Stem Cell Clinic

Stem-cell pioneer banks on future therapies

Shinya Yamanaka aims to produce cell lines from fetal blood cells.

M. Naka/Aflo/Newscom

Progress toward stem-cell therapies has been frustratingly slow, delayed by research challenges, ethical and legal barriers and corporate jitters. Now, stem-cell pioneer Shinya Yamanaka of Kyoto University in Japan plans to jump-start the field by building up a bank of stem cells for therapeutic use. The bank would store dozens of lines of induced pluripotent stem (iPS) cells, putting Japan in an unfamiliar position: at the forefront of efforts to introduce a pioneering biomedical technology.

A long-held dream of Yamanakas, the iPS Cell Stock project received a boost last month, when a Japanese health-ministry committee decided to allow the creation of cell lines from the thousands of samples of fetal umbilical-cord blood held around the country. Yamanakas plan to store the cells for use in medicine is a bold move, says George Daley, a stem-cell biologist at Harvard Medical School in Boston, Massachusetts. But some researchers question whether iPS cells are ready for the clinic.

Yamanaka was the first researcher to show, in 2006, that mature mouse skin cells could be prodded into reverting to stem cells1 capable of forming all bodily tissues. The experiment, which he repeated2 with human cells in 2007, could bypass ethical issues associated with stem cells derived from embryos, and the cells could be tailor-made to match each patient, thereby avoiding rejection by the immune system.

Japan is pumping tens of millions of dollars every year into eight long-term projects to translate iPS cell therapies to the clinic, including a US$2.5-million-per-year effort to relieve Parkinsons disease at Kyoto Universitys Center for iPS Cell Research and Application (CiRA), which Yamanaka directs. That programme is at least three years away from clinical trials. The first human clinical trials using iPS cells, an effort to repair diseased retinas, are planned for next year at the RIKEN Center for Developmental Biology in Kobe.

Those trials will not use cells from Yamanakas Stock. But if they or any other iPS cell trials succeed, demand for the cells will explode, creating a supply challenge. Deriving and testing iPS cells tailored to individual patients could take six months for each cell line and cost tens of thousands of dollars.

Yamanakas plan is to create, by 2020, a standard array of 75 iPS cell lines that are a good enough match to be tolerated by 80% of the population. To do that, Yamanaka needs to find donors who have two identical copies of each of three key genes that code for immune-related cell-surface proteins called human leukocyte antigens (HLAs). He calculates that he will have to sift through samples from some 64,000 people to find 75 suitable donors.

Using blood from Japans eight cord-blood banks will make that easier. The banks hold some 29,000samples, all HLA-characterized, and Yamanaka is negotiating to gain access to those that prove unusable for other medical procedures. One issue remains unresolved: whether the banks need to seek further informed consent from donors, most of whom gave the blood under the understanding that it would be used for treating or studying leukaemia. Each bank will determine for itself whether further consent is needed.

Yamanaka has already built a cell-processing facility on the second floor of CiRA and is now applying for ethics approval from Kyoto University to create the stock. Takafumi Kimura, a CiRA biologist and head of the projects HLA analysis unit, says that the team hopes to derive the first line, carrying a set of HLA proteins that matches that of 8% of Japans population, by next March.

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Stem-cell pioneer banks on future therapies

Marin Dog Receives Relief From Stem Cell Treatment

Stem-cell research is benefiting at least one living creature in Marin County, who would otherwise be living in excruciating athritic pain.

Emma -- the snow-white German shepherd.

Vets at the Northbay Animal Hospital injected the dog with stem cells into 10 of her joints, according to the Marin Independent Journal. The $2,000 treatment has given the 9-year old, 80-pound dog a new lease on live, her owners say.

"She doesn't limp any more," said owner Arthur Latno, in comments to the newspaper, "and she doesn't cry."

Latno is "one of the first" Marin pet owners to try the cutting-edge treatment, which not every vet is willing to endorse, the newspaper reported.

