Readers and Writers: A nonfiction sampler on the mind/body/spirit continuum – St. Paul Pioneer Press

Long distance running. A stem cell transplant. Christianity and the Galapagos Islands. Todays nonfiction books are different, but all three are on the mind/body/spirit continuum.

On the cover of this slim paperback, Minnesotan Siddons describes himself as Runner-Writer-Poet, all identities that are woven into this book that explains some of the nitty-gritty of long-distance running and what it means to him.

Running has, for over 40 years, been an outlet for me to vent frustrations and flush out some demons, he writes. It has also allowed me to meditate while being physically active and work through life issues.

Siddons admits his running life has been a roller coaster ride on the Potential Train. He was a high school runner but his seasons were marred with running injuries, and it wasnt until his early 20s that he found his way back while working in an athletic footwear store. It was decades before he would commit myself to go to war in the battle of Potential versus Performance. (Potential is the raw number that charts say a runner is good for, according to other times at shorter distances. )

After several attempts, Siddons qualified for the Boston Marathon, the Holy Grail of races, and in 2018 he and his wife participated. He writes that the four parts of any distance race, especially a marathon, are Patience (dont run like the wind from the second you pass over the start line); Trust, in your training and stick to your plan; Fortitude, that has to be mustered to maintain pace for the toughest part of the race; and Courage to succeed.

Marathon runners will relate to this book, including the technical stuff about goal pacing, how your body behaves during a race, and the physical joy of running. Readers who have never put on a running shoe will enjoy the authors enthusiasm, explanations of how hard he trains, and the love he feels for his running partners, his supportive friends and family.

Interspersed with the text are a few of Siddons poems in which he captures the emotions of running, including a long one, Unrequited, that encompasses his thoughts as he runs the Boston Marathon:

Under the blue one-mile overpass,Boston Strong in bold gold.I am so close, I am soaking up thelast miles as if I may never be back.I turn to the crowdas I come up from the last underpass, andshow my B.A.A. 5k shirt, its logo universally known.They cheer for me and I am lifted again,I am going to do this!

(For information go to BrianJamesSiddons.com)

Buechler, who lives in Eden Prairie, became Ralph after he had a stem cell transplant from an umbilical cord blood donor: Since I named my baby cord blood donor Ralph, and I acquired his DNA with my transplant, I went with How Steve became Ralph, he writes, explaining his books title.

Buechlers memoir, subtitled A Cancer/Stem Cell Odyssey (with Jokes) is made up of email reports he composed during his treatments in 2016. Although these messages went to a large circle of friends, he admits writing them also became therapy-for-me by bringing narrative coherence to chaotic experiences.

The author was ending his 32-year career teaching sociology at Minnesota State University, Mankato, when he was diagnosed with life-threatening acute myeloid leukemia, and began chemotherapy. By mid-August his doctors recommended a stem cell transplant and the University of Minnesota Medical Center Blood and Marrow transplant unit began searching national blood banks for umbilical cord blood that might provide a match and lower the chance of rejection. By October he was ready for the transplant, taking with him my tool kit of mindfulness, meditation, yoga, and various forms of exercise as well as the support, prayers, healing energy and good wishes

He certainly took his physical exercise seriously, including figuring out a way to do yoga while attached to a pole from which an IV bag hung.

My so-called transplant is really just another transfusion, he writes, explaining that the procedure does not involve surgery. After installing a Hickman central line in his chest, the umbilical cord blood was sent into his bloodstream. Afterward there was an infusion of drugs to ward off infection and other issues.

The whole process is intellectually intriguing; it requires a blend of science, art and craft from a team of oncologists, nurses, infectious disease doctors and other specialists as needed, writes Buechler, ever the sociologist. Id prefer to learn about it without my own skin in the game, but thats how it goes.

Buechler admits he had much going for him as a patient a big group of helpers during the times he was home, physical ability to keep up his yoga practice, and few financial worries. Not that his year of cancer was free of problems. His wife, Susan Scott, was in the hospital for leg problems during part of his own hospitalization, and they didnt see one another for weeks. A storm damaged their house and surrounding trees, and the author spent lots of time in his hospital bed trying to straighten out that insurance mess while waiting for what sounds like endless medical procedures.

His story ends happily. Six months out from his transplant Buechler was able to accept that he had weathered my treatments and I was actually better.

Written in the easy style of emails, How Steve Became Ralph is an interesting odyssey through a life-saving medical procedure. He prefers the word odyssey because he never liked the cliche about cancer being a journey.

Perhaps the most over-used metaphor about cancer sees it as a war in which the heroic patient valiantly battles an evil foe, he writes. This also did not ring true for me. For starters, we have enough militarized aspects of life without extending the imagery to illness. This metaphor also concedes too much to cancer. It is not a conscious, willful antagonist. Cancer is just a biological process originating from within the body. And although I felt like many things throughout my treatment, heroic warrior or combat victim were not amongst them.

About those jokes: They are funny because they are really silly, which was probably the point. But Buechlers correspondents loved them, so he kept them coming.

(For more information go to stevebuechlerauthor.com)

McLaren, a Florida-based author of a dozen books including A New Kind of Christian, gives readers a travel story and a meditation on science and faith in this paperback from a Minneapolis Christian publisher.

This former pastor sets the tone of his book in the early pages when he muses about indoor theology, created and promoted almost exclusively by privileged male human beings of European descent as opposed to a theology that arises in conversation with the wild world that flourishes beyond our walls and outside our windows and cities.

The first half of the book is about McLarens week on the islands that make up Galapagos National Park, where he scuba dived among gloriously colored fish, took nature walks, and was awed by the protected wildlife, including land iguanas and the giant Galapagos tortoises.

The books second half is weightier, as McLaren focuses on the legacy of Charles Darwin and how Darwins teachings have so often been misinterpreted.

To the conservative Christians among whom McLaren was raised, Darwin was considered an arrogant, faithless, Bible-denying, God-hating, religion-murdering monster. But when the author researched Darwins path to writing On the Origin of Species, he found that Darwin was influenced as a young man by a clergyman and he thought a lot about religion. McLaren writes that Darwin was a dutiful man who felt the duty of loyalty to his family, his nation, his culture, his tradition and to the actual observable data presented to him by the world itself, including his memorable trip to the Galapagos Islands.

During McLarens time on Galapagos, he was hoping to see a guinea-fowl puffer fish and he caught a glimpse of one during his final dive. That fish, who darted in an out of an underwater cave, becomes an imaginary conversationalist as McClaren thinks his way through how a religious man can tolerate spoiling of the earth: Why are you so disillusioned, the fish asks. What were you expecting? Might the problem be less about the realities of religion that are causing you such disillusionment, and more about your expectations of religion that are so unrealistic?

