Stem Cells Seem Safe in Treating Eye Disease

A treatment based on embryonic stem cells clears a key safety hurdle, and might help restore vision.

When stem cells were first culled from human embryos sixteen years ago, scientists imagined they would soon be treating diabetes, heart disease, stroke, and many other diseases with cells manufactured in the lab.

Its all taken longer than they thought. But today, a Massachusetts biotech firm reported results from the largest, and longest, human test of a treatment based on embryonic stem cells, saying it appears safe and may have partly restored vision to patients going blind from degenerative diseases.

Results of three-year study were described today in the Lancet by Advanced Cell Technology and collaborating eye specialists at the Jules Stein Eye Institute in Los Angeles who transplanted lab-grown cells into the eyes of nine people with macular degeneration and nine with Stargardts macular dystrophy.

The idea behind Advanced Cells treatment is to replace retinal pigment epithelium cells, known as RPE cells, a type of caretaker tissue without which a persons photoreceptors also die, with supplies grown in laboratory. It uses embryonic stem cells as a starting point, coaxing them to generate millions of specialized retina cells. In the study, each patient received a transplant of between 50,000 and 150,000 of those cells into one eye.

The main objective of the study was to prove the cells were safe. Beyond seeing no worrisome side effects, the researchers also noted some improvements in the patients. According to the researchers half of them improved enough to read two to three extra lines on an eye exam chart, results Robert Lanza, chief scientific officer of Advanced Cell, called remarkable.

We have people saying things no one would make up, like Oh I can see the pattern on my furniture, or now I drive to the airport, he says. Clearly there is something going on here.

Lanza stressed the need for a larger study, which he said the company hoped to launch later this year in Stargardts patients. But if the vision results seen so far continue, Lanza says this would be a therapy.

Some eye specialists said its too soon to say whether the vision improvements were real. The patients werent examined by independent specialists, they said, and eyesight in patients with low vision is notoriously difficult to measure. That leaves plenty of room for placebo effects or unconscious bias on the part of doctors.

When someone gets a treatment, they try really hard to read the eye chart, says Stephen Tsang, a doctor at Columbia University who sees patients losing their vision to both diseases. Its common for patients to show quick improvements, he says, although typically not as large as what Advanced Cell is reporting.

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Stem Cells Seem Safe in Treating Eye Disease

Bostons Adult Stem Cell Technology Center, LLC Releases Video Presentation of the Companys Next Generation Stem Cell …

Boston, MA (PRWEB) October 14, 2014

The most important function of tissue stem cells is the most ignored function of tissue stem cells. This seemingly paradoxical revelation is the special province of the ASCTC, upon which Director James L. Sherley, M.D., Ph.D. is staking the companys future success. A newly released video of a presentation given by Sherley at the recent 2014 BioPharm America Conference in Boston, provides an opportunity for the regenerative medicine community in particular, and the public in general, to learn directly from the source the scientific basis for this surprising statement.

Director Sherley reveals that the most important function of adult tissue stem cells is their asymmetric self-renewal. Asymmetric self-renewal is the unique property of tissue stem cells to divide continuously to make large numbers of constituent body cells while keeping their own number constant and maintaining their own stem cell function. This tissue stem cell-specific function allows stem cells to continuously renew organs and tissues and to repair them when they are diseased or damaged.

In the video, Director Sherley describes ASCTCs three main next generation technologies that motivate the companys current development goals. The first is patented biomarkers that identify tissue stem cells with sufficient specificity to allow them to be counted for the first time. This technology has potential to accelerate advances in stem cell biomedicine by providing a convenient method for counting stem cells in tissues in the body and in therapeutic cell transplant preparations. The ASCTC intends to license its biomarkers to other companies in the stem cell biotechnology and regenerative medicine industries.

