16-04-2012 16:52 Spinal cord injury patient, Chris Niles, discusses his improvements after undergoing stem cell therapy at the the Stem Cell Institute in Panama City, Panama. Chris now has sensation down to about a T10 level and has regained movement in his feet.
Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) has obtained US Food and Drug Administration (FDA) clearance to begin a Phase II clinical trial to test the safety and efficacy of its PLX-PAD placental stem cell treatment of intermittent claudication (moderate-severe limping), a subset of peripheral artery disease (PAD), caused by atherosclerosis of the legs.
The clinical trial will include 132 patients at ten locations in the US. The trial will test the safety and efficacy of two dosages of PLX-PAD cells compared with a placebo. The primary endpoint will be the change in the maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints will include hemodynamics and quality of life measurements. The trial will also test safety parameters.
Pluristem chairman and CEO Zami Aberman said, "We are excited to receive the world's FDA first clearance for an intermittent claudication clinical trial using allogeneic cell therapy as a potential preventive treatment for this disease. We believe that our approach of repeatable intramuscular injections will potentially enable us to boost the healing process of our patients. In this trial, we will take benefit of our 'off-the-shelf' PLX properties achieved by our 3D proprietary technology platform for efficient, controlled, mass production of cell therapy product candidates, for the treatment of millions of intermittent claudication patients around the world."
Pluristem cites studies which state that intermittent claudication affects 14 million people in the US, costing $2.5 billion in national healthcare costs.
Pluristem's share price rose 8.9% by mid-afternoon on the TASE today to NIS 8.89, after rising 1.6% on Nasdaq yesterday to $2.22, giving a market cap of $98 million. The share price is up 5.9% in premarket trading on Nasdaq today.
Published by Globes [online], Israel business news - http://www.globes-online.com - on April 17, 2012
Copyright of Globes Publisher Itonut (1983) Ltd. 2012
Read the rest here:
FDA approves Pluristem stem cell trial for severe limping
Public release date: 17-Apr-2012 [ | E-mail | Share ]
Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair
Tampa, Fla. (April. 17, 2012) Combined, complimentary therapies have the ability to maximize the benefits of neural stem cell (NSC) transplantation for spinal cord repair in rat models, according to a study carried out by a team of Korean researchers who published in a recent issue of Cell Transplantation (20:9), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/.
"When transplanted, neural stem cells have demonstrated their therapeutic potential to reverse complex pathological processes following spinal cord injury," said study corresponding author Dr. Byung G. Kim of the Ajou University School of Medicine's Brain Disease Research Center and Department of Neurology, Republic of Korea. "However, many obstacles cannot be overcome by NSC transplant alone."
Their study demonstrated that a combination of treatment strategies - a polymer scaffold, neurotrophin-3 (NT3) and chondroitinase (an enzyme which helps digest the glial scar that formed after a spinal cord injury) - provided added therapeutic benefits to NSC transplantation. The implantation of a polymer scaffold designed to bridge lesion cavities, created a favorable tissue environment for nerve growth. Incorporating the NT3 gene into the transplanted cells improved cell survival and migration while the addition of chondroitinase positively affected neural activity between the scaffold and the spinal cord.
"The poly (-caprolactone) [PCL] scaffold in our study appeared to function like a reservoir supplying migratory NSCs to the spinal cord," said Dr. Kim. "The NSCs grafted with the scaffolds survived the transplantation and migrated to the host spinal cord."
The study included four animal groups, only one of which received the full combination of therapies. Rats in the full combination therapy group were found to have some restored neuroplasticity and enhanced remyelation of contralateral white matter. All four groups subsequently underwent functional testing for locomotor recovery.
"Rats in the full combination group attained well-coordinated plantar stepping accompanied by improved ankle positioning and toe clearance and reduced paw placement errors," explained Dr. Kim. "Furthermore, animals with the full complement of combination strategies responded to transcranial magnetic stimulation."
The researchers concluded that, given their success, similar treatment for humans should be carried out in a chronic injury setting.
"We believe that our results have important clinical implications regarding the future design of NSC-based therapeutic strategies for human victims of traumatic spinal cord injury," concluded Dr. Kim and co-authors.
See the original post:
Neural stem cell transplants for spinal cord injury maximized by combined, complimentary therapies
Photo by Allie Garza
Dr. Zannos Grekos, a cardiologist whose practice is in Bonita Springs, speaks with a seminar attendant after one of his educational seminars about stem cell treatment, using one's own stem cells, for treating heart disease and other medical conditions, on Monday, March 14, 2011, at the Collier County Library. Allie Garza/Staff
K.K.Yankopolus
In a case involving a criminal investigation into the recent death of a 77-year-old man after stem cell treatment, state health authorities say Dr. Zannos Grekos extracted tissue from the patient while a second doctor later injected the patient with his own concentrated stem cells.