This is a physically attractive book that includes pictures. Its too bad McLaren gets the title of Darwins book wrong, calling it On the Origin of the Species instead of On the Origin of Species.)

From saints to the Christian Bible, seal pups to Darwin, tortoises to steel head trout, this journey taken by a man who has always loved the outdoors might provide for some readers theological answers about how to respond in this time of the earths destruction.

(Fortress Press books are available at bookstores)

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Readers and Writers: A nonfiction sampler on the mind/body/spirit continuum - St. Paul Pioneer Press

Breakthrough in Stem Cell Research: First Image of Niche Environment | Newsroom – UC Merced University News

By Lorena Anderson, UC Merced

Professor Joel Spencer and his lab have made a huge breakthrough in stem cell research.

Professor Joel Spencer was a rising star in college soccer and now he is an emerging scientist in the world of biomedical engineering, capturing for the first time an image of a hematopoietic stem cell (HSC) within the bone marrow of a living organism.

Everyone knew black holes existed, but it took until last year to directly capture an image of one due to the complexity of their environment, Spencer said. Its analogous with stem cells in the bone marrow. Until now, our understanding of HSCs has been limited by the inability to directly visualize them in their native environment until now.

This work brings an advancement that will open doors to understanding how these cells work which may lead to better therapeutics for hematologic disorders including cancer.

Understanding how HSCs interact within their local environments might help researchers understand how cancers use this same environment in the bone marrow to evade treatment.

Spencer studied biological sciences at UC Irvine where he was the captain of the mens Division 1 soccer team. He initially planned to pursue a career in professional soccer until faculty mentors opened doors for research and introduced Spencer to biophotonics the science that deals with the interactions of light with biological matter.

UC faculty were a big part of my research experience; they became mentors and friends, Spencer said. My first foray into research was as a lab tech, and that is where I met people who were doing biomedical imaging, and it just caught my wonder.

An image of a stem cell in its natural niche

Spencer left his native California to earn his Ph.D. in bioengineering at Tufts University in Boston and took a postdoctoral research position in the Wellman Center for Photomedicine at Massachusetts General Hospital and Harvard Medical School. In Boston, he learned about live-animal imaging and his wonder became a passion.

Now his emphasis is on biomedical optics: building new microscopes and new imaging techniques to visualize and study biological molecules, cells and tissue in their natural niches in living, fully intact small animals.

I work at the interface of engineering and biology. My lab is seeking to answer biological questions that were impossible until the advancements in technology we have seen in the past couple decades, he said. You need to be able to peer inside an organ inside a live animal and see whats happening as it happens.

Based on work conducted at UC Merced and in Boston, he and his collaborators including his grad student Negar Tehrani visualized stem cells inside the bone marrow of live, intact mice.

He and his collaborators have a new paper published in the journal Nature detailing the work they conducted to study HSCs in their native environment in the bone marrow.

We can see how the cells behave in their native niches and how they respond to injuries or stresses which seems to be connected to the constant process of bone remodeling, Tehrani said. Researchers have been trying to answer questions that have gone unanswered for lack of technology, and they have turned to engineering to solve those puzzles.

Its important for researchers to understand the mechanics of stem cells because of the cells potential to regenerate and repair damaged tissue.

Spencer, left, and students from his lab

Spencer returned to California three years ago, joining the Department of Bioengineering in the School of Engineering at UC Merced. Hes also an affiliate of the Health Sciences Research Institute and the NSF CREST Center for Cellular and Biomolecular Machines . This is his third paper in Nature, but the first stemming from work conducted in his current lab.

He didnt come to UC Merced just because he loves biology Spencer also joined the campus because of the students.

Now Im back in the UC system Im a homegrown UC student whos now faculty, Spencer said. As a student within the system I was able to participate in myriad opportunities, including mentorships that advanced my career. Now I try to encourage graduate and undergrad students to follow their dreams. I love being able to give them opportunities its something I really want to do for the next generation.

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Breakthrough in Stem Cell Research: First Image of Niche Environment | Newsroom - UC Merced University News

University of Delaware researcher receives $250K grant for new biotherapies – Technical.ly Brooklyn

As part of a pilot search for new medical breakthroughs, the partnership of King of Prussia-based plasma-based biotech company CSL Behring and the University City Science Center in Philadelphia has awarded $250,000, plus the opportunity to work alongside CSL Behring experts, to Eleftherios (Terry) Papoutsakis, Ph.D., of the University of Delaware, for his exploration of cell derived micro-particles and vesicles (MkMPs) for the treatment of thrombocytopenias and in stem-cell targeted gene therapies.

Papoutsakis is one of two researchers to receive the award, called the CSL Behring-Science Center Research Acceleration Initiative. The other, Cecelia Yates, Ph.D. of the University of Pittsburgh, uses biomimetic peptides as potential targeted therapeutic treatment of pulmonary fibrosis.

This initiative is another example of the strength of our partnership with the Philadelphia-based University City Science Center as we look in our backyard for innovative scientific advancements that have the potential to help rare disease patients lead full lives, said Dr. Bill Mezzanotte, EVP and head of research and development for CSL Behring, in a press release. Our growing R&D organization looks forward to working with Dr. Yates and Dr. Papoutsakis in the years ahead to advance their scientific research.

The therapy that Dr. Papoutsakis is developing involves gene editing of stem cells that may potentially benefit to patients for a variety of genetic blood disorders such as Wiskott-Aldrich syndrome.

The CSL Behring Science Center Research Initiative is currently accepting applications from researchers in the region developing therapeutic biotechnologies in immunology, neurology, haematology, thrombosis, transplant, respiratory and cardiovascular/metabolic to receive one of up to three grants in 2020 of up to $400,000 each. The deadline is April 13.

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Scientists Think They Know How Stress Causes Gray Hair – Thrive Global

Sorry Mom and Dad: It turns out you might not have been exaggerating when you told us your children made your hair turn gray.

Stress may play a key role in just how quickly hair goes from colored to ashen, astudyTrusted Sourcepublished this past week in the journal Nature suggests.

Scientists have long understood some link is possible between stress and gray hair, but this new research from Harvard University in Massachusetts more deeply probes the exact mechanisms at play.

The researchers initial tests looked closely at cortisol, the stress hormone that surges in the body when a person experiences a fight or flight response.

Its an important bodily function, but the long-term presence of heightened cortisol is linked to a host ofnegative health outcomes.

