“Latest Stem Cells News”

MENLO PARK, Calif., August 18, 2009 – Geron Corporation announced that its IND (Investigational New Drug application) for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency’s review of new nonclinical animal study data submitted by the company. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial.

Since filing the IND, Geron has been undertaking studies to enable dose escalation of its spinal cord injury product, and has been investigating application of the product to other neurodegenerative diseases. The company has also been performing additional product characterization and conducting further animal studies. Data from this work has been submitted to the FDA. Geron will work closely with the FDA to facilitate their review of the new data and to release the clinical hold. No patients have yet been treated in this study.

August 27, 2009 – Geron Corporation today provided additional comments on the recent clinical hold on its Spinal Cord Injury IND.

As biologic therapeutics advance in clinical trials, it is common practice to optimize product characteristics, improve manufacturing efficiency and scale, and to test the product in multiple disease models. As part of these ongoing efforts at Geron with respect to GRNOPC1, various animal studies were, and continue to be, performed to characterize the product’s effects in vivo. In previous animal studies of GRNOPC1 using materials that passed release specifications, a very low frequency of injected animals developed microscopic cysts in the regenerating injury site. These cysts were non-proliferative, confined to the injury site, and had no adverse effects on the animals. No animals developed teratomas or any other ectopic structure. Cysts of much larger size appear in the spinal cord scar tissue of up to 50% of patients with spinal cord injury.

A just completed animal study showed a higher frequency of cysts, although their characteristics were similar to the cysts seen in previous studies: non-proliferative, confined to the injury site, smaller than the injury cavity and not associated with adverse clinical outcomes.

As part of our ongoing product improvement efforts, new candidate markers and assays for product release have been identified that are linked with cyst formation across all animal studies in which cysts were found. Importantly, a manufactured lot of GRNOPC1 that was assessed using these markers and assays showed no cysts in another recently concluded animal study in spinal cord injured rats.

We have submitted these data to the FDA and are in discussions with the agency to answer its questions and proceed with the clinical trial. We are committed to the optimization of all our hESC-based products as we improve the manufacturing process and identify improved product release criteria.

from Geron

http://www.geron.com/media/pressview.aspx?id=1187

http://www.geron.com/media/pressview.aspx?id=1188

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“Behind the embryonic stem cell war is just a war of patents,” led an article in the Osservatore Romano newspaper by Angelo Vescovi, a geneticist at the Niguarda Hospital in Milan and a professor at the Università Bicocca, who has always been against embryonic stem cell research and supporter of ‘law 40’ (recently declared unconstitutional by authorities). “The production of embryonic stem cells by reprogramming adult cells discovered recently is not only better than methods that use human embryos, but is also based on new techniques, which are not protected by patents that currently govern the use of stem cells derived from embryos. Many countries are leaders only in manufacturing embryonic stem cells.”

According to Vescovi, who despite his last name (which means bishop in Italian) is notoriously secular, “numerous labs, billions of dollars in investments, an entire chain of patents, scientific techniques, and entire careers are based on the use of embryos”. “In a situation like this,” observed Vescovi, “it would be naïve to think that all of this could be abandoned in order to embrace different techniques, just because they are more efficient and ethically acceptable.” Basically, “there are too many interests for the use of human embryos to be abandoned without any reaction”.

Vescovi also says that it is “questionable” to present choices made on this basis “as the response of the ‘moral authorities’, who try to create opposition based on alleged moral or religious beliefs which are irrational and unreasonable” .These actions are branded as anti-scientific and against the interests of the sick and require these outdated people to look at the facts”. “This position,” he concluded, “cannot be defended and is distorted, since the facts cannot be denied. Nothing will slow the development and research of possible treatments, the use of human embryos is in no way a solemn necessity.”

MONSIGNOR BETORI, WE MUST CALMLY REEXAMINE THE GALILEO MATTER. IT WAS A MISUNDERSTANDING

“It is completely possible to calmly and objectively reexamine the Galileo matter, a “tragic reciprocal incomprehension” and a “painful misunderstanding”. As John Paul II said in 1992, the situation not only condemned the founder of modern science, but one of the most incredible minds in the past millennium,” said Monsignor Giuseppe Betori, Archbishop of Florence, during the inaugural ceremony of an international conference on “The Galileo Case”, which opened today in Florence at the Santa Croce church, and was attended by Italian President Giorgio Napolitano.

“Unfortunately, this painful misunderstanding has often been erroneously interpreted as an opposition between science and religion. I hope that this event,” added Betori, “demonstrates that this opinion is unfounded.” Monsignor Betori also hoped that “the important dialogue between faith and reason can be restored and resumed creatively, aiming for a permanent and constructive collaboration between the church and the institutes of scientific research, economic development, and social promotion”.