"This (the stem cell procedure) is incredibly promising, but on the other hand there is a lot of homework that needs to be done to determine whether these are valid therapeutic measures," John Peroni, an associate professor at the University of Georgia College of Veterinary Medicine and chairman of the North American Veterinary Regenerative Medicine Association told the newspaper.

More studies, like the ones Peroni as well as counterparts at UC Davis are conducting, are neeed, he said.

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Marin Dog Receives Relief From Stem Cell Treatment

Cytomedix Announces Medicare Coverage for Autologous PRP Gel in Chronic Wound Care

GAITHERSBURG, MD--(Marketwire -08/06/12)- Cytomedix, Inc. (CMXI) (CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Centers for Medicare & Medicaid Services ("CMS") has issued a final National Coverage Determination ("NCD") for autologous blood-derived products for chronic non-healing wounds. As previously reported, on May 9, 2012 CMS posted its proposed NCD, which was followed by a 30-day public comment period that ended on June 8th. In the final decision memo released August 2nd, CMS responded to these comments, refined its decision and confirmed coverage for autologous platelet rich plasma ("PRP") in patients with diabetic, pressure and/or venous wounds via its Coverage with Evidence Development ("CED") program. CED is a process through which CMS provides reimbursement coverage for items and services while generating additional clinical data to demonstrate their impact on health outcomes.

In the final decision memo, CMS noted that it " ...has reviewed the medical literature on autologous PRP in patients with chronic wounds and believes that CED is appropriate for PRP treatment," and concluded that, "when reviewed as a body of evidence, it does indicate that PRP shows promise in the populations of interest to CMS."

"We are extremely pleased with the decision by CMS to provide coverage for autologous blood-derived products for chronic non-healing wounds through the CED program. This determination reverses a nearly 20 year non-coverage determination for PRP and provides for an appropriate research study with practical study designs we are confident will demonstrate that patients treated with our autologous PRP product, the AutoloGel System, experience clinically significant health outcomes," commented Martin P. Rosendale, Chief Executive Officer of Cytomedix.

"Importantly, we believe this decision by CMS bodes well for our ongoing discussions with a top 20 global pharmaceutical company for a favorable long-term arrangement in the U.S. wound care market, as clarity around the CED evidentiary requirements was a necessary element of the commercial market assessment," added Mr. Rosendale. "In the meantime, our discussions for a distribution agreement to be executed prior to month's end are progressing well."

Related to the evidentiary requirements, CMS outlined in the final decision memo that a research study that uses data collected by a registry can enhance its persuasiveness if it has the following attributes:

Mr. Rosendale added, "This decision appears to indicate that our recent interactions with CMS have been productive, as CMS has acknowledged the rationale we presented for a comprehensive research study that can appropriately encompass practical study designs to meet the evidentiary requirements of CMS. We look forward to continuing to work with CMS in the coming weeks in further defining the specifics of the protocols for the research studies and clinical questions to be answered through the CED program."

The complete final decision memo is available on the CMS website at: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=260.

About Coverage with Evidence Development Program

CED is a process through which CMS provides conditional payment for items and services while generating additional clinical data to demonstrate their impact on health outcomes. CED is an evolving paradigm used by CMS to bring a new rationale to coverage decisions and, ultimately, cost savings to the Medicare program.

First introduced in 2005 and then refined in 2006, CED links Medicare coverage of specific promising technologies to a requirement that patients participate in a registry or clinical trial. Ultimately, the data generated is intended to be used as the basis for future coverage decisions once it is determined whether a treatment is reasonable and necessary. CED has also been referred to as a way to develop a "learning-based health care system" and the coverage to support it.

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Cytomedix Announces Medicare Coverage for Autologous PRP Gel in Chronic Wound Care

Pluristem stem cell therapy saves woman with bone marrow failure

The share price of Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) is soaring on the TASE, after the company announced that its placental stem cell therapy, Placental eXpanded (PLX), saved the life of a 54-year old Israeli woman suffering from terminal bone marrow failure. This was the second successful treatment of a patient with bone marrow failure in three months, under compassionate use protocols. The PLX therapy was administered at Hadassah Medical Center in Jerusalem.

