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Pear tart and pear butter recipes a delicious way to enjoy the fruit – The Gazette

By daniellenierenberg

By Robin Mather, Chicago Tribune

Apples may get all of autumns accolades, but its time for pears to muscle in on the action.

Understanding which pear varieties are best for which uses will help you choose wisely from the fruit youll see at farmers markets, farm stands and grocery stores.

You can eat any pear raw, from juicy Bartletts to crisp Asian pears. But in cooking, you may want the pear to retain its shape, or you may want it to melt into a concentrated sauce. I remember pear varieties that hold their shape for poached pears, and for the pear tart we offer here with a simple mnemonic of ABC: Anjou, Bosc and Comice.

Some varieties are more grainy or gritty than others but peeling any pear will help reduce that graininess. As pears ripen on the tree, they develop stone cells, and most of these lie just under the skin. Most pears are harvested before theyre fully ripe for this reason. While the skin is full of nutrients, sometimes you just want that grittiness to go away.

Like apples, cut pears will brown when exposed to air. For salads and other raw uses where appearance is important, place the pears in water acidulated with lemon juice for a quick bath to prevent browning.

These are the varieties youre likely to see this season, with a bit of information about them and their best uses.

Anjou: Firm and mild flavored, Anjous are good for cooking where you want the pear to pick up the flavors of its cooking companions. Red and green Anjous have the same flavor.

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Asian: As crisp as a ripe apple, Asian pears are very mild in flavor. Theyre the outlier in the pear family, more apple than pear.

Bartlett: The juiciest of all the pears, a ripe Bartlett will leave your chin dripping when you eat it out of hand. Choose red or green Bartletts when you want the fruit to cook into a sauce, as we do in the vanilla-cardamom pear butter recipe here.

Bosc: Crisp and mildly sweet, Boscs are the classic choice for poached pears. Theyre easy to recognize because of their cinnamon-colored russeted skin. They tend to be a nice size as well.

Comice: Brightly flavored with the quintessential pear taste, Comice pears are less grainy than many other varieties.

Concorde: A favorite in Europe, the Concorde has a long neck that makes it immediately identifiable. Its distinctively vanilla flavor makes it a favorite for roasting and grilling, but its also great out of hand.

Forelle: A pretty speckled pear thats popular in Europe, this small pear is best for snacking. Its name comes from the German word for trout, because its colors echo the flashing brilliance of the fish. Grown in small quantities in the Pacific Northwest, Forelle tells you its ripe when the skin under its red speckles turns from green to yellow.

French butter: Small with concentrated flavors, make sure French butter pears are fully ripe before use. Underripe fruit has a sharp, tannic flavor. Good for snacking, or in salads.

Seckel: Just as with French butter pears, make sure the little Seckel pears are fully ripe before eating to avoid a tannic hit. Best out of hand, or in salads.

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Robin Mather is a longtime food journalist and the author of The Feast Nearby, a collection of essays and recipes from a year of eating locally on a budget. Follow her as she writes her third book at thefeastofthedove.com.

PEAR-ALMOND TART

This simple tart will look and taste more impressive than its simple ingredients might suggest. Remember that you want pears that will hold their shape for this tart. If you cant find creme fraiche, substitute lightly sweetened sour cream as a garnish at serving time.

Prep: 30 minutes

Cook: 40 minutes

Makes: about 12 servings

Crust:

2 1/4 cups ground almond meal

4 1/2 tablespoons sugar

8 tablespoons melted salted butter

Filling:

2 cups sugar, divided use (plus more for browning)

3 Anjou, Bosc or Comice pears, peeled, sliced in half

1 1/2 cups milk

2 teaspoons vanilla

3 eggs, lightly beaten

1/4 cup flour

1/4 cup sliced toasted almonds

Creme fraiche, sweetened sour cream or whipped cream

For the crust: Heat the oven to 350 degrees. Combine almond meal, sugar and melted butter in a medium bowl. Stir to combine. Pat the crust mixture into the bottom and up the sides of a 12-inch tart pan and press into place with the bottom of a drinking glass. Bake the crust until just colored, 10 to 15 minutes. Remove and allow to cool completely before filling.

For the filling: Heat 4 cups water and 1 1/2 cups sugar to a boil in a large saucepan over medium-high heat. Reduce heat to low. Add the pears; poach until tender, 20-25 minutes. Remove pears from the syrup. Allow to cool, then cut out cores. Cut the pears into fans by slicing into 1/4-inch slices that remain attached by about 1/2 inch at the stem end. Set aside.

Combine milk and vanilla in a small saucepan and bring it to just a simmer over medium heat. (Dont let it boil over.) Combine eggs, remaining 1/2 cup sugar and the flour in a large saucepan. Temper the mixture by slowly whisking in a little of the hot milk. Then gradually whisk in the rest. Cook, whisking continuously, over medium heat. At the first sign of a boil, 3 to 6 minutes, remove pan from the heat while continuing to whisk until mixture begins to thicken. Allow the custard to cool.

Spoon cooled custard into the tart shell. Lay the fanned-out pears, stem end inward, in the custard. Scatter the sliced almonds over top. Sprinkle with 1 to 2 tablespoons sugar. Heat the broiler in the oven. Place the tart on the middle rack, 4 to 5 inches from the broil. Serve warm with creme fraiche, sweetened sour cream or whipped cream.

Nutrition information per serving: 428 calories, 22 g fat, 7 g saturated fat, 69 mg cholesterol, 54 g carbohydrates, 45 g sugar, 8 g protein, 101 mg sodium, 4 g fiber

VANILLA-CARDAMOM PEAR BUTTER

Prep: 35 minutes

Cook: 8-10 hours

Makes: about 7 half-pints

Youll definitely want to use ripe Bartlett pears for this fruit butter because they cook into a silky puree. Making this pear butter in the slow cooker means you dont have to stand over it while it cooks. Weve given directions to both can and freeze this sumptuous delight.

