Stem Cell Clinic

10-year-old girl gets new vein made from her own stem cells in medical first

By Stem Cell Doctors

(CBS News) A 10-year-old girl made medical history when a vein created from her own stem cells was transplanted into her body to treat a life-threatening blockage.

PICTURES: First lab-grown windpipe saves cancer patient

The girl had a condition called hepatic portal vein obstruction in which there is a blockage in the vein that drains blood from the intestines and spleen to the liver. A blockage here can lead to major complications like bleeding, developmental delays, an enlarged spleen and even death. Typical treatments include removing veins from other parts of the body - such as the leg - and transplanting them elsewhere to restore blood flow, but the procedures can be risky and have had mixed success.

For the new procedure, the girl was admitted to the Sahlgrenska University Hospital in Gothenburg, Sweden, where a team had already taken a 9 centimeter segment of vein from the groin of a deceased donor. The doctors stripped all cells from the vein, leaving just a tube of scaffolding, which was then injected with stem cells obtained from the girl's own bone marrow. After two weeks in a bioreactor, the graft was re-implanted in the 10-year-old girl, and her condition has been improving ever since.

The medical milestone is described in the June 14 issue of the The Lancet.

"The young girl in this report was spared the trauma of having veins harvested from the deep neck or leg with the associated risk of lower limb disorders," and avoided the need for a liver transplant, explained Dr. Martin Birchall, chair of laryngology, and Dr. George Hamilton, professor of vascular surgery, both at the University College London, U.K., in a commentary published in the same issue.

The girl had no complications from the operation and her blood flow was restored immediately.

In the year since the procedure, the girl has grown from about 4 feet 4.5 inches to almost 4 feet 7 inches and her weight increased from 66 pounds to 77 pounds. However over that year her blood flow decreased and the graft narrowed, requiring a second stem cell-based procedure. She has remained well since the second procedure, taking long walks of up to two miles and participating in light gymnastics. Especially noteworthy is her immune system has not attempted to fight off the donor tissue, despite her not taking any immunosuppressive drugs which often carry side effects.

"The new stem-cells derived graft resulted not only in good blood flow rates and normal laboratory test values but also, in strikingly improved quality of life for the patient," wrote the surgeons, led by Dr. Michael Olausson, a profsesory of surgery at the University of Gothenburg in Sweden. They added that their work opens up the possibility of trying to reproduce arteries for surgical use, such as for coronary bypass surgery.

This isn't the first procedure to use a patient's stem cells to create new tissue to save a person's life. HealthPop reported in 2011 of an Eritrean man with late-stage throat cancer who received the world's first synthetic windpipe. The organ was grown from the man's stem cells and then applied to a plastic scaffold, eliminating the need for a donor organ.

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10-year-old girl gets new vein made from her own stem cells in medical first

Lab-grown vein transplant marks another milestone in stem cell research

By Stem Cell Doctors

In a first, doctors in Sweden have transplanted into the body of 10-year-old girl a vein grown in the laboratory from her own stem cells.

The core team that performed the procedure was led by Dr Suchitra Holgersson, a transplant medicine scholar originally from Mumbai, and included four other doctors from India. The landmark transplant was published in the British medical journal The Lancet on Thursday.

The child had a blockage in her extrahepatic portal vein, which was obstructing blood supply to her liver. Options available to doctors included a liver transplant or taking a vein graft from the umbilical cord of a donor, which would have led to lifelong dependence on immunosuppressants.

A third alternative was to graft another vein usually from the leg or neck onto the liver vein. This is associated with risks of lower limb disorders, and was not considered a viable option due to the girls young age.

Speaking to The Indian Express by telephone, Dr Holgersson, a professor in the department of transplant and regenerative medicine at Sahlgrenska Science Park in Gothenburg University, said: We took a 9-centimetre graft from a deceased donor and removed all its original cells, leaving a hollow piece of vein. We then extracted stem cells of two kinds from the bone marrow of the little girl endothelial and smooth muscle cells gave it necessary growth factors, and let it incubate for two weeks.

This manufactured vessel was then transplanted into the girl. Blood flow to the liver started immediately after the procedure, and since the stem cells were the patients own, there was no fear of an adverse immune reaction either, and she needs no drugs, Dr Holgersson said.