“Faith does not benefit from a refusal of rationality, but is part of a wider reasoning. Reason, without faith, risks reducing itself to calculations,” said Bertori, “and without a conflict, it is often unaware or blind of sources of important questions, fundamental values, and dramatic human situations. Therefore, dialogue between faith and reason must continue.”

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“Gianvito Martino, the head of the Neurosciences division at the Institute of San Raffaele in Milan in a speech at Multiple Sclerosis Week, which took place from May 23-31, warned against “trips of hope to clinics that promise effective treatments using stem cells”.

According to Martino, who coordinated a Consensus Conference on last Tuesday in London on the neurodegenerative disease, where the guidelines for pre-clinical studies and clinical treatments with stem cells were defined, “hundreds of Italian patients each year go on these trips due to cures that are promised. In the best-case scenario, these patients return in the same condition in which they departed, but with a little bit less money. However, there are also many cases of infections and tumors.”

These stem cell clinics are found in various countries all over the world, including China, Thailand, the Dominican Republic, Manila, and Barbados. “They assure 40%-50% effectiveness and that they are able to treat any type of problem, from baldness to Alzheimer’s as well as muscular sclerosis, but they do not say anything about the type and quality of stem cells that they use. They use the placebo effect to indicate very few positive outcomes, but in the end, no one knows what is responsible for the cures.” Martino thinks that in many cases patients are given water instead of stem cells, or cortisone in order to give a few days of perceived improvements and to feed the illusion.

PROTECTIVE EFFECT ON BRAIN BEING STUDIED- Stem cells could represent a new opportunity to treat diseases like multiple sclerosis. Soon they will be used in testing since they are the target of many different research teams in fighting this debilitating disease. Among these is a research team at the scientific university institute at San Raffaele in Milan led by Martino, which has been working for years to understand if it is possible to use stem cells to cure diseases that strike the central nervous system with a strong inflammatory reaction provoking progressive and irreversible destruction of nerve tissue with extremely serious results (muscular sclerosis).

Martino spoke about the state of the research today in Milan at a presentation for National Multiple Sclerosis Week, a disease that strikes mainly young individuals between the ages of 20 and 30 and women. During the meeting, the new campaign to raise funds for the Italian Multiple Sclerosis Association (AISM) was presented. ‘Fastforworld’, a request to support AISM’s activities, is directed at private citizens and businesses to “speed up research efforts”. In an experiment conducted on mice, the scientists at San Raffaele observed “nerve stem cells protect the central nervous system from damage that is typical of multiple sclerosis, acting as powerful natural ‘pharmaceuticals’,” explained Martino.

It seems that these stem cells kill the blood cells that cause inflammation, saving the healthy cells present in the inflamed nerve tissue. Their role is basically a sort of natural anti-inflammatory. “The studies of the Neuroimmunology unit at San Raffaele,” continued Martino, “have demonstrated that brain stem cells, if manipulated in vitro before being injected in vivo intravenously or intracerebrally, are able to selectively reach areas of the brain and the bone marrow that have been damaged and are able to repair them by releasing soluble anti-inflammatory and neuroprotective factors.”

These studies, warned the expert, “have given positive results in laboratory animals, but there are still many unknowns and it is necessary to reduce risks and avoid that patients unknowingly become victims of uncontrolled experiments.” The turning point will be transferring the results obtained in the lab to human beings. San Raffaele should start on this long journey in the next few months. They will first have to demonstrate that these stem cells do not put the patient at any risk. Once their safety has been proven, a study on the efficiency of the therapy will begin.

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Plerixafor has allowed doctors to collect stem cells from patients where there had been previous difficulties.
The drug, which has only recently been licensed, is being used at the Beatson West of Scotland Cancer Centre.

Stem cells therapies are used to treat people with cancer of the blood. The cells are collected and reintroduced to a patient after chemotherapy.
Doctors often encounter problems collecting enough stem cells from about one in 10 cancer patients to undergo treatment.

Plerixafor has, so far, had a 100% success rate in allowing doctors at the cancer centre to collect enough cells from patients who fall into this category.
Blood specialist, Dr Kenneth Douglas, explained how the drug worked.

“Basically it blocks a chemical scent that stem cells sniff for that tells them they’re in the bone marrow,” he said.
“If you block that chemical scent they get confused and agitated and they think they are not in the bone marrow any more and they start wandering into the blood stream looking for the bone marrow.”

When more stem cells “start wandering into the blood” doctors are able to collect them for future treatment.
One patient who has benefited from this approach is retired professional golfer, Billy McCondachie.

He said his age was a barrier to potential stem cell treatment.
“We were only able to get about half of my stem cells out until Dr Douglas came along with this new drug,” he said.