6 1/2 pounds Bartlett pears, peeled, cored and cut into 1/2-inch cubes

Juice of 1 large lemon

1/2 cup sugar

1/4 teaspoon coarse salt

2 teaspoons vanilla

1 teaspoon ground cardamom

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Tumble all ingredients except butter into a slow cooker. Stir to blend, then cover and cook on low until the pear butter is very thick and mounds on a spoon, 8 to 10 hours. Test its readiness by placing a spoonful on a plate; if no liquid escapes around the edges, the pear butter is ready. If it weeps, continue to cook with the lid crosswise to allow excess liquid to evaporate.

Stir in the butter until it is fully melted. Ladle the hot pear butter into sterile half-pint jars, leaving 1/4-inch headspace. To can, apply lids and rings just until finger tight; process in a boiling water bath for 10 minutes. To freeze, allow the pear butter to cool to room temperature, then freeze without lids. Once pear butter is frozen, add lids and freeze for up to six months.

Nutrition information per tablespoon: 21 calories, 0 g fat, 0 g saturated fat, 0 mg cholesterol, 5 g carbohydrates, 3 g sugar, 0 g protein, 5 mg sodium, 1 g fiber

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AIVITA Biomedical to Present at Upcoming Regenerative Medicine, Oncology and Investor Conferences in November – P&T Community

By daniellenierenberg

IRVINE, Calif., Nov. 1, 2019 /PRNewswire/ --AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, today announced that it will be presenting at the following regenerative medicine and investor conferences in November:

Society for the Immunotherapy of Cancer (SITC) Annual MeetingOral PresentationPresenter: Dr. Daniela Bota, MD, PhD, University of California, Irvine; AIVITA GBM Principal InvestigatorTitle: Phase II trial of therapeutic vaccine consisting of autologous dendritic cells loaded with autologous tumor cell antigens from self-renewing cancer cells in patients with newly diagnosed glioblastomaTime: November 6-10, 2019Location: Gaylord National Hotel & Convention Center, National Harbor, MD

The Regenerative Medicine Consortium of the Gulf Coast Consortia for Biomedical SciencesOral Presentation Presenter: Dr. Hans S. Keirstead, AIVITA Chairman and CEOTitle: Clinical and Commercial Application of Scaled Human Stem Cell DerivatesTime: November 8, 4:00 PM CTLocation: Bioscience Research Collaborative, Houston, TX

NYC Oncology Investor ConferenceOral Presentation Presenter: Dr. Hans S. Keirstead, AIVITA Chairman and CEO Title: AIVITA Corporate PresentationTime: November 12, 4:50 PM - 5:10 PMLocation: Rockefeller Center, New York, NY

Society for NeuroOncology Annual MeetingPoster PresentationTitle: Phase II trial of AV-GBM-1 (autologous dendritic cells loaded with autologous tumor associated antigens) as adjunctive therapy following primary surgery plus concurrent chemoradiation in patients with newly diagnosed glioblastoma.Time: November 20-24, 2019Location: JW Marriott Desert Ridge, Phoenix, AZ

About AIVITA Biomedical

AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITA's skin care products support the treatment of women with ovarian cancer.

View original content to download multimedia:http://www.prnewswire.com/news-releases/aivita-biomedical-to-present-at-upcoming-regenerative-medicine-oncology-and-investor-conferences-in-november-300950053.html

SOURCE AIVITA Biomedical, Inc.

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I lost my fianc to leukaemia, but in my dreams hes just working the night shift – Telegraph.co.uk

By daniellenierenberg

The proposal was nothing fancy. Shawn Russell arrived at the pub, placed a pint on the table in front of Sarah Hodgetts and asked her to marry him.

It was out of the blue, with no ring, nothing. And I thought: Yeah, thats a really good idea, we should just get married, says Sarah. Id been in love with him for ages.

Their story began seven years earlier, in 2009, also in a pub in north London. He was sitting in his flat cap, good Yorkshireman that he was, and was reading the sports pages. I had just got off the Tube after work. From my perspective, it was love at first sight, says Sarah.

But dating wasnt easy. Shawn, a boarding school-educated boy from an Army family, who had lost his mother to leukaemia when he was two, worked as a picture editor at The Telegraph. Although Sarah was down the road in Westminster, where she worked as a civil servant (and still does), their hours were long and their schedules largely incompatible. They managed just six months initially.

It was a disaster trying to date, so we ended up with a firework display of an argument and decided there was no way we could, says Sarah over coffee near her office.

Their split didnt last, however; they had far too much in common. Besides his ridiculous sense of humour, Shawn was so into news and politics, and I worked in politics, so we couldnt not communicate. We realised we were incredibly good friends, says Sarah. Plus, she adds with a smile, he was a very attractive, 6ft 4in blue-eyed man who I was completely smitten with.

Over time, they got back together in a non-committal way, sharing weekends when their busy lives permitted. It was during this period, three-and-a-half years ago, that Shawn, then 44, proposed. The following week, he moved in with Sarah, then 41, and her son Eddy, 10, from a previous relationship, in Kings Cross, and, like all newly engaged couples, they started making plans for their future. A pair of recovering workaholics, they were going to transform their lives.

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Leukaemia: what is it, how to spot the warning signs and who is at risk? – The Telegraph

By daniellenierenberg

How isleukaemia treated?

