she could take back to Argentina, but she found new challenges to keep her in the U.S. When her mentor, Dr. Adler, died in 2007, she took over his role at Wilmer to continue their work.

In 2014, Canto-Soler and her team created a miniature human retina in a petri dish, using human stem cells. The mini retinas had functioning photoreceptor cells capable of sensing light. This cutting-edge research opened up the potential to take cells from a patient who suffers from a particular retinal disease, such as macular degeneration, and use them to generate mini retinas that would recapitulate the disease of the patient; this allows studying the disease on a human context directly, rather than depending on animal models.

This research could lead to personalized medicine and drug treatments for specific patient needs. At CellSight, Canto-Soler will work with clinicians and members of the Gates Center to create patient registries and cell banking. She hopes her research will someday result in cell-based treatments; retinal patches, for example, which could be transplanted into a patients eye, possibly curing blindness.

Once you transplant a retinal patch, the cells have to establish all the right connections with the patients own retinal cells in order to process the information and produce a visual image, she says. No one really knows how to do that yet.

But shes confident the clinicians from the Department of Ophthalmology, and the researchers at CellSight and the Gates Center, will work together to make the dream a reality.

Im definitely a dreamer, Canto-Soler says. I never imagined we could generate human mini retinas in a petri dish. And to see that happen made me a believer. I believe our scientific dreams can come true if we pursue them in the right way.

The letters and emails she receives from those who have family members or friends suffering from sight problems or blindness inspire her. Theyre also looking for answers.

Its what gets me motivated to come to work every day, she says. Im excited to think about how we could help people and the impact that would make in their lives.

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Canto-Soler joins team at Gates Center for Regenerative Medicine to develop cell-based treatments - CU Anschutz Today (press release)

What if one day, we could teach our bodies to self-heal like a lizards tail, and make severe injury or disease no more threatening than a paper cut?

Or heal tissues by coaxing cells to multiply, repair or replace damaged regions in loved ones whose lives have been ravaged by stroke, Alzheimers or Parkinsons disease?

Such is the vision, promise and excitement in the burgeoning field of regenerative medicine, now a major ASU initiative to boost 21st-century medical research discoveries.

ASU Biodesign Institute researcher Nick Stephanopoulos is one of several rising stars in regenerative medicine. In 2015, Stephanopoulos, along with Alex Green and Jeremy Mills, were recruited to the Biodesign Institutes Center for Molecular Design and Biomimetics (CMDB), directed by Hao Yan, a world-recognized leader in nanotechnology.

One of the things that that attracted me most to the ASU and the Biodesign CMDB was Haos vision to build a group of researchers that use biological molecules and design principles to make new materials that can mimic, and one day surpass, the most complex functions of biology, Stephanopoulos said.

I have always been fascinated by using biological building blocks like proteins, peptides and DNA to construct self-assembled structures, devices and materials, and the interdisciplinary and highly collaborative team in the CMDB is the ideal place to put this vision into practice.

Yans research center uses DNA and other basic building blocks to build their nanotechnology structures only at a scale 1,000 times smaller than the width of a human hair.

Theyve already used nanotechnology to build containers to specially deliver drugs to tissues, build robots to navigate a maze or nanowires for electronics.

To build a manufacturing industry at that tiny scale, their bricks and mortar use a colorful assortment of molecular Legos. Just combine the ingredients, and these building blocks can self-assemble in a seemingly infinite number of ways only limited by the laws of chemistry and physics and the creative imaginations of these budding nano-architects.

Learning from nature

The goal of the Center for Molecular Design and Biomimetics is to usenatures design rulesas an inspiration in advancing biomedical, energy and electronics innovation throughself-assembling moleculesto create intelligent materials for better component control and for synthesis intohigher-order systems, said Yan, who also holds the Milton Glick Chair in Chemistry and Biochemistry.

Prior to joining ASU, Stephanopoulos trained with experts in biological nanomaterials, obtaining his doctorate with the University of California Berkeleys Matthew Francis, and completed postdoctoral studies with Samuel Stupp at Northwestern University. At Northwestern, he was part of a team that developed a new category of quilt-like, self-assembling peptide and peptide-DNA biomaterials for regenerative medicine, with an emphasis in neural tissue engineering.

