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Orgenesis Announces Agreement to Acquire Koligo Therapeutics, a Leader in Personalized Cell Therapies – GlobeNewswire

Posted: September 29, 2020 at 6:59 am

Acquisition to support accelerated commercialization of Koligos KYSLECEL,a personalized islet cell therapy available in the U.S. for chronic and recurrent acute pancreatitis

Goal to rapidly advance KT-PC-301, an autologous cell therapy under investigationfor the treatment of COVID-19-related Acute Respiratory Disease Syndrome (ARDS)

Orgenesis to leverage Koligos 3D-V bioprinting technology across its POCare Platform

GERMANTOWN, Md., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (Orgenesis or the Company), a global biotech company working to unlock the full potential of cell and gene therapies, and Koligo Therapeutics, Inc. (Koligo), a regenerative medicine company, today announced that the two companies have entered into a definitive merger agreement, subject to final closing conditions, with expected completion before year-end (Transaction).

Koligo is a leader in developing personalized cell therapies utilizing the patients own (autologous) cells. Koligo has successfully launched its first commercial product, KYSLECEL, and plans to commence a phase 2 trial of KT-PC-301 for COVID-19-related ARDS. Koligos development stage technology utilizes 3D bioprinting and vascularization with autologous cells (3D-V technology) to create biodegradable and shelf-stable three-dimensional cell and tissue implants. The 3D-V technology is being developed for diabetes and pancreatitis, with longer term applications for neural, liver, and other cell/tissue transplants.

Following closing of the Transaction, Orgenesis plans to accelerate the commercial scaleup of KYSLECEL throughout the United States and, subject to regulatory and logistical considerations, in international markets as well. After closing of the Transaction, and subject to FDA review and clearance of the Companys Investigational New Drug application, Orgenesis expects to start patient recruitment for a phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. Orgenesis also plans to leverage Koligos 3D-V bioprinting technology across its POCare platform.

Under the terms of the merger agreement, Orgenesis will acquire all of the outstanding stock of Koligo from its shareholders (the founders and staff of Koligo and a subsidiary of Bergen Special Opportunity Fund, LP, an institutional investor managed by Bergen Asset Management, LLC). The agreed consideration terms are an aggregate of $15 million in shares of Orgenesis common stock valued at $7.00 per share which shall be issued to Koligos accredited investors (with certain non-accredited investors to be paid solely in cash) and an assumption of $1.3 million in Koligos liabilities, estimated to be substantially all of Koligos liabilities. Additional details of the Transaction will be available in the Companys Form 8-K, which will be filed with the Securities and Exchange Commission, and will be available at http://www.sec.gov.

KYSLECELKoligos KYSLECEL is commercially available in the United States for chronic and recurrent acute pancreatitis in a surgical procedure commonly called Total Pancreatectomy with Islet Autologous-Transplant (TPIAT). TPIAT has been proven to provide significant pain relief, improved quality of life, and a reduction in the need for pain medication for patients suffering from chronic or recurrent acute pancreatitis. KYSLECEL infusion after a total pancreatectomy helps preserve insulin secretory capacity and reduce the risk of diabetic complications. KYSLECEL is made from a patients own pancreatic islets the cells that make insulin to regulate blood sugar.

Koligo has commenced its commercial pilot program for KYSLECEL at six U.S. hospitals, treating 40 patients to date. The KYSLECEL pilot program has generated approximately $2 million in sales revenue. KYSLECEL has also been shown to result in significant savings to payors over traditional chronic pancreatitis management. Following the closing of the Transaction, Orgenesis plans to make KYSLECEL available to an increasing number of hospitals throughout the United States through its POCare Network.

KT-PC-301Koligos lead clinical development program is for KT-PC-301, an autologous cell therapy under investigation for the treatment of COVID-19-related Acute Respiratory Disease Syndrome (ARDS). KT-PC-301 is comprised of autologous stromal and vascular fraction cells (SVF) derived from each patients adipose (fat) tissue. KT-PC-301 contains a population of mesenchymal stem cells, vascular endothelial cells, and immune cells which migrate to the patients lungs and other peripheral sites of inflammation. Nonclinical and clinical evidence demonstrate that KT-PC-301 may: (1) stabilize microcirculation to improve oxygenation; (2) maintain T and B lymphocytes to support antibody production; and (3) induce an anti-inflammatory effect.

Koligo has completed a pre-IND (Investigational New Drug) consultation with the U.S. Food and Drug Administration to start clinical trials of KT-PC-301 in COVID-19-related ARDS. Following the closing of the Transaction, and subject to FDA review and clearance of the Companys Investigational New Drug application, Orgenesis expects to start patient recruitment for a phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. As currently planned, the phase 2 trial is expected to enroll 75 patients and evaluate the safety and efficacy of KT-PC-301. Mohamed Saad, MD, Chief of Division of Pulmonary, Critical Care, and Sleep Disorders Medicine at the University of Louisville, will be the lead clinical investigator on the trial.

3D-V Technology Koligos 3D-V bioprinting technology is designed to support development of a number of product candidates for the treatment of diabetes, cancer, neurodegenerative disease, and other serious diseases. The 3D-V technology platform is able to print three-dimensional cell and tissue constructs with a vascular network. Key benefits of the 3D-V approach include: faster revascularization/inosculation of cell/tissue transplant to improve engraftment; host tolerance of the graft while minimizing need for immune suppressive drugs; better site of transplant administration of such products; and scaffolding to keep cell/tissue in place in vivo. These solutions are ideally suited for islet transplant and other cell/tissue transplant applications.

Koligo ManagementFollowing the closing of the Transaction, Koligos management team will be joining Orgenesis to continue commercial and development activities. Koligos CEO, Matthew Lehman, is an accomplished executive in the biotech and regenerative medicine fields. Prior to co-founding Koligo, he was CEO of Prima Biomed Ltd (now Immutep Ltd, a Nasdaq (IMMP) and ASX (IMM) listed biotech company). Stuart Williams, PhD, Chief Technology Officer, is a bioengineer and thought leader in regenerative medicine, with over 300 publications and 20 issued patents in the field. Dr. Williams has co-founded three other biotech companies and is an experienced academic-industry collaborator. Michael Hughes, MD, Chief Medical Officer, is a transplant surgeon who started the islet transplant program at University of Louisville which was the genesis of Koligos KYSLECEL program. He has successfully treated nearly 50 chronic pancreatitis patients with islet autologous transplant after pancreatectomy. Balamurugan Appakalai, PhD, has more than 20 years of islet isolation experience, having processed more than 800 human pancreases. He is a leader in the field of islet transplant with 100+ publications.