The treatment of leukaemia varies depending on the patient and type of leukaemia they have.

Acute leukaemia (fast developing) is usually curable with standard treatments, such as chemotherapy.

Chronic leukaemia (slow developing), is often incurablebut treatable. For CLL (a form of chronic leukaemia) some patients are not given treatmentstraight away;however if they do require treatment it will often involve chemotherapy.

The main treatments for leukaemia are:

Chemotherapy: This treatment involves theuse ofdrugs.Chemotherapy drugs either kill cancerous cells or stop them from dividing; they can also kill normal blood cells as a side effect.The type of leukaemia you have will depend on the amount and strength of chemotherapy you are offered, along with other factors such as your age and fitness.

Radiation therapy:Similar to chemotherapy, radiation therapy can be used to destroy the cancerous cells but using radiation waves rather than drugs.Again, the type of leukaemia you have will determine what treatment you're offered. External beam radiation therapy (EBRT) is often used for CLL.It is a fast, painless procedure which usually lasts just a few minutes.

Targeted therapy:Drugs are used to block the growth of cancer cells by disturbing specific molecules in the cells. Targeted therapy can also kill cancer cells by stimulating the patient's immune system to recognise the cells as a threat and consequently kill them.

Biological therapy:This treatment does not target the cancer cells directly, but instead helps to stimulate the body's immune system to act against the cancer. It is also often referred to as "immunotherapy". It is often usedfor patients with CML.

Stem cell or bone marrow transplant: Transplants for stem cells or bone marrow are commonly carried out for patients withacute leukaemia,if chemotherapy does not prove effective.By undergoing a stem cell or bone marrow transplant it can help replenish the healthy bone marrow in patients, and stimulate new growth that restores the immune system. It is usually given to younger, or more healthy patients.

Leukaemia Care, which provides support to individuals and families affected by blood cancer, is one ofthree charities supported by this years Telegraph Christmas Charity Appeal. Our two other charities are Wooden Spoon, which works with Britains rugby community to raise money for sick, disabled and disadvantaged children; and The Silver Line, a 24-hour helpline and support service for lonely elderly people. To make a donation, visit telegraph.co.uk/charity or call 0151 284 1927

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InGeneron Announces Publication of Preclinical Results for its Cell Therapy in Chronic Ischemic Heart Failure – Business Wire

By daniellenierenberg

HOUSTON--(BUSINESS WIRE)--InGeneron, Inc., a regenerative medicine and cell therapy company, today announced the publication of promising results in developing a novel treatment for chronic ischemic heart failure using its regenerative cell therapy platform.

A newly-released research paper published in the World Journal of Stem Cells provides missing pieces of evidence for a fundamental change in the treatment of chronic ischemic heart failure, showing efficacy and safety of a novel stem cell treatment in cardiology. Patients with heart failure as a consequence of previous myocardial infarction are a large and currently underserved patient population, due to the lack of regenerative treatment options.

The publication, performed in a pig model for the study of chronic myocardial infarction, evidences for the first time that regeneration of the damaged tissue in the heart - responsible for chronic ischemic heart failure - is possible. Specifically, the study demonstrates that InGenerons fresh, uncultured, autologous adipose derived regenerative cells (UA-ADRCs) - isolated and administered at point of care - provide a significant improvement of cardiac circulatory parameters in chronic ischemic heart failure. The results show that the mean cardiac output increased by 37%, the mean left ventricular mass increased by 29% and the mean relative amount of scar volume of the left ventricular wall decreased by 21% six weeks after treatment with the cells. All results were statistically significant compared to the control group. Notably, on average only 18 gram of adipose tissue were required to recover the averaged 18 million cells injected to achieve the reported effects.

The findings represent an important step in research, laying the foundation for new frontiers on cardiac regeneration of chronic ischemic heart failure in human patients. While previous studies indicated that stem cells (including UA-ADRCs) might be of benefit in acute myocardial infarction, this benchmark had previously not been achieved by studies of autologous stem cells for chronic heart failure following myocardial infarction.

Haenel et al., the authors of the publication, attribute the success of the study to two important improvements over previous attempts. The primary success factor was the use of InGeneron's technology for isolating the stem cells at point of care. In this regard, a recent publication by Winnier et al. (PLoS One 2019;14:e0221457) demonstrated that the technology used (TransposeRT / Matrase; InGeneron, Inc., Houston, TX, USA), provides the highest published number of living, uncultured, autologous, adult pluripotent stem cells recovered per gram of adipose tissue.

The second differentiator to all previously published results for myocardial regeneration is the application method to the damaged heart. Haenel et al. administered the stem cells retrograde through the hearts venous system, precisely to the area in need of regeneration. This retrograde injection technique, combined with a temporary blockage of the coronary vein at the level of a previous arterial occlusion, allowed the stem cells to overcome the endothelial barrier and thereby created a homogenous distribution of injected cells throughout the damaged myocardial tissue.

Dr. Eckhard Alt, Executive Chair of InGeneron, Inc. and senior author of the study, commented "this therapy, which may be performed in an ambulatory setting without the known risks associated with major anticoagulation, delivers the stem cells in about 15 minutes and involves a total treatment time of approximately 3 hours. This gives hope that millions of patients suffering from chronic ischemic heart failure might benefit from rebuilding the heart with their own stem cells".

The study, entitled "Unmodified autologous stem cells at point of care for chronic myocardial infarction", by Haenel et al. was published in the World Journal of Stem Cells on October 26, 2019.

While the company is advancing its ongoing clinical programs for key orthopedic conditions, additional studies are designed to validate the clinical potential of stem cells in patients with coronary artery disease and chronic heart failure.