The second technological breakthrough is a method of expanding human tissue stem cells in culture without loss of their normal stem cell functions. Based on asymmetric self-renewal principles, the ASCTC developed technologies that induce tissue stem cells to divide reversibly with greater self-duplication than production of constituent body cells. These technologies promote the exponential production of tissue stem cells that later can be reversed back to making constituent cells. Such capability is ideal for producing large quantities of functional normal human tissue constituent cells for drug evaluations or large quantities of normal human tissue stem cells for cell therapy applications. No other currently available method for multiplying human solid organ stem cells provides normal cells as the final product.

Director Sherley relates the ASCTCs plans to develop its expansion technology to become a manufacturer of human liver stem cells and their derivatives. The company is targeting applications in drug candidate evaluation and liver transplant therapy. For this plan, it is currently working to assemble a superior management team with the first new member target being an outstanding CEO to join Dr. Sherley as the CSO and a strategic cell manufacturing partner. In his current role as director, Dr. Sherley projects that a $30 million investment over a five-year period will be required to achieve the companys first commercial target, which is supplying the pharmaceutical industry with on-demand, reproducible, clinically diverse panels of human cells with mature liver functions for use in drug evaluations.

The video presentation ends with the most recent innovation from the ASCTC. In a partnership venture with AlphaSTAR Corporation (ASC) located in Long Beach, California, ASCTC has recently completed the development of computer simulation software that can accurately estimate the number of tissue stem cells in any human tissue cell culture. ASC develops computer simulation analyses to predict the physical failure of complex composite materials used to build aircraft, racing cars, and other high stress transports like the space shuttle. The two companies have integrated their respective expertise to produce the first-of-its-kind computer simulation-based technology for quantitative monitoring of human tissue stem cells.

The new stem cell monitoring technology has several important foreseeable applications, including determining stem cell number for dosing in cell therapies; identifying agents that increase stem cell number, which might be healing agents or carcinogens; and identifying agents that are toxic to stem cells. ASCTC and ASC are partnering to develop the new technology to screen out stem cell toxic drug candidates at the beginning of the drug development pipeline, before pharmaceutical companies have wasted hundreds of millions of dollars on their evaluation at later stages of drug development, as well as in the marketplace.

Sherley suggests that many stem cell scientists and regenerative medicine companies overlook asymmetric self-renewal, because it has been difficult to study. This difficulty, which is partly due to the scarcity of stem cells in tissues, has fostered a climate of controversy about asymmetric self-renewal. Sherley assures, ASCTC is past the controversy and on to achieving significant regenerative medicine advances by employing our special know-how in this crucial aspect of adult tissue stem cell biology.

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Stem Cell Therapy For ALS Gets FDA's Fast Track Designation

By C. Rajan, contributing writer

The U.S. FDA has just granted BrainStorm Cell Therapeutics novel stem cell therapy, NurOwn, Fast Track status for the treatment of amyotrophic lateral sclerosis (ALS), the company announced via press release.

"We are pleased that the FDA has granted Fast Track status for NurOwn as this will allow us greater and more frequent dialogue with the Agency as we continue the development of this ground-breaking cell therapy for the treatment of ALS," said Tony Fiorino, MD, PhD, CEO of BrainStorm. "We expect Fast Track designation, which recognizes the potential of NurOwn as to address an unmet medical need in ALS, to help speed and improve our development program."

Israeli biotech company BrainStorm is developing novel adult stem cell technologies for neurodegenerative diseases, such as ALS. The company licensed the exclusive rights to the NurOwn technology from Ramot, the technology transfer company of Tel Aviv University.

NurOwn is a personalized stem cell product made from autologous mesenchymal stem cells. These adult stem cells are obtained from the patients bone marrow and are induced to secrete neurotrophic factors, which are growth factors that can stimulate the survival and maintenance of neurons that degenerate in neurologic disorders.