Vered Caplan, Chief Executive Officer of Orgenesis, stated, We are pleased to announce this transformative acquisition, which we expect will add broad capabilities to our therapeutic and technology platform, and will further our leadership in the cell and gene therapy field. Based on several phase 1 studies, Koligos KT-PC-301, using a patients own cells, has demonstrated safety and tolerability, and has shown signs of efficacy to support continued development in COVID-19-related ARDS. If successful for the treatment of COVID-19-related ARDS, KT-PC-301 is likely to have applications in other acute and chronic respiratory indications, areas that represent significant unmet medical need. In addition, we see significant potential in KYSLECEL, a commercial stage asset for the treatment of chronic and acute recurrent pancreatitis, which we plan to introduce through our global network of hospitals. Finally, Koligos 3D-V bioprinting technology is highly complementary to our POCare Platform, as we implement new technologies to improve efficacy and lower the costs of cell and gene therapies. I would like to personally welcome Matthew and the rest of the Koligo team to the Orgenesis organization when the Transaction closes. We believe that their skills and experience will be an important addition as we execute on our strategy to unlock the power of cell and gene therapies and make them accessible to all.

Matthew Lehman, Chief Executive Officer of Koligo Therapeutics, stated, The merger with Orgenesis marks a major milestone for our company and builds on our recent progress, including the Pre-IND package submitted to the U.S. FDA for KT-PC-301 and our pilot commercial program for KYSLECEL. The Orgenesis team brings extensive clinical, regulatory, and manufacturing expertise well suited to supporting Koligos goals. Orgenesis intellectual property is highly complementary to Koligos technology and the combined companies will work to advance a robust commercial and development product portfolio. Orgenesis POCare technologies are also ideally suited for low-cost and efficient production of autologous cell therapies at the point of care, which we believe will considerably enhance the delivery of these therapies to patients. Additionally, we believe Orgenesis global network of leading hospitals and healthcare institutions will enable us to accelerate the commercial rollout of KYSLECEL. We are quite encouraged by the outlook for the business and look forward to leveraging Orgenesis POCare Platform in order to accelerate the timeline to bringing our innovative cell therapies to market. Through this merger, we believe we can maximize value for all shareholders and we are grateful to Orgenesis for this opportunity.

Pearl Cohen Zedek Latzer Baratz LLP and KPMG advised Orgenesis on the Transaction. Maxim Group LLC acted as a finder and Nelson Mullins Riley & Scarborough, LLP advised Koligo on the Transaction.

About Koligo Therapeutics Koligo Therapeutics, Inc. is a US regenerative medicine company. Koligos first commercial product is KYSLECEL (autologous pancreatic islets) for chronic and acute recurrent pancreatitis. Koligos 3D-V technology platform incorporates the use of advanced 3D bioprinting techniques and vascular endothelial cells to support development of transformational cell and tissue products for serious diseases. More information is available at http://www.koligo.net.

About OrgenesisOrgenesis is a global biotech company working to unlock the full potential of celland gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis POCarePlatform is comprised of three enabling components: a pipeline of licensedPOCare Therapeuticsthat are processed and produced in closed, automatedPOCare Technologysystems across a collaborativePOCare Network. Orgenesisidentifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. Learn more about the work Orgenesis is doing atwww.orgenesis.com.

Notice Regarding Forward-Looking Statements The information in this release is as of September 29, 2020. Orgenesis assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments. This release contains forward looking statements about Orgenesis, Koligo, Koligos technology, and potential development and business opportunities of Koligo and Orgenesis following the closing of the Transaction, each of which involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of the Companys products; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any such regulatory authorities may approved the Companys development products, and, if approved, whether such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of the Companys products; uncertainties regarding the impact of COVID-19 on the Companys business, operations and financial results and competitive developments.

A further description of risks and uncertainties can be found in the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov.

Contact for Orgenesis:Crescendo Communications, LLCTel: 212-671-1021ORGS@crescendo-ir.com

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Dr. Pagel on the Utility of CAR T-Cell Therapy in Relapsed/Refractory DLBCL – OncLive

Posted: September 29, 2020 at 6:59 am

John M. Pagel, MD, PhD, discusses the utility of CAR T-cell therapy in patients with relapsed/refractory diffuse large B-cell lymphoma.

John M. Pagel, MD, PhD, chief of the Hematologic Malignancies Program, and directorof theHematopoietic Cell Transplantation Program at Swedish Cancer Institute inSeattle, Washington, discussesthe utility of CAR T-cell therapy in patients with relapsed/refractorydiffuse large B-cell lymphoma (DLBCL).

Althoughautologous stem cell transplant (ASCT)is still used in DLBCL, it is important to understand that it is not a viable treatment option for the vast majority of patients who relapse, says Pagel. For example, if 60 out of 100 patients are cured, that means 40 patients will relapse, adds Pagel; of those 40patients,approximatelyhalfwill receivean ASCT. Patients will not get a transplant if theyare not chemotherapy sensitive or they mayhave comorbidities that do not allow them toundergo the procedure.

Moreover, only about half of patients who under transplant will achieve cure, adds Pagel. Patients who are not cured up front or by transplant still needaneffective treatment option that can provide a significant benefit. To this end, some newer agents have emerged for patients with relapsed disease in recent years. The biggest development has beenCAR T-cell therapy, says Pagel. This approach provides curative potential to patients who failed a transplant; were never able to get to transplant because they are not sensitive to chemotherapy; or were high-risk and refractory to up-frontrituximab (Rituxan) plus cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisonechemoimmunotherapy.

CAR T-cell treatments are very important for those patients, adds Pagel, as this approach can provide long-term survival to some of these patients, concludes Pagel.

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Official Missteps in Michigan’s Worst Covid Prison Outbreak – The Intercept

Posted: September 29, 2020 at 6:57 am

Thomas Shulick prayed inside a church at the end of July at the Muskegon Correctional Facility in Michigan. He had regularly attended services since joining a faith-based dormitory at the prison for inmates within a few years of their release date. Men from the prisons other units were also in attendance, all wearing face masks.

Shulick wasnt concerned about becoming infected by the coronavirus that morning. The Muskegon prison, which has 1,319 beds set up mostly in two-man cells, had remained unscathed by the pandemic, recording zero infections even as the virus ripped through the states prison system earlier in the year. More than 5,000 prisoners at other facilities had been infected, and 68 had died.

We had dodged it so long, and out of a general trust for the administration, I assumed it was safe to go to these programs, Shulick told The Intercept. But unbeknownst to him, the virus was quietly spreading at Muskegon, which would soon become the site of the states worst prison outbreak.

On July 31, after several weeks with no reported new infections across the entire prison system, the Michigan Department of Corrections reported six positive Covid-19 cases at Muskegon. The prison then commenced testing everyone at the facility, sending the number of cases skyrocketing. By late September, 997 prisoners more than 75 percent of those in custody had tested positive for the virus, in addition to 27 staff members.

The Intercept spoke with Shulick and two other men at the prison, and collected the accounts of two others. They describe a situation in which the Michigan DOC exacerbated the incipient outbreak from the start, by shuffling prisoners between units in a haphazard attempt to separate the confirmed infected from both the uninfected and possibly infected.

I feel like this prison had plenty of time to learn from the mistakes of other prisons.

The institutional errors they cite include the frequent mixing of potentially infected and uninfected prisoners; inadequate sanitation of prison cells between occupants; and at least one improper transfer of a person who was not known to be infected to a unit full of infected prisoners.

That person, Ruben Jordan, tested positive for the virus within days and died two weeks later at a local hospital. His was the first Covid-19 death of a Michigan prisoner since June 2, and the 69th overall. The Michigan DOC confirmed that Jordan, who also worked as a groundskeeper at the prison, had been inadvertently moved to the unit for infected prisoners after his roommate tested positive, then sent back to his original unit the same day potentially carrying the virus with him. Three others who had originally been incarcerated at Muskegon died from the virus in September.