About InGeneron

InGeneron is a clinical stage cell therapy company enabling novel, safe and evidence-based regenerative medicine therapies. Our purpose is to set new therapeutic standards by developing treatments that unlock the healing potential of each patients own regenerative cells processed at the point of care for same-day application. We focus on helping patients who are impacted by musculoskeletal indications and are pursuing research to extend the application of our platform technology to additional treatment areas.

http://www.ingeneron.com

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Stem Cell Therapy: What’s Real and What’s Not at California’s For-Profit Clinics – UCSF News Services

By daniellenierenberg

Many for-profit stem cell clinics advertise therapies that are not backed by science and may actually cause harm.

For-profit stem cell clinics have popped up around California in recent years, advertising that they can treat everything from arthritis to Alzheimers, without FDA approval.

They claim that injections of stem cells (naturally occurring blank slate cells that can grow into any type of cell) can help alleviate pain or illness by replacing or regenerating diseased tissue claims that are not supported by existing research. The procedures can cost thousands of dollars out-of-pocket, and regulators have warned that patients have developed tumors, suffered infections and even lost eyesight after unapproved procedures.

No one knows how many clinics there are, but California reportedly has more than any other state. We asked Arnold Kriegstein, MD, PhD, director of the UC San Francisco Developmental & Stem Cell Biology Program, about whats real and whats not in stem cell medicine.

How do these clinics operate?

There has been an explosion of so-called clinics offering stem cell treatments for a wide range of ailments, none of which have been shown to be effective. They are largely unregulated. Many clinics claim that they can treat untreatable illnesses like Alzheimer's disease, autism, muscular dystrophy, or stroke. The list is quite extensive.

The majority are using fat tissue for their stem cells, obtained through liposuction. These are usually autologous cells, which means that they are taking the patient's own tissue and extracting cells to re-administer to the same patient, usually through an intravenous route. In addition to fat cells, some clinics administer bone marrow stem cells or umbilical cord or placental stem cells, which come from unrelated donors.

The clinics often advertise through testimonials from patients who've received their therapies. Many of the conditions that the testimonials address are the kinds that normally improve or fluctuate over time, such as joint pain, low back pain, arthritis, or multiple sclerosis.

The problem is that patients will receive a treatment, and then, within a month or two, they'll notice that the aches and pains in the joints are improving, and they will attribute the improvement to the stem cell therapy, when in fact it would've happened regardless.

What is the risk of trying an unproven stem cell treatment?

Reports of physical harm have included infections and the development of tumors. When using cells that are not the patients own, umbilical cord cells for example, immune responses can occur often triggering inflammatory conditions.

In cases where stem cells have been delivered into the eye, blindness has been reported, and when they have been delivered to the central nervous system through lumbar puncture (spinal tap), adverse outcomes including serious infections of the central nervous system and tumors have occurred.

Then there's the emotional cost associated with raising false hope, and the financial loss that comes from exorbitant fees charged for ineffective, potentially harmful therapies.

Why arent there more legitimate stem cell therapies available?

Stem cells have been in the news so much over the last decade or so that I think it has created the impression that therapies are already on the market. The reality is that it is very early days for the science. The most interesting, most promising animal studies are only now beginning to be translated into clinical trials, and the process for approval of therapies takes many years and very few are likely to succeed.

Unfortunately, the public needs to be patient, but the good news is that potential treatments are progressing along the pipeline.

What are some examples of proven stem cell therapies?

For the last 50 years or so, there have been countless patients successfully treated with hematopoietic stem cells, commonly known as bone marrow transplants. This remains the prototype for how a stem cell therapy can work. Other successful examples include corneal stem cell grafts for certain eye conditions, and skin grafts for burn victims.

There are efforts to see if stem cells could successfully treat diseases like Parkinson's and diabetes, particularly type 1 diabetes. There are clinical trials testing whether stem cell therapy might work against macular degeneration, a blinding disease that is very common as people age. There are also early stage clinical trials for nervous system disorders including stroke, spinal cord injury, and ALS (Lou Gehrigs disease).

All of these examples are still at a very early stage, where the primary goal is to make sure that the approaches are safe. To determine if they are effective will require large, well-controlled, relatively long-term clinical trials.

What will it take to advance stem cell therapy into more real treatments?

This is where basic research comes in. The field is evolving quickly, there's much to be done, and there's still a huge amount of promise in stem cell therapies down the road. But it's going to take a lot of very careful and very laborious research before we get there.

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Organ donations: What you can do to help save a life – Calgary Herald

By daniellenierenberg

Saving the life of a fellow Canadian can be as easy as checking a box online or saying yes to being an organ donor when you renew your drivers license. But, thats just the beginning for those wanting to make a difference.

Deceased donations

In Alberta, individuals over the age of 18 can register their intent to become an organ or tissue donor when they die by using the Alberta Organ and Tissue Donation Registry. (Go to myhealth.alberta.ca online and search organ donation registry.) As well, agents and provincial registries are required to ask the donor question when clients are renewing a drivers licence or identification card.

For those who have Alberta Health Cards issued prior to 2018, the back of the card can be signed (with a witness) to declare their intention to donate.

The Alberta registry has been integrated into the provinces health care system through the use of donor co-ordinators. If a person has declared his or her intent to donate and is in a position to be considered for organ or tissue donation, a co-ordinator will discuss it with family members, who ultimately make the final decision.

Each deceased donor can provide up to eight organs (both lungs, both kidneys, liver, heart, pancreas, intestines), while donated tissues can benefit up to 75 individuals.

Living donations

The vast majority of living organ donors spares one of their two functioning kidneys to a person in need, though living liver donations also occur to a lesser extent.