Weve learned from nature many of the rules behind materials that can self-assemble. Some of the most elegant complex and adaptable examples of self-assembly are found in biological systems, Stephanopoulos said.

Because they are built from the ground-up using molecules found in nature, these materials are also biocompatible and biodegradable, opening up brand-new vistas for regenerative medicine.

Stephanopoulos tool kit includes using proteins, peptides, lipids and nucleic acids like DNA that have a rich biological lexicon of self-assembly.

DNA possesses great potential for the construction of self-assembled biomaterials due to its highly programmable nature; any two strands of DNA can be coaxed to assemble to make nanoscale constructs and devices with exquisite precision and complexity, Stephanopoulos said.

Proof all in the design

During his time at Northwestern, Stephanopoulos worked on a number of projects and developed proof-of-concept technologies for spinal cord injury, bone regeneration and nanomaterials to guide stem cell differentiation.

Now, more recently, in a new studyin Nature Communications, Stephanopoulos and his colleague Ronit Freeman in the Stupp laboratory successfully demonstrated the ability to dynamically control the environment around stem cells, to guide their behavior in new and powerful ways.

In the new technology, materials are first chemically decorated with different strands of DNA, each with a unique code for a different signal to cells.

To activate signals within the cells, soluble molecules containing complementary DNA strands are coupled to short protein fragments, called peptides, and added to the material to create DNA double helices displaying the signal.

By adding a few drops of the DNA-peptide mixture, the material effectively gives a green light to stem cells to reproduce and generate more cells. In order to dynamically tune the signal presentation, the surface is exposed to a soluble single-stranded DNA molecule designed to grab the signal-containing strand of the duplex and form a new DNA double helix, displacing the old signal from the surface.

This new duplex can then be washed away, turning the signal off. To turn the signal back on, all that is needed is to now introduce a new copy of single-stranded DNA bearing a signal that will reattach to the materials surface.

One of the findings of this work is the possibility of using the synthetic material to signal neural stem cells to proliferate, then at a specific time selected by the scientist, trigger their differentiation into neurons for a while, before returning the stem cells to a proliferative state on demand.

One potential use of the new technology to manipulate cells could help cure a patient with neurodegenerative conditions like Parkinsons disease.

The patients own skin cells could be converted to stem cells using existing techniques. The new technology could help expand the newly converted stem cells back in the lab and then direct their growth into specific dopamine-producing neurons before transplantation back to the patient.

People would love to have cell therapies that utilize stem cells derived from their own bodies to regenerate tissue, Stupp said. In principle, this will eventually be possible, but one needs procedures that are effective at expanding and differentiating cells in order to do so. Our technology does that.

In the future, it might be possible to perform this process entirely within the body. The stem cells would be implanted in the clinic, encapsulated in the type of material described in the new work, and injected into a particular spot. Then the soluble peptide-DNA molecules would be given to the patient to bind to the material and manipulate the proliferation and differentiation of transplanted cells.

Scaling the barriers

One of the future challenges in this area will be to develop materials that can respond better to external stimuli and reconfigure their physical or chemical properties accordingly.

Biological systems are complex, and treating injury or disease will in many cases necessitate a material that can mimic the complex spatiotemporal dynamics of the tissues they are used to treat, Stephanopoulos said.

It is likely that hybrid systems that combine multiple chemical elements will be necessary; some components may provide structure, others biological signaling and yet others a switchable element to imbue dynamic ability to the material.

A second challenge, and opportunity, for regenerative medicine lies in creating nanostructures that can organize material across multiple length scales. Biological systems themselves are hierarchically organized: from molecules to cells to tissues, and up to entire organisms.

Consider that for all of us, life starts simple, with just a single cell. By the time we reach adulthood, every adult human body is its own universe of cells, with recent estimates of 37 trillion or so. The human brain alone has 100 billion cells or about the same number of cells as stars in the Milky Way galaxy.

But over the course of a life, or by disease, whole constellations of cells are lost due to the ravages of time or the genetic blueprints going awry.

Collaborative DNA

To overcome these obstacles, much more research funding and recruitment of additional talent to ASU will be needed to build the necessary regenerative medicine workforce.

Last year, Stephanopoulos research received a boost with funding from the U.S. Air Forces Young Investigator Research Program (YIP).

