Researchers unveil method for creating 're-specified' stem cells for disease modeling

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In a paper in Cell Stem Cell, a team led by researchers in the Boston Children's Hospital's Stem Cell Transplantation Program reports a new approach for turning induced pluripotent stem cells (iPSCs) into hematopoietic stem and progenitor cells for in vivo disease modeling.

With this strategywhich they call re-specificationthe team, including Sergei Doulatov, PhD, and George Daley, MD, PhD, of Boston Children's, may have overcome technical barriers to generating blood disease-specific animal models from the thousands of iPSC cell lines now sitting in laboratory freezers around the world.

The main advantage of the technique lies in the raw material. The research team started with iPSCs that had already been directed to grow into myeloid progenitors, which are more closely related to the desired blood progenitors than skin or other fully differentiated cell types commonly used in stem cell experiments.

The researchers then used a select set of transcription factors to turn back the molecular clock just a little on these committed myeloid cells, turning them into blood progenitors that readily engrafted and differentiated when transplanted into mice.

The re-specification technique could help generate the large number of engraftable cells needed to create animal models from iPSCs generated from human patients suffering a range of blood disorders, such as anemias, thalassemia or sickle cell disease.

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Researchers unveil method for creating 're-specified' stem cells for disease modeling

Leading experts offer advice on generating human induced pluripotent stem cell banks

Public release date: 3-Oct-2013 [ | E-mail | Share ]

Contact: Mary Beth O'Leary moleary@cell.com 617-397-2802 Cell Press

The ability to make induced pluripotent stem cells (iPSCs) from mature cells in the body holds great potential for improved drug screening, disease modeling, and medical treatments for numerous conditions. Establishing well-characterized panels of iPSC lines that reflect the diversity of the human population and include samples from patients with a wide range of diseases will be key to tapping into the potential of iPSCs. In the October 3 issue of the Cell Press journal Cell Stem Cell, leading experts in the field publish several opinion pieces on emerging issues related to generating such iPSC banks, and they provide practical recommendations and creative solutions to address challenges associated with such large-scale efforts.

Dr. Glyn Stacey of the National Institute for Biological Standards and Control, located in the United Kingdom, and his colleagues recommend approaches for utilizing the knowledge of existing, well-established human embryonic stem cell banks and their experience in standardization to promote quality control in iPSC resource centers. "Not all laboratories will have the same level of expertise in cell culture or familiarity with vital quality control procedures. These will be essential to avoid the circulation of iPSC lines that have become contaminated or switched with other cell lines," says Dr. Stacey. "Such events can lead to fundamental flaws in the published literature and a waste of precious research resources."

In another Forum, Dr. Mahendra Rao, who is the director of the intramural Center for Regenerative Medicine at the National Institutes of Health, reiterates that making iPSC lines and developing the requisite controls and tests is time consuming, expensive, and generally beyond the expertise of any single laboratory. "Fulfilling the expectations for iPSCs and their use will only be possible if we develop a new cost-effective way to share and distribute cell lines. Crowd sourcing is one solution," he says. For the model to be successful, it must be self-sustaining. "Technology holders must buy in to the idea that it will ultimately benefit them as well as the users. It would also be important to ensure that expertise existed in the various repositories to store, characterize, test, and track the cells and their derivatives and that the repositories could do so at costs that were reasonable for the end user," writes Dr. Rao.

Finally, Dr. Ian Wilmut and his colleagues present a piece that addresses important considerations for immune matching between iPSC donors and recipients. They note that while it is possible that iPSC lines could be derived on an individual basis -- so that an individual patient would receive his or her own cells as a treatment -- it seems unlikely that this method would be used as a source for large numbers of patients in the near future due to time and cost restraints. A more practical solution is to build a bank of stem cell lines from a small pool of individuals that match a majority of the patient population and could be safely transplanted without immune rejection. "Calculations suggest that cells from approximately 150 selected people would provide a useful immunological match for the majority of people," explains Dr. Wilmut. "We propose that an international network of stem cell banks working with common procedures and standards should be established now in order to provide the broadest range of immunological types. This would be a critical step in ensuring widespread availability of high quality cell therapies in the future."

