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DOH restricts hospitals amid stem- cell therapy craze

Posted: March 20, 2013 at 4:42 pm

The Department of Health (DOH) has restricted hospitals and other facilities from using genetically-altered cells and tissues of human in carrying out stem-cell therapy and treatments in the country. Health secretary Enrique Ona added that their department also prohibits the use of umbilical cord, fat-derived human stem cells, and live animal stem cells for the conduct of the procedure locally. On Wednesday, DOH released Administrative Order (AO) 2013-0012 which seeks to ensure the safety of people who want to undergo human stem cell and cell-based therapies.

The AO also prohibits for human treatment and research the creation of human embryos and their derivatives, the use of aborted human fetal stem cells and their derivatives, and plant parts labeled as stem cells, the order stated. Ona hopes AO will make effective and ethical stem cell modalities and practices that will be at par with emerging international and global standards on the very complex nature of this therapy. He explained the AO also hopes to prevent the introduction, transmission, and spread of communicable diseases by ensuring a minimum quality of service and staff qualification rendered by hospitals and other health facilities capable of utilizing human stem cell preparations and cell-based therapies. These guidelines will classify which stem cell preparations and therapies will be registered and allowed with certain restrictions, Ona said in a statement. Preparations that will be allowed include those with adult human stem cells, human umbilical cord stem cells, and human organ-specific cells, he noted. He explained that health facilities utilizing stem cell preparations and cell-based or cellular therapies will be mandated to comply with the guidelines set by DOHs Bioethics Advisory Board. The Borad, Ona notes, will ensure that ethical and professional standards are upheld and that contentious scientific, ethical and legal issues are addressed. He said charges and complaints shall be addressed to the DOH Bureau of Health Facilities & Services and the Philippine Food and Drug Agency. Stem cell therapy and treatments are medical procedures where doctors replace malignant cells with healthier cells in an effort to cure or address ailments like cancer. Some facilities also use the procedure for cosmetic purposes, targeting components of the skin like collagen to make patients look younger and healthy.

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DOH restricts hospitals amid stem- cell therapy craze

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Cell Transplantation study finds stem cells in deer antler

Posted: March 20, 2013 at 9:52 am

Public release date: 19-Mar-2013 [ | E-mail | Share ]

Contact: Robert Miranda cogcomm@aol.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Putnam Valley, NY. (Mar. 19 2013) A team of researchers in Seoul, Korea have reported finding evidence that deer antlers - unique in that they regenerate annually - contain multipotent stem cells that could be useful for tissue regeneration in veterinary medicine.

The study appears as an early e-publication for the journal Cell Transplantation, and is now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/pre-prints/ct0897seo.

"We successfully isolated and characterized antler tissue-derived multipotent stem cells and confirmed that the isolated cells are self-renewing and can differentiate into multiple lineages," said study co-author Dr. Kyung-Sun Kang of the College of Veterinary Medicine at Seoul National University. "Using optimized culture conditions, deer antler displayed vigorous cell proliferation."

Deer antler has been an issue in the news recently when professional athletes allegedly therapeutically used deer antler sprays, said to contain the insulin-like growth factor, IGF-1, to recover from injuries. The Korean research team did not investigate the potential for deer antler to be used in human therapies, but suggested that it could be used in veterinary medicine due to the impact of two important factors; the regenerative and the proliferative capabilities of the stem cells they isolated.

Stem cells, cells with the capability to differentiate into varieties of cells, have been isolated from a number of tissues, including bone marrow, fat tissues, umbilical cord blood, placenta and menstrual blood. Stem cell research in the last two decades has focused on both pluripotent stem cells, able to differentiate into all cell types of the body, and multipotent stem cells, able to differentiate into some but not all cell types, the latter of which has a longer history of study as they were identified earlier.

Researchers have sought to use transplanted stem cells for many regenerative purposes from using them to regenerate neural cells following stroke or spinal cord injuries, to using stem cells to help regenerate failing or injured organs.

Deer antler is of interest, said the researchers, "because antlers are very peculiar organs in that they are lost and re-grown annually.a rare example of a completely regenerating organ in mammals."

According to the researchers, they subjected deer antler to differentiation assays for osteogenic (bone), adipogenic (fat) and chondrogenic (cartilage) lineages under culture conditions specific for each lineage to confirm the multi-lineage differentiation ability of antler multipotent stem cells. They concluded that deer antler tissue might be a "valuable source of stem cells" that could "be a potentially useful source of regenerative therapeutics in veterinary science."

