Stem Cell Clinic

Stem cell debate could flare in Neb. regents race

By Stem Cell Medical Center

A long-standing dispute over embryonic stem cell research is likely to resurface during the general election race for candidates of the University of Nebraska Board of Regents.

Regent hopefuls in at least one district differ on the use of research, which has divided the board in past years and caught the attention of an influential Nebraska anti-abortion group.

The primary vote will eliminate candidates from three of four seats that are up for re-election. The nonpartisan, unpaid board has eight members plus one nonvoting student regent for each of the four University of Nebraska campuses. The top two vote-getters in the primary advance to the November general election, where they will compete for a six-year term in office.

The Board of Regents voted 4-4 in 2008 on a proposition to limit the stem cell research at the university to types allowed under President George W. Bush. The board needed a majority of its eight members to approve the measure, and many backers thought they had the necessary votes.

Outgoing state Sen. Lavon Heidemann, a Republican primary winner vying for a seat on the board, said he expected embryonic stem cell research to surface as an issue in the general election. Heidemann's general election opponent, Mike Jones, has said he supports embryonic stem cell research.

Both candidates are seeking to replace Regent Jim McClurg of Lincoln, who did not seek re-election after his vote to allow expanded stem cell research.

"It's not the only issue but is important," Heidemann said, pointing to his endorsement by the group Nebraska Right to Life. "I think that's going to pop up throughout the campaign."

The primary winners of another district _ Norfolk attorney David Copple and Columbus veterinarian Jim Pillen _ have both voiced opposition to stem cell research. One of the two will replace Regent Chuck Hassebrook, who has voted to allow the expanded research.

About $88 million in federal funding went to embryonic stem cell research in 2008, according to the National Institutes of Health, but the University of Nebraska saw none of that funding at the time because of tight federal guidelines. When the guidelines were lifted, university scholars applied for millions of dollars in research grants.

The race for the University of Nebraska Board of Regents attracted a number of well-known politicians and business executives for Tuesday's primary who have promised to keep college affordable and use the university as an engine for economic growth.

Read this article:
Stem cell debate could flare in Neb. regents race

9 Small Businesses Awarded Scholarships to Attend International BIO Convention

By Stem Cell Clinic

MADISON, Wis.--(BUSINESS WIRE)--

Nine Wisconsin biotechnology companies have been awarded scholarships to support attending the Biotechnology Industry Organizations (BIO) International Convention in Boston, MA. June 18-21, 2012. All recipients plan to participate in BIOs one-on-one partnering with potential customers from around the world, or to present to potential investors.

The grant fund was assembled by BioForward, and includes funds provided by Wisconsin Economic Development Corporation and Marshfield Clinic Applied Sciences. Scholarship recipients are small biotechnology businesses that demonstrate a strategic approach to the Business Forum, and have a financial need.

The scholarship recipients are:

Centrose preclinical stage company developing a novel antibody-drug conjugation technology that targets a wide variety of diseased cells.

DNASTAR company focused primarily on developing and commercializing software for scientists working with DNA sequence analysis.

InvivoSciences - contract research organization providing engineered tissue-based phenotypic compound screening services for pharmaceutical, cosmetic, biotech, food, and chemical companies.

NeoClone company designing and manufacturing monoclonal antibodies, for their ability to seek out and bind to a specific target such as a virus, toxin, bacterium or tumor cell.

Primorigen company developing innovative high-throughput protein and cell-based assay systems and novel stem cell biology research products.

Quintessence Biosciences private, clinical stage biopharmaceutical company developing novel anti-cancer compounds based on patented EVade Ribonuclease technology.