Advocates say that in addition to incompetence by prison staff, the states severely overcrowded prison system added to the difficulty of separating prisoners in time to stem the outbreak. And prisoners say these institutional flubs were aided by some correction officers callous disregard for their lives.

In response to questions from The Intercept, Michigan DOC spokesperson Chris Gautz said the prison couldnt verify the source of the outbreak. But because visitors have not been allowed into the prisons since early March and transfers have been rare, it likely came from prison staff, who Michigan Department of Health and Human Services Director Robert Gordon called the principal vector for Covid-19 to enter a prison facility. On August 22, well into the outbreak, Gordon issued an executive order mandating that all staff working at facilities with an infected prisoner be tested each week.

Staff at Muskegon werent tested for the virus until August 25.

By the time officials there discovered the outbreak, there were so many positive cases that the DOCs Correctional Facilities Administration deputy director, Ken McKee, decided to quarantine entire units at the prison based on three designations: confirmed infected, confirmed uninfected, and potentially infected (prisoners whod had close contact with confirmed infected). A Michigan DOC flow chart indicates that infected prisoners are normally transferred to one of several designated facilities, but officials did not follow this protocol at Muskegon because the outbreak was so widespread.

Prisoners who spoke with The Intercept believe that rather than contain the virus, officials actions contributed to its spread. In a handwritten letter obtained by The Intercept, one prisoner who had not tested positive for the virus said that he and dozens of others were forced to move from a unit with only two confirmed cases to a unit with more than 50 confirmed cases. The prisoner was transferred to a cell where sick prisoners had been staying less than 24 hours before, he said.

The majority of rooms we were moved to had positive case people moved out of it the same day, without sanitation of rooms until we were forced to move in, wrote the prisoner, who did not want his name published for fear of retribution. He wrote that he was provided with rubber gloves and bleach to clean the cell himself a task normally relegated to cleaning staff.

According to Michigan DOC protocol, officials are recommended to close off areas used by ill prisoners and wait up to 24 hours before cleaning and disinfection.

Gautz, the spokesperson, confirmed to The Intercept that some units were not properly cleaned but noted that the issue was promptly addressed to ensure it would not happen again.

A week after he was moved, the prisoner who wrote the letter tested positive for the virus.

Another prisoner who spoke with The Intercept, Larry Cowan, said that he was moved to a new unit in early August after being informed that he had come into close contact with somebody who tested positive. But rather than being isolated, he was moved to a cell with a bunkmate in a unit with infected prisoners.

They said we could only shower every other day, Cowan said. They were treating us like were in the hole or did something wrong.

Then, he said, prison officials started bringing him back and forth between two units at the prison until he was finally kept in his original unit, which by then had been designated for infected prisoners. Cowan had also tested positive by that point, 10 days after his initial move. For at least one night, the unit was kept on lockdown for 18 hours, and prisoners couldnt leave their cells even to use the bathroom.

Sick prisoners were beating on their doors to use the bathroom, Cowan recalled. They eventually resorted to urinating and defecating in trash bags. They didnt tell us why we were being locked down.

Theres a feeling among prisoners that the strategy is now just to let it run its course or maybe even help it along.

Another prisoner at Muskegon, who preferred to use the pseudonym Adam, was transferred out of his unit after his bunkmate tested positive for the virus. When Adam spoke to The Intercept, he was being held at a unit for those suspected of coming into contact with the virus, where prisoners were free to move around in common areas.

Every time they bring new people in, they are exposing potentially infected prisoners to whole new groups of people, he complained. They sent me over here and gave me another bunkmate, so now Im being exposed to this guy and everyone this guy was exposed to.

Shulick, the prisoner whod been at church in late July, was at first moved inexplicably from his unit to another one with his bunkmate. After that bunkmate tested positive for the virus, Shulick was moved again, this time to the same close contact unit as Adam. He hasnt tested positive but fears its inevitable.

I feel like this prison had plenty of time to learn from the mistakes of other prisons, he told The Intercept. He says that one guard told him that prisoners in his current unit should hurry up and test positive so the prison could resume normal operations without the constant transfers.

Adam echoed this perspective.

Theres a feeling among prisoners that the strategy is now just to let it run its course or maybe even help it along, he stated.

The problems at Muskegon were part of a broader year of mishaps by the Michigan DOC to properly handle the pandemic in its facilities.

In April, people incarcerated at four Michigan prisons hardest hit by the virus filed a class-action lawsuit alleging that the DOC neglected to move infected prisoners out of their cells, electing instead to quarantine entire units with both infected and non-infected prisoners.

Prisoners also alleged that officers did not change their clothing in between visits to infected and non-infected units; that they did not make cleaning supplies readily available; and that they did not properly sanitize nurses offices.

In June, officials mixed up more than 100 coronavirus test results at the Macomb Correctional Facility, leading them to house infected and non-infected people together in the same units. Several people in custody at the Michigan Reformatory prison facility also reported to The Intercept that the DOC lost track of their tests results, though this doesnt appear to have seeded an outbreak.

Daniel Manville, the lead lawyer suing the Michigan DOC, said hes heard a number of times that prison officials at other facilities moved prisoners around in a similar fashion as at Muskegon.

It doesnt make any sense, because Covid-19 is in the air, its on the beds, its on whatever [in] the housing unit, Manville said.

One place where Manville, people in custody, and the Michigan DOC agree is that the prison systems extreme overcrowding makes it impossible to effectively separate prisoners or practice social distancing. Several factors have contributed to this problem.

The state passed a truth-in-sentencing law in 1998 that mandated people serve their full minimum prison sentence, greatly reducing the number who could be eligible for early release. According to the Michigan DOC, few of its 37,000-plus prisoners are parole-eligible; 4,797 people since March have been released on parole. A lawsuit that aimed to put the repeal of truth-in-sentencing to a ballot vote in November was dismissed by a federal judge in June.

Relief for prisoners at Muskegon and elsewhere in Michigan is not likely to come any time soon.

Manvilles lawsuit stalled after an injunction approved by a U.S. district judge was stayed by the U.S. 6th Circuit Court of Appeals. The stay was prompted after another appeals court denied relief in a similar lawsuit against the federal Bureau of Prisons.

And Michigan Gov. Gretchen Whitmer, who has the power to release prisoners via executive order, has declined to do so and shown no indication of changing her mind.

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Official Missteps in Michigan's Worst Covid Prison Outbreak - The Intercept

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Regenerative medicine and war: The next breakthrough in treating injured veterans? – Genetic Literacy Project

Posted: September 29, 2020 at 6:57 am

Many Americans, and indeed people all over the world, were outraged when reports surfaced this past summer that President Trump had once dismissed the dead from one of World War Is iconic battles, The Battle of Belleau Wood, as suckers and losers. Amputees should be excluded from parades because nobody wants to see them, the article also reports he had said.

The president denied these claims, but the outcry highlighted the high regard in which the American public holds veterans; although the country is sharply divided politically, it is united by the pride and respect the people hold for those brave enough to risk life and limb for their country.

