Category Archives: Stell Cell Research


Microparticles create localized control of stem cell differentiation

Javascript is currently disabled in your web browser. For full site functionality, it is necessary to enable Javascript. In order to enable it, please see these instructions. Jul 09, 2013 Georgia Tech/Emory University Associate Professor Todd McDevitt and graduate student Anh Nguyen make microparticles to be used for delivering growth factors to stem cells. Credit: Rob Felt

Before scientists and engineers can realize the dream of using stem cells to create replacements for worn out organs and battle damaged body parts, they'll have to develop ways to grow complex three-dimensional structures in large volumes and at costs that won't bankrupt health care systems.

Researchers are now reporting advances in these areas by using gelatin-based microparticles to deliver growth factors to specific areas of embryoid bodies, aggregates of differentiating stem cells. The localized delivery technique provides spatial control of cell differentiation within the cultures, potentially enabling the creation of complex three-dimensional tissues. The local control also dramatically reduces the amount of growth factor required, an important cost consideration for manufacturing stem cells for therapeutic applications.

The microparticle technique, which was demonstrated in pluripotent mouse embryonic cells, also offers better control over the kinetics of cell differentiation by delivering molecules that can either promote or inhibit the process. Based on research sponsored by the National Institutes of Health and the National Science Foundation, the developments were reported online July 1 in the journal Biomaterials and were presented at the 11th Annual International Society for Stem Cell Research meeting held in Boston June 12-15, 2013.

"By trapping these growth factors within microparticle materials first, we are concentrating the signal they provide to the stem cells," said Todd McDevitt, an associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. "We can then put the microparticle materials physically inside the multicellular aggregate system that we use for differentiation of the stem cells. We have good evidence that this technique can work, and that we can use it to provide advantages in several different areas."

The differentiation of stem cells is largely controlled by external cues, including morphogenic growth factors, in the three-dimensional environment that surrounds the cells. Most stem cell researchers currently deliver the growth factors into liquid solutions surrounding the stem cell cultures with a goal of creating homogenous cultures of cells. Delivering the growth factors from microparticles, however, provides better control of the spatial and temporal presentation of the molecules that govern the growth and differentiation of the stem cells, potentially allowing formation of heterogeneous structures formed from different cells.

Groups of stem cells stick together as they develop, forming multicellular aggregates that form spheroids as they grow. The researchers took advantage of that by driving microparticles containing growth factor BMP4 or noggin which inhibits BMP4 signaling into layers of stem cells using centrifugation. When the cell aggregates formed, the microparticles became trapped inside.

The researchers used confocal imaging and flow cytometry to observe the differentiation process and found that growth factors in the microparticles directed the cells toward mesoderm and ectoderm tissues just as they do in solution-based techniques. But because the BMP4 and noggin molecules were directly in contact with the cells, much less growth factor was needed to spur the differentiation approximately 12 times less than what would be required by conventional solution-based techniques.

"One of the major advantages, in a practical sense, is that we are using much less growth factor," said McDevitt, who is also director of the Stem Cell Engineering Center at Georgia Tech. "From a bioprocessing standpoint, a lot of the cost involved in making stem cell products is related to the cost of the molecules that must be added to make the stem cells differentiate."

Beyond more focused signaling, the microparticles also provided a localized control not available through any other technique. That allowed the researchers to create spatial differences in the aggregates a possible first step toward forming more complex structures with different tissue types such as vasculature and stromal cells.

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Microparticles create localized control of stem cell differentiation

FDA bans stem cells from animals, plants

MANILA, Philippines - Stem cells taken from animals and plant derivatives are not allowed in the country, according to a circular of the Food and Drug Administration (FDA).

In FDA Circular 2013-017, FDA acting director Kenneth Hartigan-Go said stem cells harvested from human embryos for research purposes, human embryonic stem cells and their derivatives as well as aborted human fetal stem cells and their derivatives are also not authorized.

Go said such stem cells are prohibited from creation, importation, promotion, marketing and use.

This means that selling and manufacturing of soap and other products that supposedly contain stem cells from placenta and animals, which have been flooding the market recently, are also prohibited.

The FDA circular said imported human stem cell-based products are allowed, provided they are not hand-carried and meet other requirements.

The FDA requires the use of appropriate mode of transportation and storage in transporting allogeneic stem cells or those derived from other humans and not the patient himself.