See the article here:
9 Small Businesses Awarded Scholarships to Attend International BIO Convention

Amgen's BiTE® Antibody Blinatumomab (AMG 103) Achieved High Rate of Complete Response in Adult Patients With Relapsed …

By Stem Cell Clinic

THOUSAND OAKS, Calif., May 16, 2012 /PRNewswire/ --Amgen (AMGN) today announced updated results from a Phase 2 study that showed treatment with blinatumomab (AMG 103) helped achieve a high-rate of complete response (CR) in 72 percent of adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) treated in the study. Blinatumomab is the first of a new class of agents called bi-specific T cell engagers (BiTE) antibodies, designed to harness the body's cell-destroying T cells to kill cancer cells. Blinatumomab targets cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas, such as ALL. Full results of the study will be presented during an oral abstract session at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 4 (Abstract Number 6500, 8:00 a.m. - 8:15 a.m. CDT, E354a).

In this Phase 2 single-arm dose-ranging trial, 26 of the 36 patients treated with blinatumomab across all of the tested doses and schedules achieved a CR with partial hematologic recovery (CRh*). All but two patients achieved a molecular response, meaning there was no evidence of leukemic cells by polymerase chain reaction. No treatment related deaths or serious adverse events (AEs) were reported in the study.

At the time of the analysis, median survival was 9.0 (8.2, 15.8) months with a median follow-up period of 10.7 months. In the group of patients who received the selected dose, median survival was 8.5 months. The median duration of response in the 26 patients who responded to treatment was 8.9 months.

"For these patients with limited treatment options, the remission rate observed in the trial is a vast improvement over the current standard of care," said Professor Max Topp, Department of Internal Medicine II, University of Wuerzburg and chair of the study. "These results also represent significant progress in our research of immunotherapies; a new approach to fighting cancer that we believe could make a real difference for patients."

For patients who received the selected dose and schedule, the most common adverse events were grade one or two and included pyrexia (70 percent), headache (39 percent), tremor (30 percent) and fatigue (30 percent). These were most frequently seen at the onset of treatment in cycle one. Reversible central nervous system events led to treatment interruptions in six patients with two patients permanently discontinuing treatment. Cytokine release syndrome led to treatment interruption in two patients.

In addition to the results from this study, data from studies of 12 Amgen investigational molecules and marketed products will be presented at the ASCO Annual Meeting. These include results from studies of the immunotherapy talimogene laherparepvec, pipeline molecules such asrilotumumab (AMG 102) and AMG 386, and marketed products. A complete listing of Amgen abstracts of interest can be found at http://www.amgen.com/media/amgen_asco_2012.html. Abstracts are available online at http://www.asco.org.

Phase 2 Study DesignThis Phase 2 dose-ranging study evaluated the efficacy, safety and tolerability of blinatumomab in adult patients with B-precursor ALL who had relapsed following treatment with standard front-line chemotherapy or allogeneic stem cell transplant. Patients received blinatumomab for 28 days followed by two weeks off therapy over a six week treatment cycle, for up to five treatment cycles. Patients received a continuous intravenous infusion of blinatumomab at an initial dose of five or 15 micrograms per meter squared per day, ranging up to 30 micrograms for the remainder of the treatment. The primary endpoint of the study was the rate of CR/CRh*. Secondary endpoints included molecular response rate, duration of response and overall survival. As of April 13, 2012, all 36 patients were evaluable for efficacy and safety.

About BlinatumomabBlinatumomab (AMG 103) is a bispecific T cell engager (BiTE) antibody designed to direct the body's cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells to cancer cells. Blinatumomab is the first of the BiTE antibodies and Amgen has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of ALL, chronic lymphocytic leukemia (CLL), hairy cell leukemia, prolymphocytic leukemia and indolent B cell lymphoma and from the European Medicines Agency for the treatment of indolent B cell lymphoma, ALL, CLL and mantle cell leukemia (MCL).

About ALLAcute lymphoblastic leukemia (ALL) is an aggressive cancer of the blood and bone marrow the spongy tissue inside bones where blood cells are made. The disease progresses rapidly and affects immature blood cells, rather than mature ones.(1) Worldwide, ALL accounts for more than 12 percent of leukemia. Of the 42,000 people diagnosed worldwide, 31,000 will die from the disease.(2)Patients with ALL have abnormal white blood cells (lymphocytes) that crowd out healthy white blood cells, red blood cells and platelets, leading to infection, anemia (fatigue), easy bleeding and serious side effects.(3,4)

AboutAmgenAmgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit http://www.amgen.com/. Follow us on http://twitter.com/amgen.