NurOwn is currently being studied in randomized, double-blind, placebo-controlled phase 2 clinical trials in ALS patients in both Israel and the U.S. Reuters reports that the last patient visit has been completed in the phase 2a clinical trial in Jerusalem. The company expects to release final results of the study by the end of this year. The U.S. arm of the Phase 2 study is being conducted at three sites in the U.S., and is expected to be wrapped up in early 2015.

The FDA's Fast Track program aims to speed up the development of new drugs and biologics in order to get them to patients suffering from serious, unmet medical needs. The Fast Track designation will allow BrainStorm Cell to submit an NDA on a rolling basis and will grant the company more communication and support from FDA during the development process.

ALS, also known as Lou Gehrig's disease, is a rapidly progressive neurological disease that results in death within 2 to 5 years of diagnosis in most cases, and less than 20 percent of patients live more than 5 years after onset of symptoms. The relatively rare condition affects about 2 persons in every 100,000, with approximately 5,600 new cases diagnosed every year in the U.S, according to the ALS Association.

There is no cure for the disease to date, although the only approved ALS drug, Riluzole, has demonstrated its ability to extend survival by at least a few months.

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Stem Cell Therapy For ALS Gets FDA's Fast Track Designation

What are the potential uses of human stem cells and the …

Introduction: What are stem cells, and why are they important? What are the unique properties of all stem cells? What are embryonic stem cells? What are adult stem cells? What are the similarities and differences between embryonic and adult stem cells? What are induced pluripotent stem cells? What are the potential uses of human stem cells and the obstacles that must be overcome before these potential uses will be realized? Where can I get more information? VII. What are the potential uses of human stem cells and the obstacles that must be overcome before these potential uses will be realized?

There are many ways in which human stem cells can be used in research and the clinic. Studies of human embryonic stem cells will yield information about the complex events that occur during human development. A primary goal of this work is to identify how undifferentiated stem cells become the differentiated cells that form the tissues and organs. Scientists know that turning genes on and off is central to this process. Some of the most serious medical conditions, such as cancer and birth defects, are due to abnormal cell division and differentiation. A more complete understanding of the genetic and molecular controls of these processes may yield information about how such diseases arise and suggest new strategies for therapy. Predictably controlling cell proliferation and differentiation requires additional basic research on the molecular and genetic signals that regulate cell division and specialization. While recent developments with iPS cells suggest some of the specific factors that may be involved, techniques must be devised to introduce these factors safely into the cells and control the processes that are induced by these factors.

Human stem cells are currently being used to test new drugs. New medications are tested for safety on differentiated cells generated from human pluripotent cell lines. Other kinds of cell lines have a long history of being used in this way. Cancer cell lines, for example, are used to screen potential anti-tumor drugs. The availability of pluripotent stem cells would allow drug testing in a wider range of cell types. However, to screen drugs effectively, the conditions must be identical when comparing different drugs. Therefore, scientists must be able to precisely control the differentiation of stem cells into the specific cell type on which drugs will be tested. For some cell types and tissues, current knowledge of the signals controlling differentiation falls short of being able to mimic these conditions precisely to generate pure populations of differentiated cells for each drug being tested.

Perhaps the most important potential application of human stem cells is the generation of cells and tissues that could be used for cell-based therapies. Today, donated organs and tissues are often used to replace ailing or destroyed tissue, but the need for transplantable tissues and organs far outweighs the available supply. Stem cells, directed to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat diseases including maculardegeneration, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.

Figure 3. Strategies to repair heart muscle with adult stem cells. Click here for larger image.

2001 Terese Winslow

For example, it may become possible to generate healthy heart muscle cells in the laboratory and then transplant those cells into patients with chronic heart disease. Preliminary research in mice and other animals indicates that bone marrow stromal cells, transplanted into a damaged heart, can have beneficial effects. Whether these cells can generate heart muscle cells or stimulate the growth of new blood vessels that repopulate the heart tissue, or help via some other mechanism is actively under investigation. For example, injected cells may accomplish repair by secreting growth factors, rather than actually incorporating into the heart. Promising results from animal studies have served as the basis for a small number of exploratory studies in humans (for discussion, see call-out box, "Can Stem Cells Mend a Broken Heart?"). Other recent studies in cell culture systems indicate that it may be possible to direct the differentiation of embryonic stem cells or adult bone marrow cells into heart muscle cells (Figure 3).