Under the guidelines previously issued by the Department of Health (DOH), only autologous stem cells, or those taken from the patients themselves, are acceptable.

In Circular 2013-012 issued last May 15, the FDA had also warned the public against receiving unapproved stem cell preparations in non-health facilities.

The agency said unapproved stem cell preparations and therapy without prior FDA-DOH approval could cause infectious diseases and severe complications which may lead to permanent disabilities, physical deformities, autoimmune diseases and even death, without the benefit of health insurance coverage.

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FDA bans stem cells from animals, plants

Calimmune Initiates HIV Stem Cell Study at Two California Research Sites

LOS ANGELES--(BUSINESS WIRE)--

The HIV gene medicines company Calimmune announced today that the first patient has begun treatment in a Phase I/II clinical trial designed to determine whether a pioneering genetic medicine approach can help to protect individuals infected with HIV from the effects of the virus. The study, Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection, utilizes a gene medicine called Cal-1, developed in the lab of Nobel Laureate Dr. David Baltimore and by Calimmune.

In the study, 12 HIV-positive participants will be infused with their own T cells and stem cells (hematopoietic stem cells, HSC), which have been modified to block the HIV receptor CCR5, and to prevent HIV fusion. The procedure is designed to prevent the virus from entering and damaging protected cells. The dual approach used in the study is designed to reduce the possibility that HIV can develop resistance to the procedure.

The goal of the study is to assess the safety, feasibility and tolerability of Cal-1 in HIV-infected individuals who have previously been on highly active antiretroviral therapy (HAART) but are not currently taking any antiretroviral agent. In addition to routine clinical and laboratory assessments to monitor general health and HIV infection, the study will monitor the presence of Cal-1 protected cells in various cell types in the blood and lymphoid tissue. Other analyses will monitor the safety of Cal-1. The first patient was treated in the study in late June. Data from this study are expected in 2015.

All participants in the studys three arms will receive the Cal-1 gene transfer. Participants in two of the three study arms will also receive different doses of a preconditioning drug known as busulfan, which may make the therapy more effective.

This study is an early but important step in an emerging area of scientific exploration, representing the culmination of more than a decade of research and development, said Calimmune Chief Executive Officer Louis Breton. We are optimistic that what we learn from this study may bring us closer to the day when a one-time treatment could provide an alternative to a lifetime of antiretroviral therapy.

The study has been partially funded by the California Institute for Regenerative Medicine (CIRM). The study will take place at clinical trial sites in Los Angeles and San Francisco, Calif., under the direction of Principal Investigators Ron Mitsayasu, M.D., of UCLA and Jacob P. Lalezari, M.D., of Quest Clinical Research.

For more information, visit http://www.clinicaltrials.gov.

About Calimmune

Calimmune is a clinical-stage HIV gene medicines company focused on developing innovative cell-based therapies for HIV. The companys stem cell technology was discovered in the labs of Nobel Laureate Dr. David Baltimore (Caltech) and Dr. Irvin Chen (UCLA AIDS Institute). Calimmune is also developing a rich product candidate pipeline to address the needs of different types of individuals at different states of HIV infection and with different levels of treatment experience.

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Calimmune Initiates HIV Stem Cell Study at Two California Research Sites

Registration of Human Stem Cell-based products ordered

The Food and Drug Administration (FDA) has ordered the registration of human stem cell and cell-based or cellular therapies in the country.

"Pursuant to Administrative Order 2013-0012 known as 'Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Stem-Cell Based or Cellular Therapies in the Philippines' strengthening of the regulatory framework to ensure access to safe and quality health facilities engaging in human stem cell and cell-based or cellular therapies in the Philippines has been promulgated," the FDA said.

It said the circular "does not cover cellular or cell-based therapeutic products intended to replace blood volume or alter the coagulative properties of blood."

The order also does not cover human embryos for research, human embryonic stem cells, aborted human fetal stem cells and plant parts labeled as stem cell as the creation, importation, promotion and marketing of these products are banned in the country.

Stem-cell based products of animal origin are also prohibited from being registered with the FDA.

