Stem Cell Clinic

Maine game warden finds stem cell match

By adminJune 28, 2012Stem Cell Treatment

AUGUSTA, Maine (NEWS CENTER) --InMay,we introduced you to Maine Game Warden Major Gregg Sanborn - when the UMaine football team held a stem cell drive in his honor. Major Sanborn was diagnosed with t-cell lymphoma last September and needed to find a match as soon as possible in order to live.

Last week, Major Sanborn found out that he did find a match - a 26 year old man. He isn't allowed to know anything else about his donor due to privacy laws.

Major Sanborn is already undergoing chemotherapy and will head to Boston on July 9th and will stay there for about six weeks - to begin more aggressive treatments, which will include rebuilding his immune system.

He feels he owes it to all the people who have helped him thus far to fight as hard as he can. "An awful lot of people have done an awful lot of work to make this possible. Their efforts haven't gone in vain, they haven't gone unnoticed," he says,"It's very impressive. I've got a lot of people rooting for me, and I'm going to give it my best so that it's a positive outcome."

Wednesday was Major Sanborn's last day of work at the Maine Department of Inland Fisheries and Wildlife. He actually had to take a few tests in order to keep his license when he comes back to work after the treatments. After the six weeks of treatment, he'll be in isolation for one year.

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Maine game warden finds stem cell match

Diabetes reversed in mice using stem cells

By adminJune 28, 2012Stem Cell Treatment

ScienceDaily (June 27, 2012) University of British Columbia scientists, in collaboration with an industry partner, have successfully reversed diabetes in mice using stem cells, paving the way for a breakthrough treatment for a disease that affects nearly one in four Canadians.

The research by Timothy Kieffer, a professor in the Department of Cellular and Physiological Sciences, and scientists from the New Jersey-based BetaLogics, a division of Janssen Research & Development, LLC, is the first to show that human stem cell transplants can successfully restore insulin production and reverse diabetes in mice. Crucially, they re-created the "feedback loop" that enables insulin levels to automatically rise or fall based on blood glucose levels. The study is published online June 27 in the journal Diabetes.

After the stem cell transplant, the diabetic mice were weaned off insulin, a procedure designed to mimic human clinical conditions. Three to four months later, the mice were able to maintain healthy blood sugar levels even when being fed large quantities of sugar. Transplanted cells removed from the mice after several months had all the markings of normal insulin-producing pancreatic cells.

"We are very excited by these findings, but additional research is needed before this approach can be tested clinically in humans," says Kieffer, a member of UBC's Life Sciences Institute. "The studies were performed in diabetic mice that lacked a properly functioning immune system that would otherwise have rejected the cells. We now need to identify a suitable way of protecting the cells from immune attack so that the transplant can ultimately be performed in the absence of any immunosuppression."

The research was supported by the Canadian Institutes of Health Research, the Stem Cell Network of Canada, Stem Cell Technologies of Vancouver, the JDRF and the Michael Smith Foundation for Health Research.

Diabetes results from insufficient production of insulin by the pancreas. Insulin enables glucose to be stored by the body's muscle, fat and liver and used as fuel; a shortage of insulin leads to high blood sugar that raises the risk of blindness, heart attack, stroke, nerve damage and kidney failure.

Regular injections of insulin are the most common treatment for the type 1 form of this disease, which often strikes young children. Although experimental transplants of healthy pancreatic cells from human donors have shown to be effective, that treatment is severely limited by the availability of donors.

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Diabetes reversed in mice using stem cells

Stem Cell Breakthrough Significant For Degenerative Diseases

By adminJune 28, 2012Stem Cell Treatment

Featured Article Academic Journal Main Category: Stem Cell Research Also Included In: Eye Health / Blindness;Diabetes;Multiple Sclerosis Article Date: 27 Jun 2012 - 9:00 PDT

Current ratings for: Stem Cell Breakthrough Significant For Degenerative Diseases

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But it is a long journey from showing something works in the research lab to using it safely and ethically in patients, and there are many hurdles.