Read more from the original source:
Amgen's BiTE® Antibody Blinatumomab (AMG 103) Achieved High Rate of Complete Response in Adult Patients With Relapsed ...

Lenalidomide prolongs disease control for multiple myeloma patients after stem cell transplant

By Stem Cell Treatment

Public release date: 15-May-2012 [ | E-mail | Share ]

Contact: Elisa Williams willieli@ohsu.edu 503-494-4530 Oregon Health & Science University

PORTLAND, Ore. Multiple myeloma patients are better equipped to halt progression of this blood cancer if treated with lenalidomide, or Revlimid, following a stem cell transplant, according to a study co-authored by a physician with the Oregon Health & Science University Knight Cancer Institute.

The study, published in the New England Journal of Medicine, found a 63 percent reduction in the risk of progressive myeloma or death for the stem cell transplant patients that were treated with lenalidomide maintenance therapy.

"These results add to the evidence that the combination of standard therapies such as stem cell transplantation with the emerging biologic therapies, like lenalidomide, have extended the lives of multiple myeloma patients," said Richard Maziarz, M.D., of the OHSU Knight Cancer Institute who was one of the study's co-authors. Maziarz serves as medical director of the Adult Stem Cell Transplantation Program & Center for Hematologic Malignancies at the OHSU Knight Cancer Institute. "We know that for at least three years following a transplant that maintenance therapy with this drug vastly improves the chances that the cancer won't come back and worsen."

These data were supported by similar Phase III studies reported from France and Italy in the same issue of the New England Jounal of Medicine demonstrating that maintenance therapy after stem cell transplantation was associated with improved disease control.

Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell normally responsible for producing antibodies. In patients impacted by multiple myeloma, collections of abnormal plasma cells accumulate in the bone marrow, interfering with the production of normal blood cells. The study focused on patients who received an autologous hematopoietic cell transplant (AHCT). AHCT procedures use patients' own blood stem cells.

While lenalidomide increased a patient's ability to stave off progression of the disease, questions remain regarding future approaches recognizing that quality of life measurements were not incorporated within these studies, that long-term safety issues remain unclear as there was a small but discernable risk of second cancers observed in the treated patients. In addition to the need for that cost-benefit analysis, a comparison remains to be performed with other emerging myeloma maintenance therapies.

This Phase III study of lenalidomide was conducted at 47 medical centers and involved 568 patients. It was sponsored by the National Cancer Institute (NCI). Revlimid's manufacturer, Celgene Corp., provided the NCI with lenalidomide for this research.

###

See the original post here:
Lenalidomide prolongs disease control for multiple myeloma patients after stem cell transplant

Sebastian veterinarian performs stem cell treatment for pets

By Stem Cell Treatment

SEBASTIAN Toby, a 6-year-old golden retriever, loves to run and play catch. And Oreo, a 12-year-old border collie mix, also is a bundle of energy.

Movement for both dogs got easier about a month ago when they received a revolutionary stem cell treatment at the Highlands Animal Hospital.

Veterinarian Marcus Kramer performed the successful transplant procedures, which were developed by Kentucky-based MediVet-America.

Both dogs had been in significant pain with a restricted range of motion, as shown on X-rays.

"It's made a big difference," said Kramer. "The really amazing thing is that they both healed so quickly. Both dogs had problems with their hips and were suffering from osteoarthritis. Just 30-days later, they are able to walk and run again."

Adult animal stem cell technology uses the pet's own regenerative healing power to treat dogs, cats and horses suffering from arthritis, hip dysplasia and tendon, ligament and cartilage injuries. Under anesthesia, Kramer removed about 40 grams of fat from each dog and separated the stem cells from the fat. He then activated the stem cells under an LED light, and injected them back into the dogs.