The number of injured soldiers returning home alive has risen from 75% to 92% since the Vietnam War, but combat takes a toll on the survivors. Its estimated that one in every 10 veterans alive today was injured seriously while serving. And, for many, the nature of the injury makes treatment very difficult. Soldiers can find themselves returning home with severe burns, spinal cord injuries, paralysis, blindness, deafness, brain injuries and loss of limbs, as well as psychological trauma, some linked directly to physical injuries.

The most significant development in recent years for severely maimed veterans and other victims of physical injuries is the acceleration of whats known as regenerative medicine. Regenerative medicine was first defined in 1999 and it encompasses many disciplines of science. Its goal is to provide clinicians with the tools to effectively repair or replace a patients damaged tissues and organs in order to return normal function.

The technology really emerged into the public consciousness in the 2000s because of the Iraq war and, since then, great strides have been made in applying it to treating many different healthcare issues. So, what about the specifics? What are the most promising breakthroughs in recent years?

Some of the most challenging war-related injuries involve bones. Severe burns, spinal cord injuries, blast injuries, traumatic brain injuriesthese seemingly disparate traumas can each lead to a painful complication during the healing process called heterotopic ossification (HO).

A team at Michigan Medicines Department of Surgery is focusing its research on how the healing process often goes awry. The problem often emerges at limb amputation sites. Weeks after surgery or injury, abnormal bones often form within soft tissues like muscleplaces where theyre not supposed to be, causing the patient agonizing pain.

Theres no way to prevent it and once its formed, theres no way to reverse it, said Benjamin Levi, M.D, co-head of the research team at the Center for Basic and Translational Research at Michigan Medicines Department of Surgery.

There may be a solution thanks to a collaborative study between Levi and a research group led by Stephen Kunkel, Ph.D. at Michigans Department of Pathology. It had been theorized that HO could be linked to inflammation at the site of injury or surgery. The researchers built on this theory by studying the cells that are present at the early stages of HO.

Working with mice, they have been able to identify a specific protein that is responsible for sending the signals that trigger stem cells within the bone to start this process of uncontrolled tissue growth. By targeting this protein and stopping its action, it could be possible to stop the process in the first place. This would improve the quality of life for many injured veterans.

Treating HO is very much a case of prevention being better than cure. Progressing this discovery into a therapeutic setting could eventually provide doctors with a mechanism to stop HO before it has a chance to develop. It would be a game changer for many veterans who would otherwise be left with this agonizing condition.

Severe blast injuries and bullet traumas also leave many veterans needing implants or prosthetics to replace bone that has been lost to severe injury. If you break a leg, a doctor will put it in a cast and allow the natural healing process to occur. If its a severe break, you may need surgery. But when a soldiers bone is ripped apart by a gunshot or a blast, the damage to the network of cells within the bone is so severe that it often cannot heal on its own.

Regenerative medicine may provide a solution. After leaving the US Army more than 20 years ago, solider Luis Alvarez founded a firm at the Massachusetts Institute of Technology that developed a paint derived from key proteins that can trigger bone regeneration. The inspiration behind Alvarezs innovation?

During my time in Iraq, I witnessed service members who suffered traumatic injuries undergo amputations weeks or months after the initial wound, because there was no reliable method for regenerating the bone.

The technology developed by his company allows doctors to coat implants with specific proteins, allowing them to trigger regeneration, thus aiding recovery of the damaged tissue. They are making great progress and looking to have something ready for doctors to use in clinics by 2021. Its an inspiring story. The company is rolling out multiple therapies heading into clinical trials over the next two years.

The military is also starting to invest heavily in one of the most exciting avenues of regenerative medicine to help veterans replace lost tissue. Bioprinting uses human cells mixed with specially designed bioinks to 3D print tissue-like structures for the purpose of regenerating damaged body parts. Using bioprinting, scientists can build replacement grafts using a patients own stem cells, thus removing the issues associated with transplant rejection. The technology is still in its infancy but, thanks to recent military investment, scientists are now applying bioprinting to the generation of skin grafts to treat the severe burns that many veterans are afflicted with.

Treating severe burns is an incredibly difficult process and many rarely heal completely. Patients can be left with extreme scarring, tight and itchy skin and disfigurement. When the skin is severely burned the body focuses on preventing infection by closing the wound as quickly as possible. New skin is generated but the structure is vastly different to normal tissue.

A 5-year research project led by Prof Jeff Biernaskie at the University of Calgary Faculty of Veterinary Medicine has made a big step forward.

What weve shown is that you can alter the wound environment with drugs, or modify the genetics of these progenitor cells directly, and both are sufficient to change their behaviour during wound healing. And that can have really quite impressive effects on healing that includes regeneration of new hair follicles, glands and fat within the wounded skin.

This research could lead to new drugs that greatly improve the healing process.

It is clear from the number of veterans currently coping with a compromised quality of life that we need to do more to treat their injuries. It is estimated that the number of veterans currently living with these life changing injuries is in the millions and their healthcare needs come at an immense economic cost. Fortunately, there is now a much stronger horse in the race to a cure.

Regenerative medicine was estimated to draw nearly $15 billion in investments in 2017. That figure is predicted to rise to in excess of $79 billion by 2026. Those are serious resources, providing hope that our veterans will benefit in the decade ahead.

Sam Moxon has a PhD in regenerative medicine and is currently involved in dementia research. He is a freelance writer with an interest in the development of new technologies to diagnose and treat degenerative diseases. Follow him on Twitter@DrSamMoxon

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Hematopoietic Stem Cells (HSCs) Market Primary Research, Secondary Research, Product Research, Trends And Forecast By 2026- Kite Pharma Inc., Thermo…

Posted: September 29, 2020 at 6:57 am

Chicago, United States: The report on Global Hematopoietic Stem Cells (HSCs) Market provides the complete overview of the several key segments of the market. Report provides accurate calculation and qualitative analysis. Report gives the in depth analysis on various factors, for example market size, segmentations, competitive landscapes, geographical regions and end users. Regional analysis provides a systematic knowledge about the opportunities in business, market status & forecast, possibility of generating revenue, regional market by different end users as well as types and future forecast of upcoming years. The report entitled Global Hematopoietic Stem Cells (HSCs) Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2026 released by Report Hive Research comprises an assessment of the market which provides the real-time market scenario and its projections during 2020 to 2026 time-period [5 Years Forecast].

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Leukocyte, Lymphocytes, Red Blood Cells, Platelets

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Regional coverage: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, Colombia etc.), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

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Hematopoietic Stem Cells (HSCs) Market Primary Research, Secondary Research, Product Research, Trends And Forecast By 2026- Kite Pharma Inc., Thermo...

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Keio University Research: Combating COVID-19: Nationwide genomic analysis to study possible reasons for the low COVID-19 mortality rate in Japan -…

Posted: September 29, 2020 at 6:56 am

https://research-highlights.keio.ac.jp/

On 21 May, 2020, the Joint Research Coronavirus Task Force was launched in Japan to promote the development of a mucosal vaccine for COVID-19 based on advanced genomic analysis.