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Cell Stem Cell, Turner et al.: "Towards The Development of a Global Induced Pluripotent Stem Cell Library."

Cell Stem Cell, Rao et al.: "iPSC Crowdsourcing: A Model for Obtaining Large Panels of Stem Cell Lines for Screening."

Cell Stem Cell, Stacey et al.: "Banking Human Induced Pluripotent Stem Cells: Lessons Learned from Embryonic Stem Cells?"

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Leading experts offer advice on generating human induced pluripotent stem cell banks

UFC Contender Cat Zingano Will Undergo Stem Cell Procedure for Left Knee

Top ranked UFC bantamweight challenger Cat Zingano has been out of action for several months due to an injury to her right knee. That injury is on the mend, but it has led to issues with her left knee, for which Zingano will have a procedure on Thursday.

I am about three and a half months out (from the original injury), Zingano said on UFC Tonight. I went to my doctor on Monday. He said that Im right on track, so I should be coming back in another four months, something like March or April.

That is, of course, as long as the issues with her left knee can be rectified within that same time frame, which her doctor believes is the case.

Dr. Ronald S. Kvitne of the Kerlan-Jobe Orthopedic Clinic in Los Angeles on Monday told Zingano that if there was a tear in her left meniscus, as expected, that if they act quickly, it shouldnt extend the rehab time of her original injury.

Dr. Kvitne was initially thinking a surgery would be necessary, but Zingano on Wednesday indicated that Thursdays procedure would instead involve a stem cell treatment.

My left knee, because I think for the compensation for taking care of my right knee, has been taking a little bit more wear and tear than it was used to, said Zingano.

So Im going to have a procedure done with stem cells (on Thursday) that is going to be in place of having clean-up surgery instead.

If Zinganos rehabilitation remains on schedule, she would be able to return to the Octagon and fight sometime around April of 2014.

We think three months from now shed be back in the ring training, sparring, said Kvitne. So fighting in about four to six months from now.

Zingano also told UFC Tonight that she should expect to fight the winner of the Dec. 28 rematch between current UFC bantamweight champion Ronda Rousey and challenger Miesha Tate upon her return.

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UFC Contender Cat Zingano Will Undergo Stem Cell Procedure for Left Knee

FDA says StemCells can expand clinical trial to US

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FDA says StemCells can expand clinical trial to US

Research on treatment for ALS aided by stem cells

Though the Food and Drug Administration remains closed due to the federal government shutdown, researchers at the University are pushing forward the development of stem-cell therapies, with the hope of improving the quality of life for individuals with life-threatening disabilities.

Researchers at University Hospital and the A. Alfred Taubman Medical Research Institute are exploring the use of stem cells in the treatment of amyotrophic lateral sclerosis also known as Lou Gerhigs disease, a neurodegenerative condition that causes cell death in spinal cord neurons that control movement. Patients with ALS suffer from loss of muscle control and often die of respiratory failure.

Neurology Prof. Eva Feldman presented recent results from her research at an event Wednesday evening at the Taubman Institutes Kahn Auditorium for an audience of about 40 students and faculty. Feldman discussed the completion of Phase I trials of the new stem-cell therapy and her plans for Phase II.

While Phase I trials typically test the safety of a treatment in human patients, Phase II tests the treatments efficacy. Feldmans research team received approval for Phase II of their research in May and has since begun tests.

Shortly before the event Wednesday afternoon, a third patient enrolled in the trial had the surgical procedure, in which a surgeon injects stem cells into specific regions of the spinal cord. Although it is too early to record changes in disease progression, Feldman said the three patients have experienced no adverse consequences from the procedure.