In most cases, family members or acquaintances donate a living organ if theyre healthy enough to safely act as a donor. Once a viable donor is found, transplant programs in both Calgary and Edmonton perform the surgeries for kidneys, while live liver transplants are only performed in Edmonton.

Theres also been a rise in so-called altruistic donors, who are willing to share their organs with a stranger. Both the Kidney Foundation of Canada and Canadian Blood Services can advise prospective living donors on where to turn, while Alberta Health can connect donors to local living donor programs.

Canadian Blood Services also operates the Kidney Paired Donation Program, an inter-provincial initiative that maintains prospective donors in a registry if they arent a compatible match for their intended recipient. Since January 2009, some 500 living donors across Canada have entered the KPD program, including 90 anonymous donors who joined the program without a specific recipient in mind. Non-directed, anonymous donations are responsible for more than two-thirds of the transplants in the KPD program, and all patients with a match have received a transplant in less than a year.

The Living Donor Services Program Edmonton: Phone 780-407-8698; toll free 1-866-253-6833; email: livingdonors@ahs.ca.

Southern Alberta Transplant Program Calgary: Phone 403-944-4635.

More information on kidney health is available from the Kidney Foundation of Canada: http://www.kidney.ca; 780-451-6900 or 403-255-6108.

More information on liver health is available from the Canadian Liver Foundation: http://www.liver.ca; 403-276-3390 or 1-800-563-5483.

Details about Green Shirt Day and Logan Boulet are at greenshirtday.ca.

Stem cell donations

Stem cell transplants replace a patients unhealthy stem cells with a donors healthy ones, and can be used to treat cancers and other diseases. The three sources of stem cells are from bone marrow, peripheral (circulating) blood and umbilical cord blood.

Prior to any donation, the donor will undergo a comprehensive health assessment before undergoing the procedure. Peripheral blood stem cell donation only requires blood to be drawn from a needle in hospital following five days of under-the-skin injections to boost the number of blood cells in the bloodstream.

Bone marrow donations are performed under anesthesia, with hollow needles used to withdraw stem cells from bone marrow in the back of pelvic bones. The procedure lasts between 45 to 90 minutes and the marrow replenishes itself in four to six weeks.

Those who wish to become a stem cell donor can call Canadian Blood Services at 1-888-2-DONATE (1-888-236-6283) or by visiting the agencys website at blood.ca.

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Plant bioactives, combining tradition with technology – Cosmetics Business

By daniellenierenberg

31-Oct-2019

Ingredients

Since ancient times medicinal plants have been used for their health beneficial properties, to protect and promote the skin and for treatment of various diseases.

Plantshave an enormous capacity to produce complex chemical molecules with bioactive properties.The market for botanicals is expanding with an increasing demand for plant bioactives. It is therefore important to produce the plant raw material a sustainable way. Often traditional production does not support this.

Plant cell cultivation enables sustainable production of high-quality plant raw material. Based on this technique it is possible to target and enrich specific cell types, such as plant stem cells.

Since the cultivation takes place in a clean and controlled environment, the produced plant raw material is free from adulteration, pollution, pesticides and herbicides. Besides cell enrichment, it is further possible to increase the production of bioactives through the MET (Metabolic Enhancement Technology).

For bioactives it is also important to consider their availability in the final product, otherwise their beneficial properties will not be available to our cells. Some bioactives are not available in dry cells even when these are grinded.

This can be due to that they are tightly bound to a cell structure, such as the cell wall. However, these can be made accessible through extraction where these actives are released from their bound position.

The extract with the highest quality and health beneficial properties are high in concentration and standardised to selected actives or group of molecules. This way it is possible to ensure that the extract is always the same in terms of properties and efficacy.

In vitro Plant-tech develops and produces high quality plant raw material and extracts using the plant cell cultivation technology. We are proud of our green and sustainable production platform, producing superior products with compassion for nature.

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AIVITA Biomedical to Present at Upcoming Regenerative Medicine, Oncology and Investor Conferences in November – PRNewswire

By daniellenierenberg

IRVINE, Calif., Nov. 1, 2019 /PRNewswire/ --AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, today announced that it will be presenting at the following regenerative medicine and investor conferences in November:

Society for the Immunotherapy of Cancer (SITC) Annual MeetingOral PresentationPresenter: Dr. Daniela Bota, MD, PhD, University of California, Irvine; AIVITA GBM Principal InvestigatorTitle: Phase II trial of therapeutic vaccine consisting of autologous dendritic cells loaded with autologous tumor cell antigens from self-renewing cancer cells in patients with newly diagnosed glioblastomaTime: November 6-10, 2019Location: Gaylord National Hotel & Convention Center, National Harbor, MD

The Regenerative Medicine Consortium of the Gulf Coast Consortia for Biomedical SciencesOral Presentation Presenter: Dr. Hans S. Keirstead, AIVITA Chairman and CEOTitle: Clinical and Commercial Application of Scaled Human Stem Cell DerivatesTime: November 8, 4:00 PM CTLocation: Bioscience Research Collaborative, Houston, TX

NYC Oncology Investor ConferenceOral Presentation Presenter: Dr. Hans S. Keirstead, AIVITA Chairman and CEO Title: AIVITA Corporate PresentationTime: November 12, 4:50 PM - 5:10 PMLocation: Rockefeller Center, New York, NY

Society for NeuroOncology Annual MeetingPoster PresentationTitle: Phase II trial of AV-GBM-1 (autologous dendritic cells loaded with autologous tumor associated antigens) as adjunctive therapy following primary surgery plus concurrent chemoradiation in patients with newly diagnosed glioblastoma.Time: November 20-24, 2019Location: JW Marriott Desert Ridge, Phoenix, AZ

About AIVITA Biomedical

AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITA's skin care products support the treatment of women with ovarian cancer.