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Cell Transplantation study finds stem cells in deer antler

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Repairing the Heart with Stem Cells , From the March 2013 Harvard Women’s Health Watch

Posted: March 20, 2013 at 9:52 am

Stem cells that can morph into any type of cell are being tested for their ability to reduce scar tissue and improve the heart's function after a heart attack.

Boston, MA (PRWEB) March 19, 2013

A recent study from Cedars-Sinai Heart Institute in Los Angeles suggests that stem cells may, indeed, heal damaged hearts. The researchers treated 17 heart attack survivors with an infusion of stem cells taken from their own hearts. A year later, the amount of scar tissue had shrunk by about 50%.

These results sound dramatic, but are they an indication that we're getting close to perfecting stem cell therapy? "This is a field where, depending on which investigator you ask, you can get incredibly different answers," says Dr. Richard Lee, professor of medicine at Harvard Medical School and a leading expert on stem cell therapy.

"The field is young. Some studies show only modest or no improvement in heart function, but others have shown dramatically improved function," he says. "We're waiting to see if other doctors can also achieve really good results in other patients."

Studies are producing contradictory results partly because researchers use different methods to harvest and use stem cells. Some are taken from the bone marrow of donors, others from the recipient's own heart. It's not clear which approach works the best.

"Some investigators think this is just a few years away," says Dr. Lee. "And then there are others who feel that there is much more work to be done."

Right now, stem cell therapy is available only to people who participate in a research trial. Anyone who has had a heart attack or who is living with heart failure and wants to take part in a stem cell study can visit http://www.clinicaltrials.gov and search for trials in their area (for example, search "stem cells," "heart," "Los Angeles").

Read the full-length article: "Repairing the heart with stem cells"

Also in the March 2013 issue of the Harvard Women's Health Watch:

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Repairing the Heart with Stem Cells , From the March 2013 Harvard Women's Health Watch

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Study finds stem cells in deer antler

Posted: March 20, 2013 at 9:52 am

A team of researchers in Seoul, Korea have reported finding evidence that deer antlers - unique in that they regenerate annually - contain multipotent stem cells that could be useful for tissue regeneration in veterinary medicine.

The study appears as an early e-publication for the journal Cell Transplantation, and is now freely available on-line.

"We successfully isolated and characterized antler tissue-derived multipotent stem cells and confirmed that the isolated cells are self-renewing and can differentiate into multiple lineages," said study co-author Dr. Kyung-Sun Kang of the College of Veterinary Medicine at Seoul National University. "Using optimized culture conditions, deer antler displayed vigorous cell proliferation."

Deer antler has been an issue in the news recently when professional athletes allegedly therapeutically used deer antler sprays, said to contain the insulin-like growth factor, IGF-1, to recover from injuries. The Korean research team did not investigate the potential for deer antler to be used in human therapies, but suggested that it could be used in veterinary medicine due to the impact of two important factors; the regenerative and the proliferative capabilities of the stem cells they isolated.

Stem cells, cells with the capability to differentiate into varieties of cells, have been isolated from a number of tissues, including bone marrow, fat tissues, umbilical cord blood, placenta and menstrual blood. Stem cell research in the last two decades has focused on both pluripotent stem cells, able to differentiate into all cell types of the body, and multipotent stem cells, able to differentiate into some but not all cell types, the latter of which has a longer history of study as they were identified earlier.

Researchers have sought to use transplanted stem cells for many regenerative purposes from using them to regenerate neural cells following stroke or spinal cord injuries, to using stem cells to help regenerate failing or injured organs.

Deer antler is of interest, said the researchers, "because antlers are very peculiar organs in that they are lost and re-grown annually.a rare example of a completely regenerating organ in mammals."

According to the researchers, they subjected deer antler to differentiation assays for osteogenic (bone), adipogenic (fat) and chondrogenic (cartilage) lineages under culture conditions specific for each lineage to confirm the multi-lineage differentiation ability of antler multipotent stem cells. They concluded that deer antler tissue might be a "valuable source of stem cells" that could "be a potentially useful source of regenerative therapeutics in veterinary science."

The researchers noted that the development of deer-specific antibodies "is essential to confirm the identification of antler multipotent stem cells".

They specifically noted that injury to wild animals, including deer, might be treated using deer antler derived cells. They also pointed out that studies involving the use of horse stem cells have found clinical application of equine-derived stem cells.