But the culprit ended up being a different part of the bodys fight or flight response the sympathetic nervous system.

These nerves are all over the body, including making inroads to each hair follicle, the researchers reported.

Chemicals released during the stress response specifically norepinephrine causes pigment producing stem cells to activate prematurely, depleting the hairs reserves of color.

The detrimental impact of stress that we discovered was beyond what I imagined,Ya-Chieh Hsu, PhD, a lead study author and an associate professor of stem cell and regenerative biology at Harvard, said in apress release. After just a few days, all of the pigment-regenerating stem cells were lost. Once theyre gone, you cant regenerate pigments anymore. The damage is permanent.

But stress isnt the only or even the primary reason that most people get gray hair.

In most cases, its simple genetics.

Gray hair is caused by loss of melanocytes (pigment cells) in the hair follicle. This happens as we age and, unfortunately, there is no treatment that can restore these cells and the pigment they produce, melanin,Dr. Lindsey A. Bordone, a dermatologist at ColumbiaDoctors and an assistant professor of dermatology at Columbia University Medical Center in New York, told Healthline. Genetic factors determine when you go gray. There is nothing that can be done medically to prevent this from happening when it is genetically predetermined to happen.

That doesnt mean environmental factors such as stress dont play a role.

Smoking, for instance, is a known risk factor for premature graying, according to a2013 studyTrusted Source. So kick the habit if you want to keep that color a little longer.

Other contributing factors to premature graying include deficiencies in protein, vitamin B-12, copper, and iron as well as aging due in part to an accumulation of oxidative stress.

That stress is prompted by an imbalance between free radicals and antioxidants in your body that can damage tissue, proteins, and DNA,Kasey Nichols, NMD, an Arizona physician and a health expert atRave Reviews, told Healthline.

And some degree of oxidative stress is a natural part of life.

We would expect increasing gray hair as we advance in age, and we see about a 10 percent increase in the chance of developing gray hair for every decade after age 30, Nichols said.

Changes you can pursueto delay premature grays include eating a diet high in omega-3 fatty acids such as walnuts and fatty fish, not spending too much time in the skin-damaging and hair-damaging ultraviolet light of the sun, and taking vitamin B-12 and vitamin B-6 supplements.

That said, if you are going gray prematurely, it wouldnt hurt to go have a checkup just in case natural genetic factors arent the sole culprit.

The new Harvard research is only a mouse study, so replicating the same results in a human study would be necessary to strengthen the findings.

But the Harvard research has implications far beyond graying hair, with the hair color change merely one obvious sign of other internal changes as a result of prolonged stress.

By understanding precisely how stress affects stem cells that regenerate pigment, weve laid the groundwork for understanding how stress affects other tissues and organs in the body, said Hsu. Understanding how our tissues change under stress is the first critical step towards eventual treatment that can halt or revert the detrimental impact of stress.

Might that also mean someday halting and reverting the march of premature gray hair? Its too soon to tell.

We still have a lot to learn in this area, Hsu said.

Originally published on Healthline.

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Isolated Extramedullary Relapse in Acute Lymphoblastic Leukemia: What Can We Do Before and After Transplant? – Cancer Network

Santiago Riviello-Goya, MD1; Aldo A. Acosta-Medina, MD2; Sergio I. Inclan-Alarcon, MD3; Sofa Garcia-Miranda, MD2; and Christianne Bourlon, MD, MHSc2

1Department of Medicine, Instituto Nacional de Ciencias Mdicas y Nutricin Salvador Zubirn, Mexico City, Mexico; 2Department of Hematology, Instituto Nacional de Ciencias Mdicas y Nutricin Salvador Zubirn, Mexico City, Mexico; 3Cancer Center, Centro Mdico ABC, Mexico City, Mexico

A 43-year-old male with a history of B-cell acute lymphoblastic leukemia (ALL), who underwent allogeneic hematopoietic stem cell transplantation (HSCT) 5 months prior, presented to the emergency department with a 5-day history of progressive bilateral lower extremity weakness. On physical examination, there were no additional neurologic findings; sensory function and urethral and anal sphincter tone were preserved.

Initial clinical laboratory testing showed peripheral blood cell counts, a peripheral blood smear, and a comprehensive metabolic panel within normal limits. Neuroimaging by computed tomography (CT) and magnetic resonance showed no evidence of acute intracranial processes or lesions suggestive of leukemic relapse. A lumbar puncture for cerebrospinal fluid (CSF) analysis was performed and documented the presence of lymphoid-appearing blasts (Figure 1). Flow cytometry (FC) confirmed central nervous system (CNS) infiltration by B-lineage lymphoid blasts (CD34+, CD45+, CD22+, CD19+, and CD10+) (Figure 2). Bone marrow aspirate and biopsy, including FC evaluation, were negative for systemic relapse. Bone marrow chimerism was 98%.

With a diagnosis of isolated extramedullary leukemic relapse (iEMR), the patient was initiated on weekly intrathecal chemotherapy and was weaned off graft-versus-host disease (GVHD) prophylaxis, achieving CSF clearance after 4 weeks of therapy. Against Hematology service recommendations, the patient declined systemic therapy and received only whole brain radiation therapy (24 Gy in 12 fractions).

The patient experienced remission of neurologic symptoms; however, after 5 months, he developed bilateral testicular tenderness and enlargement. An ultrasound was performed and was suggestive of leukemic infiltration (Figure 3). Chemotherapy with methotrexate and L-asparaginase in addition to radiotherapy to the testes (24 Gy in 12 fractions) was given without complications.

One year after initial CNS iEMR, the patient developed overt bone marrow relapse (BMR), as evidenced by development of bone pain throughout the lumbosacral region, and the appearance of multiple blastic and lytic lesions throughout the appendicular and axial skeleton. A positron emission tomography-CT scan documented abdominal lymphadenopathy (Figure 4). With this rapidly progressive picture, the patient was transitioned to supportive care and died 2 months later.

Is the risk of iEMR following HSCT modified by the choice of conditioning regimen? If so, which of the following approaches would have been the best choice to prevent iEMR in this patient?

A. There is no role of conditioning therapy in preventing iEMRB. Reduced intensity of regimen to favor graft-versus-leukemia (GVL) effectC. Nonmieloablative regimens including fludarabineD. Mieloablative regimens including total body irradiation (TBI)

CORRECT ANSWER: D. Mieloablative regimens including total body irradiation (TBI).

