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Autologous bone marrow-derived mononuclear cell transplants can reduce diabetic amputations

Public release date: 18-Apr-2012 [ | E-mail | Share ]

Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Tampa, Fla. (April. 18, 2012) Autologous (self-donated) mononuclear cells derived from bone marrow (BMMNCs) have been found to significantly induce vascular growth when transplanted into patients with diabetes who are suffering from critical limb ischemia caused by peripheral artery disease (PAD), a complication of diabetes. The team of researchers in Seville, Spain who carried out the study published their results in a recent issue of Cell Transplantation (20:10), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/.

"Critical limb ischemia in diabetic patients is associated with high rates of morbidity and mortality; however, neovascularization induced by stem cell therapy could be a useful approach for these patients," said study corresponding author Dr. Bernat Soria of the Andaluz Center for Biologic and Molecular Regenerative Medicine in Seville, Spain. "In this study we evaluated the safety and efficacy of inter-arterial administration of autologous bone marrow-derived mononuclear cells with 20 diabetic patents with severe below-the-knee arterial ischemia."

The researchers noted that surgical or endovascular revascularization options for patients such as those in the study are limited because of poor arterial outflow. Although optimum dose, source and route of administration were outstanding questions, proper BMMNC dose for best results was an issue that the researchers hoped to clarify. They subsequently used a dose ten times smaller than other researchers had used previously in similar studies.

According to the authors, the rationale for their study was that intra-arterial infusions of autologous BMMNCs contain endothelial progenitors that are locally profuse at severely diseased vascular beds in the lower limb. Their hope was that the BMMNCs could promote early and effective development of new vascularization.

Patients were evaluated at three months and twelve months post-transplantation.

"As previously reported, the one-year mortality rate for diabetic patients with PAD - most of which are associated with cardiac complications - has been found to be 20 percent," explained Dr. Soria. "Our study documented significant increases in neovasculogenesis for the majority of our study patients and a decrease in the number of amputations. However, overall PAD mortality for our patients was similar to that generally experienced."

The researchers concluded that BMMNC therapy for lower limb ischemia was a "safe procedure that generates a significant increase in the vascular network in ischemic areas" and promotes "remarkable clinical improvement."

"While this study did not demonstrate a significant effect on mortality, it does suggest an improvement in the quality of life based on limb retention as shown by the significant reduction in the number of amputations", said Amit N. Patel, director of cardiovascular regenerative medicine at the University of Utah and section editor for Cell Transplantation.

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Autologous bone marrow-derived mononuclear cell transplants can reduce diabetic amputations

Stemlogix Selects Butler Schein Animal Health to Distribute Versatile In-Clinic Stem Cell Therapy System to …

WESTON, Fla., April 17, 2012 (GLOBE NEWSWIRE) -- Stemlogix, a regenerative medicine company offering premier in-clinic stem cell therapy solutions to veterinarians, announced today that it has selected Butler Schein Animal Health(TM) to distribute its regenerative medicine system, stem cell therapy kits and other biological therapies. Butler Schein Animal Health(TM) - a Henry Schein Company - is the largest companion animal health distribution company in the U.S.

Based in the U.S., Stemlogix is an innovative leader in the rapidly emerging field of veterinary regenerative medicine. The Company develops and manufactures stem cell therapy kits and platelet rich plasma kits domestically according to FDA cGMP regulations. Stemlogix offers scientifically validated technologies and protocols that will enable veterinarians to provide their patients with affordable, versatile regenerative medicine solutions including adipose (fat) and bone marrow derived stem cells, platelet rich plasma (PRP) and cytokine therapies at the point-of-care, all in less than 90 minutes. The Company also offers stem cell banking and stem cell expansion services to veterinarians around the country.

Butler Schein Animal Health(TM) will now offer the Stemlogix regenerative medicine system to its network of over 26,000 veterinary clinics in the U.S., helping Stemlogix to expand its market presence across North America. "We are excited to be working with Butler Schein to offer the Stemlogix in-clinic regenerative medicine system to their vast network of veterinarians," said Kristin Comella, CEO of Stemlogix. "This partnership will enable Stemlogix to help standardize and advance the field of regenerative medicine."

Clinical research has shown that regenerative stem cell therapies have been safely and effectively used to treat degenerative diseases and acute tissue injuries including arthritis, laminitis, tendon injuries and ligament injuries. Stemlogix has developed an array of convenient, affordable, same-day regenerative therapies designed to achieve reproducible and superior clinical outcomes. Stemlogix also has developed an innovative technique to remove stem cell rich fat tissue from horses in a minimally invasive, scar-free method, called Equine VetLipo(TM).

About Stemlogix, LLC

Stemlogix is an innovative veterinary regenerative medicine company committed to providing veterinarians with the ability to deliver the best possible stem cell therapy to dogs, cats and horses at the point-of-care. Stemlogix provides veterinarians the ability to produce PRP and isolate regenerative stem cells from a patient's own fat tissue or bone marrow in their own clinic. Stemlogix is the first company to provide veterinarians with the ability to produce multiple cellular therapies using the same system and the company offers the most versatile regenerative medicine system available. Stemlogix has a full scale cGMP stem cell manufacturing facility and a scientific team with expertise in developing stem cell products, FDA compliance and clinical research. For more information about veterinary regenerative medicine please visit http://www.stemlogix.com.

About Butler Schein Animal Health(TM)

Butler Schein Animal Health (Butler Schein) -- the veterinary division of Henry Schein (Nasdaq: HSIC - News) is the leading companion animal health distribution company in the United States headquartered in Dublin, Ohio. Butler Schein employs approximately 900 team members including 300 field sales representatives and 200 telesales and customer support representatives. With 15 strategically positioned, state-of-the-art distribution facilities and 10 inside sales centers nationwide, we maintain 98%+ order-fill ratio, accomplishing our mission of providing the right product at the right place and at the right time.

Partnering with over 400 leading animal health manufacturers in the world, Butler Schein is positioned to bring the broadest selection of veterinary products and strategic solutions to veterinary professionals nationwide, including:

1.

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Stemlogix Selects Butler Schein Animal Health to Distribute Versatile In-Clinic Stem Cell Therapy System to ...

Stem Cell Therapy – T6 Spinal Cord Injury (complete) at Stem Cell Institute Panama City, Panama – Video

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.

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Stem Cell Therapy - T6 Spinal Cord Injury (complete) at Stem Cell Institute Panama City, Panama - Video

FDA approves Pluristem stem cell trial for severe limping

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

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FDA approves Pluristem stem cell trial for severe limping

Neural stem cell transplants for spinal cord injury maximized by combined, complimentary therapies

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.

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Neural stem cell transplants for spinal cord injury maximized by combined, complimentary therapies

State: Grekos extracted tissue from stem cell patient who died, damaged patient's abdomen

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.

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State: Grekos extracted tissue from stem cell patient who died, damaged patient's abdomen

ETEX Corporation to Present at GTC Stem Cell Summit

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.

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ETEX Corporation to Present at GTC Stem Cell Summit

Cancer stem cell vaccine in development shows antitumor effect

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.

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Cancer stem cell vaccine in development shows antitumor effect

Advocacy group linked to stem cell industry asks medical board for less-strict rule

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.

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Advocacy group linked to stem cell industry asks medical board for less-strict rule

Treating cancer as a chronic disease?

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.

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Treating cancer as a chronic disease?