One such hurdle is providing stem cells lines "developed under stringent ethical guidelines, from traceable and tested donors, preferably in an animal-free, GMP-grade culture system," write the researchers in a comprehensive paper published online on 20 June in the open access journal PLoS ONE.

Another, is to ensure the hESCs meet safety criteria, and do not have traces of animal components, such as from mice and cows, as these can introduce the risk of animal pathogens running amok in the patient's body.

Now after 12 years of painstaking work, researchers at the Hadassah University Medical Center in Jerusalem, have announced they have created three new lines of "xeno-free and GMP-grade human embryonic stem cells".

In their paper, lead investigator professor Benjamin Reubinoff, a world-renowned stem-cell pioneer and the new chairman of obstetrics/gynecology at the Ein Kerem medical center, and colleagues, describe the journey they took to produce clinically-compliant hESCs.

They conclude that the three hESC lines they produced "may be valuable for regenerative therapy".

And they also suggest that the "ethical, scientific and regulatory methodology" they followed may serve as a model for developing further clinical-grade hESCs.

California Stem Cell Medical Director Robert O. Dillman, M.D. to Present Details, Phase II Trial Results of Melanoma …

By adminJune 28, 2012Stem Cell Treatment

IRVINE, Calif.--(BUSINESS WIRE)--

Concluding a series of conference presentations in recent months, California Stem Cell (CSC) Medical Director and Principal Investigator Robert O. Dillman, M.D. will be delivering an oral presentation at todays Biotherapeutics & Stem Cell Processing Symposia in London, UK. The presentation will provide details and phase II clinical trial results from a promising therapy for the treatment of metastatic melanoma, recently acquired by CSC from Hoag Hospital in Newport Beach. In two previous presentations at both the AACR and ASCO conferences in Chicago, Dr. Dillman compared pooled data from this and two other phase II immunotherapies for the treatment of metastatic melanoma.

Data pooled from three successive phase II trials were compared in order to determine the impact on overall survival rates of patient specific immunotherapies utilizing antigens from autologous cancer stem cells. Results demonstrated that autologous dendritic cells loaded with antigens from cancer stem cells significantly improved survival rates and time to recurrence when compared with treatments using irradiated cancer cells alone. 2-year overall survival rates tracked at 72%, as compared to 45% from the therapy using only irradiated cancer stem cells. 5-year median survivals of patients tracked over 50%, double that of any other current treatments.

California Stem Cell acquired the entirety of Hoag Hospitals metastatic melanoma research program in October of 2011 and plans to initiate Phase III trials in the near future.

About California Stem Cell

California Stem Cell, Inc. (CSC) is an Irvine, CA based company which has developed proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes. CSC is able to supply its human cell populations to companies and institutions worldwide for use in the development of therapies, efficacy screening or the creation of toxicity profiles for candidate drugs, and experimental research tools.

CSC is focused on the development of stem cell based therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease), and metastatic cancers.

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California Stem Cell Medical Director Robert O. Dillman, M.D. to Present Details, Phase II Trial Results of Melanoma ...

FDA critical of stem-cell firm

By adminJune 27, 2012Stem Cell Medicine

The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration.

In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for therapeutic reinjection.

You have not performed a validation of your banking and thawing process to assure viability of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive.

The FDA report, which followed an April inspection of Celltex, was released under the Freedom of Information Act on Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained that Celltex is a potential danger to patients and not in compliance with federal law.

The report, partially redacted, was not accompanied by a warning letter.

A former FDA official who asked not to be identified, said the deficiencies 79 in all, from incorrectly labeled products to failed sterility tests are so serious that Celltex risks being shut down if it does not remedy the problems quickly.

Adult stem cells are cells in the body that multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have shown promise for tissue repair in many other diseases in the last decade, although most scientists in the field consider them not ready for mainstream use.

Celltex has been in the public eye since it was revealed that Perry's Houston doctor treated him with his own stem cells during back surgery last July and in follow-up appointments. His stem cells were stored and grown at Celltex.

Perry subsequently called for Texas to become the nation's leader of adult stem-cell medicine, which he touts as an ethical alternative to embryonic stem cells. Perry worked with his Houston doctor and a state representative to write legislation intended to commercialize the therapy in Texas.