SOURCE AIVITA Biomedical, Inc.

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AIVITA Biomedical to Present at Upcoming Regenerative Medicine, Oncology and Investor Conferences in November - PRNewswire

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Three UCLA scientists receive grants totaling more than $18 million – Newswise

By daniellenierenberg

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Newswise Three researchers at theEli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLAhave received awards totaling more than $18 million from the California Institute for Regenerative Medicine, the states stem cell agency.

The recipients are Dr. Sophie Deng, professor of ophthalmology at the UCLA Stein Eye Institute;Yvonne Chen, a UCLA associate professor of microbiology, immunology and molecular genetics; and Dr. Caroline Kuo, a UCLA assistant clinical professor of pediatrics. The awards were announced at a CIRM meeting today.

Dengs four-year, $10.3 million award will fund a clinical trial for a blinding eye condition called limbal stem cell deficiency. Limbal stem cells are specialized stem cells in eye tissue that help maintain the health of the cornea. Because of genetic defects or injuries caused by infections, burns, surgeries or other factors, some people do not have enough limbal stem cells, which results in pain, corneal scarring and blindness.

The approach she is testing involves extracting a small number of limbal stem cells from a persons eye, multiplying them in a lab, and then transplanting them back into the eye, where they could regenerate the cornea and restore vision. The research will be conducted in collaboration with theUCLAUCI Alpha Stem Cell Clinic, a partnership between UCLA and UC Irvine.

The grants awarded to Chen and Kuo are for projects that are heading toward the FDAs investigational new drug application process, which is required by the agency before a phase 1 clinical trial the stage of testing that focuses on a treatments safety.

Chens two-year, $3.2 million award will fund efforts to create a more effectiveCAR T cell therapyfor multiple myeloma, a blood cancer that affects white blood cells. The research will evaluate a specialized form of CAR T therapy that simultaneously targets two markers, BCMA and CS1, commonly found on multiple myeloma cells. CAR T therapies that target BCMA alone have been effective in clinical trials, but the presence of BCMA on multiple myeloma cells is not uniform.

Previous research has shown that the marker CS1 is present in around 90% of multiple myeloma cells. A CAR T therapy that targets both markers could potentially help more patients and reduce the likelihood of a cancer relapse.

Kuos 2 1/2-year, $4.9 million award, will support the development of a stem cell gene therapy for a deadly immunodeficiency called X-linked hyper IgM syndrome, or XHIM.

The syndrome, which is caused by a mutation in the CD40LG gene, results in invasive infections of the liver, gastrointestinal tract and lungs. Currently, the only potential cure is a bone marrow transplant from a matched donor, which carries life-threatening risks and is often less effective for XHIM patients than patients with other forms of immune deficiency. Even with current treatments, only 30% of people with the syndrome live to age 30.

Kuo will evaluate a stem cell gene therapy that corrects the genetic mutation that causes XHIM. After removing blood-forming stem cells from a person with the syndrome, the therapy would use a genetic engineering technique called CRISPR to insert a correct copy of the affected gene into the DNA of the stem cells. The corrected blood-forming stem cells would be infused back into the patient, where they could regenerate a healthy immune system.

She will collaborate with Dr. Donald Kohn, a UCLA distinguished professor of microbiology, immunology and molecular genetics who has successfully treated two other immune deficiencies bubble baby disease and X-linked chronic granulomatous disease with a similar therapy.

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Ezer Mizion’s Evening of Heroes is November 9 in Teaneck – The Jewish Standard

By daniellenierenberg

Ezer Mizion, the worlds largest Jewish bone marrow registry, will host its Evening of Heroes for the Teaneck, Bergenfield, and New Milford communities on Saturday, November 9, at Congregation Keter Torah in Teaneck.

The evening begins with a musical Havdalah and mini-concert by the chasidic superstar Shulem Lemmer, the first chasidic singer to sign with Universal Records. Then Ezer Mizion will introduce IDF heroes who defend the State of Israel and have saved lives with their stem cells.

A stem cell recipient will recount the day he received a call letting him know that Ezer Mizion had identified a stem cell match for him a match that saved his life. Bret Stephens, a New York Times Pulitzer Prize-winning columnist, and Nachum Segal will give a fireside chat about innovations from Israel, including the export of more than 60 percent of Ezer Mizions stem cell transplants.

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There will be a swabbing station for people who meet the basic criteria for donations. Israeli wines and shuk foods will be served.

The program aims to bring awareness of the organizations role in saving hundreds of lives around the world every year with its growing bone marrow registry. It has more than 1 million potential stem cell donors, and more than 550,000 of these donors are from the IDF. There is no cost to attend the adults-only evening; RSVPs are requested. For more information, go to eveningofheroes.com; email Ezer Mizions national director of development, Ryan Hyman, at ryan@ezermizionusa.org or call him at (718) 853-8400, ext. 109.

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BioLineRx to Present Two Posters at the Society for Immunotherapy of Cancer (SITC) 2019 – P&T Community

By daniellenierenberg

TEL AVIV, Israel, Oct. 31, 2019 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, announced today that it will deliver the following poster presentations at the Society for Immunotherapy of Cancer(SITC) 34th Annual Meeting to take place November 6-10, 2019 at the Gaylord National Hotel & Convention Center in Baltimore, Maryland:

About BL-8040

BL-8040 is a short synthetic peptide that functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor over-expressed in many human cancers, where it has been shown to be correlated with poor prognosis, and plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance. CXCR4 is also directly involved in the homing and retention of hematopoietic stem cells (HSCs) and various hematological malignant cells in the bone marrow.