Stem cells have the unique ability to fulfill a wide variety of tasks by developing into specialized cells depending on their environment. When these cells are injected into the spinal cord of ALS patients, they surround diseased cells and slow the progression of cell death, Feldman said.

Depending on how you grow them they can become any cell in the body, Feldman said.

Feldmans treatment uses a relatively new strain of human embryonic stem cells developed at the University through partnerships with the National Institutes of Health. She referenced the work of Physiology Prof. Gary Smith at MStem Cell Laboratories the Universitys stem cell institution as a crucial component to the development of the treatment.

What weve done here at the University of Michigan is make embryonic stem cell lines, which are now being used for understanding disease course as well as for treatment, Feldman said.

Stem cells have the potential to aid in the treatment of not only ALS, but a wide range of debilitating and life-threatening diseases, including Parkinsons disease, Alzheimers disease and multiple sclerosis, Feldman said.

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Research on treatment for ALS aided by stem cells

BrainStorm Launches US Activities for Its Multi-Center ALS Clinical Trial

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that it has launched its activities in the US in preparation for its Phase IIa multi-center clinical trial, with the initiation of the NurOwn technology transfer process at the Dana Farber Cancer Institute (DFCI). DFCIs Connell and O'Reilly Cell Manipulation Core Facility will produce NurOwn in its cGMP-compliant clean room facilities for the MGH and UMass Hospital clinical sites. The third clinical site in the trial, Mayo Clinic, will produce NurOwn at its own cleanroom facility.

We are very pleased with the progress we are making at DFCI, this being the final step for submission of the Company's IND application to the US FDA, commented Mr. Chaim Lebovits, BrainStorms President.

The Cell Manipulation Core Facility (CMCF) at Dana-Farber Cancer Institute (DFCI) is a manufacturing facility that produces safe and effective novel cellular component therapy that meets all regulatory guidelines for clinical use and also facilitates research to be translated from the bench to the bedside. All procedures are performed in environmentally controlled conditions according to current Good Manufacturing Practices (cGMP) for cell and tissue processing.

In 2012 BrainStorm successfully completed its first-in-man Phase I/II clinical study at Hadassah Medical Center in Jerusalem with 12 ALS patients, demonstrating initial indications of clinical benefit in six patients. BrainStorms Phase IIa dose-escalating trial at Hadassah is currently underway and the company will release the preliminary efficacy data at the conclusion of the trial.

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. For more information, visit the companys website at http://www.brainstorm-cell.com.

Safe Harbor Statement

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as may, should, would, could, will, expect, likely, believe, plan, estimate, predict, potential, and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorms forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or managements beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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BrainStorm Launches US Activities for Its Multi-Center ALS Clinical Trial

Tendon treatment firm seeks new markets

Regenerative medicine company Orthocell has been recognised in a prestigious peer-reviewed journal for its tendon injury treatment, which uses stem cell technology.

The treatment, known as Autologous Tenocyte Implantation (ATI), involves taking a biopsy of the patient's healthy tendon, isolating and cultivating tendon stem cells from the tissue, then injecting them into the injured tendon.

The Perth-based company says the process takes about 20 minutes and is less invasive than surgery.

Professor Ming Hao Zheng of the University of Western Australia's Centre for Translational Orthopaedic Research, who led the development team, said treatment options for people suffering from tendon injury and related disorders were limited.

"There are no targeted drug therapies and surgery often delivers unsatisfactory results," Prof Zheng said.

But ATI has been hailed in the American Journal of Sports Medicine as a safe and effective procedure that repairs tendons and reduces the pain of conditions such as tennis elbow.

"This novel treatment is encouraging for the treatment of tendinopathy and warrants further evaluation," the journal concluded.

Orthocell managing director Paul Anderson said the company was now focused on offering the treatment more widely to patients throughout Australia and New Zealand, and was also investigating potential overseas markets.

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Tendon treatment firm seeks new markets