In April, the Texas Medical Board approved rules regulating the therapy, which isn't approved by the FDA. The rules allow doctors to use stem cells as long as they get the approval of a review board that evaluates clinical research for safety. The board members were all appointed by Perry.

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FDA critical of stem-cell firm

Stem cell transplantation into mouse cochlea may impact future hearing loss therapies

By adminJune 26, 2012Uncategorized

Researchers in Japan who evaluated the risks and efficacy of transplanting two varieties of stem cells into mouse cochlea have concluded that both adult-derived induced pluripotent stem (iPS) cells and mouse embryonic stem (ES) cells demonstrate similar survival and neural differentiation capabilities. However, there is a risk of tumor growth associated with transplanting iPS cells into mouse cochleae. Given the potential for tumorigenesis, they concluded that the source of iPS cells is a critical issue for iPS cell-based therapy.

Their study is published in a recent issue of Cell Transplantation (21:4), now freely available online.

"Hearing loss affects millions of people worldwide," said Dr. Takayuki Nakagawa of the Department of Otolaryngology, Graduate School of Medicine, Kyoto University, Japan. "Recent studies have indicated the potential of stem-cell based approaches for the regeneration of hair cells and associated auditory primary neurons. These structures are essential for hearing and defects result in profound hearing loss and deafness."

The authors noted that embryonic stem cells have previously been identified as promising candidates for transplantation, however they have also been associated with immune rejection and ethics issues. Consequently, this study compared the survival and neural differentiation capabilities of ES and three clones of mouse iPS cells.

"Our study examined using induced pluripotent stem cells generated from the patient source to determine if they offer a promising alternative to ES cells," explained Dr. Nakagawa. "In addition, the potential for tumor risk from iPS cells needed clarification."

Four weeks after transplantation, the researchers found that the majority of cochleae that had been transplanted exhibited the settlement of iPS or ES-derived neurons. However, there was a difference in the number of cells present based on cell lines. They noted that the number of cells able to be transplanted into cochleae is limited because of the cochleae's tiny size. Thus, the number of settled cells is low.

They also noted the formation of a teratoma (encapsulated tumor) in some cochlea after transplantation with one group of iPS cells.

"To our knowledge, this is the first documentation of teratoma formation in cochleae after cell transplantation," said Dr. Nakagawa.

The researchers concluded that the teratoma formation in one iPS cell line indicated the necessity for selecting appropriate iPS cell lines for avoiding tumorigenesis. They also noted the need for developing methods to eliminate undifferentiated cells after neural induction in order to establish safe iPS-based therapy for the inner ear.

"While this study did not look at the ability of the transplanted cells to repair hearing loss, it does provide insight into the survival and fate of transplanted cells. It highlights the importance of factors such as knowing the original source of the cells and their degree of undifferentiation to enable the cells to be ranked in order of their likelihood of forming tumors" said Dr. John Sladek, professor of neurology and pediatrics at the University of Colorado School of Medicine.

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Stem cell transplantation into mouse cochlea may impact future hearing loss therapies

FDA report faults Houston stem-cell company

By adminJune 26, 2012Uncategorized

The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration.

"You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive.

The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law.

The report, partially redacted, was not accompanied by a warning letter.

A former FDA official who asked not to be identified, however, said the deficiencies - 79 in all, from incorrectly labeled products to failed sterility tests - are so serious that Celltex risks being shut down if it does not remedy the problems quickly.

Rules take effect July 8

Perry subsequently called for Texas to become the nation's leader of adult stem cell medicine, which he touts as an ethical alternative to embryonic stem cells. Perry worked with his Houston doctor and a state representative to write legislation intended to commercialize the therapy in Texas.

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FDA report faults Houston stem-cell company

Magnet helps target transplanted iron-loaded cells to key areas of heart

By adminJune 26, 2012Uncategorized

Optimal stem cell therapy delivery to damaged areas of the heart after myocardial infarction has been hampered by inefficient homing of cells to the damaged site. However, using rat models, researchers in France have used a magnet to guide cells loaded with iron oxide nanoparticles to key sites, enhancing the myocardial retention of intravascularly delivered endothelial progenitor cells.