Allogeneic HSCT is an effective treatment for ALL, which can achieve long-term remission and even a potential cure.1 Antineoplastic activity is dependent on both high-dose chemotherapy and graft alloreactivity, with the latter manifested in the GVL effect, and undesirably yet inherently, in GVHD.2 Despite recent advances in allogeneic HSCT strategies, disease relapse is common and remains the most important cause of death in this population. Relapse is reported in 30% to 40% of patients but can increase to 60% in patients who are in a second complete remission (CR) at time of HSCT.2,3

Risk factors for relapse in patients with ALL who have undergone HSCT include disease- and transplant-related features. Reported high-risk disease characteristics include: hyperleukocytosis at diagnosis (white blood cell count >30 x109/L for B-lineage ALL and >100 x109/L for T-lineage ALL); cytogenetics associated with poor outcomes, including chromosome 11 translocations and t(9;22); a short remission timespan; more than a first CR; and a failed or delayed remission after induction therapy.4 In the HSCT population, transplant-related factors should be considered, including alternative donors other than those who are matched related and matched unrelated, the type of conditioning regimen, and the development of GVHD.2

ALL relapse following HSCT most commonly involves the medullary compartment, with a cumulative incidence of 41% at 5 years. Conversely, extramedullary relapse (EMR) is uncommon, with a 5-year cumulative incidence of 11.0% and 5.8% for EMR and iEMR, respectively.5 Due to the rarity of EMR, its prognostic impact remains controversial and the ideal management strategies are a subject of active study.

EMR is associated with poor clinical outcomes; however, the subgroup of patients with iEMR (as presented in this patient case) is gaining attention due to its increasing frequency, its role heralding a systemic relapse, and its clinical behavior showing better survival outcomes compared with BMR and EMR.6-8

Isolated EMR is defined as the presence of clonal blasts in any tissue other than the medullary compartment; bone marrow evaluation must show less than 5% of clonal blasts and a full donor chimerism. Most commonly affected sites include the skin, soft tissues, lymph nodes, and immune sanctuaries including the CNS and testes.1,5,9 Because prevention rather than treatment of relapse is related to improved survival outcomes, it is important to define subgroups of patients who may benefit fromearly intervention with a personalized transplant strategy.

Higher rates of iEMR have been linked to patients of younger age. This is thought to be secondary to: (1) a higher incidence of ALL compared with acute myeloid leukemia (AML) in this age subgroup, the former of which is most associated with EMR; (2) the relative overrepresentation of myelomonocytic/monocytic phenotypes in AML presenting in young individuals; and (3) the higher likelihood of a history of EMR in children compared with adults.1,10

A history of extramedullary (EM) disease, which has consistently been found to impact the development of iEMR, is preexistent in up to half of patients. In 2 out of 3 cases of EMR, disease affects the site of original EM involvement, possibly due to low efficacy of both high-dose chemotherapy and the GVL effect.1,5 An exception to this is CNS involvement, despite being a risk factor for subsequent CNS iEMR, which is commonly reported de novo, reflecting the protective effect of regularly administered prophylaxis to patients at high risk of CNS infiltration.11

The effect of GVHD on risk of iEMR is highly nuanced. Despite its well-known role as a protective factor for BMR, the same effect does not appear to hold true for iEMR.12 Initial reports in this population showed no differences in relapse-free survival regardless of acute or chronic GVHD (cGVHD) or a positive association between extensive cGVHD and iEMR development.10,13 This has led to investigators to postulate that the underlying physiopathology differs among different types of relapse, with decreased expression of human leukocyte antigen (HLA) minor histocompatibility antigens and adhesion molecules and decreased penetration of both immune cells and high-dose chemotherapy to EM sites.14 These mechanisms lead to decreased effectivness of T-cell dependent cytotoxicity of donor lymphocytes as compared with the medullary compartment, with subsequent clone selection and escape, enabling the development of iEMR.6

With the increased use of alternative donors, this has been contested in the haploidentical setting, with a recent report showing significantly increased rates of iEMR in patients who do not develop cGVHD. It is suggested that the role of GVL, coupled with GVHD, in this HLA-mismatched setting could partially explain the added benefit of GVHD in this subgroup. This report also evidenced increased tumor chemosensitivity in patients with EMR compared with BMR, possibly explained by reduced concentrations of conditioning therapy at EM sites.9

Cytogenetics associated with poor outcomes and advanced disease at the time of HSCT were described as risk factors for iEMR in initial cohort studies.1,5,10,15,16 However, recent publications that include alternative-donor HSCT recipients have reported that a haploidentical source could overcome this negative impact.9

The influence of type of conditioning regimen on likelihood of iEMR has been studied only retrospectively, mainly comparing TBI-based versus chemotherapy-based approaches. The landmark paper by Simpson et al showed a significantly elevated rate of iEMR in patients receiving busulfan-based conditioning. This finding has been related to the lack of penetration of drugs into the immune sanctuaries with chemotherapy-only regimens.17

Multiple approaches, including combination and single treatment for iEMR, have been described. Combination therapy including systemic chemotherapy plus local radiotherapy (or in CNS disease, radiation to the craniospinal axis, intrathecal chemotherapy, and systemic chemotherapy) has been associated with higher response rates than single-treatment strategies.9 Nonetheless, the best responses have been observed when combination therapy is followed by a cellular therapy (eg, second allogeneic HSCT, donor leukocyte infusion, and donor stem cell infusion), leading to CR rates of greater than 80%.5,13 Whether this increase in CR rate translates to an increase in survival outcomes remains debatable due to conflicting results in the current literature for iEMR.

Financial Disclosure: The authors have no significant financial interest in or other relationship with the manufacturer of any product or provider of any service mentioned in this article.

Corresponding author:

Christianne Bourlon, MD, MHScVasco de Quiroga No. 15.Belisario Domnguez Seccin XVI

Tlalpan, C.P. 14080, Ciudad de Mxico, Mxico

E-mail: chrisbourlon@hotmail.com

References:

1. Ge L, Ye F, Mao X, et al. Extramedullary relapse of acute leukemia after allogeneic hematopoietic stem cell transplantation: different characteristics between acute myelogenous leukemia and acute lymphoblastic leukemia. Biol Blood Marrow Transplant. 2014;20(7):1040-1047. doi: 10.1016/j.bbmt.2014.03.030.

2. Pavletic SZ, Kumar S, Mohty M, et al. NCI First International Workshop on the Biology, Prevention, and Treatment of Relapse after Allogeneic Hematopoietic Stem Cell Transplantation: report from the Committee on the Epidemiology and Natural History of Relapse following Allogeneic Cell Transplantation. Biol Blood Marrow Transplant. 2010;16(7):871-890. doi: 10.1016/j.bbmt.2010.04.004.