Cardiovascular disease (CVD), which includes hypertension, coronary heart disease, stroke, and congestive heart failure, has ranked as the number one cause of death in the United States every year since 1900 except 1918, when the nation struggled with an influenza epidemic. Nearly 2,600 Americans die of CVD each day, roughly one person every 34 seconds. Given the aging of the population and the relatively dramatic recent increases in the prevalence of cardiovascular risk factors such as obesity and type 2 diabetes, CVD will be a significant health concern well into the 21st century.

Cardiovascular disease can deprive heart tissue of oxygen, thereby killing cardiac muscle cells (cardiomyocytes). This loss triggers a cascade of detrimental events, including formation of scar tissue, an overload of blood flow and pressure capacity, the overstretching of viable cardiac cells attempting to sustain cardiac output, leading to heart failure, and eventual death. Restoring damaged heart muscle tissue, through repair or regeneration, is therefore a potentially new strategy to treat heart failure.

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TeleHealth Now Accepting New Patients for Insurance Based Stem Cell Procedures at La Jolla Office

La Jolla, California (PRWEB) October 13, 2014

One of the top stem cell clinics in California, Telehealth, is now accepting new patients for insurance based stem cell procedures at an additional location in La Jolla CA. Most insurance is accepted for the stem cell therapies for such conditions as degenerative arthritis, tendonitis, ligament injuries, sports injuries and more. Call (888) 828-4575 for more information and scheduling.

For years, Telehealth has been offering regenerative medicine procedures for such conditions as rotator cuff tendonitis, achilles tears, tennis elbow, plantar fasciitis, degenerative arthritis of the joints and more. The stem cell procedures offered include bone marrow derived or fat derived stem cell procedures, or amniotic therapy. The Board Certified doctors are highly skilled in the musculoskeletal stem cell procedures, and treat patients with the utmost expertise and compassion.

The newest location in La Jolla joins the existing clinics in Orange CA and Upland CA. Coverage for the procedures exists for PPO's, Medicare and Tricare. The procedures are extremely low risk, and small studies have consistently shown beneficial results of the injections.

The treatments at Telehealth represent a new paradigm for pain relief. Whereas most pain treatments mask pain well, such as with steroids, the stem cell treatments offer patients the capability to regenerate and repair damaged tissue. This helps to potentially regenerate cartilage, tendon, ligament tissue in those with arthritis or soft tissue injuries.

For those with sports injuries, arthritis, fractures, plantar fasciitis, tendonitis, etc, and desire insurance covered stem cell therapy, call Telehealth at (888) 828-4575.

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TeleHealth Now Accepting New Patients for Insurance Based Stem Cell Procedures at La Jolla Office

Stem cell therapy could create new blood vessels

New York, Oct 13 (IANS): Diseases that occur due to blood flow problems could soon become a lot easier to treat as researchers have developed a technique to jump-start the body's system for creating blood vessels.

The research could lead to new therapies for illnesses such as peripheral artery disease - a painful leg condition caused by poor blood circulation which can lead to skin problems, gangrene and even amputation.

"While the body has cells that specialise in repairing blood vessels and creating new ones, called endothelial colony forming cells, these cells can lose their ability to proliferate into new blood vessels as patients age or develop diseases like peripheral arterial disease," said lead researcher Mervin Yoder Jr. from the Indiana University School of Medicine.

If younger, more enthusiastic endothelial colony forming cells could be injected into the affected tissues, they might jump-start the process of creating new blood vessels, the findings showed.