The study is published in a recent issue of Cell Transplantation (21:4), now freely available online.

"Cell therapy is a promising approach to myocardial regeneration and neovascularization, but currently suffers from the inefficient homing of cells after intracavitary infusion," said Dr. Philippe Menasche of the INSERM U633 Laboratory of Surgical Research in Paris. "Our study was aimed at improving and controlling homing by loading human cord-blood-derived endothelial progenitor cells (EPCs) for transplant with iron oxide nanoparticles in order to better position and retain them in the hearts of myocardial-injured test rats by using a subcutaneously implanted magnet."

The researchers found that the cells were sufficiently magnetic to be able to be remotely manipulated by a magnet subsequent to implantation.

According to the researchers, an objective assessment of the technique to enhance the homing of circulating stem cells is the ability to track their fate in vivo. This was accomplished by visualization with MRI.

"We found a good correlation between MRI non-invasive follow-up of the injected cells and immunofluoresence or quantitative PCR data," said Dr. Menasche. The researchers concluded that further studies were needed to follow cell homing at later time points. They noted that the magnitude of homing they experienced may have been reduced by the relatively small number of cells used, owing to their large size and the subsequent risk of coronary thrombosis.

"In a rat model of myocardial infarction, this pilot study suggested homing of circulating stem cells can be improved by magnetic targeting and warrants additional benchwork to confirm the validity of concept," said Dr. Menasche. "There is also a need to optimize the parameters of targeting and assess the relevance of this approach in a clinically relevant large animal model."

"This study highlights the use of magnets to target transplanted cells to specific sites which could increase their regenerative impact. Factors to still be extensively tested include confirming the safety of the cells containing the magnetic particles and whether this process alters the cell's abilities" said Dr. Amit N. Patel, director of cardiovascular regenerative medicine at the University of Utah and section editor for Cell Transplantation.

More information: Chaudeurge, A.; Wilhelm, C.; Chen-Tournoux, A.; Farahmand, P.; Bellamy, V.; Autret, G.; Mnager, C.; Hagge, A.; Larghro, J.; Gazeau, F.; Clment, O.; Menasch, P. Can Magnetic Targeting of Magnetically Labeled Circulating Cells Optimize Intramyocardial Cell Retention? Cell Transplant. 21 (4):679-691; 2012.

Journal reference: Cell Transplantation

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Magnet helps target transplanted iron-loaded cells to key areas of heart

HemoGenix® FDA Master File to Measure Blood Stem Cell Potency for Cellular Therapy Products:

By adminJune 26, 2012Uncategorized

COLORADO SPRINGS, Colo.--(BUSINESS WIRE)--

HemoGenix announced today that FDA CBER has given HemoGenix its first Master File Number for an in vitro blood stem cell potency, quality and release assay (HALO-96 PQR) (1)for cellular therapy products(2)used for stem cell transplantation purposes. HALO-96 PQR is the first commercially available stem cell potency assay for cellular therapy products. It incorporates the most sensitive readout available to measure changes in the cells energy source (ATP) as a function of the potential for stem cells to proliferate. Potency and quality of stem cell therapeutic products are required to be measured prior to use to help predict the engraftment of the cells in the patient. At the present time, tests such as cell number, viability and a stem cell marker called CD34 are routinely used. However, none of these tests specifically measure stem cells and none determine the stem cell biological activity required for a potency assay. The only cell functionality test presently used in this field, especially for umbilical cord blood transplantation, is the colony-forming unit (CFU) assay, which is subjective, non-validated and has been used since the early 1970s. HALO-96 PQR changes this paradigm. It is particularly needed in the umbilical cord blood stem cell transplantation field by providing an application-specific test incorporating all of the compliance characteristics required not only by regulatory agencies(3) and standards organizations, but also the cord blood community(4).

