Stem Cell Clinic

Interleukin-10 aids survival of cells transplanted to repair cardiac tissues after MI

By Uncategorized

The long-term, positive benefits of transplanted allogenic (other-donated) smooth muscle cells (SMCs) to repair cardiac tissues after myocardial infarction (MI) have been enhanced by the addition of interleukin 10 (IL-10) to the transplanted cells, report researchers in Canada. Their study with rats modeled with MI has shown that SMCs modified with IL-10 - a small, anti-inflammatory protein - benefitted cell survival, improved heart function, and also provided protection against the host's rejection of the allogenic SMCs.

The study will be published in a future issue of Cell Transplantation.

Three groups of rats modeled with MI were treated with SMC injections into the MI-damaged area of the heart. One group received unmodified autologous (self-donated) SMCs; a second group received unmodified allogenic (other-donated) SMCs; the third group received allogenic SMCs modified with IL-10. After three weeks, the unmodified autologous cells had engrafted while the unmodified allogenic cells had been rejected by the hosts. However, the IL-10-modified allogenic cells were found to greatly improve cell survival, improve ventricular function, increase myocardial wall thickness, and also prevent host immune response and rejection of the foreign cells.

"While the most appropriate cell type for cardiac repair remains controversial, mesenchymal stem cells (MSCs) that have been differentiated toward myogenic cells restore ventricular function better, as previous studies have shown," said study co-author Ren-Ke Li of the MaRS Centre in Toronto, Canada. "This study demonstrated that IL-10 gene-enhanced cell therapy prevented immune response, increased survival of SMCs in the heart, and improved cardiac function when compared to the results with the control groups."

The researchers noted that while the use of autologous SMCs donated by patients may be optimal for cell therapy, SMCs self-donated by older, debilitated patients who likely have other serious health problems, have limited regenerative capability. Thus, allogenic SMCs from young, healthy donors are the most beneficial cells, but rejection of foreign cells by the host has been a problem in allogenic cell transplantation. This study suggests that the use of allogenic SMCs modified with IL-10 can prevent host rejection.

"Future studies will be required to determine the long-term effects of IL-10 transduced SMCs to evaluate cell survival and cardiac function at six months and one year," concluded the researchers.

"The use of IL-10 overexpression to reduce rejection of allogenic SMCs is an interesting idea" said Dr. Amit N. Patel, director of cardiovascular regenerative medicine at the University of Utah and section editor for Cell Transplantation. "Further studies will help to determine if this manipulation could prove useful for translation of allogenic SMC therapies to humans".

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The above story is based on materials provided by Cell Transplantation Center of Excellence for Aging and Brain Repair. Note: Materials may be edited for content and length.

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Interleukin-10 aids survival of cells transplanted to repair cardiac tissues after MI

Weekends with Engadget: Tokyo's vending machines, new buyer's guides and more!

By Stem Cell Treatment

This week, we learned about the dangers of stem cell treatment, explored the world of 3D motion capture and went on a vending machine shopping spree in Tokyo. Read on for Engadget's news highlights from the last seven days. Oh, and be sure to subscribe to our Flipboard magazine!

Stem cells have the potential to be one of modern medicine's most promising advances and we're still learning a lot about how they work. A paralyzed woman in the US discovered this, after an experimental treatment caused her to grow a nose-like tumor on her back.

The virtual simians in Dawn of the Planet of the Apes are impressively lifelike, but 3D motion capture animations haven't always been so awe-inspiring. Read on as Steve Dent explains the history behind this century-old technique.

If you've ever had to break in a new baseball glove, you know that the process take time -- usually a few months at best. Not so with Nike's new fielding mitt.

Why is it so hard to buy a Tesla? It's a combination of archaic laws and a stubborn automotive industry.

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Weekends with Engadget: Tokyo's vending machines, new buyer's guides and more!

ViaCyte files investigational new drug application and device master file with FDA for novel cell replacement therapy …

By Stem Cell Treatment

Published 18 July 2014

ViaCyte a privately held regenerative medicine company developing a cell replacement therapy for the treatment of diabetes, announced that it has filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes.

The trial would evaluate the safety and efficacy of ViaCyte's VC-01 product candidate, a stem cell-derived, encapsulated cell replacement therapy. In a related development, ViaCyte submitted a Medical Device Master File (called MAF) to the FDA in support of the Encaptra drug delivery system, the device component of the VC-01 product candidate.

"The filing of this IND represents the culmination of many years of research and development by a dedicated team focused on developing a cell replacement therapy for patients with type 1 diabetes and advancing our VC-01 product candidate to human clinical trials," said Paul Laikind, Ph.D., President and Chief Executive Officer of ViaCyte. "The ViaCyte team has been assisted and supported by the California Institute for Regenerative Medicine (CIRM) a leading organization focused on advancing the field of stem cell-based technologies, and JDRF, the leading advocacy organization for patients with type 1 diabetes," added Dr. Laikind.