The patient, who was diagnosed with lymphoma cancer, failed to respond to chemotherapy and bone marrow transplants. Intermuscular injection of PLX cells improved the woman's clinical condition and blood count, and she was released from the isolation unit and subsequently discharged from the hospital.

"This is a real breakthrough - the woman was in isolation due to low white blood cells and high susceptibility to infections and in addition her red blood cells and platelets were low, leading to a very dangerous and life-threatening situation," said Professor Reuven Or, Director of Bone Marrow Transplantation and Cancer Immunology at Hadassah. "Further, autologous bone marrow transplantation that she received engrafted poorly, and as a last resort, we applied for a compassionate treatment using Pluristem's PLX cells based on our previous experience with those cells. The treatment with PLX has saved her life and can certainly be classified as a medical miracle."

Prof. Or added, "The result of this unique case demonstrates that PLX cells could potentially be effective for use in cancer patients, who receive bone marrow transplantation following severe radiation and chemotherapy treatments, which severely damage their bone marrow."

Pluristem is preparing to apply for Orphan Drug Status for its PLX cells with the US Food and Drug Administration (FDA) for the treatment of aplastic bone marrow. The bone marrow transplant market is an estimated $1.3 billion per year in the US alone, based on 30,000 bone marrow transplants in the US per annum.

In May, Pluristem announced that a seven year-old girl, whose condition was rapidly deteriorating due to an aplastic bone marrow, experienced a reversal of her condition with a significant increase in her red blood cells, white blood cells and blood platelets following the intramuscular injection of the company's PLX cells. The patient has subsequently been released from the hospital and returned home."

Pluristem's share price rose 14.2% by midday on the TASE today to NIS 14.92, following the announcement, after rising 3.4% on Nasdaq on Friday to $3.31, giving a market cap of $148 million.

Published by Globes [online], Israel business news - http://www.globes-online.com - on August 6, 2012

Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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Pluristem stem cell therapy saves woman with bone marrow failure

San Rafael dog gets arthritis relief from stem cell treatment

Emma, a snow-white German shepherd, has been plagued with arthritis for two years, limping and sometimes crying out in pain. But an innovative new procedure using her own stem cells has helped, her veterinarian and owner say.

"Her joint mobility has improved. I can move her elbows into a flexed position now," said Kristina Hansson, a veterinarian with San Rafael's Northbay Animal Hospital. Hansson injected Emma's own stem cells into 10 of her joints three months ago in a yet-unproven procedure that cost about $2,000, promoted by MediVet America, a Kentucky company.

"We're very pleased," said Arthur Latno of San Rafael, owner of the 9-year-old, 80-pound dog. "She doesn't limp any more and she doesn't cry."

Latno is not the only dog owner in the United States with such concerns; an estimated 8 million American dogs suffer from the degenerative condition. When acupuncture and other remedies didn't have a lasting effect on Emma's pain, Latno was happy to spend the money in hopes of helping his pet.

He is apparently one of the first Marin pet owners to do so. Though there are some practitioners in Marin who use stem cell therapy, it is not yet widespread, according to Andrew Lie, a veterinarian at the East San Rafael Veterinary Clinic and president of the Marin County Veterinary Medical Association.

Lie himself doesn't use the therapy. "Personally, I think I would wait to see more research and studies come out. I think it's a little early

"This (the stem cell procedure) is incredibly promising, but on the other hand there is a lot of homework that needs to be done to determine whether these are valid therapeutic measures," said John Peroni, an associate professor at the University of Georgia College of Veterinary Medicine.

Peroni also chairs the North American Veterinary Regenerative Medicine Association. Peroni himself, along with colleagues at other universities including the University of California at Davis, is engaged in controlled clinical trials involving stem cells and animals. When such trials, peer-reviewed work and long-term studies are published, the effectiveness of the procedures will be easier to determine.