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Study finds stem cells in deer antler

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Cord Blood Registry is Advancing Regenerative Medicine Research at Exciting Pace

Posted: March 20, 2013 at 9:52 am

SAN BRUNO,Calif., March 19, 2013 /PRNewswire/ --Cord Blood Registry (CBR), the world's largest newborn stem cell bank, is fueling innovation in newborn stem cell research. As CBR prepares to release its 250th cord blood unit for medical use this month, the newborn stem cell bank announces that 71% of all its units released for use have been for emerging applications in regenerative medicine, such as brain injury, autism and type 1 diabetes. The other 29% have been for traditional transplant use, such as leukemia and sickle cell disease. This rapid increase in the use of family banked units for regenerative medicine applications is a complete reversal from the figures just six years ago, where 25% of the units released were for regenerative medicine applications and 75% for traditional transplant use. More than 50% of all cord blood units released for use in emerging regenerative therapies by family banks have been processed and stored at CBR. CBR is the only family newborn stem cell bank to have established FDA-regulated trials and is connecting client families to more potential treatments. As the industry leader in this initiative, Cord Blood Registry continues to focus on advancing the clinical applications of newborn stem cells.

(Photo: http://photos.prnewswire.com/prnh/20130319/SF78273-INFO)

(Logo: http://photos.prnewswire.com/prnh/20120216/AQ54476LOGO)

Over the past 20 years, cord blood stem cells have been used to treat more than 80 life-threatening diseases and disorders including certain cancers, blood disorders, immune diseases, and metabolic disorders. Today, promising treatments are paving the way for further research. Current FDA-regulated clinical trials are exploring the use of a child's own cord blood stem cells in regenerative medicine for conditions that have no cure today. Most of these groundbreaking trials only use cord blood stem cells processed and stored by Cord Blood Registry for consistency and because of their commitment to quality.

"At an increased pace, CBR is providing families exclusive access to promising new potential treatment options through our focus on clinical trials," said Geoffrey Crouse, CEO of Cord Blood Registry. "We are proud to partner with researchers at the forefront of stem cell medicine."

Clinical Trials Break New Ground in Regenerative Medicine

Cord blood stem cells are currently being evaluated in a series of clinical trials exclusive to CBR clients as potential treatment for autism, cerebral palsy, traumatic brain injury and pediatric stroke. Results will be published upon the completion of the trials.

Dr. Michael Chez, director of pediatric neurology at Sutter Medical Center, is leading a landmark FDA-regulated clinical trial to test the use of a child's own cord blood stem cells as a potential therapy to improve language and behavior in children with autism who have no obvious cause for the condition such as a known genetic syndrome or brain injury.

Dr. James Carroll at Georgia Regents University is conducting the first FDA-regulated clinical trial evaluating the use of cord blood stem cell infusions to treat children with cerebral palsy. Drake Haynes, who suffered a stroke after birth and was later diagnosed with cerebral palsy, was infused with his own CBR processed stem cells. Drake's progress is constantly being monitored and he continues to see multiple physical therapists. His family reports anecdotal evidence of steady progress in Drake's speech and mobility. Drake's mother, Nikki Haynes, describes it as the "blinds being lifted." A second FDA-regulated trial for cerebral palsy is underway at Duke University. A number of CBR families are currently participating in this key research as well.

Dr. Charles Cox, professor of pediatric surgery at The University of Texas Health Science Center in Houston (UT Health), is leading an FDA-regulated trial studying the use of a child's own cord blood stem cells in the treatment of traumatic brain injury (TBI).

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NeoStem’s Subsidiary, Progenitor Cell Therapy , Launches Web-Based Service for Real-Time Cell Therapy Product Tracking

Posted: March 18, 2013 at 11:47 pm

NEW YORK, March 18, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy market, today announced that the Company's contract development and manufacturing ("CDMO") subsidiary, Progenitor Cell Therapy ("PCT"), has launched a new service offering, using a custom developed Internet/Web application to further its position as a technology leader for cell therapy. The new service, an automated software system called "PCTFORME.COM", resides in a highly secure, cloud based computing environment, available 24/7, and serves to enhance PCT's service offering to its growing client base. This service has been launched for a major client and is now available for all of PCT's existing and future stem cell clients.

PCTFORME allows PCT's clients to securely access patient details on-line and provides for real time product ordering, processing and retrieval via automated communications between PCT's clients and laboratory staff. The system is expected to significantly enhance communication by enabling easy tracking of current processing, increasing PCT's efficiencies and streamlining the process for the ordering of patient cells for infusion. PCTFORME is HIPAA compliant and built on a proven Microsoft software platform and supporting cloud based hardware infrastructure.