... contd.

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Lab-grown vein transplant marks another milestone in stem cell research

Doctors Use Stem Cells To Grow Vein For Young Patient

By Stem Cell Doctors

June 14, 2012

Brett Smith for redOrbit.com

A successful transplant operation in Sweden points to a medical future where your doctor can grow a transplant organ from your own cells, making organ donation a thing of the past.

Doctors have now successfully transplanted a vein grown with a patients own stem cells without complications or the need for immunosuppressants, according to a report published this week in The Lancet. The patient was a 10-year-old girl in Sweden who was suffering from a potentially fatal blockage in the vein which drains blood from the intestines and spleen to the liver.

Last March, a team of doctors at the University of Gothenburg decided to grow the new blood vessel used to bypass the blocked vein instead of using an invasive neck or leg surgery to extract one of her own.

The young girl in this report was spared the trauma of having veins harvested from the deep neck or leg with the associated risk of lower limb disorders, and avoided the need for a liver or multivisceral transplantation, Martin Birchall and George Hamilton of University College London wrote in The Lancet.

To start the procedure, doctors took a three-inch section of a cadaver groin vein and stripped it of all living cells, leaving only an inert protein structure. The team then injected it with blood-forming stem cells taken from the girls bone marrow. After growing the vein for two weeks in an incubator, the stem cells had multiplied and converted into vein wall cells, to create a biologically-engineered replacement. The new vein was then implanted into the patient a year ago.

The new stem-cells derived graft resulted not only in good blood flow rates and normal laboratory test values but also, in strikingly improved quality of life for the patient, the report said.

In noting the success of the transplant, the doctors reported that the patient grew 2 inches and gained 11 pounds over the following year. In addition, her parents said that she was more physically active, had improved articulated speech, and had concentrated better on her studies.

The only major complication was the slight constriction of the vein nine months after the operation, which was corrected in a follow-up procedure. During the course of following up on the operation, scientists found no antibodies for the donor vein in the girls blood. This meant her body was not rejecting the transplant because it was recognized as being made of her own cells.

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Doctors Use Stem Cells To Grow Vein For Young Patient

Team devises stem-cell method for retinal tissue

By Stem Cell Medicine

KOBE A method to generate multilayered retinal tissue from human embryonic stem cells, developed by a Japanese biological research unit and Sumitomo Chemical Co., has been published in the June 13 edition of the U.S. scientific journal Cell Stem Cell.

It is the first time multilayered retinal tissue has been developed from human ESCs. In the article, the research team at the Riken Center for Developmental Biology and Sumitomo Chemical said, "We demonstrate that an optic cup structure can form by self-organization in human ESC culture."

The method could be applied to regenerative medicine by transplanting the tissue generated to treat conventionally incurable eye diseases such as retinitis pigmentosa, an inherited, degenerative eye disease that causes severe visual impairment and blindness.

"Human ESC-derived neural retina grows into multilayered tissue containing both rods and cones, whereas cone differentiation is rare in mouse ESC culture," the article said.

The researchers developed a method to generate a large amount of such tissue in a short period of time as well as a method that enables en bloc cryopreservation of stratified neural retina of human origin, with useful applications.

Kyodo

LONDON Japanese scientist Shinya Yamanaka has received this year's Millennium Technology Prize for his discovery of a new method to produce induced pluripotent stem cells at a ceremony in Helsinki.

He shared the prize with Finland's Linus Torvalds, 42, who developed the Linux open-source computer operating system. They will split the ?1.2 million in prize money, given by Technology Academy Finland, a foundation partially funded by the Finnish government.

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Team devises stem-cell method for retinal tissue

Millennium Highlights Updated Survival Data from ADCETRIS® (Brentuximab Vedotin) Pivotal Trial in Patients with …

By Stem Cell Medical Center

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

Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced updated survival data from a pivotal Phase II clinical trial of single-agent brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplant (ASCT) showing that the median overall survival has not been reached after a 26.5 month median follow-up. The data will be reported during an oral presentation at the 17th European Hematology Association (EHA) Annual Meeting being held June 14-17, 2012 in Amsterdam, Netherlands. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of the majority of types of HL.

