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Pluristem Therapeutics is an Israeli company engaged in the development of human placental adherent stromal cells for commercial use in disease treatment. According to the company's website, it extracts adult stem cells exclusively from postnatal placentas. In 2012 a procedure involving a stem cell treatment developed by Pluristem saved the life of a 7-year-old girl suffering from bone marrow aplasia. Wikipedia.

Kranz A.,Fraunhofer Institute for Cell Therapy and Immunology | Wagner D.-C.,Fraunhofer Institute for Cell Therapy and Immunology | Kamprad M.,University of Leipzig | Scholz M.,University of Leipzig | And 8 more authors.
Brain Research | Year: 2010

The beneficial effects of bone marrow-derived mesenchymal stromal cell (MSC) administration following experimental stroke have already been described. Despite several promising characteristics, placenta-derived MSC have not been used in models of focal ischemia. The aim of the current study is to investigate the impact of intravenously transplanted placenta-derived MSC on post-stroke recovery. Permanent occlusion of the middle cerebral artery was induced in spontaneously hypertensive rats. MSC were obtained from the human maternal or fetal placenta and intravenously administered after 24 h (single transplantation) or after 8 h and 24 h (dual transplantation). Sensorimotor deficits were quantified for 60 days using the beam walk test and the modified Neurological Severity Score system. Infarct volume was determined in vivo by means of magnetic resonance imaging on days 1, 8, 29 and 60. Astroglial reactivity was semiquantitatively ascertained within a small and a broad region adjacent to the lesion border. The double infusion of placental MSC was superior to single transplantation in the functional tests. However, a significant difference to the control group in all outcome parameters was observed only for maternally derived MSC. These findings suggest that placental tissue constitutes a promising source for experimental stroke therapies. © 2009 Elsevier B.V. All rights reserved.

A new animal study presented this week at the American Society of Hematology’s Annual Meeting in Orlando, shows promise for a cell therapy derived from the human placenta, as a way to restore bone marrow damage caused by high levels of radiation. The therapy, called PLX-R18 was developed by Israeli biotech company Pluristem Therapeutics Inc., and was created to treat bone marrow that cannot produce blood cells due to a number of reasons, including certain cancers or cancer treatments, and acute radiation syndrome (ARS). Researchers presented findings that show the mechanism of action by which the therapy treats radiation-induced bone marrow damage in mice. The study will be published online in the journal Blood. “We have a growing body of preclinical evidence demonstrating PLX-R18’s profound capacity to generate and regulate an adaptive cell response to in vivo chemical signals from damaged tissue. This response, a tailored, time-dependent secretion of a broad array of cytokines that contribute to the healing of the hematopoietic and immune systems, was shown to protect and restore bone marrow function,” Pluristem CEO Zami Aberman said in a prepared statement.

An Israeli biotechnology firm is harvesting stem cells from human placentas that appear to successfully treat multiple sclerosis, diabetes, alcoholism, and even sports-related injuries. Pluristem Therapeutics processes stem cells obtained from donors' placentas into a variety of ready-to-use medications, which is more than just cool science—it's also an indication of where biotech will be headed over the next decade. Pluristem CEO Zami Aberman told Fast Company that the stem cells obtained from "one placenta can help treat 10,000 people." The company's latest project is a preclinical trial at New York University to test whether placenta-derived stem cells can be used to treat diabetic foot ulcers. Diabetic foot ulcers occur in more than 10% of all patients with the disease and frequently lead to amputation. Doctors at NYU are hoping that the stem cells can help successfully grow new blood vessels from pre-existing blood vessels in patients' feet and to help aid in tissue regeneration. The core of Pluristem's arsenal of stem cells consists of a proprietary line marketed under the name of PLacental eXpanded (PLX). The PLX cells are developed from adherent stromal cells harvested from human placentas following birth that are then placed in a bioreactor for several weeks. The bioreactor expands the cells, which are later separated from the culture used in the bioreactor. According to Aberman, potential donors sign a consent form allowing for their placentas to be used for stem cell extraction. The cells are then extracted using a proprietary method in the bioreactor shortly after. Pluristem currently markets PLX cells for the treatment of multiple sclerosis, peripheral artery disease, inflammatory bowel disease, and for stroke recovery. The company's reports indicated that stem cell treatment helped improve post-stroke physical coordination: Patients receiving treatment with the PLX cells have them directly injected into the target area. Other stem cell products marketed or tested by Pluristem appear to help patients with chronic pain, sports injuries, and side effects from alcoholism. A medical test in Germany appears to indicate that placenta-derived stem cells can be used to treat neuropathic pain from causes such as diabetes, chemotherapy, and long-term alcohol abuse. Meanwhile, the company is attempting to test the usefulness of their PLX cells for treatment of sports injuries such as hamstring tears. This will include a Investigational New Drug (IND) application and a Phase II clinical trial of Pluristem's cells to test their ability to help strengthen pelvic girdle muscles after hip replacement. There are profits to be made in the area—approximately $30 billion is spent annually in the therapeutic and regenerative cellular market. It is important to note that Pluristem's method of extracting stem cells from the placenta does not involve embryos in any way. A variety of other biotech firms are marketing stem cells and banking plans obtained from other methods, including bone marrow extraction and umbilical cords. For more stories like this, follow @fastcompany on Twitter. Email Neal Ungerleider, the author of this article, here.