Robert A. Preti, PhD, President and Chief Scientific Officer of PCT, said, "The need to service the demand, in both volume and variety of procedures, continues to grow as PCT serves our client base. The efficiencies gained in order entry, cell product inventory management, and real time procedure result reporting is expected to improve patient care through enhanced communication, control and transparency. In this regard, PCTFORME represents a patient product management breakthrough in stem cell processing."

"As the field of cell therapy continues to emerge, we believe technology will enable us to reduce costs, better service our clients and build scalable operations to be ready for the future when cell therapy becomes standard of care in medical practice," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "Our management is focused on evaluating, developing and incorporating such technologies into our state-of-the-art contract development and manufacturing business to assist our clients, as well as our clinical development subsidiaries, with their cell therapy product development, and in preparation to launch them into the clinic."

About NeoStem, Inc.

NeoStem, Inc. ("NeoStem" or the "Company") is a leader in the emerging cellular therapy industry. Our business model includes the development of novel proprietary cell therapy products as well as operating a contract development and manufacturing organization ("CDMO") providing services to others in the regenerative medicine industry. The combination of a therapeutic development business and revenue-generating service provider business provides the Company with capabilities for cost effective in-house product development and immediate revenue and cash flow generation. http://www.neostem.com

About Progenitor Cell Therapy, LLC ("PCT")

PCT, a wholly owned subsidiary of NeoStem, Inc., is a leading CDMO in the cellular therapy industry. Since its inception in 1997, PCT has provided pre-clinical and clinical current Good Manufacturing Practice ("cGMP") development and manufacturing services to over 100 clients advancing regenerative medicine product candidates through rigorous quality standards all the way through to human testing. PCT has two cGMP, state-of-the art cell therapy research, development, and manufacturing facilities in New Jersey and California, serving the cell therapy community with integrated and regulatory compliant distribution capabilities. Its core competencies in the cellular therapy industry include manufacturing of cell therapy-based products, product and process development, cell and tissue processing, regulatory support, storage, distribution and delivery and consulting services. http://www.pctcelltherapy.com

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its contract development and manufacturing business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 11, 2013 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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NeoStem's Subsidiary, Progenitor Cell Therapy , Launches Web-Based Service for Real-Time Cell Therapy Product Tracking

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Stem cells transplantation technique has high potential as a novel therapeutic strategy for erectile dysfunction

Posted: March 18, 2013 at 5:45 pm

Mar. 15, 2013 Transplantation of mesenchymal stem cells cultivated on the surface of nanofibrous meshes could be a novel therapeutic strategy against post-prostatectomy erectile dysfunction (ED), conclude the authors of a study which is to be presented at the 28th Annual EAU Congress later this week.

The study was conducted by a group of Korean scientists and will be awarded 3rd prize for best abstract in non-oncology research on the opening day of the congress.

During their investigation, the group aimed to examine the differentiation of human mesenchymal stem cells cultivated on the surface of nanofibrous meshes (nano-hMSCs) into neuron-like cells and repair of erectile dysfunction using their transplantation around the injured cavernous nerve (CN) of rats.

"The objectives of the study reflect a very pertinent need in today's urology practice," said the lead author of the investigation Prof. Y.S. Song of Soonchunhyang University School of Medicine in South Korea. "Post-prostatectomy erectile dysfunction results from injury to the cavernous nerve that provides the autonomic input to erectile tissue. It is a common complication after radical prostatectomy which decreases the patient's quality of life."

"Although advances in equipment and surgical techniques reduce this complication, patients still experience erectile dysfunction after radical prostatectomy," he explained.

Treatment of phosphodiesterase 5 inhibitors shows insufficient effectiveness in the treatment of post-prostatectomy ED and it is believed that the transplantation of stem cells cultivated on the surface of nanofibrous meshes can promote cavernous neuronal regeneration and repair erectile dysfunction.

In the course of the study, the synthesised polymer was electrospun in a rotating drum to prepare nanofibrous meshes and hMSCs were prepared and confirmed. Eight week old male Sprague-Dawley rats were divided into 4 groups of 10 each, including sham operation (group 1), CN injury (group 2), hMSCs treatment after CN injury (group 3) and nano-hMSCs treatment after CN injury (group 4). Immediately after the CN injury in group 4, nano-hMSCs encircled the injured CN. Erectile response was assessed by CN stimulation at 2, 4 weeks. Thereafter, penile tissue samples were harvested and examined using morphological analysis and immuno-histochemical stain against nerves (nestin, tubulin III and map2), endothelium (CD31,vWF) and smooth muscle (smooth muscle actin).