3. Devillier R, Crocchiolo R, Etienne A, et al. Outcome of relapse after allogeneic stem cell transplant in patients with acute myeloid leukemia. Leuk Lymphoma. 2013;54(6):1228-1234. doi: 10.3109/10428194.2012.741230.

4. Hoelzer D, Bassan R, Dombret H, Fielding A, Ribera JM, Buske C; ESMO Guidelines Committee. Acute lymphoblastic leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v69-v82. doi: 10.1093/annonc/mdw025.

5. Shem-Tov N, Saraceni F, Danylesko I, et al. Isolated extramedullary relapse of acute leukemia after allogeneic stem cell transplantation: different kinetics and better prognosis than systemic relapse. Biol Blood Marrow Transplant. 2017;23(7):1087-1094. doi: 10.1016/j.bbmt.2017.03.023.

6. Lee JH, Choi SJ, Lee JH, et al. Anti-leukemic effect of graft-versus-host disease on bone marrow and extramedullary relapses in acute leukemia. Haematologica. 2005;90(10):1380-1388.

7. Xie N, Zhou J, Zhang Y, Yu F, Song Y. Extramedullary relapse of leukemia after allogeneic hematopoietic stem cell transplantation. Medicine (Baltimore). 2019;98(19):e15584. doi: 10.1097/MD.0000000000015584.

8. Shi JM, Meng XJ, Luo Y, et al. Clinical characteristics and outcome of isolated extramedullary relapse in acute leukemia after allogeneic stem cell transplantation: a single-center analysis. Leuk Res. 2013;37(4):372-377. doi: 10.1016/j.leukres.2012.12.002.

9. Mo XD, Kong J, Zhao T, et al. Extramedullary relapse of acute leukemia after haploidentical hematopoietic stem cell transplantation: incidence, risk factors, treatment, and clinical outcomes. Biol Blood Marrow Transplant. 2014;20(12):2023-2028. doi:10.1016/j.bbmt.2014.08.023.

10. Harris AC, Kitko CL, Couriel DR, et al. Extramedullary relapse of acute myeloid leukemia following allogeneic hematopoietic stem cell transplantation: incidence, risk factors and outcomes. Haematologica. 2013;98(2):179-184. doi: 10.3324/haematol.2012.073189.

11. Hamdi A, Mawad R, Bassett R, et al. Central nervous system relapse in adults with acute lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2014;20(11):1767-1771. doi: 10.1016/j.bbmt.2014.07.005.

12. Giralt SA, Champlin RE. Leukemia relapse after allogeneic bone marrow transplantation: a review. Blood. 1994;84(11):3603-3612.

13. Solh M, DeFor TE, Weisdorf DJ, Kaufman DS. Extramedullary relapse of acute myelogenous leukemia after allogeneic hematopoietic stem cell transplantation: better prognosis than systemic relapse. Biol Blood Marrow Transplant. 2012;18(1):106-112. doi: 10.1016/j.bbmt.2011.05.023.

14. Kolb HJ. Graft-versus-leukemia effects of transplantation and donor lymphocytes. Blood. 2008;112(12):4371-4383. doi: 10.1182/blood-2008-03-077974.

15. Lee KH, Lee JH, Choi SJ, et al. Bone marrow vs extramedullary relapse of acute leukemia after allogeneic hematopoietic cell transplantation: risk factors and clinical course. Bone Marrow Transplant. 2003;32(8):835-842. doi: 10.1038/sj.bmt.1704223.

16. Clark WB, Strickland SA, Barrett AJ, Savani BN. Extramedullary relapses after allogeneic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome. Haematologica. 2010;95(6):860-863.

17. Simpson DR, Nevill T, Shepherd JD, et al. High incidence of extramedullary relapse of AML after busulfan/cyclophosphamide conditioning and allogeneic stem cell transplantation. Bone Marrow Transplant. 1998;22(3):259-264. doi: 10.1038/sj.bmt.1701319.

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Isolated Extramedullary Relapse in Acute Lymphoblastic Leukemia: What Can We Do Before and After Transplant? - Cancer Network

Health care professionals offer insight to stem cell injection claims – WOWT

OMAHA, Neb. (WOWT) -- Imagine the pain from nerve damage so severe you can hardly move, but hope for relief is being offered by a company pitching stem cell injections that dont come cheap

Ron Elliott may be willing to endure financial pain.

Elliott, a Neuropathy sufferer said, It could be $5,000 or so and whether insurance would cover any of it or not.

Thats the low-end cost of stem cell injections pitched by Vitality Nebraska in advertised seminars at metro area hotel conference rooms.

Vitality Nebraska presentation said, The reason this works so well is because of the source of the stem cells were using, very young vital capable cells from Dr. Riordans lab.

Neil Riordans resume lists a leading stem cell laboratory in Panama.

Many pain sufferers, mostly senior citizens attend the seminars and our request to record was denied, so Dr. James Billups wore a hidden camera.

The next day after the needle went in there it made me feel better, read the presentation.

Dr. James Billups said, They make broad claims on the ability to do this. Everything they presented was anecdotal and anecdotal is not science.

In a statement to Six on Your Side Vitality, Nebraska states, each patient is evaluated by a licensed practitioner to see if regenerative medicine is a viable option. We do not make any promises or guarantees.

Some of the worlds leading research in the use of stem cells for treatment is being done here at the University of Nebraska Medical Center. We brought the seminar video here to get a second and third opinion.

Dr. James Armtage an Oncologist said, You need to know for example with stem cells how are the cells being made, there are standards for the use of these things.

Dr. Lynell Klassen an Immunologist said, Its hard for me to understand how those cells would actually stay around long enough to repurpose itself and transform and reprogram in order to be a functioning cell.

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Health care professionals offer insight to stem cell injection claims - WOWT

AlloVir Receives the European Medicines Agency PRIME Designation for Viralym-M, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T-Cell Therapy -…

Feb. 12, 2020 12:00 UTC

Viralym-M pivotal and proof-of-concept studies to be initiated in 2020 for treatment and prevention of severe and life-threatening viral diseases

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- AlloVir, a late-clinical stage T-cell immunotherapy company, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to Viralym-M (ALVR105), the companys lead allogeneic, off-the-shelf, multi-virus specific T-cell therapy, for the treatment of serious infections with BK virus, cytomegalovirus, human herpes virus-6, Epstein Barr virus, and/or adenovirus in allogeneic hematopoietic stem cell transplantation (HSCT) recipients.