Israeli biotech firm Pluristem Therapeutics said it hopes its anti-radiation therapy will protect Fukushima workers decommissioning nuclear reactors and save lives in the future if ever a similar catastrophe occurs. The Haifa-based company said they have developed a placenta-based cell therapy injection that can fully cure patients with multiple organ failure caused by high radiation exposure. Pluristem Therapeutics' Vice President of Medical and Clinical Affairs Dr. Esther Lukasiewicz Hagai said cells grown from placentas donated by women who had undergone a C-section, are harvested to create a cocktail of therapeutic proteins which combat potentially lethal damage to the lungs, skin, bone marrow and gastrointestinal tract caused by radiation exposure. "We've been investigating the placenta for the last decade and we have discovered that the placenta cells have unique properties that can help the body to recover after exposure to high level of radiation," Lukasiewicz Hagai said. "We are injecting these cells to the bodies' muscles...that will help the bone marrow to recover after radiation." The effect of the treatment has been tested on different levels of radiation, including a level of radiation that could cause up to 70 percent mortality rate, Lukasiewicz Hagai said. In January Pluristem's PLX-R18 therapy was cleared by the U.S. Food and Drug Administration (FDA) for clinical trials in animals. Clinical trials which have been conducted both in the United States, with the National Institute of Health and at Hadassah-University Medical Center in Jerusalem, have shown a nearly 100 percent recovery rate in animals exposed to radiation. Yaky Yanay, President and Chief Operations Officer at Pluristem Therapeutics and co-chairman of Israel Advanced Technology Industries (IATI), said clinical trials have so far shown optimal results if the vial is injected within 48 hours of exposure to lethal radiation. "It will be very easy to use, off-the-shelf and readily available," Yanay said adding that it requires no DNA matches prior to administration into the muscle. The only other available therapy is bone marrow transplant which requires DNA compatibility and is costly, he added. In March 2011 the Fukushima Daiichi nuclear power plant suffered the worst nuclear disaster since Chernobyl 25 years earlier, following an earthquake and tsunami. The Tokyo Electric Power Co is still struggling to bring the situation inside its plant under control. It has estimated removing the melted fuel from the wrecked reactors and cleaning up the site will cost tens of billions of dollars and take decades to complete. Pluristem Therapeutics has partnered with Japan's Fukushima Medical University to test its placental-derived cellular therapy for radiation treatment and has been asked to join the United States National Institute of Allergy and Infectious Diseases program. The goal of U.S. authorities, Yanay said, is to stockpile the treatment in the U.S. in case of a nuclear catastrophe. "My wish that our therapy was available five years ago when we had the Fukushima disaster or 30 years ago when we had the Chernobyl not mentioning the Second World War which was a significant exposure to radiation," said Yanay. "Our goal is to develop...a counter measure biological defense....for Acute Radiation Syndrome for any radiation event across the globe. It can be either a terror attack or nuclear melting but I hope that our therapy will be there". Pluristem's Chief Executive Zami Aberman said the uniqueness of the therapy treatment is in its ability to treat multiple organ failure and bring full recovery from the high radiation exposure. "In radiation catastrophe the organ that are exposed to radiation are many, not only one of them. The fact that the cells have the capacity to treat multi organ failures give us the unique therapeutic potential," Aberman said. The company said it received the rights to commercialize the placenta-based cell therapy products in 2007. Israel sees a potential nuclear threat from Iran and has two nuclear reactors of its own. Israel is widely believed to have an atomic arsenal. "We are living in an area which have a variety of threats including nuclear bombs and radiation catastrophes so we developed the product in mind that those may happen. When the Fukushima disaster happened it inspired our feeling that we have to do it stronger and quicker and we developed an aggressive plan in order to bring the product into awareness and today with NIH (National Institute of Allergy and Infectious Diseases) support and the cooperation of the Fukushima center, we strongly believe that we can bring the product to cure many patients," said Aberman. The next phase is to develop treatments for disorders like Crohn's Disease and other products to treat the central nervous system.

Eaker S.,International Society for Cellular Therapy | Eaker S.,General Electric | Armant M.,International Society for Cellular Therapy | Armant M.,Harvard University | And 17 more authors.
Stem Cells Translational Medicine | Year: 2013

Cell therapy is poised to play an enormous role in regenerative medicine. However, little guidance is being made available to academic and industrial entities in the start-up phase. In this technical review, members of the International Society for Cell Therapy provide guidance in developing commercializable autologous and patient-specific manufacturing strategies from the perspective of process development. Special emphasis is placed on providing guidance to small academic or biotech researchers as to what simple questions can be addressed or answered at the bench in order to make their cell therapy products more feasible for commercial-scale production. We discuss the processes that are required for scale-out at the manufacturing level, and how many questions can be addressed at the bench level. The goal of this review is to provide guidance in the form of topics that can be addressed early in the process of development to better the chances of the product being successful for future commercialization. © AlphaMed Press 2013.

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