Heavily pretreated Hodgkin lymphoma patients who relapse following autologous stem cell transplant often have a poor prognosis and there is a high unmet medical need for effective treatment options, said Scott Smith M.D., Ph.D., Loyola University Medical Center. These updated overall survival results from the pivotal trial are encouraging and suggest that brentuximab vedotin may play an important role in the treatment of patients with relapsed or refractory disease.

Long-term Follow-up Results of an Ongoing Pivotal Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma

A pivotal trial was conducted in 102 patients with relapsed or refractory HL after ASCT. The primary endpoint was objective response rate (ORR) per independent review. The secondary endpoints were complete remission (CR) rate, duration of response, progression-free survival (PFS), overall survival (OS), and safety and tolerability. At the time of the long-term follow-up analysis, the median observation time from first dose was 26.5months. Data, to be presented by Dr. Smith, include:

Patients received 1.8milligrams per kilogram of brentuximab vedotin every 3 weeks as a 30-minute outpatient intravenous infusion for up to 16cycles. Patients received a median of nine cycles of brentuximab vedotin while on trial. The median age of patients in the pivotal trial was 31 years. Enrolled patients had received a median of 3.5 (range 113) prior cancer-related systemic therapies, excluding ASCT. Seventy-one percent of patients had primary refractory disease, defined in the study protocol as patients who relapsed within three months of attaining CR or failed to achieve a CR, and 42 percent had not responded to their most recent prior therapy.

Details of the oral presentation are as follows:

About Brentuximab Vedotin

Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

Brentuximab vedotin is not approved for use outside the United States. The marketing authorization application for brentuximab vedotin in relapsed or refractory Hodgkin lymphoma and sALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted for review by the European Medicines Agency for review in June 2011.

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Millennium Highlights Updated Survival Data from ADCETRIS® (Brentuximab Vedotin) Pivotal Trial in Patients with ...

Harvard To Resume Allston Science Center Development in 2014

By Stem Cell Clinic

After halting construction on its Allston science center more than two years ago, Harvard announced on Wednesday that it will resume development in 2014.

The facility, which will be called the Health and Life Science Center, will house academic projects for stem cell science and engineering and physical sciences.

Douglas A. Melton, a co-director of theHarvard Stem Cell Instituteand co-chair of the Harvard stem cell and regenerative biology department, added that this development "should leadto the kinds of collaborations and exciting advances, and interesting experiments in undergraduate teaching, that otherwise might not take place."

Previous plans for the new science center included stem cell science, but the second componentengineering and physical sciences with application to biological and life sciencesis new.

By allowing stem cell scientists and bioengineers with common goals to work literally side-by-side, in close proximity to the I-Lab and Business School, Harvard will be hastening the day discoveries in our labs can be moved into the clinic, where they will benefit patients, Melton said in a statement.

Associate Vice President for Public Affairs and Communications Kevin Casey, who presented the plan at a Harvard-Allston Task Force meeting, told attendees that that the complex would likely be 500,000 to 600,000 square feet in size,providing office space for 500 scientists and an additional support staff.

Harvard halted construction in Allston in 2009 following a credit crunch caused by the 2008 recession. Allston planning restarted in December 2011.

According to Harvard Executive Vice President Katherine N. Lapp, Harvard hopes to begin readying its Western Avenue site forconstruction towards the end of 2013.

"The Health and Life Science Center will represent the single largest investment in a science facility ever made by Harvard, and the biggest investment in science space envisioned for at least the next decade," Lapp wrote in a public update.

Harvard officials also updated Task Force members on the progress of its other efforts in Allston. University officials said that they will work with Boston-based Samuels & Associates to develop residential and retail spaces in Barrys Corner, few blocks away from the future site of the Health and Life Science Center.

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Harvard To Resume Allston Science Center Development in 2014

WPI spinoff VitaThreads to make biopolymer sutures

By Stem Cell Clinic

Harry Wotton, CEO, VitaThreads

VitaThreads LLC, a new life sciences company focused on making biopolymer threads and sutures for stem cell delivery and other uses, has been spun out of Worcester Polytechnic Institute.