Stem cell potency is one of the most important parameters necessary for any therapeutic product, especially stem cells. Without it, the dose cannot be defined and the transplantation physician has no indication as to whether the product will engraft in the patient. The number of cord blood units collected and stored and the number of cord blood stem cell transplantations have increased exponentially over the last 12 years. During this time, significant advancements have been made in pre- and post stem cell transplantation procedures. Yet the tests used during the preparation and processing of the cells have remained unchanged and do not even measure the biological functionality of the stem cells being transplanted. Indeed, the standards organizations responsible for applying regulatory guidance to the community have so far failed to allow any new and alternative assays to be used during cord blood processing. HALO-96 PQR is the first test that actually quantitatively characterizes and defines the stem cells in cord blood, mobilized peripheral blood or bone marrow as high quality and potent active ingredients for release prior to transplantation. Presently, approximately 20% engraftment failure is encountered in cord blood transplantation. HALO-96 PQR could help reduce the risk of engraftment failure by providing valuable and time-sensitive information on the stem cells prior to use. HALO-96 PQR complies with the guidelines not only with the cord blood community, but also with regulatory agencies thereby providing a benefit to both the stem cell transplantation center and the patient, said Ivan Rich, Founder and CEO of HemoGenix (www.hemogenix.com).

About HemoGenix, Inc.

HemoGenix is a privately held Contract Research Service and Assay Development Laboratory based in Colorado Springs, Colorado. Specializing in predictive in vitro stem cell toxicity testing, HemoGenix provides its services to small, medium and many of the largest biopharmaceutical companies. HemoGenix has developed several assays for stem cell therapy and regenerative medicine applications. These and other patented and proprietary assays are manufactured and produced in Colorado Springs and sold worldwide. HemoGenix has been responsible for changing the paradigm and bringing in vitro stem cell hemotoxicity testing into the 21st century. With HALO-96 PQR the company is now also changing the paradigm to become a leader in stem cell therapy assays. To this end, HemoGenix is a member of the Alliance for Regenerative Medicine and working with other companies to decrease risk and improve safety for the patient.

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HemoGenix® FDA Master File to Measure Blood Stem Cell Potency for Cellular Therapy Products:

FDA Criticizes Perry’s Stem Cell Lab

By adminJune 26, 2012Stem Cell Treatment

HOUSTON (AP) - The U.S. Food and Drug Administration has issued a new report criticizing the Texas company that stored adult stem cells from Texas Gov. Rick Perry for use in an experimental procedure for his back pain, according to a newspaper report Monday.

An FDA report obtained by the Houston Chronicle said CellTex Therapeutics cannot guarantee the stem cells it takes from patients remain sterile and alive. The nine-page report dated April 27 says the lab, located in the Houston suburb of Sugar Land, does not have procedures to prevent contamination of products that are supposed to be sterile.

The report also says the lab didnt have written records of investigations into the failure of a batch of cells. It also says the lab has not marked some lab products properly.

The deficiencies identified reflect significant problems, serious issues, said Paul Knoepfler, an associate professor at the University of California-Davis School of Medicine, in an interview with the newspaper. If I were a patient, they would scare me off big time.

CellTex was thrust into the news last year when Perry, then running for the Republican nomination for president, revealed that he had stem cells taken from fat in his body, grown in a lab and then injected into his back during a July operation to address his back pain.

Perrys stem cells were stored and grown at CellTex, the Chronicle reported. The firm is co-owned by Dr. Stanley Jones, Perrys friend who performed the operation.

Subsequently, the Texas Medical Board approved new rules on similar experimental stem cell therapies. Perry appointed the board. The FDA has not approved any adult stem cell therapies for orthopedic use, but experimentation by doctors in the U.S. and abroad is common.

Some scientists tout possible benefits of stem cell treatments, including treatment for heart disease, diabetes and some cancers. Others argue adult stem cell experimentation actually increases the risk of cancer and can cause blood clots.

A Perry spokeswoman called Perrys surgery a success and reaffirmed his commitment to adult stem cell research. She said the FDA report was between the agency and CellTex.

CellTex CEO David Eller said the company invited the FDA inspection, which took place over nearly two weeks in April, according to the report.

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FDA Criticizes Perry’s Stem Cell Lab