“One could say that pretty much saved my life.”
The centre in Glasgow has now treated 13 people with the drug and every one has been able to proceed with stem cell treatment.

from BBC news

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Scientists genetically “reprogrammed” human skin cells to possess the same properties as those that make up the retina.

The process involved first turning them into pluripotent stem (IPS) cells, which have the potential to develop into virtually every kind of tissue in the body.

By exposing the IPS cells to a specific cocktail of chemicals, the scientists then caused them to grow into partially developed retina cells – the light-sensitive cells at the back of the eye which transmit nerve signals to the brain.
Although the work, published in the Proceedings of the National Academy of Sciences, is at a very early stage, it paves the way for treatments that allow retinas to be repaired with cells grown from a patient’s own skin.

In the more immediate future scientists could use the cultivated cells to study genetically-linked eye disorders, or screen new drugs for retina conditions.

Study leader Dr David Gamm, from the University of Wisconsin, said: “This is an important step forward for us, as it not only confirms that multiple retinal cells can be derived from human IPS cells. but also shows how similar the process is to normal human retinal development.

“That is quite remarkable given that the starting cell is so different from a retinal cell and the whole process takes place in a plastic dish.

“We continue to be amazed at how deep we can probe into these early events and find that they mimic those found in developing retinas.
“Perhaps this is the way to close the gap between what we know about building a retina in mice, frogs and flies with that of humans.”

Tests showed that the IPS cells gave rise to many types of retina cell, including the photoreceptors that turn light impulses into electrical nerve signals.
In previous research, scientists have succeeded in restoring vision to blind mice by repairing their retinas with stem cells.

Future treatments could help patients with conditions such as macular degeneration, the leading cause of blindness among the elderly.

Another disorder involving damage to the retina is retinitis pigmentosa, which causes tunnel vision and blindness.
* Meanwhile, a new kind of “patch” made from stem cells that can mend a broken heart after an attack has been successfully tested by scientists.

Cells lost from the heart do not grow back naturally, leaving the organ in a weakened and vulnerable state.
Researchers in Israel demonstrated the new patch in rats with injured hearts.

from Telegraph

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In a stem cell research trial that isn’t getting enough news, liver patients are now being treated with their own Adult Stem Cells at Hammersmith Hospital in London, England. They have treated more than 30 patients now with “good results.” This is good news for those liver patients facing a transplant (and death).

I covered this stem cell story back in September 2008, and since then it seems they have treated more liver patients with their own stem cells with more good results. This excerpt is from the most recent stem cell article:

The stem cells help to grow new liver cells so that a damaged liver can begin to function normally again.

The team, which is based at London’s Hammersmith Hospital, has used the technique on around 30 patients so far with good results. They hope the treatment will become mainstream within three to five years.

It involves taking blood from patients, removing stem cells that circulate in the bloodstream and multiplying them in a laboratory. They are infused back into the liver via a main artery where they continue to multiply as liver cells.

The technique, which is undergoing trials, could revolutionise treatment of patients with liver failure. At present there is no method of keeping them alive as there is with kidney disease.

The Original Is Always Better Than the Sequel

However, the original post back in September 2008, had more details about this new stem cell treatment:

Administering autologous expanded mobilized adult progenitor CD34+ cells into the hepatic artery of patients with alcoholic liver cirrhosis (ALC) leads to considerable benefit, researchers report in the September issue of the American Journal of Gastroenterology.

“We are encouraged that the majority of patients in this study experienced a significant improvement in their liver functions,” senior investigator Dr. Nagy A. Habib told Reuters Health.

Dr. Habib of Imperial College, London, and colleagues studied nine ALC patients who had been abstinent for at least 6 months. The patients underwent granulocyte colony-stimulating factor mobilization and leukapheresis. Autologous CD34+ cells were then expanded in vitro by an average of 5 times and injected into the hepatic artery.

All patients tolerated the procedure well and over 12 weeks of follow-up there were significant decreases in serum bilirubin. A significant reduction in levels of alanine transaminase and aspartate transaminase was seen 1 week after the transfusion and showed improvement through the study period.

Seven of the patients showed an improvement in Child-Pugh scores, and on imaging at 12 weeks, three patients showed a complete resolution of ascites and two had a significant reduction.

Stem Cell Therapy for Liver- Faster Please

This is fantastic news for cirrhosis patients, as well as Hepatitis C patients.  However, once again, the stem cell therapy isn’t getting to the patient fast enough.  The stem cell research trial seems to have been going on for more than 1 year, yet only 30 liver patients have been treated.  Think about all those liver patients who can probably be improved by this and safe as well- nothing to lose.

(original post by Don Margolis)

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