ViaCyte's VC-01 product candidate consists of pancreatic progenitor cells, called PEC-01 cells, which are derived from a proprietary human embryonic stem cell line. These cells are then encapsulated by use of ViaCyte's Encaptra device. When implanted under the skin, the PEC-01 cells are designed to mature and further differentiate into insulin-producing beta and other endocrine cells that regulate blood glucose in a manner similar or identical to the normal islets that comprise the endocrine pancreas.

Based on a pre-IND meeting with the FDA and subsequent consultations, ViaCyte is proposing to initiate clinical evaluation of the VC-01 product candidate directly in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. In addition to evaluating the safety of the product candidate in these patients, the study is designed to demonstrate the effectiveness of the VC-01 product candidate in replacing lost endocrine function that is central to the disease.

In the proposed clinical trial, insulin production from the VC-01 implant would be assessed by measuring C-peptide, a biomarker for insulin produced by beta cells that is expected to provide a sensitive measure of efficacy in these patients. As proposed, the trial would also evaluate secondary end-points related to the need for administration of pharmaceutical insulin to control the disease and the incidence of hypoglycemia, a common side effect associated with pharmaceutical insulin usage.

ViaCyte's proprietary Encaptra device is designed to contain the implanted cells, preventing biodistribution, as well as shielding them from the immune system. Although PEC-01 cells are human cells, they are not the patient's actual cells. As such, they are considered an allogeneic graft, which typically requires immunosuppression in order for the recipient to tolerate the implant. However, the Encaptra device is designed to prevent the patient's immune system from accessing the implanted cells, thereby facilitating successful engraftment and subsequent maturation to islets.

The VC-01 product candidate is designed to be placed under the skin of the patient and can be monitored and readily removed, if or when required. The option to remove the cells is designed to provide an important safety benefit for this novel stem cell-derived cell therapy candidate. It is being regulated as a biologic through interaction with the Office of Cell, Tissue and Gene Therapy within CBER at the FDA. Given the combination product nature of the product candidate, the Center for Devices and Radiological Health at the FDA is also involved in its regulation.

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ViaCyte files investigational new drug application and device master file with FDA for novel cell replacement therapy ...

Okyanos Heart Institute Live on 850 WFTL: Adult Stem Cell Therapy for Heart Disease – Video

By Stem Cell Treatment


Okyanos Heart Institute Live on 850 WFTL: Adult Stem Cell Therapy for Heart Disease
Okyanos #39; Chief Medical Officer Dr. Howard (Bo) Walpole and Chief Science Officer sat down with Karen Curtis at 850 WFTL in Ft. Lauderdale to discuss the promise of adult stem cell therapy as...

By: Okyanos Heart Institute

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Okyanos Heart Institute Live on 850 WFTL: Adult Stem Cell Therapy for Heart Disease - Video

Conflicts of interest pervasive on California stem cell board

By Stem Cell Treatment

There's no good time for a public agency to be embroiled in a conflict-of-interest scandal, but this is an especially delicate time for California's stem cell agency.

The California Institute for Regenerative Medicine, as the program is known formally, is on track to finish doling out its $3 billion in funding from the state's voters as soon as 2017. Its original sponsor, Northern California real estate developer Robert Klein II, has been quoted talking about another $5-billion infusion, perhaps via the 2016 ballot.

Any such effort will refocus attention on the program board's inherent conflicts of interest, which were baked in by the terms of Proposition 71, Klein's 2004 ballot initiative that created CIRM and funded it through a bond issue. The prestigious Institute of Medicine in a 2012 report found these conflicts to lead to questions about "the integrity and independence of some of CIRM's decisions."

And now here comes another case. This one involves CIRM former President Alan Trounson, an Australian biologist who left the agency on June 30 and joined the board of one of its highest-profile financial partners a mere seven days later. Trounson's new employer, Stem Cells Inc., is the recipient of a nearly $20-million loan for Alzheimer's research.

CIRM says Trounson's quick move to Stem Cells Inc., where he'll receive a stipend of at least $90,000 a year, is legally "permissible." But officials there acknowledge they were blindsided; the agency learned about Trounson's new position from the company's press release.

Afterward, CIRM rushed out a statement acknowledging that Trounson's appointment to the board of a CIRM loan recipient "creates a serious risk of a conflict of interest." The agency says it will place the relationship between CIRM and the company under "a full review." Administrators reminded Trounson, board members and agency staff that state law bars him from communicating with them on any administrative matter involving Stem Cells Inc. The company declined to comment.

The relationship already reeked of cronyism. As we reported in 2012, the Newark, Calif.-based firm's co-founder, Irving Weissman, director of Stanford University's Institute for Stem Cell Biology and Regenerative Medicine, had been one of the most prominent and outspoken supporters of Proposition 71.

He's also a leading recipient of CIRM funding, listed as the principal investigator on four Stanford grants totaling nearly $35 million. CIRM contributed $43.6 million toward the construction of his institute's $200-million research building at the Stanford campus. Weissman and his wife, Ann Tsukamoto, owned nearly 380,000 shares of the firm as of last April, according to a corporate disclosure. Tsukamoto is one of the company's top executives; Weissman is a board member.