Under the guidelines, companies have to submit various documents, including the good manufacturing practice certificate of the stem-cell based manufacturer, information of the product and its manufacture and scientific evidence to support each claimed indication, copy of marketing authorization from the national regulatory authority of the exporting country, claimed shelf-life and stability studies, list of countries where the product is already approved and date of approval. (With a report from Jenny F. Manongdo)

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Registration of Human Stem Cell-based products ordered

Maxim Group Issues Stem Cell Sector Report on IntelliCell BioSciences Based on Treatment Process

NEW YORK, July 08, 2013 (eTeligis via ACCESSWIRE) -- IntelliCell BioSciences, Inc. (SVFC), a developer of novel, patented technology used to isolate stromal vascular fraction cells (stem cells) from adipose (fat) tissue. These cells are used to address the regenerative, curative and preventative conditions of disease, announced New York based Maxim Group has issued a research opinion on stem cell sector, and our position within the industry.

Jason Kolbert, the research analyst at Maxim Group commented in his report, IntelliCells position on the legal/regulatory status of SVFC (stromal vascular fraction cells) is that the product is a human cell, tissue, and cellular and tissue-based product (HCT/Ps) and is regulated under the regulations created under 21 C.F.R. 1271. The Company maintains that the SVFC product falls within the exemption from FDA regulation found under 21 C.F.R. 1271.15(b). This is because the HCT/Ps are removed from and reintroduced into the same patient during the same surgical procedure as that term is used in the practice of medicine. The cells that are reintroduced are exactly the same cells (i.e., such cells) as the cells removed from the autologous patient. Thus, the SVFC product falls under an exemption to FDA regulation.

Alternatively, even if the SVFC product is not exempt under 21 C.F.R. 1271.15(b), the company maintains that it meets the requirements in 21 C.F.R. 1271.10(a) for regulation solely under PHS Act 361 and Part 1271 as a 361 HCT/P and not as a drug, device, and/or biologic requiring an approved application. Under that section of the regulation, HCT/Ps that are from an autologous source, minimal manipulation, and for homologous use, and do not include added components (with some minor exceptions) are exempt from FDA pre-approval as a drug.

Under these guidelines IntelliCell Biosciences is empowering clinicians to treat patients today for everything from orthopedic injuries to multiple sclerosis. The company has treated over 300 patients and in some cases with dramatic results. We went so far as to review patients stories and case histories, publications and even met with the companys attorneys (ex-FDA reviewers) to understand the definitions of minimally manipulated and the legal guidelines by which the companys process allows physicians to treat patients. We left believing that this is the only company, at the moment that qualifies with a process that meets current guidelines.

To download the full report from Maxim group please visit http://www.filesanywhere user: Victor07 Password: Anna249249

Register for Mailing List

If you would like to be added to SVFC mailing list, receive updates, or submit a question to the company, please register online at http://www.wallstreetnewscast.com/request/svfc.html

About IntelliCell BioSciences

IntelliCell BioSciences is a Regenerative Medicine company developing novel technologies that address the regenerative, curative and preventative conditions of disease states with high unmet clinical needs. The Company has patented technology for the use of ultrasonic cavitation for separating stromal vascular fraction with stem cells from adipose tissue and several patent-pending. The Company is also pioneering the development of autologous and allogeneic cells from living and non-living tissue donors for research purposes. IntelliCell is planning a series of in-human clinical studies with top tier universities for the treatment of cardiac disease, osteoarthritis, multiple sclerosis, lower limb ischemic wounds, and gum regeneration in the oral cavity as well as medical aesthetics. The Company has developed a first class cGTP cellular processing facility in New York City, purpose built and designed to be fully integrated into an ambulatory surgery center and hospitals. http://www.intellicellbiosciences.com

Forward-Looking Statements

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Maxim Group Issues Stem Cell Sector Report on IntelliCell BioSciences Based on Treatment Process

Scéil Launches World’s First iPS Stem Cell Back-up Service

NEW YORK & LOS ANGELES--(BUSINESS WIRE)--

Scil is launching a service, the first of its kind, that allows individuals to benefit from 2012 Nobel Prize-winning medical research to store a backup of their adult selves literally freezing their healthy cells in time. Scils world-leading experts use cutting-edge techniques to take cells from a small sample of an individuals skin and reboot them at the "Day Zero state". These skin cells are processed into stem cells (iPS) that are stored long-term for potential future uses, which could repair damaged organs, rebuild tissue or fight disease, as personalised genetic-based medicine continues to develop.