Dogs aren't the only mammals getting stem cell therapy for arthritis. The treatment is being used on humans as well. One example is the Centeno-Schultz Clinic in Broomfield, Colo, which offers a treatment called Regenexx that has received a good deal of media coverage. As with the animal procedure, it involves using a patient's own stem cells.

When the term "stem cells" is used, it brings to mind controversial procedures involving human embryos. In the MediVet procedure, however, the stem cells come from the animal's own body.

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San Rafael dog gets arthritis relief from stem cell treatment

Pluristem stem cells save second patient with bone marrow failure

Pluristem Therapeutics said another patient suffering from bone marrow failure was saved using its placenta-based stem cell treatment.

This is the second time in three months that a patient suffering from bone marrow failure was successfully treated with its PLX cells, the Israeli company said on Monday.

The patient, a 54 year-old woman with lymphoma cancer, was treated with chemotherapy but her condition continued to deteriorate, necessitating a bone marrow transplant. The transplant, as well as alternate therapies, were not successful.

Pluristem's PLX cells were then administered to the patient at Jerusalem's Hadassah Medical Center under the Israeli government's compassionate use program.

Following the injection of the PLX cells intramuscularly, the woman's clinical condition and blood counts improved to the point where the patient was released from the isolation unit and subsequently discharged from the hospital.

"This is a real breakthrough - the woman was in isolation due to low white blood cells and high susceptibility to infections and in addition her red blood cells and platelets were low, leading to a very dangerous and life-threatening situation," Reuven Or, director of bone marrow transplantation and cancer immunology at Hadassah, said in a statement.

"The treatment with PLX has saved her life and can certainly be classified as a medical miracle."

The improvements observed in this and a previous patient treated with PLX cells demonstrate that these cells could potentially assist in the recovery of bone marrow following bone marrow transplant failure or other conditions where the bone marrow is significantly compromised, Pluristem said.

The company said last month it is preparing to apply for orphan drug status for its PLX cells with the U.S. Food and Drug Administration for the treatment of aplastic bone marrow.

The U.S. bone marrow transplant market is an estimated $1.3 billion a year, based on 30,000 bone marrow transplants.

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Pluristem stem cells save second patient with bone marrow failure

Stem Cell Therapy Could Offer New Hope For Head, Mouth Injuries, Defects

ANN ARBOR In the first human study of its kind, researchers found that using stem cells to re-grow craniofacial tissues mainly bone proved quicker, more effective and less invasive than traditional bone regeneration treatments.

Researchers from the University of Michigan School of Dentistry and the Michigan Center for Oral Health Research partnered with Ann Arbor-based Aastrom Biosciences Inc. in the clinical trial, which involved 24 patients who required jawbone reconstruction after tooth removal.

Patients either received experimental tissue repair cells or traditional guided bone regeneration therapy. The tissue repair cells, called ixmyelocel-T, are under development at Aastrom, which is a UM spinout company.

For a video of the procedure, see: http://youtu.be/lWu_DEJfZVk

In patients with jawbone deficiencies who also have missing teeth, it is very difficult to replace the missing teeth so that they look and function naturally, said Darnell Kaigler, principal investigator and assistant professor at the UM School of Dentistry. This technology and approach could potentially be used to restore areas of bone loss so that missing teeth can be replaced with dental implants.

William Giannobile, director of the Michigan Center for Oral Health Research and chair of the UM Department of Periodontics and Oral Medicine, is co-principal investigator on the project.

The treatment is best suited for large defects such as those resulting from trauma, diseases or birth defects, Kaigler said. These defects are very complex because they involve several different tissue types bone, skin, gum tissue and are very challenging to treat.

The main advantage to the stem cell therapy is that it uses the patients own cells to regenerate tissues, rather than introducing man-made, foreign materials, Kaigler said.

The results were promising. At six and 12 weeks following the experimental cell therapy treatment, patients in the study received dental implants. Patients who received tissue repair cells had greater bone density and quicker bone repair than those who received traditional guided bone regeneration therapy.

In addition, the experimental group needed less secondary bone grafting when getting their implants.