But when Grekos, a Bonita Springs cardiologist, initially harvested fatty tissue from Richard Poling's stomach on March 2, he unknowingly damaged the patient's abdomen which led to bleeding, according to a state Department of Health complaint.
New documents obtained by the Daily News shed more light on the case of Grekos and Dr. Konstantine Yankopolus, a Fort Myers obstetrician who assisted Grekos. They face potential disciplinary action from the state Board of Medicine for doing a stem cell treatment that the state says was experimental and dangerous.
The state issued separate administrative complaints against them in late March and early April, a few weeks after Poling died the same day of the treatment. He suffered a cardiac arrest in Grekos' practice on Bonita Beach Road and was pronounced dead at NCH North Naples Hospital.
The Lee County Sheriff's Office launched a criminal investigation in early March and it is ongoing, agency spokesman Larry King said.
Grekos also faces potential discipline when the state restricted his license in February, 2011 in connection to the death of a 69-year-old woman who went to him in 2010 for stem cell therapy.
She sought a remedy for neurological damage after chemotherapy for breast cancer. She fell in her home after the treatment, suffered a brain injury and later was taken off life support.
Follow this link:
State: Grekos extracted tissue from stem cell patient who died, damaged patient's abdomen
CAMBRIDGE, Mass., April 17, 2012 /PRNewswire/ --ETEX Corporation, an advanced biomaterials company, today announced two presentations at the upcoming Global Technology Community 8th Stem Cell Summit, April 19-20, 2012 at the Hyatt Harborside Hotel in Boston, MA. ETEX will highlight their cell carrier development program in two concurrent tracks: Stem Cell Commercialization & Partnering as well as Stem Cell Research & Regenerative Medicine.
(Logo: http://photos.prnewswire.com/prnh/20080424/NETH117LOGO )
Brian Ennis, President and CEO of ETEX Corporation, will deliver an oral presentation entitled "Orthobiologic Market Dynamics, Vision of the Future" during the Stem Cell Commercialization & Partnering session. Mr. Ennis will highlight key elements of a product lifecycle / replacement technology business model, outlining a new approach to skeletal repair and orthopedic innovation. This approach incorporates the combination of biomaterials and hardware, localized bone treatment with systemic therapy and stem cell delivery.
Dr. David Kaplan, Tufts University and Dr. Jerry Chang, ETEX Corporation scientific team will showcase recent advancements in their Stem Cell Carrier program during the Stem Cell Research & Regenerative Medicine session. The poster & power point presentation is entitled "Calcium Phosphate Combination Biomaterials as Human Mesenchymal Stem Cell (hMSC) Delivery Vehicles for Bone Repair".
Brian Ennis comments, "As a pioneer in growth factor and cell delivery technology, ETEX is excited to participate in this important event. We believe a cell carrier/scaffold is a grossly underestimated critical element for the successful execution of cell therapy in skeletal repair and soft tissue regeneration."
Questions regarding ETEX's participation may be directed to Jerry Chang, PhD., jchang@etexcorp.com or 617-577-7270.
About ETEX Corporation Established in 1989, ETEX Corporation develops, manufactures and commercializes calcium phosphate-based biomaterials for improved orthopedic clinical outcomes. A leader in bioresorbable bone substitute materials, ETEX focuses on expanding applications through combinations with cells, biologics, or therapeutic agents delivered in minimally invasive and easy to use systems. For more information, visit http://www.etexcorp.com.
The rest is here:
ETEX Corporation to Present at GTC Stem Cell Summit
Public release date: 2-Apr-2012 [ | E-mail | Share ]
Contact: Jeremy Moore Jeremy.Moore@aacr.org 215-446-7109 American Association for Cancer Research
PHILADELPHIA -- Scientists may have discovered a new paradigm for immunotherapy against cancer by priming antibodies and T cells with cancer stem cells, according to a study published in Cancer Research, a journal of the American Association for Cancer Research.
"This is a major breakthrough in immunotherapy research because we were able to use purified cancer stem cells to generate a vaccine, which strengthened the potency of antibodies and T cells that selectively targeted cancer stem cells," said Qiao Li, Ph.D., a research assistant professor in the department of surgery at the University of Michigan.
Cancer stem cells are tumor cells that remain present, and ultimately resistant, after chemotherapy or radiation treatment. Scientists disagree on whether these cells have unique properties, but those who support the uniqueness idea have argued that these cells regenerate the tumors that lead to relapse.