In a number of clinical and pre-clinical studies, BL-8040 has shown a critical role in immune cell trafficking, tumor infiltration by immune effector T cells and reduction in immunosuppressive cells within the tumor niche, turning "cold" tumors, such as pancreatic cancer, into "hot" tumors (i.e., sensitizing them to immune check point inhibitors). BL-8040-mediated inhibition of the CXCR4-CXCL12 (SDF-1) axis has also shown robust mobilization of HSCs for transplantation in hematological malignancies.

BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

About BioLineRx

BioLineRx is a clinical-stage biopharmaceutical company focused on multiple oncology indications. The Company'slead program, BL-8040, is a cancer therapy platform currently being evaluated in a Phase 2a study in pancreatic cancer in combination with KEYTRUDA and chemotherapy under a collaboration agreement with MSD. BL-8040 is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. In addition, the Company has an ongoing collaboration agreement with Genentech, a member of the Roche Group, evaluating BL-8040 in combination with Genentech's atezolizumab in two Phase 1b/2 solid tumor studies.

BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being evaluated in a Phase 1/2a study.

For additional information on BioLineRx, please visit the Company's website at http://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook,Twitter, and LinkedIn.

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 28, 2019. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contact:Tim McCarthyLifeSci Advisors, LLC+1-212-915-2564tim@lifesciadvisors.com

or

Tsipi HaitovskyPublic Relations+972-52-598-9892tsipihai5@gmail.com

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SOURCE BioLineRx Ltd.

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SCD, HIV Gene Therapy Efforts Get $200M from NIH, Gates Foundation – Sickle Cell Anemia News

By daniellenierenberg

The National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation will each invest $100 million over the next four years to speed the development of affordable gene therapies for sickle cell disease (SCD) and the human immunodeficiency virus (HIV) on a global scale.

This unprecedented collaboration focuses from the get-go on access, scalability and affordability of advanced gene-based strategies for sickle cell disease and HIV to make sure everybody, everywhere has the opportunity to be cured, not just those in high-income countries, said NIH Director Francis S. Collins, MD, PhD.

Seventy-five percent of babies born with SCD live in sub-Saharan Africa. It is hoped that experimental gene therapies would advance to clinical trials in the United States and relevant African countries within the next seven to 10 years, and that safe, effective, and inexpensive gene therapies be made available globally, including in low-resource settings where the cost and complexity of these therapies make them inaccessible to many.

In recent years, gene-based treatments have been groundbreaking for rare genetic disorders and infectious diseases, Trevor Mundel, MD, PhD, president of the global health program at the Bill & Melinda Gates Foundation said in a news release.

While these treatments are exciting, people in low- and middle-income countries do not have access to these breakthroughs. By working with the NIH and scientists across Africa, we aim to ensure these approaches will improve the lives of those most in need and bring the incredible promise of gene-based treatments to the world of public health, he added.

Hemoglobin is the protein in red blood cells that binds oxygen, allowing oxygen to be transported around the body. Mutations in the HBBgene, which encodes a component of hemoglobin, result in the formation of sickle hemoglobin that causes sickle cell anemia.

Currently, gene therapies for SCD involves altering the patients own hematopoietic stem cells (bone marrow cells that divide and specialize to produce blood cells including red blood cells). Genes are introduced into the cells using a modified, harmless virus (known as a viral vector). The cells are then transplanted back into the patient where they will produce healthy red blood cells. Gene therapy has an advantage over a bone marrow transplant, as it circumvents the complications associated with a bone marrow donation.

The first goal of the collaboration between the NIH and the Gates Foundation is to develop an easy-to-administer gene-based intervention to correct the mutations in the HBBgene or deliver a functional gene that will promote the production of normal levels of hemoglobin without the need to extract cells from patients and modify them in the lab before introducing the cells back. However, this strategy, known as in vivotreatment, requires the advancement of more efficient delivery systems that can deliver the gene therapy specifically to hematopoietic stem cells.

A second goal of the collaboration will be to work together with African partners and bring potential therapies to clinical trials.

Further research is required to understand the burden of SCD in sub-Saharan Africa and to screen newborns at high risk for the disease, a task that the National Heart, Lung and Blood Institute (NHLBI) has started to tackle by building the necessary infrastructure for clinical research.

The NIH and the Gates Foundation will help boost this infrastructure to allow point-of-care screening (for example, when infants receive vaccinations), and to initiate a standard of care. This will occur outside of the official collaboration.

Our excitement around this partnership rests not only in its ability to leverage the expertise in two organizations to reduce childhood mortality rates in low-resource countries, but to bring curative therapies for sickle cell disease and HIV to communities that have been severely burdened by these diseases for generations, said Gary H. Gibbons, MD, director of the NHLBI.

A persons health should not be limited by their geographic location, whether rural America or sub-Saharan Africa; harnessing the power of science is needed to transcend borders to improve health for all, he added.

Matshidiso Rebecca Moeti, the regional director for Africa at the World Health Organization said, We are losing too much of Africas future to sickle cell disease and HIV.

Beating these diseases will take new thinking and long-term commitment. Im very pleased to see the innovative collaboration announced today, which has a chance to help tackle two of Africas greatest public health challenges, Moeti added.

Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.

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Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Tcnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.

