“Latest Stem Cells News”

Aastrom Biosciences, Inc. (Nasdaq:ASTMD), a leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported results from a planned interim analysis of the company’s multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI. According to the interim analysis the safety profile was similar between the treatment and placebo arms.

Based on a composite efficacy endpoint assessing time to treatment failure (including major amputations, wound size and gangrene), Aastrom’s autologous vascular repair cells (VRCs) were more effective than placebo (P<0.05). Other clinically meaningful endpoints (e.g., major amputation rate, complete wound closure) approached but did not reach statistical significance at interim analysis. Forty-six critical limb ischemia (CLI) patients who had at least 6-month follow up, including 33 patients with 12-month follow up, contributed to the interim analysis.

BioMedReports: There has been some talk about the upcoming opening of your new state-of-the-art facility. Can you tell us about that?

CEO Matthew L. Schissler: We always try to focus on three core goals and in 2010 we are opening our new state of the art laboratory. One of those three core goals is the diversification of revenue streams. Not only will we have our own organic growth engine, by processing and storing for our own company, but we recently entered into a letter of agreement to process and store for another very successful stem cell company. That’s going to be the flavor for 2010 and onward- diversification of revenue streams by using our new facility to its full capacity. The other goal is continued growth- like we saw mention of when we announced in late 2009 when we signed an agreement with a national labor association, Blue Cross and Blue Shield Association. That’s how we’ll grow some more, through the insurance companies. And finally, we’re going to be very focused on acquisitions. In fact, I’ll tell you that in 2010 we have a voracious appetite for acquisitions. With the economy the way it is, a lot of stem cell companies are struggling and we’ve been very fortunate to have our company go in the right direction by reducing debt and raising capital. We feel it’s a very good time for us to make some acquisitions and so we’re going to be very focused on that this year.

BioMedReports: So I would imagine that these acquisitions are somehow related to the goal of increasing your revenue streams in some way?

CEO Matthew L. Schissler: The overall goal in our mission statement is to not only become the world’s number one most respected stem cell company but also to be the largest as well. As we say in our mission statement, the world’s globally dominant stem cell storage company and so, those acquisitions will be in related fields, but I can’t say too much but it’s all about cryogenic preservation of stem cells and other forms of biologics.

Reviewing the technology, business models, intellectual property, regulatory concerns, transplantation and immune rejection.

from http://biobusiness.tv/videos/202

Russia’s Stem Cell Institute said on Wednesday it plans to raise up to 165 million roubles ($5.53 million) in what will be the country’s first initial public offering since the financial crisis erupted last year.

If the IPO goes ahead as expected, Stem Cell Institute would have an implied market capitalisation of 825 million roubles.

Stem Cell Institute set an indicative price range of the IPO at between 9 and 11 roubles per ordinary share and the offering will comprise approximately 15 million ordinary shares.

from http://www.reuters.com/article/rbssHealthcareNews/idUSL562611120091007

Pluristem Therapeutics Inc. today announced that it has begun enrolling patients in the U.S. for a Phase I clinical trial with its unmatched placenta-derived stem cell product, PLX-PAD, the Company`s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

Enrollment began at the Center for Therapeutic Angiogenesis in Birmingham, Ala., one of two clinical sites in the U.S. Duke University Medical Center will also be screening patients for the trial. The initiation of this study follows the approval of the Company`s Investigational New Drug (IND) application to begin clinical trials with PLX-PAD by the U.S. Food & Drug Administration (FDA). The Phase I study is designed to evaluate the safety of PLX-PAD in patients with CLI. A total of up to 12 adults with the disease will be included in this dose escalating trial (…)

from http://www.reuters.com/article/pressRelease/idUS125367+10-Sep-2009+BW20090910

After making news on several occasions, scientists may have made a definitive breakthrough, with the first possible transfusion using blood obtained from embryonic stem cells possibly coming within the next three years. The transfusion would be done with type O blood, which can be donated to any patient, and would be obtained by researchers using excess embryos from assisted fertilization. The project, which will be led by Marc Turner of Edinburgh University, will also receive contributions from the Transfusion and Transplant Service of the British National Health Service, as well as the same department and Scotland, and the Welcome Trust, a large charitable group for medical research. The story was reported by the Independent and immediately created controversy and distorted information.

“This isn’t just talk, this time it is a serious breakthrough, and the group behind the project is very serious,” said Professor Carlo Alberto Redi, the scientific director of the IRCCS (Hospital and Medical Treatment) Foundation of the San Matteo General Hospital in Pavia, commenting on the story. Redi emphasized that the capability for the regeneration of the hematopoietic progenitor cells in vitro is well-known and the time is right for real blood to be created, with the term artificial blood no longer appropriate. “When the term synthetic blood is used, people imagine silicone blood, when in reality, in all effects, this is real blood,” said Redi.

IT CANNOT REPLACE BLOOD DONATIONS

The blood that the British researchers plan to use in human treatments in the next three years will only “support and complement” blood donation. Giuseppe Novelli, a geneticist of the University of Rome Tor Vergata, commenting to Adnkronos Salute, was less optimistic. “This is only an announcement, and it seems premature to talk about a victory. This research is starting off well because it has millions in financing and is based on evidence that is very hopeful. But we are only talking about one piece of a very complex puzzle.”

The puzzle, in this case, is represented by the blood that runs through our veins and arteries, “made up of red and white blood cells, platelets, and plasma,” said Novelli. “It is a very complex liquid, which carries out an essential function in our body.” The British study which is currently being launched “is limited to red blood cells, which are certainly not able to resolve all of the problems with transfusions”. The British studies are also developing type O negative blood, a group that is able to donate to any patient without any risk of rejection. “This is blood that can be used, and is used, only in case of emergency.” Novelli continued to say that “the new blood will not be able to replace real blood donation, and I don’t want these announcements to inhibit people from donating blood, or make them underestimate the value or the importance blood donation”.

As for an estimate on how much time it will take to create a synthetic blood that will resolve all problems linked to a lack of donations, Novelli said: “I’m not a magician! Science needs realism, and predictions cannot be made for this type of study. Certainly,” he concluded optimistically, “the progress made with stem cells in the past 12 years since their discovery is a great cause for hope”.