The Air Force Office of Scientific ResearchYIP award will facilitate Nicks research agenda in this direction, and is a significant recognition of his creativity and track record at the early stage of his careers, Yan said.

Theyll need this and more to meet the ultimate challenge in the development of self-assembled biomaterials and translation to clinical applications.

Buoyed by the funding, during the next research steps, Stephanopoulos wants to further expand horizons with collaborations from other ASU colleagues to take his research teams efforts one step closer to the clinic.

ASU and the Biodesign Institute also offer world-class researchers in engineering, physics and biology for collaborations, not to mention close ties with the Mayo Clinic or a number of Phoenix-area institutes so we can translate our materials to medically relevant applications, Stephanopoulos said.

There is growing recognition that regenerative medicine in the Valley could be a win-win for the area, in delivering new cures to patients and building, person by person, a brand-new medicinal manufacturing industry.

Stephanopoulos recent research was carried out at Stupps Northwesterns Simpson Querrey Institute for BioNanotechnology. The National Institute of Dental and Craniofacial Research of the National Institutes of Health (grant 5R01DE015920) provided funding for biological experiments, and the U.S. Department of Energy, Office of Science, Basic Energy Sciences provided funding for the development of the new materials (grants DE-FG01-00ER45810 and DE-SC0000989 supporting an Energy Frontiers Research Center on Bio-Inspired Energy Science (CBES)).

The paper is titled Instructing cells with programmable peptide DNA hybrids. Samuel I. Stupp is the senior author of the paper, and post-doctoral fellows Ronit Freeman and Nicholas Stephanopoulos are primary authors.

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Bio-inspired Materials Give Boost to Regenerative Medicine - Bioscience Technology

The global regenerative medicine market size is expected to reach USD 5.59 billion by 2025, according to this new report. Increased prevalence of neurodegenerative, orthopedic, and other aging-related disorders in geriatric population coupled with rising global geriatric population is anticipated to drive market growth.

Developments in biotechnology have enabled gaining in-depth knowledge pertaining to cell division and differentiation as well as the metabolism mechanism of various cells. This enriched knowledge, coupled with emergence of novel streams of biotechnology such as gene therapy and nanotechnology, further prospered use of cell-based technology in therapeutic treatment.

Identification of ability of stem cells to develop into various different cell lines further propelled the advancements in regenerative medicine. Frequent media exposure due to regulatory as well as ethical controversies around embryonic stem cells has increased awareness among the masses. This encouraged researchers to explore and develop other potential fields for similar applications, such as induced pluripotent stem cells (iPSC).

Furthermore, the emergence of gene therapy techniques with potential to rectify and restore effects of gene mutations in cells is under development. Conditions caused due to Single Nucleotide Polymorphism (SNP) as well as mutations that induce degenerative characteristics are primarily targeted.

Companies Mentioned

Key Topics Covered:

1 Research Methodology

2. Executive Summary

3. Regenerative Medicnie Market Variables, Trends & Scope

4. Regenerative Medicine Market: Product Type Estimates & Trend Analysis

5. Regenerative Medicine Market: Therapeutic Category Estimates & Trend Analysis

6. Regenerative Medicine Market: Regional Estimates & Trend Analysis, by Product And Therapeutic Category

7. Competitive Landscape

For more information about this report visit https://www.researchandmarkets.com/research/948x9s/regenerative

Media Contact:

Laura Wood, Senior Manager press@researchandmarkets.com

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View original content:http://www.prnewswire.com/news-releases/regenerative-medicine-market-to-reach-55-billion-by-2025-increased-prevalence-of-neurodegenerative-orthopedic--other-aging-related-disorders-300506534.html

SOURCE Research and Markets

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Regenerative Medicine Market to Reach $5.5 Billion by 2025 ... - PR Newswire (press release)

SAN CARLOS, Calif.--(BUSINESS WIRE)--Cellerant Therapeutics, Inc., a clinical-stage company developing innovative immunotherapies for hematologic malignancies and other blood-related disorders, today announced it has been awarded a grant from the California Institute for Regenerative Medicine (CIRM) for up to $6.86 million to support preclinical development and the filing of an Investigational New Drug application (IND) for CLT030-ADC, Cellerants antibody-drug conjugate (ADC) product for the treatment for acute myeloid leukemia (AML). AML is an aggressive cancer with high relapse rates and low overall survival, which are thought to be due to the persistence of leukemic stem cells that are relatively resistant to current chemotherapy regimens. CLT030-ADC targets C-type-like lectin 1 (CLL1), a cell surface antigen highly expressed on leukemic stem cells but not on normal hematopoietic stem and progenitor cells.