Andr Choulika, CEO of Scil, said: Scil offers people the best possible chance in the future. People should be able to live young, no matter how old they grow. Scil gives them the opportunity to take advantage of the wave of regenerative medicine. Were offering the potential for people to use their cells for their cure as soon as regenerative medicine treatments become available.

iPS (induced pluripotent stem cells) are capable of developing into any cell type. They can be derived from adult cells at any time of life, but given the fast rate at which cell DNA degenerates (the human body accumulates about 1.8 million DNA mutations per second), Scils experts recommend taking this step sooner rather than later to ensure the healthiest possible cells are stored.

With the Scil service, the iPS cells are stored at -180C for as long as needed for potential future use as soon as regenerative medicine treatments become available. It is the first time ever that such a service has been made available to individuals commercially.

Regenerative medicine is the process of replacing or regenerating human cells, tissues and organs to restore or establish normal function or, by stimulating the body's own repair mechanisms, to heal previously irreparable tissues or organs.

The service is very simple and painless for the individual. A skin tissue sample is taken under local anaesthetic and by arrangement at your convenience. The skin cells are then rebooted into iPS cells by Scils world-leading biotechnology teams; and finally they are stored by Scil for a lifetime in cutting-edge laboratory conditions until they are needed for future medical applications as soon as they become available.

You can read more about Scil, the benefits of stem cell banking, and the leading role its parent company Cellectis plays in genetic research at http://www.sceil.com

About Scil

Scil, part of the Cellectis Group, delivers a service that allows individuals to freeze their adult stem cells and harness the future potential of regenerative medicine. Based on Nobel Prize-winning research, Scils world-leading experts use cutting-edge techniques to take cells from a small sample of an individuals skin and reset them at the Day Zero state. These skin cells are processed into induce pluripotent stem cells (iPS) that are stored long-term for potential future needs to repair damaged organs, rebuild tissue and fight disease as personalised genetic-based medicine continues to develop. For further information about Scil, please visit http://www.sceil.com

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Scéil Launches World’s First iPS Stem Cell Back-up Service

DOH: Stem cell therapy not yet proven to be curative

by Buena Bernal Posted on 07/06/2013 4:28 PM |Updated 07/08/2013 2:16 PM

STEM CELLS. Health Secretary Enrique Ona says stem cell therapy is a procedure still under clinical evaluation and study. Photo by Rappler/Naoki Mengua

MANILA, Philippines (UPDATED) Amid increasing interest in and the risks of stem cell treatment in the country, the health secretary said doctors are required to disclose to their potential patients that the procedure is still "investigative" its potential is still being explored, and there's no definite word that it can heal diseases.

This is in line with the ethical standards of medical practice that seek to empower patients with enough information prior to consenting to the treatment.

The patient must exactly know that he is part of an investigative process. And that is what we require as far as the Department of Health is concerned right now, Department of Health (DOH) Secretary Enrique Ona said in an interview with Rappler on Friday, July 5.

Stem cell therapy or regenerative medicine is the use of the bodys repair cells as a substitute to old cells that may cause debilitating diseases.

(READ: 6 things you need to know about stem cell therapy)

The treatment has gained controversy of late, after 3 unnamed high-profile politicians allegedly died due to botched procedures performed abroad. The deaths are currently being investigated by the Philippine Medical Association (PMA).

Not to stifle innovation

So why is the DOH encouraging the development of the science despite the treatment being under clinical evaluation and study?

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DOH: Stem cell therapy not yet proven to be curative

Deaths from stem cell RX

Heart to Heart Talk By Philip Chua Cebu Daily News

VARIOUS complications and even deaths (like those of the two Filipino politicians recently) have been reported following stem cell therapy. We are revisiting this issue to put in proper perspective the facts about this widely advertised form of therapy, which has been misrepresented and abused by some enterprising people.

What are stem cells?

The building block, the foundation cell, for every cell, tissue and organ in the body is the stem cell. Stem cells are undifferentiated, with no specific

assigned task as yet. This has been likened to a blank computer microchip that could be programmed to perform any number of special tasks. Subjected to proper conditions, stem cells will develop into

specialized tissues and organs (heart, liver, kidneys, etc). Also, stem cells are self-sustaining and can replicate themselves for long periods of time.

What is the controversy about?

Scientists, working on mouse models, have discovered that stem cell therapy could SOMEDAY possibly help cure many common diseases that afflict man today. Some of these include stroke, spinal cord injury, heart diseases, Parkinsons, Alzheimers, osteoarthritis, retinal degeneration and blindness, rheumatoid arthritis, liver and kidney diseases, burns, type 1 diabetes, and muscular dystrophies. While the goal of the stem cell research is unquestionably laudable, and its potential benefit to mankind tremendous, the controversy centers on its efficacy and safety today, ethical, moral, religious, legal and social ramifications.