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Stem Cell Therapy Could Offer New Hope For Head, Mouth Injuries, Defects

Aurka-to-p53 signaling: A link between stem cell regulation and cancer

ScienceDaily (Aug. 3, 2012) Researchers at Mount Sinai School of Medicine, the University of Manchester, and the MD Anderson Cancer Center have found a new role for an oncogenic signaling pathway in embryonic stem cell (ESC) self-renewal and in reprogramming adult cells into an ESC-state, which will aid in the development of future cancer therapies.

The findings promote the understanding of the self-renewal mechanism in embryonic stem cells and provide insight into the role of Aurka, an oncoprotein that is amplified in several human cancers. The research is published in the August 3rd issue of the journal Cell Stem Cell.

Embryonic stem cells (ESCs) and, more recently, induced pluripotent stem cells (iPSCs) hold great promise for biomedicine as a major source of differentiated cells for developing new ways to study disease etiology, the development of more effective drugs and diagnostic methodologies, and for future transplantation-based therapies. Cancer cells and ESCs can both proliferate indefinitely and show some similarities.

The researchers, a team at Mount Sinai School of Medicine led by Ihor Lemischka, PhD, Director of the Black Family Stem Cell Institute, in collaboration with groups at the University of Manchester and the MD Anderson Cancer Center, applied a functional genomics strategy and identified the protein kinase Aurora A (Aurka) as an essential component of ESC function.

These studies showed that Aurka functions by inactivating the well-known tumor suppressor gene p53. The p53 protein acts as the "guardian of the genome" and mutations as well as deletions of the p53 gene are associated with a wide range of tumors.

In the absence of Aurka, up-regulated p53 signaling causes ESCs to differentiate and thus lose their stem cell state. By connecting the loss of Aurka to re-activation of p53 it was shown that Aurka adds a phosphate group (a process called phosphorylation) to a single amino acid in p53, thus shifting ESCs from a differentiation-prone state to self-renewal.

"These studies are exciting not only from a basic science point-of-view, but also because they suggest that stem cell research may impact the development of novel treatments for cancer. Conversely, cancer research may facilitate the realization of the biomedical potential of stem cells," said Dr. Lemischka.

Interestingly, in contrast to the low p53 levels in mature cells, this protein is highly expressed in ESCs and iPSCs. In addition, p53 has a limited role in promoting apoptosis -- the process of programmed cell death -- and cell cycle inhibition in pluripotent cells. The present findings provide a possible explanation to an unsolved mystery.

The study will aid in developing future cancer therapies and support the science underlying multiple clinical trials using Aurka inhibitors that are currently used to treat cancers.

The study was spearheaded by Dung-Fang Lee, a New York Stem Cell Foundation-Druckenmiller Post-Doctoral Fellow, and Jie Su, a graduate student, both in the Lemischka laboratory.

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Aurka-to-p53 signaling: A link between stem cell regulation and cancer

Aaron Curry using stem cell therapy to help knees

AP

Raiders linebacker Aaron Curry isnt sure when hell be able to get back on the field, but hes pretty sure that stem cell therapy will be the thing that winds up getting him back there.

Paul Gutierrez of CSNBayArea.com reports that Curry has received the therapy on both of his knees. Bone marrow from his hips was used in the treatment and Curry told Gutierrez that it is the only thing hes tried that has helped him feel better. Curry is still working out on the side during Raiders practices and said hell only return to practice when hes fully able to help the Raiders.

My goal is to get healthy and just go out there and be violent, be fast, be a pain in the offenses butt and whatever I have to do on the defense, do it, Curry said. And do it full speed. I cant do that until my body says its ready.

The treatment has been popular with Oakland athletes. Linebacker Rolando McClain said that the treatment helped his legs feel better earlier this offseason and As pitcher Bartolo Colon has credited stem cell treatment on his shoulder with saving his baseball career.

With McClain facing a possible suspension under the Personal Conduct Policy and Oakland short on linebacking depth, the Raiders need Curry to be healthy for the start of the season.

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Aaron Curry using stem cell therapy to help knees