"We will analyze 600 blood samples taken from Japanese COVID-19 patients located in approximately 100 hospitals throughout Japan," explains Takanori Kanai of the Keio University School of Medicine, who leads the task force. "One of the goals of the research is to try to understand why the mortality rate due to COVID-19 has remained significantly lower in Japan than the United States and European countries. We think it may be related to genetic differences. We want to resolve this issue and share our results with our colleagues around the world."

Background and goals

This research is being undertaken by experts affiliated with Keio University, Tokyo Medical and Dental University, Osaka University, the Institute of Medical Science at the University of Tokyo, the National Center for Global Health and Medicine, the Tokyo Institute of Technology, Kitasato University, and Kyoto University.

"Our research team includes specialists in infectious diseases as well as other fields such as molecular genetics, computational science, and gastroenterology, which is my area of expertise, and is not directly related to epidemiology or infectious diseases," says Kanai. "This project was conceived by a small group of medical doctors and researchers without experience of handling infectious diseases. But the actual project is interdisciplinary, with members including ICU and medical care staff at university hospitals, community healthcare practitioners, immunologists, and even members of the general public. Ultimately, we want to contribute to society through medicine and science."

Working hypotheses for possible reasons for fewer COVID-19 deaths in Japan and Asia

The members of the task force compiled the following list of potential reasons for the low mortality rate in Japan: Japan's world-class medical system; a history of regular face mask use and attention to hygiene (including hand washing) in daily life; a culture of avoiding physical contact akin to social distancing; low expression of virus receptors; BCG vaccination; and differences in immune response due to differences in racial HLA and other polymorphisms.

Gathering samples and genetic information

The task force's goals are to establish a medical response system to predict who is at risk of contracting severe COVID-19 and develop a vaccine using proprietary technology. Genomic analysis technology is being employed to elucidate the genetic basis of the mechanisms that trigger COVID-19 infections to worsen, and thereby develop methods to fight the disease and develop a mucosal vaccine.

The team is focusing on the fact that the number of COVID-19 deaths per capita is far smaller in the Japanese population than it is in Western countries. The 600 blood samples are being studied by methods including high-resolution HLA analysis, SNP array and whole-genome sequence analysis, and T-cell repertoire analysis.

"Our analysis is being used to compare severe cases with mild and asymptomatic cases to identify genes that may be responsible for the exacerbation of COVID-19 in Japanese patients," explains Kanai. "Regarding vaccine development, predicting the target epitope is a major challenge. We are planning to use supercomputer simulations to identify potential antigens for SARS-CoV-2 based on our results for determining the genes that lead to severe cases of COVID-19 in Japanese patients."

Initial findings will be announced in September 2020

The task force plans to announce the initial findings of their research in September 2020. This will include the identities of the genes associated with triggering severe cases of COVID-19 among Japanese people that could be used to predict potential severity during early diagnostics.

"We want to use our results to produce guidelines to mitigate the dangers of overloading the medical care system during potential second or possibly third waves of COVID-19," says Kanai. "Furthermore, our immunological genetic information will be valuable for designing potential vaccines for SARS-CoV-2 for many Japanese people. We will share our results with colleagues in other countries so that they can use them to develop strategies to combat COVID-19 for their own populations."

About the researcher

Takanori Kanai Professor

Department of Gastroenterology and Hepatology, School of Medicine

Takanori Kanai graduated from the Keio University School of Medicine in 1988. Between 1989 and 2003 he held teaching positions at the Keio University School of Medicine, Keio Cancer Center, and Tokyo Medical and Dental University (TMDU). He has also held distinguished positions including as a committee member of the Harvard Medical Institute Educational Program at TMDU; Section Editor of the journal Inflammatory Bowel Diseases; Associate Editor of Journal of Gastroenterology; Editorial Board Member, American Journal of Physiology and Gastrointestinal and Liver Physiology; and Clinical Professor of Medicine (Visiting), TMDU. At the Keio University School of Medicine, he was appointed as an associate professor in 2007 and a professor in 2013, and he has been serving as a vice dean since 2017.

Links

COVID-19 taskforce https://www.covid19-taskforce.jp/en/home/

Takanori Kanai informationhttps://k-ris.keio.ac.jp/html/100002919_en.html

Further informationKeio UniversityOffice of Research Development and Sponsored Projects2-15-45 Mita, Minato-ku, Tokyo 108-8345 JapanE-mail: [emailprotected]

WebsitesKeio Universityhttps://www.keio.ac.jp/en/

Keio Research Highlightshttps://research-highlights.keio.ac.jp/

About Keio University

Keio University is a private, comprehensive university with six major campuses in the Greater Tokyo area along with a number of affiliated academic institutions. Keio prides itself on educational and research excellence in a wide range of fields and its state-of-the-art university hospital.

Keio was founded in 1858, and it is Japan's first modern institution of higher learning. Over the last century and a half, it has evolved into and continues to maintain its status as a leading university in Japan through its ongoing commitment to producing leaders of the future. Founder Yukichi Fukuzawa, a highly respected educator and one of the most important intellectuals of modern Japan, aspired for Keio to be a pioneer of new discoveries and contribute to society through learning.

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Scientists discover genetic and immunologic underpinnings of some cases of severe COVID-19 – National Institutes of Health

Posted: September 29, 2020 at 6:56 am

Media Advisory

Thursday, September 24, 2020

New findings by scientists at the National Institutes of Health and their collaborators help explain why some people with COVID-19 develop severe disease. The findings also may provide the first molecular explanation for why more men than women die from COVID-19.

The researchers found that more than 10% of people who develop severe COVID-19 have misguided antibodiesautoantibodiesthat attack the immune system rather than the virus that causes the disease. Another 3.5% or more of people who develop severe COVID-19 carry a specific kind of genetic mutation that impacts immunity. Consequently, both groups lack effective immune responses that depend on type I interferon, a set of 17 proteins crucial for protecting cells and the body from viruses. Whether these proteins have been neutralized by autoantibodies orbecause of a faulty genewere produced in insufficient amounts or induced an inadequate antiviral response, their absence appears to be a commonality among a subgroup of people who suffer from life-threatening COVID-19 pneumonia.

These findings are the first published results from the COVID Human Genetic Effort, an international project spanning more than 50 genetic sequencing hubs and hundreds of hospitals. The effort is co-led by Helen Su, M.D., Ph.D., a senior investigator at the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH; and Jean-Laurent Casanova, M.D., Ph.D., head of the St. Giles Laboratory of Human Genetics of Infectious Diseases at The Rockefeller University in New York. Major contributions were made by Luigi Notarangelo, M.D., chief of the NIAID Laboratory of Clinical Immunology and Microbiology (LCIM); Steven Holland, M.D., director of the NIAID Division of Intramural Research and senior investigator in the NIAID LCIM; clinicians and investigators in hospitals in the Italian cities of Brescia, Monza and Pavia, which were heavily hit by COVID-19; and researchers at the Uniformed Services University of the Health Sciences in Bethesda, Maryland.

The wide variation in the severity of disease caused by SARS-CoV-2, the virus behind COVID-19, has puzzled scientists and clinicians. SARS-CoV-2 can cause anything from a symptom-free infection to death, with many different outcomes in between. Since February 2020, Drs. Su and Casanova and their collaborators have enrolled thousands of COVID-19 patients to find out whether a genetic factor drives these disparate clinical outcomes.