Basically, the grave concerns are (1) The hype and claims are too premature and mostly untrue; (2) where the stems cells will be harvested from (adult, fetus or embryo), and (3) the possible misuse and abuse of this new technology. And I could not agree more.

As I have stated in my talk before the Rotary Club of Cebu last February, at CITE in Talamban, Cebu City, this evolving science merits more randomized, double-blind and voluminous clinical studies in various medical centers around the world before it becomes a standard in medical care. It also requires a deep soul-searching introspection, and a serious, intense, and thoughtful deliberation to arrive at a morally, ethically, and medically sound stem cell treatment protocol that will also ensure the protection of the unborn, besides healing the sick, and at the same time preserve the dignity of humankind it seeks to serve.

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Deaths from stem cell RX

Proteins key in stem cell production identified

July 5, 2013 A team of Toronto-based researchers may be one step closer to a 'recipe' for large-scale production of stem cells for use in research and therapy.

Induced pluripotent stem cells (iPSCs) can be of great value for medical research because they can flexibly develop into many different types of cells. However, producing these cells is challenging because the proteins that control their generation are largely unknown.

But researchers from the University of Toronto, the Hospital for Sick Children and Mount Sinai Hospital (with colleagues from the United States and Portugal) say they have identified certain proteins that play a key role in controlling pluripotency, which may mean a potential breakthrough in producing these cells.

The findings were recently published in Nature. One of the authors is University of Toronto Engineering professor Brendan Frey. He said the researchers discovered the proteins using the splicing code developed a few years ago by a team led by he and U of T Donnelly Centre researcher Benjamin Blencowe. "The mechanisms that control embryonic stem cell pluripotency have remained a mystery for some time. However, what Dr. Blencowe and the research team found is that the proteins identified by our splicing code can activate or deactivate stem cell pluripotency," Frey said.

When asked why the identification of these proteins is important, Frey gave the following analogy: "Suppose you've tasted many wonderful gourmet dishes, but you have absolutely no idea what's needed to make them. Then, one day, you discover that there's something called a 'measuring cup' that is used by all of the gourmet chefs. Now you understand something important about how dishes are prepared, and you also know about a 'control knob' that can be turned in order to make different dishes, just as adjusting the amount of butter and flour will give a different kind of pastry."

And while a complete recipe for producing iPSCs may not be available yet, Frey said, it's beginning to look more likely.

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Proteins key in stem cell production identified

A First: Human Liver Created from Stem Cells

Scientists in Japan said they had grown human liver tissue from stem cells in a first that holds promise for alleviating the critical shortage of donor organs.

Creating lab-grown tissue to replenish organs damaged by accident or disease is a Holy Grail for the pioneering field of research into the premature cells known as stem cells.

Now Takanori Takebe of the Yokohama City University Graduate School of Medicine and a team reported Wednesday in the journal Nature that they grew tissue "resembling the (human) adult liver" in a lab mouse.

They first created induced pluripotent stem (iPS) cells which they mixed with other cell types and coaxed into "liver buds" -- the precursor clusters that develop into a liver. The buds, each about five millimeters (0.2 inches) big, were then transplanted onto a mouse brain, where they were observed transforming into a "functional human liver" complete with blood vessels, the scientists wrote.

"To our knowledge, this is the first report demonstrating the generation of a functional human organ from pluripotent stem cells," said the report.

The technique has yet to be tested in humans, but serves as an important proof of concept, it added.

Stem cells are infant cells that can develop into any part of the body. Until a few years ago, when iPS cells were created, the only way to obtain stem cells was to harvest them from human embryos. This is controversial because it requires the destruction of the embryo, a process to which religious conservatives and others object.

But iPS cells are easily obtainable mature cells that are "reprogrammed" into a versatile, primitive state from where they can develop into any kind of cell in the body. Takebe told a press conference ahead of the report's release that the man-made liver was observed through a replacement glass skull that was fitted around the mouse's brain.

The liver developed blood vessels which fused with those of the animal. It also performed certain human-specific liver functions -- producing proteins and processing specific drugs. "We have concluded that this liver is functioning," the scientist said. "We think this is enough for improving the survival after liver failure."

Scientists commenting on the research described it as promising.

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A First: Human Liver Created from Stem Cells