The company, which CEO Harry Wotton said was incorporated two weeks ago, was founded by two WPI biomedical engineering professors, George Pins and Glenn Gaudette. It will commercialize the microthread technology under a license from WPI as a new treatment for common sports injuries and heart attacks and as a new way to deliver stem cells to regenerate damaged tissues in people and animals.

The company will have access to a computer-controlled extruder designed and built in Gaudettes lab to ramp up microthread production. It will operate initially within WPIs Bioengineering Institute at Gateway Park.

Pins and Gaudette will be scientific advisors to VitaThreads management, which includes co-founders Adam Collette, vice president of product development, and Wotton, who graduated from WPI in 1994. The four are the only employees now.

Cell therapies and tissue regeneration are coming to the clinic, and we believe the VitaThreads platform will be an important delivery system for these new therapies, said Wotton. He has two other startups to his name, veterinary orthopedics company Securos Inc. and International Veterinary Distribution Network Inc., both of Charlton. He sold both in 2007 for a total of $5 million to MWI Veterinary Supply Inc. of Idaho.

It was a great experience, and but I was ready for new challenges, Wotton said. It was time for me to get out of the big corporate environment and get back to a startup, which is what I really love. And the opportunity to work with the team at VitaThreads was a perfect fit.

About $1 million in National Institutes of Health and other grants has gone into the technology development at WPI, and Wotton said the company has $200,000 in funding now from government Small Business Innovation Research (SBIR) grants and from the companys owners. We need to get $500,000 to $1 million over the next 18 months to get to the next level, said Wotton, who also is trying to entice angel investors to contribute.

Made of collagen, fibrin, and other biologic materials, biopolymer microthreads about the width of a human hair can be braided into cable-like structures that mimic natural connective tissues. First developed in Pinss lab as a potential tool for repairing torn anterior cruciate ligaments in the knee, the microthreads were adapted by Pins and Gaudette for use as biological sutures to deliver bone marrow-derived stem cells to regenerate cardiac muscle damaged during a heart attack. Other WPI labs are using the threads, seeded with various cell types, as scaffolds for wound-healing and skeletal muscle regeneration, among other purposes, according to WPI.

VitaThreads plans to develop the microthread technology for a range of human clinical uses, but its first commercial product will deliver stem cells for the animal medicine market. Stem cell therapies are still in the research and development phase for humans, but they are a reality today in animal medicine, Wotton said. Every year thousands of horses and dogs have stem cell injections that heal torn ligaments and other connective tissues; this technology will be able to deliver those stem cells much more efficiently. He said the types of injuries that ended the careers of race horses like Barbaro and more recently Ill Have Another are targets for the stem cell treatment. It has high efficiency in delivery of stem cells, he said. Current methods use intravenous delivery, injections, hydrogels and scaffolds.

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WPI spinoff VitaThreads to make biopolymer sutures

Jets safety LaRon Landry’s rehab speeding along thanks to advanced medicine

By Uncategorized

The left Achilles tendon that forced LaRon Landry to miss most of the last two seasons with the Washington Redskins is totally healed and, remarkably, no surgery was required.

LaRon Landry hopes to add some lumber to New Yorks secondary. (Nick Wass - Associated Press) The New York Jets safety spurned advice to go under the knife, instead opting for alternative medicine. And so far, so good. Landry joined his new teammates at minicamp this week, and, although he could not practice, his progress has Coach Rex Ryan giddy.

LaRon is way ahead of where our trainers thought hed be, Ryan told the teams Web site on Wednesday. Weve just got to be smart the next couple of days that he doesnt overdo things. Hes on the right track and we feel good about it.

Landrys secret? A stem cell treatment called AminoMatrix and a couple of platelet-rich plasma transfusions. PRP treatments are becoming increasingly popular for athletes looking to avoid surgery. Tiger Woods used them to recover from a knee injury.

Im progressing and things are looking real well I was kind of shocked myself, Landry said. I cant wait to get back out there and be with the team.

Landrys bulging biceps and muscular physique were as familiar as his massive hits in the Washington secondary. In February, Landry tweeted a photo of himself in which he looked particularly large, leading to some public speculation about steroid use. In a Twitter conversation with a concerned Redskins fan, Landry defended his weight, which was up to 218 pounds in March.