Stem cell therapy allows an animal to get off pain and anti-inflammatory drugs, Kramer said. MediVet-America's therapy is done entirely at the animal hospital in about three hours, and costs about $1,800 for dogs and $2,400 for horses. That compares to thousands of dollars that pet owners could expect to pay for medication over a pet's lifetime.

Erica Kent, a spokesman for MediVet-America, said using the LED light is integral to the patented-process, because the light helps to awaken stem cells and makes them more active. The three-color light stimulates millions of dormant cells to initiate repair from the moment the cells are injected into the animal's body, according to the MediVet-America website.

The company is also offering a program that allows pet owners to bank stem cells when animals are younger to use if their pet develops illnesses like arthritis in old age.

STEM CELL THERAPY

Read more from the original source:
Sebastian veterinarian performs stem cell treatment for pets

Stem cell donors needed for former schools superintendent

By Stem Cell Treatment

Friends of John Glaser, the former superintendent of the Napa Valley Unified School District, are seeking stem cell donors to help with his medical treatment.

Glaser is dealing with two cancers: Multiple myeloma and leukemia. He is in need of a second stem cell transplant, his supporters said.

Potential donors can request a cheek swab kit online, and mail the swab in to be registered in the worldwide pool of stem cell donors. To qualify for the registry, a person needs to be between the ages of 18 and 60 and in good health.

Those who match Glaser or another transplant patient would be asked to go to a nearby lab for a blood draw and have their blood cells further analyzed.

People who are chosen as donors would then return to the lab for a blood donation, where the stem cells would be extracted and their blood would be returned to them. The process takes three to four hours.

For more information on how to donate stem cells, visit marrow.org.

View post:
Stem cell donors needed for former schools superintendent

Two stem cell therapies from Cytomedix to start trials; stroke study expands

By Stem Cell Treatment

When regenerative medicine firm Cytomedix (OTC:CMXI) acquired biotechnology company Aldagen, the stem cell-based stroke treatment in clinical trials was the centerpiece of the all stock deal.

Cytomedix is now making moves to develop other stem cell treatments from its Aldagen acquisition. Two more clinical trials will start later this year, CEO Martin Rosendale told analysts on a conference call to discuss first-quarter financial results. Rosendale wouldnt identify the indications that will be studied, and said only that they will be announced this summer: one for an arterial disease and the other a neurological condition.

Cytomedixs goal is to ultimately find large pharmaceutical partners to commercialize these treatments. These additional clinical studies dont represent those kinds of partnerships. Rosendale said there are two facilities that will conduct investigator-led clinical trials. But those trials will be funded by outside sources, not by Cytomedix.

Read this article:
Two stem cell therapies from Cytomedix to start trials; stroke study expands

Cellerant Announces Publication Demonstrating Significant Survival Benefits and Preclinical Proof of Concept With …

By Stem Cell Medical Center

SAN CARLOS, Calif.--(BUSINESS WIRE)--

Cellerant Therapeutics, Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced the publication of a radiation countermeasure study demonstrating that cryopreserved, allogeneic mouse myeloid progenitor cells significantly improved survival in mice irradiated with lethal doses of radiation. The study, published on May 4, 2012 in the scientific journal, Radiation Research, represents the first report of an effective radiation countermeasure for Acute Radiation Syndrome (ARS) across a broad range of lethal radiation doses when administered as late as seven (7) days after irradiation. These results show that myeloid progenitor cells are one of the most promising radiation countermeasures among all therapeutics currently under development with respect to efficacy, timing and practicality of administration.

The work was carried out in collaboration with scientists at the Armed Forces Radiobiology Research Institute (AFRRI) and is entitled Myeloid Progenitors: A Radiation Countermeasure that is Effective when Initiated Days after Irradiation which appears online ahead of print on the website http://www.rrjournal.org/doi/abs/10.1667/RR2894.1?journalCode=rare.