Although these cells are relatively difficult to find in adults, especially in those with peripheral arterial disease, they are present in large numbers in umbilical cord blood.

The researchers said they had developed a potential therapy through the use of patient-specific induced pluripotent stem cells, which are normal adult cells that have been "coaxed" via laboratory techniques into reverting into the more primitive stem cells that can produce most types of bodily tissue.

Those laboratory created endothelial colony forming cells were injected into mice, where they were able to proliferate into blood vessels and restore blood flow to tissues in damaged mouse retinas and limbs.

"This is one of the first studies using induced pluripotent stem cells that has been able to produce new cells in clinically relevant numbers - enough to enable a clinical trial," Yoder noted.

The findings appeared in the journal Nature Biotechnology.

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Stem cell therapy could create new blood vessels

Kansas Regenerative Medicine Center | Your Stem Cells …

The Drs With Dr Mark Berman

President and CEO Patrick Farley said he was thril...

Regenerative Medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to damage, or congenital defects. This field holds the promise of regenerating damaged tissues and organs in the body by stimulating previously irreparable organs to heal themselves. (Wikipedia).

These adult stem cells are known as progenitor cells. This means they remain dormant (do nothing) unless they witness some level of tissue injury. Its the tissue injury that turns them on. So, when a person has a degenerative type problem, the stem cells tend to go to that area of need and stimulate the healing process. Were still not sure if they simply change into the type of injured tissue needed for repair or if they send out signals that induces the repair by some other mechanism. Suffice it to say that there are multiple animal models and a plethora of human evidence that indicates these are significant reparative cells.

Stem cell therapy relies on the bodys own regenerative healing to occur. The regenerative process may take time, particularly with orthopedic patients, who may not see results for several months. In some diseases, more immediate responses are possible.

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Global Stem Cells Group Launches New Corporate Website

MIAMI (PRWEB) October 13, 2014

Global Stem Cells Group, Inc. has launched a new corporate website (http://www.stemcellsgroup.com) designed to better highlight its six stem cell-related operating companies and provide up-to-date information on upcoming conferences, corporate news, stem cell research findings and more.

The website offers detailed information on each stem cell division including:

For more information about any of the Global Stem Cells Group operating companies, visit the Global Stem Cells Group website, email bnovas(at)regenestem(dot)com, or call 305-224-1858.

About Global Stem Cells Group:

Global Stem Cells Group, Inc. is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions.

With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.

Global Stem Cells Groups corporate mission is to make the promise of stem cell medicine a reality for patients around the world. With each of GSCGs six operating companies focused on a separate research-based mission, the result is a global network of state-of-the-art stem cell treatments.

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Global Stem Cells Group Launches New Corporate Website

Regenestem Names Renowned Stem Cell Specialists to Launch New Regenerative Medicine Clinic in Antofagasta, Northern …

MIAMI (PRWEB) October 13, 2014

Regenestem, one of the largest membership networks of regenerative medicine clinics worldwide, has announced the launch of a new stem cells clinic in Antofagasta, Northern Chile. The clinic, to be headed by renowned stem cell specialists DRA Maria G. Soledad Gonzalez and Angel Gallegos Freire, M.D., will provide the latest advancements in stem cell treatments and protocol for a variety of eye conditions and diseases including macular degeneration and retinitis pigmentosa, as well as the latest anti-aging and aesthetic treatments and therapies.

Soledad Gonzalez specializes in opthamology at the Laser Surgery Clinic in Higher Vision of Antofagasta since 2003, where he focuses on refractive surgery to treat conditions like myopia, hyperopia, astigmatism and presbyopia. He incorporated minimally invasive aesthetic medicine protocols to his practice in 2012 and specializes in the harvest, preparation, activation and application of stem cell therapies for a number of chronic degenerative diseases.