The results of the study revealed that at 2, 4 weeks, transplantation of nano-hMSCs increased the expression levels of cavernous neuronal, endothelial and smooth muscle makers more than hMSCs alone.

Additionally, nano-hMSCs increased the neuronal differentiation of mesenchymal stem cells more than hMSCs alone. At 2, 4 weeks, the mean percent collagen area of caversnosum increased following CN injury and recovered after transplantation of nano-hMSCs more than hMSCs alone.

At 2, 4 weeks, the group with CN injury had significantly lower erectile function than the group without CN injury (p<0.05). The group transplanted with hMSCs showed higher erectile function than the sham operation group (p<0.05), whereas the group transplanted with nano-hMSCs showed higher erectile function than the group with hMSCs alone (p<0.05).

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Stem cells transplantation technique has high potential as a novel therapeutic strategy for erectile dysfunction

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Stem cell therapy is new hope for liver transplant patients

Posted: March 18, 2013 at 5:42 pm

Stem cell therapy has been found useful in over 60 per cent of the patients due for liver transplant, as per a paper submitted by doctors at Sir Ganga Ram Hospital in Delhi recently. Not only is the treatment less cumbersome and risky, its cost is also comparatively very reasonable.

According to the papers principal author and chairman of the Department of Gastroenterology and Liver Diseases at the Hospital, Dr. Anil Arora, a large number of patients requiring liver transplantation cannot afford it for two reasons cost and donor availability.

A living donor is needed in such plantation cases with a matching blood group and he or she also has to be a family member or a first or second degree relative. They have to donate the liver. Since Rs.20 lakh is the average cost of liver transplantation, a majority of liver cirrhosis patients can not afford it. Many times they also do not have a donor, he said.

In view of the logistical problems faced by such patients, Dr. Arora said: We started looking at the feasibility of alternative methods like using reserve cells in the body called stem cells for such treatment as it costs even less than Rs.50,000. Some of these cells can be mobilised from the bone marrow as it has the capacity to regenerate the cells. So we stimulate the bone marrow by an injection.

This injection is given for five days and it mobilises the bone marrow and some of the cells. They then come into the blood circulation. In the study we tried to filter these cells from the blood marrow using a specialised filtering machine and the concentrate of these cells. About 5 ml to 10 ml of the blood containing these concentrated group of cells was then injected into the hepatic artery, which supplies blood to the liver, explained Dr. Arora. He said this process was carried out by a number of different mechanisms and it proved quite successful. We started about two years ago and finished last year. Then these patients were followed up for another one year and we were happy to see a significant proportion of the patients having substantial improvement in the liver functions as assessed by a score called Child score.

Dr. Arora said, All patients tolerated the treatment well without any side effects. Of the 10 patients, six to seven benefited. So we believe that more frequent administration of the stem cells in large number might have a more beneficial impact.

While the study by the Sir Ganga Ram Hospital team was published this year and was approved by the Department of Biotechnology and Ministry of Science and Technology, Government of India, Dr. Arora said there is also other published data now which calls for stimulating the bone marrow and letting the cells automatically go into the liver. By this, he said, you avoid filtering and putting the blood with the stem cells into the liver. This is also equally beneficial.

Dr. Arora said stem cell therapy might act as a bridge for liver transplant and can provide some time to the patients to arrange for treatment. But just like a damaged car tyre, he said, a damaged liver after minor repairs has to be replaced. However, if a person stops taking liquor or if the therapy goes on well, then a patient can lead a healthy life for many more years.

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Stem cell therapy is new hope for liver transplant patients

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Stem Cell Treatment for Spinal Cord Injury at the Stem Cell Institute in Panama – Daniel Campbell – Video

Posted: March 18, 2013 at 2:43 am


Stem Cell Treatment for Spinal Cord Injury at the Stem Cell Institute in Panama - Daniel Campbell
After stem cell therapy at the Stem Cell Institute in Panama, Daniel Campbell describes how his condition has improved since his first treatment. Daniel is i...

By: cellmedicine

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Stem Cell Treatment for Spinal Cord Injury at the Stem Cell Institute in Panama - Daniel Campbell - Video

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Using Adult Stem Cells to Treat Diabetic Wounds – Video

Posted: March 18, 2013 at 2:43 am


Using Adult Stem Cells to Treat Diabetic Wounds
Pre-clinical research has generated some very promising findings using adult stem cells for the treatment of diabetic wounds. The research carried out by sci...

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