Despite the similar name, cancer stem cells are distinct from embryonic stem cells, and the two avenues of research are separate.
For the current study, Li and colleagues extracted cancer stem cells from two immunocompetent mouse models and used them to prepare the vaccine.
"We found that these enriched cancer stem cells were immunogenic and far more effective as an antigen source compared with the unselected tumor cells normally used in previous immunotherapy trials," said Li. "The mechanistic investigations found that when antibodies were primed with cancer stem cells, they were capable of targeting cancer stem cells and conferring antitumor immunity."
The researchers also found that cytotoxic T lymphocytes harvested from cancer stem cell-vaccinated hosts were capable of killing cancer stem cells in vitro.
###
See the original post here:
Cancer stem cell vaccine in development shows antitumor effect
By Mary Ann Roser
AMERICAN-STATESMAN STAFF
An Austin-based group funded mainly by a company that develops stem cell therapies is petitioning the Texas Medical Board for a less-strict rule on adult stem cells an issue the board has struggled with for more than a year.
The board will hold a hearing April 13 on its proposed rule, which would require doctors to get informed consent from patients before performing a stem cell procedure as well as approval from an institutional review board.
Such boards review research to protect patients and are overseen by the U.S. Food and Drug Administration.
At the meeting, the board must either adopt or pull down the much-revised rule, said Mari Robinson, executive director of the medical board.
The group, MedRebels Foundation, which seeks to raise awareness and educate the public about stem cells, will present its petition at the hearing. It has more than 2,500 signatures, many of them gathered near the company's Red River Street office during the South by Southwest Music Conference and Festival, Executive Director Shay McBurney said Friday. The office space is provided by SpineSmith and its parent, Celling Biosciences, which develops products and therapies using a person's own adult stem cells.
The petition asks the board not to put any additional restrictions on adult stem cells that are obtained from a patient's own body, provided they are used in the same medical procedure and not extensively processed or grown outside the body, frozen or stored.
"We were pretty amazed at how many people came and signed our petition," McBurney said.
MedRebels hopes the medical board recognizes that there are different types of stem cells, unlike its proposed rule, which "would classify all stem cells in the same bucket," said Matthew Murphy, a senior scientist at Celling Biosciences who spoke on behalf of MedRebels.
See the original post:
Advocacy group linked to stem cell industry asks medical board for less-strict rule
ScienceDaily (Mar. 29, 2012) New research from the Technion-Israel Institute of Technology Rappaport Faculty of Medicine and Research Institute and the Rambam Medical Center may lead to the development of new methods for controlling the growth of cancer, and perhaps lead to treatments that will transform cancer from a lethal disease to a chronic, manageable one, similar to AIDS.
By placing cancer cells in and near a growth developed from a population of human stem cells, scientists have demonstrated that the cancer cells grow and proliferate more robustly when exposed to human cells than they do in a typical petri dish or mouse model. The cancer cell population is also more diverse than had previously been understood. The research was published in the current advanced online issue of the journal Stem Cells. Maty Tzukerman, Rambam senior research scientist and the project leader and senior co-author on the report, says that this model will facilitate targeted drug discovery aimed at blocking the cancer cell self-renewal process.
Previous studies have determined that some tumor cells appear to be differentiated, while others retain the self-renewal property that makes cancer so deadly. According to Technion Professor Karl Skorecki, director of Medical Research and Development at Rambam Health Care Campus and senior co-author on the report, this new research attempts to understand how cancer grows, and to find ways to halt the runaway replication.
In order to mimic the human cancer environment as closely as possible, the research team developed a teratoma -- a tumor made of a heterogenous mix of cells and tissues -- by enabling the differentiation of human embryonic stem cells into a variety of normally occurring human cell lines on a carrier mouse. The human cellular teratoma constitutes a new platform of healthy human cells for monitoring the behavior and proliferation of human cancer cells.
For this study, the team took cells from one woman's ovarian clear cell carcinoma and injected them either into or alongside the human stem cell-derived environment. "We noticed very early on, rather strikingly, that the human cancer cells grow more robustly when they are in the teratoma environment compared to any other means in which we grew them, such as in a mouse muscle or under the skin of a mouse," says Skorecki.
The scientists were able to tease out six different kinds of self-renewing cells, based on behavior -- how quickly they grow, how aggressive they are, how they differentiate -- and on their molecular profile. This was a previously unknown finding, that one tumor might have such a diversity of cells with crucial fundamental growth properties. Tzukerman explains that the growth of the cancer cell subpopulations can now be explained by their proximity to the human cell environment.