Trounson's move comes as CIRM must begin looking to the future, but any discussions about extending the agency's life span will have to address the flaws created by Proposition 71. Among them is the program's very structure, and even its scientific goals.

Klein's ballot proposition exempts CIRM from virtually any oversight or accountability. Each of the 29 governing board members has to be associated with a California public or private research institution or company, or an advocacy group for patients of one disease or another. The qualifications for board chairman are so specific they initially yielded a single credible candidate: Bob Klein.

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Conflicts of interest pervasive on California stem cell board

USC, UCLA and UCSF put their heads together to find cures for craniofacial defects

By Stem Cell Medical Center

PUBLIC RELEASE DATE:

17-Jul-2014

Contact: Cristy Lytal lytal@med.usc.edu 323-442-2172 University of Southern California - Health Sciences

One in every 2,000 babies is born with a skull that can't grow normally. Various sections of these babies' skulls are fused together at joints called sutures, constricting the developing brain and disrupting vision, sleep, eating and IQ. For these young patients, risky skull-expanding surgeries become an almost annual event.

Now, three leading universities for stem cell research the University of Southern California (USC); the University of California, Los Angeles (UCLA); and the University of California, San Francisco (UCSF) have joined forces to find better solutions for these and other patients with craniofacial defects.

All three institutions have leading stem cell research centers established with support from Eli and Edythe Broad, and all three are home to top scientists and clinicians in the field of craniofacial biology.

"The value of this collaboration is bringing together a bunch of interested scientists from three major institutions in California around really important problems," said Andy McMahon, director of the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at USC. "It's really going to take a group of scientists across these different places with different expertise to be able to make progress towards helping these patients."

Mark Urata a plastic and reconstructive surgeon at USC, Children's Hospital Los Angeles and Cedars-Sinai Medical Center underscores the need to invent less painful, dangerous and disruptive treatments for babies with fused skulls. "The operation we perform is state-of-the-art," he explained. "We're doing this better than most people in the country, and yet it's not good enough."

Yang Chai the George and MaryLou Boone Professor, director of the Center for Craniofacial Molecular Biology (CCMB) and associate dean of Research at the Ostrow School of Dentistry of USC sees tremendous value in teaming up with clinicians such as Urata. "Really, our faces are our identities, and the first thing you see when you look at someone is his or her face," said Chai. "And when someone has a craniofacial malformation, it really presents a significant challenge to that individual. By working closely with the clinicians, researchers can do more for these kids."

The group has already convened for two day-long faculty retreats, which have attracted funding from USC's CCMB, the UCSF Program in Craniofacial and Mesenchymal Biology, and the UCLA Clinical and Translational Science Institute. Participants included: McMahon, Urata, Chai, Ruchi Bajpai, Gage Crump, Scott Fraser, Robert Maxson, Amy Merrill, Janet Oldak, Pedro Sanchez, Michael Paine, Songtao Shi, Malcolm Snead, Stephen Yen and Jian Xu from USC; Jeffery Bush, Lindsey Criswell, Ophir Klein, Sarah Knox, Margaret Langham, Ralph Marcucio, Sneha Oberoi, Jason Pomerantz, Richard Schneider and Nathan Young from UCSF; and Daniel Cohn, Katrina Dipple, Deborah Krakow, Justine Lee and Kristen Yee from UCLA.

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USC, UCLA and UCSF put their heads together to find cures for craniofacial defects

International Stem Cell Corporation Should Win EU Patent Case

By Stem Cell Medical Center

The European Union Court of Justice will likely agree that stem cells can be patented, setting a new precedent for scientists to use this controversial method for research and development.

This is an extremely important case with industry-wide consequences, Dr. Simon Craw, of the International Stem Cell Corporation, the American biotech company at the center of the case.

The California-based firm applied for two patents on the technology it uses to produce stem cells but was rejected. European Union laws dictate that embryos cannot be patented on ethical grounds, because they can develop into humans.

Technically, embryos are eggs that have been fertilized with human sperm. But ISC Corp. uses chemicals to activate the cells instead, which are then called parthenotes.

EU Advocate General Pedro Cruz Villaln wrote in a Thursday opinion that since these cells cannot possibly develop into humans, they arent subject to the ethical laws that apply to human beings.

Its a great day for scientific rationale with the Judge correctly recognizing the difference between human parthenogenesis and fertilization, Craw said.

Three years ago, the EU court ruled against patents on discoveries that involve the stem cells, saying the use of human cells in this was immoral.

But it all started in 2004 when Greenpeace challenged a patent filed by a German stem cell researcher, which described a method to turn stem cells into nerve cells.

Greenpeace said the work was contrary to public order because the embryos were destroyed, according to a report in the Guardian from the time.

A group of 13 scientists wrote in the journal Nature that year to express profound concern over the recommended ban, which represents a blow to years of effort to derive medical applications from embryonic stem cells.

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International Stem Cell Corporation Should Win EU Patent Case

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