Stem Cell Clinic

Lab-grown stem cell trial gets green light

Irelands first human stem cell trial using lab-grown cells is due to get underway in Galway in the new year following approval from the medicines watchdog.

The trial will involve extracting adult mesenchymal stem cells (MSC) from the bone marrow of patients with a condition known as critical limb ischemia (CLI) a severe blockage of the arteries resulting in marked reduction in blood flow to the extremities.

Reduction in blood flow to the legs puts patients at risk of gangrene, ulceration, and amputation, and the Galway trial will look at the use of MSCs to grow new stems cells which will then be injected back into the patients leg with the hope of growing new blood cells and improving circulation.

The harvested stem cells will be grown to much greater quantities in a highly specialised lab before being injected back into the patients leg.

Tim OBrien, director of the Galway-based Regenerative Medicine Institute, said their research was focused on whether MSC therapy could improve blood flow to the legs in patients with CLI a condition common in diabetics and therefore avoid the need for amputation. The trial is aimed predominantly at testing the safety and feasibility of what is very much an experimental therapy, Prof OBrien said.

We will be doing a dose escalation study, with some patients given a small dose, others a medium dose and the remainder a high dose, he said. We want to try and establish how many cells do you need to give a patient.

The study, the first in humans in Ireland, will be a year-long study involving nine patients. Prof OBrien said they would not be advertising for participants, but rather would let clinicians know and await referrals of suitable patients.

In the meantime, they would be preparing the custom-built facility where the cells are grown, at the Centre for Cell Manufacturing Ireland in NUI Galway, the first such facility in Ireland to receive a licence from the Health Products Regulatory Authority.

Prof OBrien said MSCs have a lot of properties that may make them useful in treating a wide variety of disease because of their reparative and regenerative qualities.

Prof OBrien delivered a talk yesterday on the Therapeutic Potential of MSCs in Diabetic Complications on the second day of a two-day international stem cell conference at NUI Galway.

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Lab-grown stem cell trial gets green light

Bostons Adult Stem Cell Technology Center, LLC Introduces A New Technology for Monitoring Previously Elusive Adult …

Boston, MA (PRWEB) October 30, 2014

James Sherley says he has been working towards ASCTCs new advance in adult tissue stem cell technology since his days as a principal investigator at the Fox Chase Cancer Center (FCCC) in Philadelphia in the late 1990s. Sherley founded the ASCTC as a new Boston biotech start-up last year. The company holds all the intellectual property developed in Sherleys research over the years since FCCC, first as a professor at the Massachusetts Institute of Technology (MIT), and more recently as a senior scientist at the now closed Boston Biomedical Research Institute.

The basic concept for ASCTCs new technology was first published in 2001, after Sherleys arrival to MIT in 1998. The report introduced the new concept that the characteristic limited cell output of human tissue cell cultures was caused entirely by the special multiplication pattern of adult stem cells in the cultures known as asymmetric cell kinetics. Sherley recounts, My idea was pretty much ignored by everyone, because of a very popular ten-years older hypothesis to explain the short growth period of human cell cultures. The preexisting explanation, which was based on the concept of shortening chromosome ends, called telomeres, is still widely accepted today.

At the time of its first report, Sherleys asymmetric cell kinetics theoretical concept was lacking a quantitative model that could be used to test it. This situation began to change in the summer of 2011, when he met Dr. Frank Abdi, Chief Scientist of the Long Beach California company AlphaSTAR Corporation (ASC). The two were at a research conference organized to bring engineers and biologists together to inspire interdisciplinary research in the new field of bio-mesomechanics.

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. In the ensuing period after the 2011 introduction, ASCTC was founded, and the two companies integrated their respective expertise to produce the first-of-its-kind quantitative asymmetric stem cell kinetics model for human tissue cell cultures.

During its development, Sherley has described the concept for the new technology in brief in biotechnology and pharmaceutical industry forums. However, his talk at the Novel Stem Cells & Vesicles Symposium, organized at Rhode Island Hospital by Brown Universitys National Institutes of Health Stem Cell Biology Center of Biomedical Research Excellence (COBRE), will be the first presentation in an academic research forum. Dr. Sherley will discuss how the asymmetric stem cell kinetics model not only quantitatively accounts for human cell culture properties, but also accounts for features for which the telomerase shortening concept cannot.