PRIME designation offers an accelerated regulatory pathway for Viralym-M in Europe, under the EMAs program to accelerate review of promising therapies targeting unmet medical needs. Designation for Viralym-M was granted based on data from a positive Phase 2 proof-of-concept study that showed greater than 90% of patients who failed conventional treatment and received Viralym-M had a complete or partial clinical response based on predefined criteria, with most patients achieving complete resolution of major clinical symptoms. These data were published in the Journal of Clinical Oncology (Tzannou, JCO, 2017). AlloVir plans to initiate Phase 3 pivotal and Phase 2 proof-of-concept studies with Viralym-M in 2020 targeting six common, devastating viral pathogens.

AlloVir previously received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for Viralym-M for the treatment of hemorrhagic cystitis (HC) caused by BK virus in adults and children following allogeneic HSCT. The company holds worldwide development and commercialization rights to Viralym-M. AlloVir is dedicated to developing and delivering transformative cell therapies for patients suffering from life-threatening viral diseases.

For immunocompromised patients, viral diseases can cause devastating and life-threatening consequences and todays PRIME designation acknowledges the urgent medical need for these patients, said David Hallal, Chief Executive Officer of AlloVir and co-founder of ElevateBio. We believe Viralym-M has the potential to fundamentally transform the lives of patients with viral diseases by substantially reducing or preventing disease morbidity and dramatically improving patient outcomes. We look forward to advancing pivotal and proof-of-concept studies for Viralym-M in multiple indications this year, and we hope that PRIME designation by the European Medicines Agency speeds our efforts to get treatment to patients in need.

The PRIME program aims to optimize development plans and speed up evaluation of medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. The PRIME designation is awarded by the EMA to promising medicines that target an unmet medical need. To be eligible and accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data coupled with non-clinical data. Through the PRIME program, the EMA offers enhanced support to medicine developers including early interaction and dialogue, and a pathway for accelerated evaluation by the agency. The program is intended to optimize development plans and expedite the review and approval process so that these medicines may reach patients as early as possible.

About Opportunistic Viral Diseases

In healthy individuals, virus-specific T-cells (VSTs) from the bodys natural defense system provide protection against numerous disease-causing viruses. However, in patients with a weakened immune system these viruses may be uncontrolled. Viral diseases are common, with potentially devastating and life-threatening consequences in immunocompromised patients. For example, up to 90% of patients will reactivate at least one virus following an allogeneic stem cell transplant and two-thirds of these patients reactivate more than one virus, resulting in significant and prolonged morbidity, hospitalization and premature death. Typically, when viruses infect immunocompromised patients, standard antiviral treatment does not address the underlying problem of a weakened immune system and therefore, many patients suffer with life-threatening outcomes such as multi-organ damage and failure, and even death.

About Viralym-M (ALVR105)

Viralym-M is the lead investigational therapy in AlloVirs pipeline of allogeneic, off-the shelf multi-virus specific T-cell therapies designed to treat active viral diseases in immunocompromised patients, including in patients following HSCT, solid organ transplant, or in patients suffering with primary immunodeficiencies, cancer, or HIV. In a positive Phase 2 proof-of-concept study, published in the Journal of Clinical Oncology (Tzannou, JCO, 2017), greater than 90% of patients who failed conventional treatment and received Viralym-M demonstrated a complete or partial clinical response, and most exhibited complete resolution of major clinical symptoms. Viralym-M has the potential to fight or prevent a range of severe and life-threatening viral diseases in patients while they are immunocompromised.

About AlloVir

AlloVir (formerly ViraCyte), founded in 2013 by researchers at Baylor College of Medicines Center for Cell and Gene Therapy, is the leader in the development of novel cell therapies with a focus on restoring and maintaining virus-specific T-cell immunity in patients suffering from, or at risk for, life-threatening viral diseases. The companys technology platforms deliver commercially scalable solutions by leveraging off-the-shelf, allogeneic, multi-virus specific T-cells targeting devastating viral pathogens for patients under viral attack. AlloVirs technology and manufacturing process enables the potential for the treatment and/or prevention of up to six devastating viruses with its lead allogeneic product, Viralym-M (ALVR105), and allows potentially hundreds of patients to be treated with virus-specific T-cells manufactured from a single donor, using a proprietary cell selection strategy to match the companys bank of donor-derived cell lines to patients. AlloVir is advancing multiple mid- and late-stage clinical trials across its product portfolio.

AlloVir is an ElevateBio portfolio company. More information can be found at allovir.com.

About ElevateBio

ElevateBio, LLC, is a Cambridge-based biotechnology company, established to create and operate a broad portfolio of cell and gene therapy companies with leading academic researchers, medical centers and entrepreneurs. ElevateBio builds single- and multi-product companies by providing scientific founders with fully integrated bench-to-bedside capabilities including world-class scientists, manufacturing facilities, drug developers and commercial expertise. ElevateBio BaseCamp, a company-owned Cell and Gene Therapy Center of Innovation, will serve as the R&D, process development and manufacturing hub across the entire ElevateBio portfolio while also supporting selected strategic partners. For more information, please visit https://www.elevate.bio.

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AlloVir Receives the European Medicines Agency PRIME Designation for Viralym-M, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T-Cell Therapy -...

New Report Counters Claims on the Origin of Gastric Cancer – The Scientist

Chief cells lie at the base of the stomachs gastric glands, and in healthy individuals they are responsible for secreting enzymes required for digestion. Scientists have proposed that, in the face of injury or genetic mutations, these cells revert back to stem cellsor dedifferentiateand give rise to abnormal changes in tissue called metaplasia, a precancerous state.

This idea emerged more than a decade ago from the observation of a specific type of metaplasia in stomach tissue called spasmolytic polypeptide-expressing metaplasia (SPEM), which appeared to originate from chief cells. Over the years, the body of evidence supporting this hypothesis has grown. But some scientists still question whether chief cells truly give rise to the precursors of cancer.

Yoku Hayakawa, a professor of gastroenterology at the University of Tokyo in Japan, is one of the skeptics. He says there have been technical limitations with the previous work, such as the lack of specificity of chief cell markers, and the use of transgenic mouse models that required tamoxifen, a drug that can induce injury and inflammation, to activate the oncogenic Krasgene.

In a study published last week(February 4) in Gastroenterology, Hayakawa and his colleagues investigate some of these issuesand conclude that their findings tip the scales against the chief cell hypothesis.