The researchers discovered that among nearly 660 people with severe COVID-19, a significant number carried rare genetic variants in 13 genes known to be critical in the bodys defense against influenza virus, and more than 3.5% were completely missing a functioning gene. Further experiments showed that immune cells from those 3.5% did not produce any detectable type I interferons in response to SARS-CoV-2.

Examining nearly 1,000 patients with life-threatening COVID-19 pneumonia, the researchers also found that more than 10% had autoantibodies against interferons at the onset of their infection, and 95% of those patients were men. Biochemical experiments confirmed that the autoantibodies block the activity of interferon type I.

Q Zhang et al. Inborn errors of type I IFN immunity in patients with life-threatening COVID-19. Science DOI: 10.1126/science.abd4570 (2020).

P Bastard et al. Auto-antibodies against type I IFNs in patients with life-threatening COVID-19. Science DOI: 10.1126/science.abd4585 (2020).

NIAID Director Anthony S. Fauci, M.D., NIAID Senior Investigator Helen C. Su, M.D., Ph.D., and Luigi Notarangelo, M.D., chief of the NIAID Laboratory of Clinical Immunology and Microbiology, are available for interviews.

To schedule interviews, please contact NIAID Office of Communications, (301) 402-1663, NIAIDNews@niaid.nih.gov.

NIAID conducts and supports research at NIH, throughout the United States, and worldwide to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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182 Genes Identified That Regulate Interactions Between Cancer Cells and T Cells – Technology Networks

Posted: September 29, 2020 at 6:56 am

Toronto scientists have mapped the genes allowing cancer cells to avoid getting killed by the immune system in a finding that paves the way for the development of immunotherapies that would be effective for larger patient populations and across different tumour types.

"Over the last decade, different forms of immunotherapy have emerged as really potent cancer treatments but the reality is that they only generate durable responses in a fraction of patients and not for all tumour types," says Jason Moffat, a professor of molecular genetics in the Donnelly Centre for Cellular and Biomolecular Research at the University of Toronto who led the work.

The study also revealed the need for new therapy to take into account the genetic composition of tumours because of mutations in the cancer cells that can potentially make the disease worse in response to treatment, often referred to as cancer resistance mutations.

"It's very important to understand at the molecular level how cancer develops resistance to immunotherapies in order to make them more broadly available. Advances in systematic genetic approaches have let us key in on genes and molecular pathways that are commonly involved in resistance to therapy," says Moffat, who holds Canada Research Chair in Functional Genomics of Cancer.

In immunotherapy, a patient's own immune cells, known as T killer cells, are engineered to find and destroy cancer. But treatment resistance has precluded its use in most patients, especially those with solid tumours.

"It's an ongoing battle between the immune system and cancer, where the immune system is trying to find and kill the cancer whereas the cancer's job is to evade that killing," says Keith Lawson, a co-lead author completing a PhD in Moffat's lab as part of his medical training in the Surgeon-Scientist Program at U of T's Faculty of Medicine.

Tumour heterogeneity--genetic variation in tumour cells within and across individuals that can impact therapy response--further complicates things.

"It's important to not just find genes that can regulate immune evasion in one model of cancer, but what you really want are to find those genes that you can manipulate in cancer cells across many models because those are going to make the best therapeutic targets," says Lawson.

The team, including collaborators from Agios Pharmaceuticals in Cambridge, Massachusetts, looked for genes that regulate immune evasion across six genetically diverse tumor models derived from breast, colon, kidney and skin cancer. The cancer cells were placed in a dish alongside the T cells engineered to kill them, where the ensuing onslaught served as a baseline. The researchers next deployed the gene editing tool CRISPR to switch off one-by-one every gene in the cancer cells and measured the resulting deviations from the killing baseline.

They identified 182 "core cancer intrinsic immune evasion genes" whose deletion makes the cells either more sensitive or more resistant to T cell attack. Among the resisters were all the genes known to develop mutations in patients who stopped responding to immunotherapy, giving the researchers confidence that their approach worked.

Many of the found genes had no previous links to immune evasion.

"That was really exciting to see, because it means that our dataset was very rich in new biological information", says Lawson.

Genes involved in autophagy, a process when cells ramp up recycling their components to mitigate damage following stress, came up as key for immune evasion. This raises a possibility that cancer's susceptibility to immunotherapy could be boosted by targeting its autophagy genes.

But as the researchers delved deeper, they found that deleting certain autophagy genes in pairs rendered the cells resistant to T cell killing. It means that if a tumour already harbors a mutation in one autophagy gene, a treatment that combines immunotherapy with a drug targeting another autophagy gene could make the disease worse in that patient.

"We found this complete inversion of gene dependency", says Moffat. "We did not anticipate this at all. What it shows us is that genetic context, what mutations are present, very much dictates whether the introduction of the second mutations will cause no effect, resistance or sensitivity to therapy".

As more research explores combinatorial effects of mutations across different types of cancer cells, it should become possible to predict from a tumour's DNA what type of therapy will be most effective.

Reference: Lawson KA, Sousa CM, Zhang X, et al.Functional genomic landscape of cancer-intrinsic evasion of killing by T cells. Nature, 2020. doi:10.1038/s41586-020-2746-2

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Molecular Biomarkers Market Incredible Possibilities, Growth Analysis and Forecast To 2026 |112233 – The Daily Chronicle

Posted: September 29, 2020 at 6:56 am

Molecular Biomarkers Market Overview 2020 2025

This has brought along several changes in This report also covers the impact of COVID-19 on the global market.

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Key Competitors of the Global Molecular Biomarkers Market are: , Alere, Atossa Genetics, Biophysical, Abbott, BioCept, BioTheranostics, DiagnoCure, GenomeDx, Genomic Health, Gen-Probe, Life Technologies, 20/20 GeneSystems, Cynvenio, Dako (Agilent), Epic Sciences, Foundation Medicine, Genomic Health, Molecular Response, Nodality, PGD

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Molecular Biomarkers Market Incredible Possibilities, Growth Analysis and Forecast To 2026 |112233 - The Daily Chronicle

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Kill fish to save fish: Behind Colorado’s effort to revive the Rio Grande cutthroat trout – The Colorado Sun

Posted: September 29, 2020 at 6:56 am

On a beautiful early September day, Ken Gierhart hiked a trail familiar since boyhood to Music Pass in the Sangre de Cristo mountains above Westcliffe. As he dropped off the saddle toward the Sand Creek lakes, he noticed people heading the opposite direction with fishing poles.

Hows the fishing? he asked one woman.

Theyre all dead, she replied, saying nothing more as she passed.

Puzzled, Gierhart came upon another woman heading away from the lakes and tried his question again.

There is no fishing, she said. Theyre all dead.

This time, the angler paused to explain that Colorado Parks and Wildlife, according to signs posted in the area, had used a chemical called rotenone to kill all the fish in the lakes and Sand Creek, which meanders south down the mountain before veering west to eventually disappear, after 13 miles, into the depths of the Great Sand Dunes.