Of the injuries that prematurely ended his 2011 season, Landry said the Achilles is totally healed and that hes waiting for the heel bone that is connected to the tendon to fully heal.

When he returns, hell join former Dolphin Yeremiah Bell and Eric Smith to form a formidable trio of safeties for the Jets secondary.

I think these guys can do a lot more than just go in there and blast you on the running game, Ryan said of Landry and Bell. Landry, when hes healthy, is a 4.3-something-in-the-40 type of guy. Hes got tons of God-given ability.

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Jets safety LaRon Landry’s rehab speeding along thanks to advanced medicine

Cell Therapeutics Appoints New Chief Medical Officer

By Uncategorized

June 14, 2012, SEATTLE /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, today announced that former OncoMed Pharmaceuticals executive, Steven E. Benner, M.D., M.H.S., has joined CTI as Executive Vice President and Chief Medical Officer ("CMO"), reporting to James A. Bianco, M.D., Chief Executive Officer. Dr. Benner will take over all drug development activities at the company.Dr. Benner was previously senior vice president and chief medical officer at OncoMed, a venture-backed biotechnology company focused on the development of cancer stem cell targeting agents. Prior to OncoMed, he was CMO at Protein Design Labs ("PDL"), where he was accountable for all development activities including clinical development, clinical operations, biometry, regulatory affairs, and safety. He also served as Chair of the Portfolio and Clinical Development Management Committees of PDL. Before PDL he held several senior executive roles at Bristol-Myers Squibb in global development, life cycle management, and licensing and alliances.

"Dr. Benner brings to CTI his proven track record of success in advancing the development of innovative therapies for cancer patients," said Dr. Bianco. "His appointment is the first step in re-aligning our portfolio efforts, as we focus on advancing pacritinib into Phase III pivotal studies later this year."

With the new company initiative of the planned Pixuvri launch in Europe later this year, Jack W. Singer, M.D., will assume the newly-created role of Executive Vice President ("EVP") of Global Medical Affairs and Translational Medicine, responsible for cancer drug development strategy, global medical affairs, and life cycle management.

"Given Jack's impressive academic credentials, the respect he receives from an international network of key opinion leaders in the field, and his track record in oncology drug development, this was a natural promotion as we introduce Pixuvri in Europe," said Dr. Bianco.

"CTI has assembled an impressive late-stage portfolio of novel targeted therapies that address a spectrum of blood related cancers," said Dr. Benner. "With two drugs in Phase III and two more expected to enter Phase III trials within a year, this is an exciting and transformational time to join the team at CTI."

About Pixuvri (pixantrone)Pixuvri is a novel aza-anthracenedione with unique structural and physio-chemical properties. Unlike related compounds,Pixuvri forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity, and, because Pixuvri is not a vesicant, allow it to be safely delivered via a peripheral intravenous catheter.

In May 2012 Pixuvri received conditional marketing authorization in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.The Summary of Product Characteristics ("SmPC") has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at http://ec.europa.eu/health/documents/communityregister/html/h764.htm#ProcList.

Pixuvri is currently available in the EU through Named Patient Programs.

Pixuvri does not have marketing approval in the United States.

About Conditional Marketing AuthorizationSimilar to accelerated approval regulations inthe United States, conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessmentthat address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

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Advanced Cell Technology to Present at the 2012 Bio International Convention and the Clinical Outlooks for …

By Uncategorized

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the company is presenting at two upcoming conferences: the 2012 Bio International Convention and Clinical Outlooks for Regenerative Medicine meeting, both in Boston, on Tuesday, June 19. The presentations will cover the companys three ongoing clinical trials using human embryonic stem cell-derived retinal pigment epithelial cells to treat macular degeneration, and other programs.

Gary Rabin, chairman and CEO, will present at the 2012 Bio International Convention on Tuesday, June 19 at 8:15 a.m. EDT, at the Boston Convention & Exhibition Center.

Matthew Vincent, Ph.D., director of business development, will present at the Clinical Outlooks for Regenerative Medicine meeting at 9:15 a.m. EDT on the same date, at the Starr Center, Schepens Eye Research Institute, at 185 Cambridge Street in Boston.

Both presentation slide decks will be available on the conference presentations section of the ACT website.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

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