Gallegos Freire, Medical Director, Policlinico Bhpbilliton M: BHP Billiton Spencea in Ubicacin, Chile, specializing in aesthetic and anti-aging stem cell medicine. Gallegos Freire in an active member of the Argentina Society of Aesthetic Medicine (SOARME), Institutional Member of the Medical Association of Argentina (AMA), the Pan-American Society of Aesthetic Medicine (PASAM) and the Antiaging & Aesthetic Medicine International Society (AAAMISO).

The Antofagasta Regenestem clinic is the companys third international stem cell treatment center opened since Global Stem Cells Group opened the Regenestem Asia Clinic in Manila, Philippines in June and the Regenestem Mexico Clinic in Villahermosa Tabasco. These new, state-of-the-art regenerative medicine facilities join the company's growing global presence that includes clinics in Miami, New York, Los Angeles and Dubai. Regenestem Asia facility marks the first Regenestem brand clinic in the Philippines.

The Global Stem Cells Group and Regenestem are committed to providing the highest of standards in service and technology, expert and compassionate care, and a philosophy of exceeding the expectations of their international patients.

For more information, visit the Regenestem website, email info(at)regenstem(dot)com, or call 305-224-1858.

About Regenestem:

Regenestem, a division of the Global Stem Cells Group, Inc., provides stem cell treatments for a variety of diseases and conditions including arthritis, autism, chronic obstructive pulmonary disease (COPD), diabetes and multiple sclerosis at various facilities worldwide. Each Regenestem clinic offers an international staff experienced in administering the leading cellular therapies available.

Regenestem is certified for the medical tourism market, and staff physicians are board-certified or board-eligible. Regenestem clinics provide services in more than 10 specialties, attracting patients from the United States and around the world.

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Scientists close in on diabetes cure with production of insulin-producing cells

Stem cell researchers at Harvard University have devised a method for creating large quantities of human insulin-producing beta cells, which could soon lead to a cure for type 1 diabetes as well as a new treatment for type 2 diabetes. The cells are currently being trialled in animals and non-human primates with hopes human trials could take place in the near future..

The researchers built a three-dimensional cell culture system using 500 ml spinner flasks containing undifferentiated human pluripotent stem cells. The flasks were placed on a magnetic stirrer and the cells were fed special proteins over a 33-day period. After further treatment and imaging, the insulin-secreting stem-cell-derived- cells were transplanted into diabetic mice, which had a higher survival rate and lower blood glucose level than the control group under three different scenarios.

The cells produced were found to mimic the function of human islets (clusters of cells scattered throughout the pancreas), which are crucial in regulating blood sugar. Type 1 diabetics lack the beta cells that monitor blood sugar levels and release insulin to normalize it because their immune system attacks and destroys these cells. Transplanted beta cells grown in a lab may provide a long-term solution, but until now they could not be grown in sufficient quantities to treat the disease.

The other remaining piece in the diabetes cure puzzle involves pinpointing a method for protecting the transplanted cells around 150 million of them in each patient from immune system attack (otherwise patients would require repeated and regular or semi-regular transplantations). Lead researcher Doug Melton is collaborating with Daniel G. Anderson of the Koch Institute at MIT on an implantation device that has thus far protected beta cells implanted in mice for many months.

Anderson described the work of Melton's lab as "an incredibly important advance for diabetes" as it "opens the doors to an essentially limitless supply of tissue for diabetic patients awaiting cell therapy."

Type 1 diabetes affects an estimated three million Americans, who for the most part must currently regulate their blood sugar levels by injecting insulin multiple times a day. But without the kind of fine-tuned metabolic control that glucose-sensing, insulin-secreting beta cells can provide, they face potential complications as severe as blindness and loss of limbs. Transplanted beta cells could also help type 2 diabetics who are dependent on insulin injections.

"We are now just one pre-clinical step away from the finish line," said Melton, who hopes to see transplantation trials in humans begin in the next few years.

A paper describing the research was published in the journal Cell.

Source: Harvard University

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Scientists close in on diabetes cure with production of insulin-producing cells