The publication describes the use of Cellerants cryopreserved, allogeneic myeloid progenitor cells developed in mice to elucidate its potential as a radiomitigator against lethal doses of ionizing radiation in various strains of mice. Pooled allogeneic myeloid progenitor cells were transfused into unmatched recipients irradiated with lethal doses of ionizing radiation known to cause ARS in hematopoietic tissues. Survival benefit was dose dependent and significant even when administration of the product was delayed up to seven (7) days post-irradiation. The ability to delay the administration of a radiomitigator by 24 to 48 hours is critical to allow for the time it takes disaster teams to respond to radiation victims in an emergency situation.

"These study results exceed our expectations of the potential survival benefits of myeloid progenitor cells, said Ram Mandalam, President and CEO of Cellerant. "We are excited about the data as it represents demonstration of proof of concept for our CLT-008 human myeloid progenitor therapy as a radiation medical countermeasure. We continue to work closely with AFFRI in performing further studies and with the government in advancing our product closer to approval for therapeutic use.

Cellerant is developing CLT-008, human myeloid progenitor cells, for the treatment of ARS under a United States Government contract awarded on September 1, 2010 and valued up to $170 million over five years with the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services.

In ARS applications, CLT-008 is intended to provide hematopoietic cellular support after exposure to ionizing radiation from a nuclear weapon or from a nuclear accident. Cellerant has conducted various preclinical studies to evaluate whether a single administration of myeloid progenitor cells has the potential to provide effective treatment for ARS in an emergency situation when administered up to seven days post-exposure to radiation. CLT-008 is being developed under the U.S. Food and Drug Administrations Animal Rule for ARS. This approval pathway is available when human efficacy studies are neither ethical nor feasible and requires demonstration of efficacy in representative and well-characterized animal models along with safety and pharmacokinetic testing in human clinical trials. There is currently no FDA-approved medical countermeasure to treat ARS. If licensed by the FDA, the federal government could purchase CLT-008 for the Strategic National Stockpile under Project Bioshield. Project Bioshield is designed to accelerate the research, development, purchase and availability of effective medical countermeasures for the Strategic National Stockpile.

About CLT-008

CLT-008 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human Myeloid Progenitor Cells derived from adult hematopoietic stem cells that have the ability to mature into functional granulocytes, platelets and red blood cells in vivo. In preclinical models, CLT-008 has been shown to be highly effective in providing protection from lethal radiation, preventing infection, facilitating stem cell engraftment and improving overall survival with a high degree of efficacy. Cellerant is developing CLT-008 as an effective treatment for chemotherapy-induced neutropenia, protection following exposure to acute radiation, and facilitating engraftment of cord blood transplantation.

CLT-008 is currently in a Phase 1 study in patients undergoing cord blood transplants for the treatment of hematological malignancies. CLT-008 is intended to rapidly produce neutrophils and platelets in vivo and facilitate long-term engraftment in patients undergoing bone marrow or cord blood transplantation. A second Phase I/II study is evaluating CLT-008 in acute leukemia patients with chemotherapy-induced neutropenia. CLT-008 may shorten the time to neutrophil recovery and decrease the risks of febrile neutropenia and infection.

Read the original post:
Cellerant Announces Publication Demonstrating Significant Survival Benefits and Preclinical Proof of Concept With ...

Local News In Cancer Care

By Stem Cell Medical Center

MANILA, Philippines As the Cancer Center of the Makati Medical Center celebrates its first year, the hospital unveils to the public two of its latest offerings: the Cellular Therapeutics Laboratory and its new cutting-edge radiation treatment TomoTherapy.