The project is part of a long-planned strategy to restore the native Rio Grande cutthroat trout to waters where its numbers have dwindled toward the edge of extinction.

Increasingly scarce in a dwindling native range and hybridized with other species like non-native cutthroats, which had been stocked alongside it many years ago, the Rio Grande cutthroat eventually will be reintroduced to the mountain lakes and streams where it once thrived. But the process can be disconcerting especially to an unsuspecting hiker like Gierhart.

It wasnt until he got closer to Lower Sand Creek Lake that he saw the informational signs for himself. Then he headed toward the upper lake, following the trail that crosses the creek several times along the way. He said piles of dead earthworms filled seemingly every crevice in the rocks. And then it got worse.

It was horrifying at that level to see what had been done to the lake, Gierhart said. When I got to the lake I saw fish belly-up, carcasses on the bank where animals or birds had pulled them out.

Gierhart, a 54-year-old wholesale tree grower, hadnt heard anything about the fish management plan, and he stewed all the way back to his home in Westcliffe. There, he fired up his Facebook account and vented in a post that estimated thousands of dead fish and that attracted nearly 100 comments, most expressing concern over an undertaking they, too, seemed unaware of.

Ive always been preservation conscious, Gierhart said, still steamed a couple weeks later, but to see aquatic life dead like that, I started thinking about the watershed, the lasting effects, side effects.

The rant and its response caught the attention of CPW officials, who expressed frustration over response to a broad regional project that has been years in the making and which framed its intent in a compact signed in 2003 and renewed in 2013 by six federal entities, state agencies in Colorado and New Mexico and three American Indian tribal agencies. The agreement also received non-signatory support from two Trout Unlimited groups.

The Sand Creek drainage was officially listed in a 2013 strategy document.

In 2019, meetings on both the Westcliffe and Alamosa sides of the mountain yielded no opposition other than concern over the temporary loss of fishing and little public comment. The project moved ahead, though a year later than originally scheduled due to a late fish spawn.

Its something we need to do, said John Alves, the Durango-based senior aquatic biologist for CPWs Southwest Region. With only 11% of its historic range left, the Rio Grande cutthroat trout is always susceptible to petitions to list it as endangered, and also to extrication if there are events like fire. Its a constant process for us.

Joe Lewandowski, spokesman for CPWs Southwest Region, which includes the Sand Creek drainage, notes that the state agency has done similar projects before and will do more of them throughout Colorado.

We dont get a great deal of pleasure having to poison a stream, but it is necessary to restore native species, he said in an email to The Colorado Sun. This has been done in waters to restore the Rio Grande, greenback and the Colorado River cutthroat; and these projects will continue.

We know people are not happy to see dead fish, and it is confusing. Its very difficult often impossible to explain to the general public why we have to do these projects.

The intersection of history, science and politics of wildlife management can be complex. And while in this case the ultimate goal to restore the Rio Grande cutthroat to its native range is mostly a shared interest, the path to achieving it can be challenging.

After the 2003 conservation agreement, federal and state authorities started doing reconnaissance in 2004 to determine if the drainage could be restored. Geography that essentially isolated water flow, and therefore fish migration, proved fortuitous.

Its an ideal situation in a lot of regards, because its a closed system, said Fred Bunch, chief of resources management for the Great Sand Dunes National Park and Preserve, which takes in the Sand Creek drainage. The creeks have their headwaters high in the Sangres, they flow into those lakes and the lakes flow out to the dunes. Thirty-four square miles of sand is a pretty substantial fish barrier.

Bunch points to several reasons why reintroduction of the Rio Grande cutthroat looms important. First, theres federal policy that favors native species in national parks and preserves. Another has to do with the essential characteristics of a wilderness area. A third is for preservation of the species.

This is an ideal opportunity to restore 13 miles of habitat for the Rio Grande cutthroat trout, he said.

The stakeholders who signed the conservation agreement meet annually to discuss the status of its efforts. The key thing, Bunch said, is to prevent the listing of the Rio Grande cutthroat as an endangered species and ensure it has robust habitat.

And thats where politics can come in.

The Center for Biological Diversity, a nonprofit organization that claims roots in the fear that government authority alone will not always protect flora and fauna when powerful business interests can exert political leverage. (The timber industry was its founders nemesis.) Now, it contests threats to biodiversity on a range of levels, from climate change to encroachment of off-road vehicles.

The group has petitioned multiple times to place the Rio Grande cutthroat trout on the endangered species list, including one case thats still pending an appeal.

From the standpoint of state wildlife managers like Alves, who shares the groups desire to see the native species rebound, the fishs presence on the list represents another potential layer of bureaucracy that state workers on the ground would have to contend with.

Once a species is listed by the U.S. Fish and Wildlife Service, local agencies dont make decisions, he said. Theyre made by the federal government. For years, since the late 90s, there have been petitions to list the Rio Grande cutthroat trout. (The Center for Biological Diversity) sees listing as a way to get timber and mining off public lands.

That is true, said Noah Greenwald, the centers Portland, Oregon-based endangered species director.

Those things present a real threat to their habitat and to the species, so we want to make sure those things are done in a careful way or theres avoidance of trout habitat or, to the extent that theres damage, theres mitigation which is what the Endangered Species Act requires.

Aside from territorial concerns stemming from listing the species, both the center and the state agree on some key issues. The center supports and applauds the effort to repopulate the Sand Creek drainage with the native fish. But Greenwald also claims that his organizations petitions to list the Rio Grande trout spurred the state to take action to conserve them more than they were before.

We havent succeeded in putting them on the protected list, but weve pressured the state to do more for them, which is a benefit for the species, he said. Theyve done a tremendous amount of surveys and used staffing resources in an effort to avoid listing them. We dont think thats the right tradeoff. It makes more sense to list them and work for recovery.

The center doesnt even have problems with the kill-to-restock method, or the rotenone compound used to achieve it.

Greenwald calls the CPW a credible messenger with regard to the safety of rotenone.

We dont love having to use poisons, he said. But theres been a lot of work done on this issue, and there are not other effective means. As chemicals go, rotenone is pretty specific to fish. We definitely think it needs to be done carefully and we dont relish the thought of poison being used. But its the only way.

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Although the battle over listing the fish persists, all sides celebrate the ideas that in the case of the Sand Creek drainage, the area could become a refugium for the species, where the fish could naturally multiply and be used as a source for future stocking or restoration if some other habitat experiences problems say, from wildfire.

So were doing it for many things, Bunch said. One is the philosophy of land managers, but theres also the species itself. Also theres a recreational piece. Its a great situation where a hiker can backpack in and catch native fish. Thats a pretty great situation to have, and thats what were shooting for.

From the start, the effort to restore the species has been a multipartner project, including federal, state and county agencies and even private groups like Trout Unlimited. Some of the early upfront money came from the National Park Service but functionally, the reintroduction process is a CPW project done in a national preserve. Cost of a helicopter, boats and other equipment is covered mostly by the state.

This year, phase one of the process got underway. But before fish and wildlife authorities took any action, they needed to know exactly how many different species they were dealing with in those waters that stretch from the Sand Creek lakes to the sand dunes.

And thats where science played a big role.

John Wood founded Pisces Molecular more than 20 years ago, just a few years before efforts began in earnest to restore the Rio Grande cutthroat trout.