To address some of the limitations of previous research, Hayakawa and his colleagues identified a new, more-specific chief cell maker that targets the estrogen receptor GPR30 and established a mouse model of gastric metaplasia that activates Kras within the stomach without tamoxifen. When they induced a cancer-causing mutation in the mice, they found that most of the GPR30-expressing chief cells died instead of reverting their identity to stem cells. The team reported similar results when they injured the stomach using drugs or Helicobacter pylori,a bacterium known to increase the risk for cancer.

These findings counter results from previous studies supporting the chief cell hypothesis, Hayakawa tells The Scientist.They think chief cells are dedifferentiated, but [they are] lost.

The team did find stem cells that gave rise to metaplasia in the spots where the chief cells had died. But based on lineage tracing experiments with their Kras-activatedmice, the authors conclude that these cells were not derived from chief cells, but had instead migrated from higher up in the gland. This observation is consistent with a long-standing idea that stem cells from elsewhere in the gland are responding to replenish the dead chief cells, Hayakawa tells The Scientist. The epithelium has to regenerate to maintain homeostasis. So, in this case, stem cells actually expand and try to give rise to chief cells, which are lost.

According to Hayakawa, although these findings dont rule out that chief cells may give rise to metaplasia in rare cases, they suggest that gastric stem cells from the upper part of the gland are the main source of metaplasia in the stomach. The data clearly suggests stem cells or progenitors give rise to metaplasia but chief cells do not, he says.

Jason Mills, whose lab at Washington University School of Medicine has published several studies supporting the hypothesis that dedifferentiated chief cells can give rise to metaplasia, is not convinced. A key limitation of this study, he says, is that the authors conclusions depend largely on the assertion that GRP30labels all chief cells and only chief cells, which he does not think has been adequately demonstrated. (He notes there are differences in GPR30expression patterns in some of the papers figures, indicating that chief cells arent consistently or uniformly labeled.)

Mills adds that the results from this study arent actually too far off from those obtained in his own work, which has also revealed a subset of chief cells that do not undergo metaplasia. However, while his lab demonstrated that there are other chief cells that do give rise to SPEM, Hayakawas team concludes that the cells that give rise to the metaplasia in their experiments must not be chief cells. If you focus on the positive rather than the negative [in their results], we probably would not be too far off in our conclusions about chief cell behavior, he says.

Linda Samuelson of the University of Michigan says that a tamoxifen-independent mouse model of gastric metaplasia is an important contribution to the field. However, she, too, disagrees that this study rules out the chief cell dedifferentiation hypothesis. Its likely that both hypothesesa precancerous state arising from either stem cells or dedifferentiated chief cellsare correct, Samuelson tells The Scientist.She adds that the differences in outcome likely depend on factors such as how metaplasia is induced and the method used to track the cellular changes.

Regardless of whether the chief cell hypothesis turns out to be true, the question of how SPEM gives rise to gastric cancer remains unanswered, Hayakawa says. James Goldenring, who studies gastric cancer at Vanderbilt University Medical Center and is among those who originally proposed that chief cell dedifferentiation can give rise to SPEM, agrees that this an open question. But hes not convinced that his hypothesis should be discarded. It took me at least 10 years to get people to actually even admit that SPEM existed. So its perhaps ironic that were now arguing over how its created, he says. I guess thats better than where it started out, right? Weve taken the discussion to a different level.

M. Hata et al., GPR30-expressing gastric chief cells do not dedifferentiate but are eliminated via PDK-dependent cell competition during development of metaplasia,Gastroenterology,doi:10.1053/j.gastro.2020.01.046, 2020.

Diana Kwon is a Berlin-based freelance journalist. Follow her on Twitter @DianaMKwon.

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New Report Counters Claims on the Origin of Gastric Cancer - The Scientist

BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn Regulatory Pathway for Approval in ALS – GlobeNewswire

NEW YORK, Feb. 11, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc., (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company recently held a high level meeting with the U.S. Food and Drug Administration (FDA) to discuss potential NurOwn regulatory pathways for approval in ALS. Repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) is currently being evaluated in a fully enrolled Phase 3 pivotal trial in ALS (NCT03280056).

In the planned meeting with senior Center for Biologics Evaluation and Research (CBER) leadership and several leading U.S. ALS experts, the FDA confirmed that the fully enrolled Phase 3 ALS trial is collecting relevant data critical to the assessment of NurOwn efficacy. The FDA indicated that they will look at the "totality of the evidence" in the expected Phase 3 clinical trial data. Furthermore, based on their detailed data assessment, they are committed to work collaboratively with BrainStorm to identify a regulatory pathway forward, including opportunities to expedite statistical review of data from the Phase 3 trial.

Both the FDA and BrainStorm acknowledged the urgent unmet need and the shared goal of moving much needed therapies for ALS forward as quickly as possible.

This is a key turning point in ourworktowardprovidingALSpatientswith a potential new therapy,said ChaimLebovits, President and CEO ofBrainStorm. We commend the FDA foritscommitmentto the ALS communityandtofacilitating the development, and we ultimately hope, the approvalofNurOwn.The entire BrainStorm team is grateful for the ongoing and conscientious collaboration in the quest to beat ALS.

Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, stated, The entire team at BrainStorm has collectively worked to ensure that we conduct the finest, science-based clinical trials. We had the opportunity to communicate with Senior Leadership at the FDA and discuss how we can work together to navigate the approval process forward along a novel pathway. We appreciate their willingness and receptiveness to consider innovative approaches as we all seek to better serve the urgent unmet medical needs of the ALS community.

Brian Wallach, Co-Founder of I AM ALS stated: There is nothing more important to those living with ALS than having access to therapies that effectively combat this fatal disease. We have been working with BrainStorm for months now because we believe that NurOwn is a potentially transformative therapy in this fight. We were privileged to represent the patient voice at this meeting and are truly grateful to the company and the FDA for this critical agreement. This is a truly important moment of hope and we look forward to seeing both the Phase III data and the hopeful approval of NurOwn as soon as is possible.

About NurOwnNurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc.is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean Medicines Agency(EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. BrainStorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

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Katie Gallagher | Account Director, PR and MarketingLaVoieHealthScience Strategic CommunicationsO: 617-374-8800 x109M: 617-792-3937kgallagher@lavoiehealthscience.com

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BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn Regulatory Pathway for Approval in ALS - GlobeNewswire

Hemostemix Announces the Appointment of Dr. Ronnie Hershman to the Board of Directors and Provides a Corporate Update – BioSpace

CALGARY, Alberta, Feb. 10, 2020 (GLOBE NEWSWIRE) --Hemostemix. (Hemostemix or the Company) (TSXV: HEM; OTC: HMTXF) is pleased to announce the appointment of Dr. Ronnie Hershman, M.D., F.C.C.S., to its Board of Directors. Dr. Hershman is a successful, practicing cardiologist with over three decades of experience. Dr. Hershman graduated Magna Cum Laude from the Sophie Davis Center for Biomedical Research in 1980 and received his medical degree from Mount Sinai Medical Center in 1982. He then continued his medical and cardiovascular training at Mt. Sinai Medical Center.