By defining human cell culture output in terms of the specific actions of adult tissue stem cells, the new technology provides an exciting new tool for drug development and regenerative medicine. It gives the capability to monitor adult stem cell number, which previously has not been possible. The ability to monitor stem cell number opens a long closed door to many important biomedical applications. These include identifying drugs that would be harmful because of toxicity against tissue stem cells; identifying drugs that might improve normal tissue stem cells repair function; identifying new cancer drugs that attack aberrant cancer tissue stem cells; and providing a means to determine the number of stem cells needed for successful stem cell transplants (e.g., blood stem cell transplants).

As a first commercial target, ASCTC and ASC are developing the new technologys ability to provide an early screen for drug candidates that would fail later at more expensive places along the drug development pipeline due to tissue stem cell toxicity. Toxicity against tissue stem cells is one of the most devastating forms of drug toxicity. The new technology could save the U.S. pharmaceutical industry as much as $4 billion of the estimated $40 billion that it spends on failed drug candidates each year. Besides reducing cost and accelerating development of needed new drugs, the new tissue stem cell monitoring technology would also reduce the exposure of patients to particularly harmful drug candidates.

******************************************************************************************** The Adult Stem Cell Technology Center, LLC (ASCTC) is a Massachusetts life sciences company established in September 2013. ASCTC Director and founder, James L. Sherley, M.D., Ph.D. is the foremost authority on the unique properties of adult tissue stem cells. The companys patent portfolio contains biotechnologies that solve the three main technical problems production, quantification, and monitoring that have stood in the way of successful commercialization of human adult tissue stem cells for regenerative medicine and drug development. In addition, the portfolio includes novel technologies for isolating cancer stem cells and producing induced pluripotent stem cells. Currently, ASCTC is employing its technological advantages to pursue commercialization of mass-produced therapeutic human liver cells and facile assays that are early warning systems for drug candidates with catastrophic toxicity due to adverse effects against adult tissue stem cells.

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Bostons Adult Stem Cell Technology Center, LLC Introduces A New Technology for Monitoring Previously Elusive Adult ...

Identifying the source of stem cells

7 hours ago Amy Ralston, MSU biochemist and molecular biologist, has identified a possible source of stem cells, which can advance regenerative and fertility research. Credit: G.L. Kohuth

When most animals begin life, cells immediately begin accepting assignments to become a head, tail or a vital organ. However, mammals, including humans, are special. The cells of mammalian embryos get to make a different first choice to become the protective placenta or to commit to forming the baby.

It's during this critical first step that research from Michigan State University has revealed key discoveries. The results, published in the current issue of PLOS Genetics, provide insights into where stem cells come from, and could advance research in regenerative medicine. And since these events occur during the first four or five days of human pregnancy, the stage in which the highest percentage of pregnancies are lost, the study also has significant implications for fertility research.

Pluripotent stem cells can become any cell in the body and can be created in two ways. First, they can be produced when scientists reprogram mature adult cells. Second, they are created by embryos during this crucial four-day window of a mammalian pregnancy. In fact, this window is uniquely mammalian, said Amy Ralston, MSU assistant professor of biochemistry and molecular biology, and lead author on the study.

"Embryos make pluripotent stem cells with 100 percent efficiency," she said. "The process of reprogramming cells, manipulating our own cells to become stem cells, is merely 1 percent efficient. Embryos have it figured out, and we need to learn how they're doing it."

The researchers' first discovery is that in mouse embryos, the gene, Sox2, appears to be acting ahead of other genes traditionally identified as playing crucial roles in stem cell formation. Simply put, this gene could determine the source of stem cells in mammals. Now researchers are trying to decipher why Sox2 is taking the lead role.

"Now we know Sox2 is the first indicator that a cell is pluripotent," Ralston said. "In fact, Sox2 may be the pre-pluripotent gene. We show that Sox2 is detectable in just one or two cells of the embryo earlier than previously thought, and earlier than other known stem cell genes."

The second discovery is that Sox2 has broader influence than initially thought. The gene appears to help coordinate the cells that make the fetus and the other cells that establish the pregnancy and nurture the fetus.

Future research will focus on studying exactly why Sox2 is playing this role. The team has strong insights, but they want to go deeper, Ralston said.

"Reprogramming is amazing, but it's inefficient," she said. "What we've learned from the embryo is how to improve efficiency, a process that could someday lead to generating stem cells for clinical purposes with a much higher success rate."

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Identifying the source of stem cells