CIRM is an agency of the State of California whose mission is to accelerate stem cell treatments to patients with unmet medical needs. CIRM grants are awarded through a competitive process which includes rigorous review and evaluation by independent scientific and medical experts.

"We are honored to receive this award from CIRM, which will help us advance the development of CLT030-ADC, said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant. Based on target characteristics and preclinical results, CLT030-ADC has the potential to increase survival and become a first-in-class treatment for AML patients. We are excited to be working with CIRM to develop this novel therapeutic for an unmet medical need.

Our mission here at CIRM is to support novel stem cell-based therapeutics, including those that target cancer stem cells, added Maria Millan, M.D., interim President and CEO of CIRM. Cancer stem cells are believed to play a key role in tumor formation and growth, so attacking them has the potential to improve patient outcomes in deadly diseases such as AML.

CLT030-ADC consists of an antibody targeting CLL1 linked to a DNA-damaging cytotoxic payload. CLL1 is an antigen expressed specifically on AML cancer stem cells and not on normal hematopoietic stem cells. The Company and others have shown that CLL1 is expressed in approximately 90% of all AML patient types, including all French American British classifications, all cytogenetic risk categories, and in patients independent of FLT-3 status. In preclinical AML models, CLT030-ADC demonstrated complete target-dependent tumor regression. Importantly, CLT030-ADC should have minimal effect on the formation of

normal blood cell types because CLL1 is not expressed on normal hematopoietic stem cells and minimally on progenitor cells. This would potentially be an important safety advantage compared to other targeted therapies for AML where the target antigen is expressed on normal stem and progenitor cells, such as CD33.

About Cellerant Therapeutics

Cellerant Therapeutics is a clinical-stage company developing innovative cell- and antibody-based immunotherapies for hematologic malignancies and other blood-related disorders. Cellerants CLT-008 (human myeloid progenitor cells) is a universal cell therapy for the treatment of neutropenia. Chemotherapy-induced neutropenia is a severe side effect of many chemotherapy regimens, particularly for AML and other hematologic malignancies. CLT-008 is currently in a randomized, controlled Phase 2 clinical trial in patients with AML. Cellerants is developing two antibody drug-conjugate (ADC) product candidates: CLT030-ADC, intended to treat AML by selectively targeting and killing leukemic stem and blast cells, and CLT012-ADC, which could be a potential treatment for AML and a number of solid tumors. For more information, visit: http://www.cellerant.com

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Cellerant Therapeutics, Inc. Awarded $6.86 Million Grant From California Institute for Regenerative Medicine to ... - Business Wire (press release)

In a new studyin Nature Communications, Stephanopoulos and his colleague Ronit Freeman successfully demonstrated the ability to dynamically control the environment around stem cells, to guide their behavior in new and powerful ways. Credit: Northwestern University

What if one day, we could teach our bodies to self-heal like a lizard's tail, and make severe injury or disease no more threatening than a paper cut?

Or heal tissues by coaxing cells to multiply, repair or replace damaged regions in loved ones whose lives have been ravaged by stroke, Alzheimer's or Parkinson's disease?

Such is the vision, promise and excitement in the burgeoning field of regenerative medicine, now a major ASU initiative to boost 21st-century medical research discoveries.

ASU Biodesign Institute researcher Nick Stephanopoulos is one of several rising stars in regenerative medicine. In 2015, Stephanopoulos, along with Alex Green and Jeremy Mills, were recruited to the Biodesign Institute's Center for Molecular Design and Biomimetics (CMDB), directed by Hao Yan, a world-recognized leader in nanotechnology.

"One of the things that that attracted me most to the ASU and the Biodesign CMDB was Hao's vision to build a group of researchers that use biological molecules and design principles to make new materials that can mimic, and one day surpass, the most complex functions of biology," Stephanopoulos said.

"I have always been fascinated by using biological building blocks like proteins, peptides and DNA to construct self-assembled structures, devices and materials, and the interdisciplinary and highly collaborative team in the CMDB is the ideal place to put this vision into practice."