Dr. Hershman has been an Invasive Cardiologist since 1987 and was involved in many clinical trials for emerging catheter technologies. He was a pioneer in performing laser-assisted coronary angioplasty, starting in private practice on Long Island in 1989. Presently the Medical Director of NYU Langone Long Island Cardiac Care he built and manages a large medical practice, employing cutting-edge technology and continues his practice for patients with cardiovascular and peripheral vascular diseases, employing a non-invasive therapy for patients with intractable Angina and Congestive Heart Failure.

Dr. Hershman has also been an entrepreneur and investor for more than two decades. He has been involved in life science investing and consulting for several years and previously or currently serves on the boards of medical biotechnology companies Solubest, Ltd., TheraVitae Inc., Nasus Pharma, SanoNash and Optivasive. He also serves as an advisor to a latestage, life science venture capital company that has funded 24 companies to-date. Dr. Hershman is now an investor in OurCrowd, Ltd., a leading crowd funding company and is the Co-Founder and CEO of HealthEffect, LLC and CLiHealth, LLC, SoLoyal and Nasus Pharma along with SanoNash.

Dr. Hershman continues to evaluate new medical technologies in the USA and Israel. His main interests lie in bringing improved medical technologies from the bench to the clinic, quickly and globally. He is actively seeking to commercialize technologies that improve lives and cure illnesses in the most effective and cost efficient manner.

Stem Cell therapies are the future in so many chronic illnesses and Hemostemix is an exciting company with a lot of promise in providing solutions and therapeutic options for many patients with critical Cardiovascular illnesses and ischemia, commented Dr. Hershman. As an investor and Board Member, I hope to assist in advancing these therapies further and create optimal value for patients and shareholders, alike, he said.

Dr. Hershman is replacing Mr. Yari Nieken and Mr. Bryson Goodwin who both resigned from their positions with the Company effective February 10, 2020. Ms. Natasha Sever has also resigned from the position of CFO. The Company will look for suitable replacements for both CEO and CFO positions and Mr. Smeenk will act as the interim CEO until a replacement is hired. The Company thanks Bryson, Yari and Natasha for their service and wishes them well in their future endeavors.

It is a great pleasure to welcome Dr. Hershman to the Board of Directors, said David Wood, Chairman, as he compliments us with his broad medical experience, biotechnology and business investment acumen and counsel.

I am honored and delighted to welcome Dr. Hershman to the Board of Directors and I very much look forward to his counsel, said Thomas Smeenk, President.

The Company also announces that on January 9, 2020, J.M. Wood Investment Inc. (JMWI) sent the Company a Notice of Default and Demand for the immediate repayment of the Companys previously announced convertible debenture and demand loan. Based on the repayment conditions of the debts, the Company took the position the January 9th notice was premature. On January 24th, JMWI made an application to the Court of Queens Bench of Alberta for the issuance of an order appointing a receiver. The Company responded with a 347 page affidavit including appendices, sworn on January 30th by David Wood, Chairman. The application was heard on January 31st by Madame Justice Horner, who granted a consent order to adjourn the JMWI receivership application to February 20, 2020 to enable the Company to close its financing; granted an order appointing Grant Thornton as inspector; granted an order that the costs of the application of January 31st would only be payable by the Company if the application proceeds on February 20th. On February 6, 2020 cross examinations on the Affidavits of David Wood and JMWI were heard.

Also, on February 3, 2020 the Company received an action from Aspire Health Science, LLC filed with the Ninth Judicial Circuit Court for Orange County, State of Florida, in connection with the Amended and Restated License Agreement rescinded by Hemostemix on December 5, 2019 due to Aspires failure to meet the Condition Precedent of paying US$1,000,000 within 30 business days of September 30, 2019. The Company believes the action is frivolous, without merit, and it intends to vigorously defend its position.

The Company intends to effect repayment of the secured debts and it will provide a further update to the market at that time. Although the Company is optimistic that it will be successful in raising sufficient funds to meet its obligations, there can be no assurance that the financing will close as anticipated or within the time frames required.

ABOUT HEMOSTEMIX INC.

Hemostemix is a publicly traded autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company developed and is commercializing its lead product ACP-01 for the treatment of CLI, PAD, Angina, Ischemic Cardiomyopathy, Dilated Cardiomyopathy and other heart conditions. ACP-01 has been used to treat over 300 patients, including no-option end-stage heart disease patients, and it has been the subject of four open label phase II clinical studies which proved its safety and efficacy.

On October 21, 2019, the Company announced the results from its presentation from its Phase II CLI trial abstract presentation entitled Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup which noted healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years. The Companys clinical trial for CLI is ongoing at 20 clinical sites in North America and 56 of 95 subjects have been enrolled to-date.

The Company owns 91 patents across five patent families titled: Regulating Stem Cells, In Vitro Techniques for use with Stem Cells, Production from Blood of Cells of Neural Lineage, and Automated Cell Therapy. For more information, please visit http://www.hemostemix.com.

Contact:

Thomas Smeenk, President & CEOSuite 1150, 707 7th Avenue S.W.Calgary, Alberta T2P 3H6Tel: 905-580-4170

Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words expects, plans, anticipates, believes, intends, estimates, projects, potential, and similar expressions, or that events or conditions will, would, may, could, or should occur. Although Hemostemix believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Hemostemix management on the date such statements were made. By their nature forward-looking statements are subject to known and unknown risks, uncertainties, and other factors which may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the Companys ability to fund operations and access the capital required to continue operations and repay its secured debts, the Companys stage of development, the ability to complete its current CLI clinical trial, complete a futility analysis and the results of such, future clinical trials and results, long-term capital requirements and future developments in the Companys markets and the markets in which it expects to compete, risks associated with its strategic alliances and the impact of entering new markets on the Companys operations. Each factor should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise. Additional information identifying risks and uncertainties are contained in the Companys filing with the Canadian securities regulators, which filings are available at http://www.sedar.com.

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Hemostemix Announces the Appointment of Dr. Ronnie Hershman to the Board of Directors and Provides a Corporate Update - BioSpace