Though it has just four people on staff, the Boulder-based biotech lab has clients all over the world, not to mention right in its backyard. Woods lab has worked with Colorado Parks and Wildlife on multiple different fish projects, including when in 2007, in conjunction with University of Colorado post-doc Jessica Metcalf, it discovered that CPWs stock of supposed greenback cutthroat trout which happens to be Colorados state fish were actually Colorado River cutthroat trout.

How do scientists figure out what species are in a waterway? One method is simply catching a sample of fish, clipping off the tiniest bits of their fins, and sending the material to a lab for DNA sequencing. Wood notes that can be laborious and difficult to get an accurate representation of the species makeup of a waterway.

The other option is environmental DNA testing. Just as humans regularly shed skin, hair, saliva and other sources of DNA, so do fish. Field researchers can collect a sample of water, filter out all the bits from the water, and send the gunked-up, DNA-laden filter to the lab for testing. These results will indicate the presence of species upstream of where the sample was taken.

Regardless of the type of sample, once it gets to the lab, Woods team uses polymerase chain reactions, also known as PCR, to check for species-specific genetic markers. For reference, this is the same kind of procedure used in the SARS-CoV-2 coronavirus test; Wood says its become a very sexy technique since the patent on PCR expired in the 2000s. And its remarkably precise; if one-tenth of a drop of a fishs DNA solution were mixed into an Olympic-sized swimming pool, Wood said, we would pick it up.

The only technical field that is changing as fast as computers is molecular genetics, so the sort of techniques that we use now are incredibly more sophisticated than when I was in graduate school, and I find that really fun, Wood said.

Theoretically, this could happen all in the field, but Wood says that it requires a lot of coordination, because you dont keep wild fish outside of their water body for very long. More often, its an iterative process between the lab and the wildlife managers testing the waterway, analyzing the results for the percent purity for individual fish or the population at large, then removing or restocking fish as needed, and doing it all over again.

Though Pisces was not directly involved with last months rotenone treatment, it has generally worked on identifying species in the Upper Sand Creek Lake drainage. In 2015, Woods team found evidence that the drainage had native Rio Grande cutthroat trout that were hybridizing with other subspecies, including Yellowstone cutthroat, greenback cutthroat and Colorado River cutthroat.

Wood called CPWs attitude on restoring native species enlightened, especially when compared to previous practices. Much of the 20th century was spent stocking the states waterways with outside fish such as rainbow trout, which are especially susceptible to whirling disease; when that struck the state in the 1990s, the rainbow trout population quickly spread it to other fish species, including native cutthroats. And this wasnt just in one or two rivers; in the process of moving fish around from waterway to waterway, stocking and other efforts inadvertently introduced the disease to 15 of the 17 hydrographic drainages in the state.

Along Sand Creek, the CPW found ponds on private property that harbored the parasites that transmit whirling disease. But the ponds were removed with stimulus funds during the Great Recession. Since they qualified as gravel pits, they could be remediated as abandoned mines. The whirling disease went away and the reintroduction plans moved forward.

Humans, when we mess with ecology, we generally make a mess, Wood said. So its probably philosophically better to do less interventions and strive to maintain whats there than presume that were smarter than Mother Nature.

That said, its not like leaving the river to rebound on its own would work. Part of it has to do with the different life cycles of fish species: brook trout, for example, spawn in the fall, giving them a full six months head start to grow before cutthroats spawn in the spring. And while rainbow trout spawn in the spring, like cutthroats, Wood notes that the jurys still out as to the impact of the two species interbreeding freely.

In other words: humans made this mess, and only humans can clean it up.

We now know more about genetics, we can discern finer level details, we have a longer history of how our attempts to alter ecologies tend not to work very well, so lets see if we can remediate some of the damage that weve done, Wood said.

In June, weeks before implementation of the first phase of the Rio Grande cutthroat project began, the CPW declared a fish emergency public salvage in the Sand Creek drainage. That tactic, which allows anglers to catch an unlimited number of fish from the waterways, has been used more times this summer, for a variety of reasons, than in the past 10 years.

On this occasion, the CPW wanted to let anglers help make best use of the fish before the chemical rotenone was administered to kill any that remained.

Alves, of the CPWs Southwest Region, noted that removing the bag limit seemed to be a particularly effective strategy in the lakes.

Get enough anglers out there, he said, they do a pretty good job.

The rest is left to rotenone, a plant-based compound effective only on gill-breathing organisms primarily fish and insects. The CPW workers secured the necessary permissions and trained to use it. During the first week of September, they began the process in the two high mountain lakes and the creeks below up to a point where waterfalls along Sand Creek provide a natural barrier to fish migration. Phase 2 of the operation will involve clearing Sand Creek from below the waterfalls to the Great Sand Dunes.

A helicopter from the Colorado Division of Fire Protection and Control had been busy fighting wildfires, but eventually was freed up to transport boats, motors, pumps and the 5-gallon buckets of rotenone itself to the lakes. Workers mixed the chemical with water. It was administered from a boat throughout the lake, in volumes dictated by the waters depth. The mixture shaded the water slightly white, a change that diminishes within several hours.

To apply rotenone to streams, workers spread out drips that added the rotenone/water solution to the flow every 15 seconds. A four-hour drip produced the desired solution throughout the streams.

The chemical works quickly. At one of the drip stations, Alves noticed that as soon as the organic green dye marker reached him from a drip point upstream, fish started dying. Workers also sprayed backwaters where fish might be lurking.

Rotenone, though extremely toxic to fish and some insects, is harmless to man and all warmblooded vertebrates, according to the journal Nature. Alves notes that it breaks down quickly in streams, but in lakes, at a water temperature of 50 degrees, takes about 28 days to decompose.

Then, the waiting begins. The dead fish decompose and, if all goes perfectly, the waterways will be clear for stocking. First, the water is tested environmental DNA sampling comes in handy here to make sure no fish survived that could taint the reintroduction of the native Rio Grande.

Youve got to wait and see,Alves said. Well do a lot of sampling, electrofishing in the streams, gill netting in the lakes, probably use environmental DNA, and test to see if there are genetic markers. We use that as a confirming tool.

If any fish remain, CPW will come back and repeat the process.

If theres zero live fish, Alves said, well start to restock in the fall.

Typically, CPW uses airplanes to stock the high mountain lakes. Workers on foot or on horseback, and sometimes by helicopter, stock the streams. By stocking fish in a variety of age groups, managers can hasten the turnaround.

The Sand Creek drainage, with its hiking trails and beautiful vistas, is a highly used area, Alves said. Though remote, its only about an hour-and-a-half hike in from the trail head. What he wants people to understand is that what the CPW is doing is definitely the right thing. Yes, the fish are all gone but thats only temporary.

As soon as we can, well put in Rio Grande cutthroat trout, really a pretty fish, growing to the same size theyre used to catching, a 15- or 16-inch fish, he said. So theyre temporarily losing their opportunity, but itll come back. I predict within five years, theyll see really good cutthroat trout in the lakes.

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Kill fish to save fish: Behind Colorado's effort to revive the Rio Grande cutthroat trout - The Colorado Sun

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