Yan's research center uses DNA and other basic building blocks to build their nanotechnology structuresonly at a scale 1,000 times smaller than the width of a human hair.

They've already used nanotechnology to build containers to specially deliver drugs to tissues, build robots to navigate a maze or nanowires for electronics.

To build a manufacturing industry at that tiny scale, their bricks and mortar use a colorful assortment of molecular Legos. Just combine the ingredients, and these building blocks can self-assemble in a seemingly infinite number of ways only limited by the laws of chemistry and physicsand the creative imaginations of these budding nano-architects.

Learning from nature

"The goal of the Center for Molecular Design and Biomimetics is to use nature's design rules as an inspiration in advancing biomedical, energy and electronics innovation through self-assembling molecules to create intelligent materials for better component control and for synthesis into higher-order systems," said Yan, who also holds the Milton Glick Chair in Chemistry and Biochemistry.

Prior to joining ASU, Stephanopoulos trained with experts in biological nanomaterials, obtaining his doctorate with the University of California Berkeley's Matthew Francis, and completed postdoctoral studies with Samuel Stupp at Northwestern University. At Northwestern, he was part of a team that developed a new category of quilt-like, self-assembling peptide and peptide-DNA biomaterials for regenerative medicine, with an emphasis in neural tissue engineering.

"We've learned from nature many of the rules behind materials that can self-assemble. Some of the most elegant complex and adaptable examples of self-assembly are found in biological systems," Stephanopoulos said.

Because they are built from the ground-up using molecules found in nature, these materials are also biocompatible and biodegradable, opening up brand-new vistas for regenerative medicine.

Stephanopoulos' tool kit includes using proteins, peptides, lipids and nucleic acids like DNA that have a rich biological lexicon of self-assembly.

"DNA possesses great potential for the construction of self-assembled biomaterials due to its highly programmable nature; any two strands of DNA can be coaxed to assemble to make nanoscale constructs and devices with exquisite precision and complexity," Stephanopoulos said.

Proof all in the design

During his time at Northwestern, Stephanopoulos worked on a number of projects and developed proof-of-concept technologies for spinal cord injury, bone regeneration and nanomaterials to guide stem cell differentiation.

Now, more recently, in a new study in Nature Communications, Stephanopoulos and his colleague Ronit Freeman in the Stupp laboratory successfully demonstrated the ability to dynamically control the environment around stem cells, to guide their behavior in new and powerful ways.

In the new technology, materials are first chemically decorated with different strands of DNA, each with a unique code for a different signal to cells.

To activate signals within the cells, soluble molecules containing complementary DNA strands are coupled to short protein fragments, called peptides, and added to the material to create DNA double helices displaying the signal.

By adding a few drops of the DNA-peptide mixture, the material effectively gives a green light to stem cells to reproduce and generate more cells. In order to dynamically tune the signal presentation, the surface is exposed to a soluble single-stranded DNA molecule designed to "grab" the signal-containing strand of the duplex and form a new DNA double helix, displacing the old signal from the surface.

This new duplex can then be washed away, turning the signal "off." To turn the signal back on, all that is needed is to now introduce a new copy of single-stranded DNA bearing a signal that will reattach to the material's surface.

One of the findings of this work is the possibility of using the synthetic material to signal neural stem cells to proliferate, then at a specific time selected by the scientist, trigger their differentiation into neurons for a while, before returning the stem cells to a proliferative state on demand.

One potential use of the new technology to manipulate cells could help cure a patient with neurodegenerative conditions like Parkinson's disease.

The patient's own skin cells could be converted to stem cells using existing techniques. The new technology could help expand the newly converted stem cells back in the laband then direct their growth into specific dopamine-producing neurons before transplantation back to the patient.

"People would love to have cell therapies that utilize stem cells derived from their own bodies to regenerate tissue," Stupp said. "In principle, this will eventually be possible, but one needs procedures that are effective at expanding and differentiating cells in order to do so. Our technology does that."

In the future, it might be possible to perform this process entirely within the body. The stem cells would be implanted in the clinic, encapsulated in the type of material described in the new work, and injected into a particular spot. Then the soluble peptide-DNA molecules would be given to the patient to bind to the material and manipulate the proliferation and differentiation of transplanted cells.