The researchers cloned and expanded the six distinct cell populations and injected them into the human stem cell teratomas. One key observation is that some cells, which were not self-replicating in any other model, became self-replicating when exposed to the human cells.
Skorecki said that while he wasn't surprised that the human environment affected the growth, he was in fact surprised by the magnitude of the effect: "We've known for years now that cancers are complex organs, but I didn't think the power of the human stem cell environment would be so robust, that it would make such a big difference in how the cells were grown."
The researchers point out that they do not yet know the cues that particularly enhance the cancer's proliferation, and the team is now working on isolating the factors from human cells that promote such plasticity and self-renewing properties. The scientists explain that this may eventually allow physicians to manage cancer as a chronic disease: instead of one therapy against the entire tumor, researchers may develop a method to tease out the variety of self-renewing cell lines of a particular tumor and determine what allows each to thrive, then attack that mechanism.
Skorecki and Tzukerman say that an important next step in this line of cancer research will be to identify and develop ways of blocking the factor or factors that promote this essential self-renewing property of cancer, thus relegating many forms of cancer to controllable, chronic diseases.
See the article here:
Treating cancer as a chronic disease?
California's $3 billion stem cell agency, now more than 7 years old, has joined research partnerships with science and health agencies in eight foreign countries, the San Francisco institute announced.
The agreements call for collaboration in efforts aimed at speeding stem cell research from the laboratory to the hospital, where researchers hope that basic human cells will be programmed to treat scores of human degenerative diseases.
Research partnerships between American and foreign stem cell scientists are encouraged, but the California institute's funds would only be spent within the state, institute officials said.
Alan Trounson, president of the California Institute for Regenerative Medicine, signed agreements with stem cell funding agencies in Brazil and Argentina last week, he said Thursday.
"Both Brazil and Argentina have strong and robust stem cell research communities in basic science and transitional clinical science, which should create exciting synergies with many scientists in California," Trounson said in a statement.
He has signed similar pacts with stem cell agencies in Canada, Britain, France, Spain, Australia, Japan, China and Indiana.
The California institute was created in 2004 after Proposition 71, a $3 billion bond issue, was approved by California voters at a time when use of federal funds was barred for research into the promising field of embryonic stem cells.
So far the state agency has committed $1.2 billion to scientists and training centers at 56 California institutions, and the rest of the bond money should last until 2020, a spokesman said.
This article appeared on page C - 9 of the SanFranciscoChronicle
View original post here:
Stem cell institute to work with foreign agencies
Daniel Leonard is doing all he can to walk again, and after a recent course of stem cell treatment hes as close as he has been since a few months after the 2005 injury that put him a wheelchair.
He was 22 years old and about to begin his third year of college when he woke up one August morning on the floor at his familys Johnson City home unable to move and struggling to breathe.
While the cause of his injury remains a mystery, what is known is that three vertebrae near the top of his spine had been crushed, leaving him paralyzed from the neck down, on a ventilator and not expected to never walk or even breathe on his own again.
Six months after undergoing surgery to remove the bone fragments from his spinal cord, Leonard, who had played several sports in high school and was boxing at the Johnson City Athletic club prior to his injury, was exceeding all expectations.
In treatment at the Patricia Neal Rehabilitation Center in Knoxville, he was not only breathing independently, he was pulling himself up on parallel bars and being fitted with leg braces to help him take his first steps.
Then the unthinkable happed, again. Because there had been nothing done to stabilize his damaged vertebrae, his spine collapsed at the site of his injury and all of his progress was lost.
I worked my butt off to get to the point I was about to start walking, he said. But the gains he had made in upper body strength were erased and there was no longer any movement in his legs.
After a second surgery to fuse the bones, his condition was labeled as incomplete paraplegia characterized by limited movement and sensation in all the muscles below his neck and none at all in his legs. Doctors told his family he would never be able to move his legs, and for many years he could not.
For a while, he lived independently with the assistance of a caregiver. When his caregiver left, he moved to a nursing home, expecting to stay only long enough to find another place and another caregiver. But without money to finance that plan, months turned into years and the Four Oaks Health Care Center in Jonesborough became his home for the long term.
Early last year, things took a turn for the better when for reasons unknown he began to regain some movement in his legs. Encouraged, Leonard once again threw all his effort into physical therapy. In October, he began working out regularly with Amy Caperton, a personal trainer at the Tri-Cities Lifestyles fitness center in Johnson City, and coupled that with physical therapy at the new Mountain States Rehabilitation Center.
Continued here:
The fight to walk