KRAUSE’S GROVE, 2 Beach Road, Halfmoon, NY


1:00 PM TO 6:00 PM ~ RAIN OR SHINE

$30.00 per adult ticket at gate - $20.00 for children under 12

includes donation to Harvard Stem Cell Institute.

5 hour picnic with soda, beer, games, raffles, 50/50, live music




Abundant food and dessert being served 1:00 p.m. to 5:00 p.m.

Those who wish to join a pre-picnic motorcycle cavalcade around the beautiful Tomhannock Reservoir in Ali’s honor will meet at the Troy Plaza on Hoosick Street at 10:00 A.M. for sign up and the cavalcade will kick off at 11:00 A.M. sharp.

For more info: https://www.facebook.com/Rally4Ali

For Further Information


For the Run, Wally Urzan


For the Picnic & Cause

Alison Fisk


Sunday, October 27, 2013

Stem cell therapy not effective nor safe for diabetes, doctors say

Shown is a tray containing stem cells. (AFP)
The online news portal of TV5
Stem cell therapy--or introducing fresh cells that can regenerate to help treat disease--remains an experimental treatment for those suffering from Type 1 and Type 2 diabetes.
Experts from the the Philippine Society of Endocrinology and Metabolism (PSEM) made this announcement during a press conference held on Tuesday, saying that "no conclusive evidence that stem cell therapy is effective and safe for diabetes."
"As such, it cannot be made available to individuals with diabetes as a standard treatment like the usual drug prescriptions. Stem cell can only be given to individuals with diabetes under controlled conditions such as, under experimental protocols of clinical trials," a statement from the PSEM said, quoting Dr. Cecilia Jimeno, PSEM President.
PSEM, a subspecialty organization under the Philippine College of Physicians, as well as the PCP itself, belong to a coalition of other medical societies, academic institutions and other health groups that have organized themselves to educate the public about stem cell therapy.
The coalition maintains that the effectiveness and safety of stem cell have unproven indications yet on heart, lung, neurologic, rheumatologic, kidney and gastrointestinal diseases, diabetes mellitus, hypertension, autism, cancer, aging and aesthetics, HIV, AIDS, and other conditions.
These groups have issued a public advisory to caution diabetes patients and their families who may be "vulnerable to exploitation," the statement said.
"Other types involve claims using anecdotes advertised and endorsed by well-known personalities who have no scientific credibility to make such claim, except for his or her limited experience. The public needs protection from this unethical use of still unproven therapy which may have unknown and unquantified harmful effects. For PCP, exposing our patients to these unknown risks is ethically unacceptable," Dr. Priscilla Caguioa, PCP President, said in the same statement.
Patients receiving stem cell therapy under clinical trials should not pay for these experimental treatments and must sign an informed consent form that explains the procedure, its benefits, and possible harms, the statement said.
The PSEM together with the Philippine College of Physicians (PCP) expressed concern that patients who are usually very sick may easily be swayed to use unproven therapies because of the hope for cure.
Under Food and Drug Administration (FDA) Circular No. 2013-020 dated August 13, 2013, only hematopoietic stem cell transplantation, corneal resurfacing with limbal stem cells, and skin regeneration with epidermal stem cells for burns are the three standards of health care that are generally recognized by the Food and Drug Administration, the statement said.
“Stem cell provides medical practitioners an innovative approach to restore health and offers the patients alternative choices. However, the promise of stem cell therapy must be backed by science- and evidence-based medicine, before it can be part of the standard health care. Any clinical use of stem cell products outside of the FDA-approved indications is illegal,” Jimeno added.