Scaling the barriers

One of the future challenges in this area will be to develop materials that can respond better to external stimuli and reconfigure their physical or chemical properties accordingly.

"Biological systems are complex, and treating injury or disease will in many cases necessitate a material that can mimic the complex spatiotemporal dynamics of the tissues they are used to treat," Stephanopoulos said.

It is likely that hybrid systems that combine multiple chemical elements will be necessary; some components may provide structure, others biological signaling and yet others a switchable element to imbue dynamic ability to the material.

A second challenge, and opportunity, for regenerative medicine lies in creating nanostructures that can organize material across multiple length scales. Biological systems themselves are hierarchically organized: from molecules to cells to tissues, and up to entire organisms.

Consider that for all of us, life starts simple, with just a single cell. By the time we reach adulthood, every adult human body is its own universe of cells, with recent estimates of 37 trillion or so. The human brain alone has 100 billion cells or about the same number of cells as stars in the Milky Way galaxy.

But over the course of a life, or by disease, whole constellations of cells are lost due to the ravages of time or the genetic blueprints going awry.

Collaborative DNA

To overcome these obstacles, much more research funding and recruitment of additional talent to ASU will be needed to build the necessary regenerative medicine workforce.

Last year, Stephanopoulos' research received a boost with funding from the U.S. Air Force's Young Investigator Research Program (YIP).

"The Air Force Office of Scientific Research YIP award will facilitate Nick's research agenda in this direction, and is a significant recognition of his creativity and track record at the early stage of his careers," Yan said.

They'll need this and more to meet the ultimate challenge in the development of self-assembled biomaterials and translation to clinical applications.

Buoyed by the funding, during the next research steps, Stephanopoulos wants to further expand horizons with collaborations from other ASU colleagues to take his research team's efforts one step closer to the clinic.

"ASU and the Biodesign Institute also offer world-class researchers in engineering, physics and biology for collaborations, not to mention close ties with the Mayo Clinic or a number of Phoenix-area institutes so we can translate our materials to medically relevant applications," Stephanopoulos said.

There is growing recognition that regenerative medicine in the Valley could be a win-win for the area, in delivering new cures to patients and building, person by person, a brand-new medicinal manufacturing industry.

Explore further: New technology to manipulate cells could help treat Parkinson's, arthritis, other diseases

More information: Ronit Freeman et al. Instructing cells with programmable peptide DNA hybrids, Nature Communications (2017). DOI: 10.1038/ncomms15982

Original post:
Bio-inspired materials give boost to regenerative medicine - Medical Xpress

WASHINGTON, DC--(Marketwired - Aug 18, 2017) - The Alliance for Regenerative Medicine (ARM) released today its most recent quarterly data report, offering an in-depth look at cell therapy, gene therapy, tissue engineering and broader global regenerative medicine sector trends and metrics in the second quarter and first half of 2017.

Using information provided by ARM's data partner Informa, the quarterly data report details industry-specific statistics compiled from more than 822 cell therapy, gene therapy, tissue engineering and other regenerative medicine companies worldwide, including total financings, partnerships and other deals, clinical trial information, key clinical data events and current legislative and regulatory priorities.

The Q2 2017 data report also features expert perspectives from ARM member representatives and other key stakeholders, highlighting important focus areas for the sector:

Expert perspective on the growing interest and advantages of induced pluripotent stem cells as a therapeutic platform, with insights from:

Addressing the unique aspects of market access and reimbursement policy for cell and gene therapies, with insights from:

"At mid-point 2017, this sector has nearly or actually surpassed 2016 year-end totals by several metrics, signifying a renewed uptick in dealmaking and partnering activity across the sector," said Janet Lynch Lambert, ARM's Chief Executive Officer. "We are looking forward to an eventful second half of the year, with several anticipated high-profile product approvals and additional clinical progress in several key therapeutic areas."

Highlighted findings from the Q2 2017 data report include:

ARM will continue to update this information through new reports to be released after the close of each quarter, tracking sector performance, key financial information, clinical trial numbers and clinical data events.

The report is available online here. For more information, please visit http://www.alliancerm.org or contact Lyndsey Scull at lscull@alliancerm.org.

About The Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 270 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit http://www.alliancerm.org

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The Alliance for Regenerative Medicine Releases Q2 2017 Data ... - Benzinga