In two seperate occasions, the hospital invited select media representatives to witness its unveiling. Present on the first occasion was neurosurgeon Dr. Eric Flores, head of the new and impressive state-of-the art facility. "This is the future of medicine. It's time the hospital enters the molecular age,"

In the medical field, stem cell therapy is used to treat a host of diseases, from Parkinson's Disease and Multiple Sclerosis to Type 1 Diabetes and a slew of orthopedic ailmetns. It has aided doctors in successful plastic and reconstructive surgeries, and can even give a patient immunity from cancer.

In MakatiMed, stem cells are used to repopulate the blood and bone marrow with normal blood elements after ablative chemotherapy in the treatment of such conditions as leukemia, multiple myeloma Hodgkin's and Non-Hodgkin's Lymphoma. Stem Cell Rescue can also make Type 1 Diabetes a thing of the past: after ablataive chemotherapy ot the abnormal cellular immune system, stem cells produce a normal immune system, thereby allowing normal cells in the pancreas to grow.

Dr. Flores also expounds on the reasons why the hospital's new laboratory is the best in the country.

"Compared to other facilities in the Philippines, our laboratory is unmatched in terms of providing the best cellular product of quality. In comparison with other laboratories, the lab is at least three notches better in providing a sterile environment. Most cancer patients have weakened immune systems, hence, we put premium importance in the quality and sterility of the product."

He continues, "Separation of the cellular products is carried out within our Biosafety level 5 facilities automated magnetic-based cell separation. Our technology is approved by the US-FDA in clinical trials to perform cell purification without compromising cell physiology. Thus, the laboratory is totally unmatched in terms of the cell purity and cell viability of the product."

Dr. Flores also stressed on the 10-point DNA matching capability. "In a condition wherein the stem cells will be sourced out from a donor, our laboratory will perform the strictest standards in identifying a possible cross-match for the recipient. We have the technology to push this cellular transplantation process that will significantly minimize complications. Full disclosure of the patient's cell status, characteristics and quality will be provided."

New radiation therapy system

Meanwhile, another recent addition to the hospital's superb cancer care is TomoTherapy treatment, a new radiation therapy system which employs intensity modulated radiation therapy (IMRT). It is valued as the most superior radiation treatment technique for delivering the desired dose to the tumor while limiting healthy tissue exposure.

Originally posted here:
Local News In Cancer Care

Parcell Laboratories Honored as 2012 SBANE Innovation Award Winner

By Uncategorized

NEWTON, Mass., May 14, 2012 /PRNewswire/ --Parcell Laboratories, a leading adult stem cell company based in Newton, MA, was awarded the prestigious 2012 Innovation Award by the Smaller Business Association of New England (SBANE). Parcell joins the select list of winning companies from the last 26 years whose innovations have delivered proven value to customers.

SBANE uses its highly competitive Innovation Awards program to showcase technology driven enterprises that are potentially "game changers" in their markets. Parcell's ELA stem cell technology is a platform technology that has unlimited applications for tissue regeneration and is positioned to change the face of regenerative medicine. "We are honored to have been recognized by SBANE for our accomplishments and to be included among the roster of extremely successful companies that have been previous winners of the award," said Pamela Layton, the CEO of Parcell Laboratories. "The award is a testament to the dedication and tenacity of our terrific team." Past award winners include some of the most recognizable names in New England business, including Staples, Genzyme, Ben & Jerry's and Nantucket Nectars.

Parcell Laboratories holds the license and intellectual property to the ELA stem cell, which is considered to be the earliest lineage adult stem cell in the adult body. The cell is able to differentiate into all tissues and has the added benefit of being immune privileged, allowing it to be implanted without the risk of rejection. Parcell's ELA cells are being used by surgeons nationwide to enhance bone regeneration in the aging spine. The product is marketed under the name of PureGen Osteoprogenitor Cell Allograft by Alphatec Spine of Carlsbad, CA. Parcell is also in the development phase of therapeutics using the ELA stem cell for disc and cartilage repair.

Press Contact Susan Kinslow Kinslow@parcelllabs.com +617-928-9803

Go here to read the rest:
Parcell Laboratories Honored as 2012 SBANE Innovation Award Winner

→←