Thursday, October 10, 2013

Harvard Stem Cell Institute publishes first clinical trial results

Corey Cutler (left) and Leonard Zon (right) were part of the team that brought a compound found to expand blood stem cell populations in zebrafish to human clinical trials.
October 8, 2013
Starting with a discovery in zebrafish in 2007, Harvard Stem Cell Institute (HSCI) researchers have published initial results of a Phase Ib human clinical trial of a therapeutic that has the potential to improve the success of blood stem cell transplantation. This marks the first time, just nine short years after Harvard’s major commitment to stem cell biology, that investigators have carried a discovery from the lab bench to the clinic—fulfilling the promise on which HSCI was founded.
The Phase 1b safety study, published in the journal Blood, included 12 adult patients undergoing umbilical cord blood transplantation for leukemia or lymphoma at the Dana Farber Cancer Institute and Massachusetts General Hospital. Each of the patients received two umbilical cord blood units, one untreated and another treated with the small molecule, 16,16 dimethyl prostaglandin E2 (dmPGE2). All 12 patients had reconstitution of their immune systems and renewed blood formation, and 10 of the 12 patients had blood formation derived solely from the dmPGE2-treated umbilical cord blood unit.
The clinical testing is now entering Phase II, which will assess the treatment’s efficacy at 8 medical centers with 60 patients. Results are expected within 18-24 months.
Like much of the work conducted under the HSCI umbrella, this “first” depended upon the collaboration of scientists at different Harvard-affiliated institutions, and, in this case, an industrial partner:
  • The initial finding occurred in the laboratory of Leonard Zon, MD, chair of the HSCI Executive Committee and Professor of Stem Cell and Regenerative Biology at Harvard, who studies blood formation in zebrafish at Boston Children’s Hospital;
  • Clinical research was conducted at Dana-Farber Cancer Institute and Massachusetts General Hospital, led by hematologic oncologist and HSCI Affiliated Faculty member Corey Cutler, MD, MPH; and
  • Fate Therapeutics, Inc., a San Diego-based biopharmaceutical company of which Zon is a founder, sponsored the Investigational New Drug application, under which the clinical program was conducted, and translated the research findings from the laboratory into the clinical setting.
“The exciting part of this was the laboratory, industry, and clinical collaboration, because one would not expect that much close interplay in a very exploratory trial,” Cutler said. “The fact that we were able to translate someone’s scientific discovery from down the hall into a patient just a few hundred yards away is the beauty of working here.”
Gastroenterologists have studied dmPGE2 for decades, because of its ability to protect the intestinal lining from stress. However, its ability to amplify stem cell populations—the first molecule discovered in any system to have such an effect—was identified in 2005 during a chemical screen exposing 5,000 known drugs to zebrafish embryos. That work, published in the journal Nature in 2007, was conducted by two former Zon postdoctoral fellows, and current HSCI Principal Faculty members, Wolfram Goessling, MD, PhD, and Trista North, PhD.
“We were interested in finding a chemical that could amplify blood stem cells and we realized looking at zebrafish embryos that you could actually see blood stem cells budding from the animal’s aorta,” Zon said. “So, we elected to add chemicals to the water of fish embryos, and when we took them out and stained the aortas for blood stem cells, there was one of the chemicals, which is this 16,16 dimethyl prostaglandin E2, that gave an incredible expansion of stem cells—about a 300 to 400 percent increase.”
The dramatic effects of this molecule on blood stem cells made Zon, a pediatric hematologist, consider ways in which the prostaglandin could be applied to bone marrow transplantation, often used to treat blood cancers, including leukemia and lymphoma. Bone marrow contains the body’s most plentiful reservoir of blood stem cells, and so patients with these conditions may be given bone marrow transplants to reconstitute their immune systems after their cancer-ravaged systems are wiped out with chemotherapy and radiation.
Zon designed a preclinical experiment, similar to the one later done with cord blood patients, in which mice undergoing bone marrow transplants received two sets of competing bone marrow stem cells, one set treated with dmPGE2 and a second untreated set.
“What we found was the bone marrow stem cells that were treated with prostaglandin, even for just two hours, had a four times better chance of engrafting in the recipient’s marrow after transplant,” he said. “I was very excited to move this into the clinic because I knew it was an interesting molecule.”
Zon and his team’s next step was to visit Dana Farber Cancer Institute (DFCI), where they presented the mouse research at bone marrow transplant rounds and found physicians interested in giving the prostaglandin to patients.
“We basically sat down in a room and we brainstormed a clinical trial based on their scientific discovery, right then and there,” said Farber oncologist Corey Cutler. “They knew that it was something they could bring to the clinic, but they just didn’t know where it would fit. We said, if this molecule does what you say it does, significant utility would lie in umbilical cord blood transplants.”
A cord blood transplant is similar to a bone marrow transplant, however the blood stem cells are derived from the umbilical cord blood of a newborn, rather than from an adult donor. One of the advantages of umbilical cord blood is that matching between donor and recipient does not need to be as exact because potentially fatal graft-versus-host disease is less common. Although about 10-20 percent of stem cell transplantation procedures now use umbilical cord blood, the downside is that engraftment is more difficult, because the number of stem cells in an umbilical cord blood donation is far fewer than in an adult stem cell donation.
Umbilical cord blood transplants fail about 10 percent of the time; so increasing the procedure’s success would significantly help patients who do not have adult bone marrow donors, including a disproportionate number of non-Caucasian patients in North America. Increasing the engraftment rate would also allow the use of smaller umbilical cord blood units that are potentially better matches to their recipients, increasing the number of donations that go on to help patients.
Once the go-ahead for the trial was received by Fate Therapeutics from the US Food and Drug Administration, and the DFCI Institutional Review Board, the umbilical cord blood processing was done by Dana-Farber's Cell Manipulation Core Facility, directed by HSCI Executive Committee member Jerome Ritz, MD. The study hit a stumbling block, however, once the human trial was underway with the first nine patients. The protocol that produced the dramatic blood stem cell expansion in mice did not translate to improved engraftment in humans.
“The initial results were very disappointing,” Cutler said. “We went back to the drawing board and tried to figure out why, and it turned out some of the laboratory-based conditions were simply not optimized, and that was largely because when you do something in the lab, the conditions are a little bit different than when you do it in a human.”
Fate Therapeutics discovered that the human cord blood was being handled at temperatures too cold (4-degrees Celsius) for the prostaglandin to biologically activate the stem cells and improve their engraftment properties. Fate further demonstrated that performing the incubation of the hematopoietic stem cells at 37-degrees Celsius and increasing the incubation time from 1 hour to 2 hours elicited a much stronger gene and protein expression response that correlated with improved engraftment in animal models.
In running a second cohort of the Phase Ib trial, which included 12 patients, dmPGE2 appeared to enhance the engraftment properties of the blood stem cells in humans and was deemed safe to continue into Phase II. “It’s probably the most exciting thing I’ve ever done,” Zon said. “Basically, to watch something come from your laboratory and then go all the way to a clinical trial is quite remarkable and very satisfying.”
The research was funded by the National Institutes of Health, the Howard Hughes Medical Institute, the Stem Cell Cyclists of the Pan-Mass Challenge, and the Patrick Carney Foundation.