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

Stem Cell Therapy May Fix Defects From Injuries To Head And Mouth

Editor's Choice Main Category: Stem Cell Research Article Date: 03 Aug 2012 - 14:00 PDT

Current ratings for: Stem Cell Therapy May Fix Defects From Injuries To Head And Mouth

The clinical trial was a collaboration of researchers from the University of Michigan School of Dentistry and the Michigan Center for Oral Health Research together with Ann Arbor-based Aastrom Biosciences Inc. involving 24 patients who required jawbone reconstruction after tooth removal. The researchers divided the patients into two groups, with one group receiving experimental tissue repair cells (ixmyelocel-T) and the other group receiving traditional guided bone regeneration therapy. The tissue repair cells ixmyelocel-T are currently being development at Aastrom.

Leading investigator Darnell Kaigler, who is assistant professor at the U-M School of Dentistry said:

Kaigler stated that the treatment is best suited for large defects, like those resulting from trauma, diseases or birth defects, since these are very challenging to treat due to their complex nature of requiring various different tissue types, including bone, skin and gum tissue.

He continued saying that the key advantage of using stem cell therapy is that the patient's own cells are used to regenerate tissue instead of using man-made, foreign materials.

The study achieved promising results. Study participants in the cell therapy group received dental implants at 6 and 12 weeks after their experimental cell therapy and were noted to have a greater bone density and quicker bone repair compared with those who underwent traditional guided bone regeneration therapy. They also needed less secondary bone grafting when receiving their implants compared with the traditional bone regeneration group.

The team used cells extracted from the patient's hip bone marrow, which was subsequently processed using Aastrom's proprietary system. This allows the growths of many different cells, including stem cells, which were then relocated into different areas in the patient's mouth and jaw.

Kaigler concluded saying that stem cell therapies are still probably 5-10 years away from becoming a standard treatment for oral and facial injuries and defects and that more clinical trials need to be conducted, which include a larger number of patients with larger craniofacial defects.

Written by Petra Rattue Copyright: Medical News Today Not to be reproduced without permission of Medical News Today

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Stem Cell Therapy May Fix Defects From Injuries To Head And Mouth

Stem Cell Therapy Space Worth Review for Investors

By Tedra DeSue - August 3, 2012 | Tickers: BAX, OSIR | 0 Comments

Tedra is a member of The Motley Fool Blog Network -- entries represent the personal opinions of our bloggers and are not formally edited.

Advances continue to be made in the field of regenerative medicine, with many products and procedures being made possible from stem cell therapy. While large companies are making headway in this area, many small companies are just as active, raising much-needed funds through the capital markets.

The main challenge all of these companies face is convincing naysayers that their research and subsequent results are ethical. There has been much ado about regenerative medicine efforts that involve stem cells. This has especially been the case for research and therapy involving human embryonic stem cells. For this reason, investors who may be bullish about the industry may avoid these stocks.

The stem cell market is expected to grow to be a $5.1 billion industry by 2014. One of the reasons stem cell research is important to these companies is that it can help them grow their pipelines, according to a research report on the industry Stem Cells in Regenerative Medicine: Benchmarking Analysis of Big Companies Entering the Market.Researchers also see stem cell research as a way to find out the effectiveness of therapies without having to use animals for testing.

Lets take a look at a few of the public companies that have made strides in the stem cell therapy space.

One of the largest pharmaceutical companies active in the stem cell therapy space is Baxter Healthcare (NYSE: BAX). It is in the process of developing stem cell therapy for people who suffer from chronic myocardial ischemia or CMI. The condition stems from coronary artery disease. The company is in the midst of clinical trials to prove that its therapy can repair damaged heart muscles. Its referred to as stem cell therapy CD34+.

Also noteworthy for Baxter is a purchase it made last year. It bought Synovis Life Technologies, which made a name for its self because of the mechanical and biological products it made to repair soft tissue. The acquisition is expected to help Baxter further expand its offerings in the biosurgery and regenerative treatment.

Osiris Therapeutics (NASDAQ: OSIR) accomplished an important feat in the stem cell space by becoming the first company in the world to be able to market its stem cell therapy called Prochymal. On that news in May, its stock traded 20% higher, indicating that investors have more confidence in stocks in this space when they have some kind of meaningful approval by regulators. This product was approved by Health Canada.

Now the company is embroiled in a battle over Prochymal with a French pharmaceutical company that it partnered with to test the therapy. News that the sides have been unable to resolve their differences sent Osiriss stock lower this week. At the time of writing, it had lost 5.32% of its value and was trading around $9.

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Stem Cell Therapy Space Worth Review for Investors

Is it drug manufacturing or the practice of medicine? Stem cell therapy debate just getting started

The latest round of a stem cell debate may have concluded, but as far as the lawyers representing an orthopedics company that has offered stem cell treatments are concerned, its a long way from over.

The lawyers representing Colorado-based Regenerative Science said they were filing a notice of appeal this week after a U.S. District Court judges ruling in favor of the U.S. Food and Drug Administration that its stem cell therapy is a drug. The case is being closely watched by everyone with a stake or an interest in the use of stem cells in medicine and could have significant ramifications for stem cell entrepreneurs who dont believe their procedures amount to a drug or biologic.

Regenerative Science

Colorado-based Regnerative Sciences Regenexx procedure is presented as an alternative to traditional surgery that can treat fractures that have failed to heal, joint cartilage problems, partial tears of tendons, muscles, or ligaments, among other problems. It works like this: A physician takes a small bone marrow sample from the back of the patients hip through a needle. Blood samples are taken from a vein in the patients arm. The samples are sent to the Regenerative laboratory where the mesenchymal stem cells are isolated from the bone marrow and grown to greater numbers using growth factors in the patients blood. The stem cells are injected back into the relevant area in the patient.

The FDA initially sent a warning letter to Regenerative in 2008 after seeing its website. The company turned around and sued the FDA, and two years ago the FDA sought an injunction to shut it down.

The companies that occupy the stem cell treatment landscape are as diverse a group as you could hope to find in medicine. Some offer age-defying beauty solutions, others provide life-saving technology, others have quality-of-life-improving treatments for joints and muscles. There are entrepreneurs leading startups and Big Pharma companies too.

In 2010, the stem cell therapy market was $139.6 million and it was projected to grow to $1 billion by 2015, according to data compiled by Robin Young, the publisher of Orthopedics Week and the CEO of medical data mining company PearlDiver Technologies.

This is on the very cutting edge of medicine and the FDA needs to move forward with it by making sure they have the best information on this science available to inform their decision-making,said Michelle Hart Yeary, counsel with Decherts life science practice.

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ACT Announces First Dry AMD Patient Treated with Higher Dosage of Embryonic Stem Cell-Derived RPE Cells

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fourth patient, the first in the second patient cohort, in the companys Phase I/II clinical trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The surgery was performed on Wednesday, Aug. 1 atWills Eye Institutein Philadelphia, by a surgical team lead by Carl D. Regillo, M.D., Chief of the Wills Eye Institute Retina Service, and professor of ophthalmology at Thomas Jefferson University. The patient was injected with 100,000 hESC-derived RPE cells and is recovering uneventfully.

We are very pleased to have the second dose cohort in both of our U.S. clinical trials underway, commented Gary Rabin, chairman and CEO of ACT. We are encouraged by our ongoing progress in all three of our clinical trials using our hESC-derived RPE cells to treat forms of macular degeneration. We have not observed any complications or side effects from the stem cell-derived RPE cells, and we will continue to monitor the patients for safety, tolerability and efficacy of this therapy.

The dry AMD trial is one of three clinical trials being carried out by the company in the U.S. and in Europe. Each trial will enroll 12 patients, with cohorts of three patients in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD or Stargardt's macular dystrophy (SMD) at 12 months, the studys primary endpoint. Preliminary results from the two U.S. trials were reported in The Lancet earlier this year.

Doubling the cell dosage in both our U.S. trials is an important step forward in our clinical programs, said Robert Lanza, M.D., ACTs chief scientific officer. We anticipate continued progress and safety findings in both our U.S. trials as well as our concurrent European trial.

Dry AMD is the most common cause of vision loss in patients over 50 years and affects around 30 million people worldwide, said Dr. Regillo. Dry AMD is a form of macular degeneration with no approved drug treatment available to date. ACTs hESC-derived RPE cells could address the unmet medical need of combating dry AMD and other macular degenerations such as Stargardts disease. We are looking forward to analyzing the safety and efficacy data.

Further information about patient eligibility for ACTs dry AMD study and the concurrent studies in the U.S. and the E.U. for SMD is available atwww.clinicaltrials.gov,with the following Identifiers: NCT01344993 (dry AMD), NCT01345006 (U.S. SMD), and NCT01469832 (E.U. SMD).

About dry AMD

Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. Age-related macular degeneration (AMD) is the leading cause of blindness in people over age 60 in the United States, and the vast majority of cases of AMD are of the dry form, which is currently untreatable.

About Advanced Cell Technology, Inc.

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ACT Announces First Dry AMD Patient Treated with Higher Dosage of Embryonic Stem Cell-Derived RPE Cells