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Cell Harvesting Market Global Strategies and Insight driven transformation 2019-2024 – The Chicago Sentinel

By daniellenierenberg

Cell Harvesting MarketReport has newly added to its massive repository. Different industry-specific methods have been used for analyzing the market carefully. The informative data has been inspected through primary and secondary research techniques. The global Cell Harvesting market has been analyzed by focusing on different verticals of the businesses such as market trends, regional outlook, competitive landscape, key players, business approaches, technologies, and standard operating procedures.An exclusiveCell Harvesting Marketresearch report contains a brief on those trends which may enable the companies operating into know to strategize and the current sector to their small enterprise expansion. The investigation report analyses the market size, industry share, growth, key sections, CAGR, and drivers.

Top Companies in the GlobalCell HarvestingMarket:PerkinElmer (US), Brandel (US), TOMTEC (US), Pall Corporation (Danaher), Connectorate (Switzerland), Scinomix (US), ADSTEC (Japan), Sartorius, Terumo Corporation.

Cell harvesting usually for use in cancer or other treatment. Usually the cells are removed from the patients own bone marrow. Stem cells can be harvested from the blood or bone marrow. Umbilical cords have been saved as a future source of stem cells for the baby.

https://www.marketinsightsreports.com/reports/05161234118/global-cell-harvesting-market-size-status-and-forecast-2019-2025/inquiry?mode=46

The market engineering comprises the structured, systematic and theoretically founded procedure of analyzing, designing, introducing and also quality assuring of markets as well as their legal framework regarding simultaneously their market mechanisms and trading rules, systems, platforms and media, and their business models.

This report segments the globalCell HarvestingMarket on the basis ofTypesare:ManualAutomated

On The basis OfApplication,the GlobalCell HarvestingMarket is Segmented into:BiopharmaceuticalStem Cell Research

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Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), and market share and growth rate ofCell HarvestingMarketthese regions, from 2018 to 2025 (forecast), covering

North America,Europe,China,Japan, Southeast Asia, India, North America(USA, Canada and Mexico)Europe(Germany, France, UK, Russia and Italy)Asia-Pacific(China, Japan, Korea, India and Southeast

-Comprehensive assessment of all opportunities and risk in the market. Cell Harvesting market recent innovations and major events.-Detailed study of business strategies for growth of the market-leading players.-Conclusive study about the growth plot of Cell Harvesting market for forthcoming years.-In-depth understanding of market-particular drivers, constraints and major micro markets.-Favourable impression inside vital technological and market latest trends striking the market.

https://www.marketinsightsreports.com/reports/05161234118/global-cell-harvesting-market-size-status-and-forecast-2019-2025?mode=46

MarketInsightsReportsprovides syndicated market research on industry verticals including Healthcare, Information and Communication Technology (ICT), Technology and Media, Chemicals, Materials, Energy, Heavy Industry, etc.MarketInsightsReportsprovides global and regional market intelligence coverage, a 360-degree market view which includes statistical forecasts, competitive landscape, detailed segmentation, key trends, and strategic recommendations.

Irfan Tamboli (Head of Sales) Market Insights ReportsPhone: + 1704 266 3234 | +91-750-707-8687sales@marketinsightsreports.com|irfan@marketinsightsreports.com

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Cell Isolation Market ||Becton, Dickinson, and Company, Thermo Fisher Scientific, Inc., Merck KGaA – Industry News Info

By daniellenierenberg

Zion Market Research published a new 110+ pages industry researchCell Isolation Market by Product (Instruments and Consumables), by Cell Type (Animal and Human), by Cell Source (Adipose Tissue, Embryonic/Cord Blood Stem Cells, and Bone Marrow), by Technique (Surface Marker-Based Cell Isolation, Centrifugation-Based Cell Isolation, and Filtration-Based Cell Isolation), by Application (Cancer Research, Biomolecule Isolation, Tissue Regeneration & Regenerative Medicine, Stem Cell Research, In Vitro Diagnostics, and Others), and By End-User (Hospitals & Diagnostic Laboratories, Research Laboratories & Institutes, Biotechnology & Biopharmaceutical Companies, and Others): Global Industry Perspective, Comprehensive Analysis, and Forecast, 20182025.

TheGlobal Cell Isolation Market Is Expected To Reach Around USD 15.16 Billion By 2025complete outline is crystal clear penned down in the GlobalCell Isolation Marketresearch report such that not only an unskilled individual but also a professional can easily extrapolate the entire Cell Isolation Market within a few seconds.The research study covers research data which makes the document a handy resource for managers, analysts, industry experts, and other key people get ready-to-access and self-analyzed study along with TOC, graphs and tables to help understand the market size, share, trends, growth drivers and market opportunities and challenges.

Download FREE PDF Sample Brochure for more Industry Insights @CLICK HERE NOW

The Cell Isolation Market research report covers major industry player profiles that include:

Becton, Dickinson, and Company, Thermo Fisher Scientific, Inc., Merck KGaA, Beckman Coulter Inc., Terumo BCT, Bio-Rad Laboratories, Inc.

This report employs the SWOT analysis technique for the assessment of the development of the most remarkable market players. It additionally considers the latest upgrades while assessing the development of leading market players. Moreover, in the global Cell Isolation Market report, the key product categories of the global Cell Isolation Market are included. The report similarly demonstrates supportive data related to the dominant players in the market, for instance, product offerings, revenue, segmentation, and business synopsis. The global Cell Isolation Market is as well analyzed on the basis of numerous regions.

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Global Cell Isolation Market: Regional Analysis

To understand the competitive landscape in the market, an analysis of Porters five forces model for the market has also been included. The study encompasses a market attractiveness analysis, wherein all segments are benchmarked based on their market size, growth rate, and general attractiveness. This report is prepared using data sourced from in-house databases, secondary and primary research team of industry experts.

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The report answers important questions that companies may have when operating in the Global Cell Isolation Market. Some of the questions are given below:

What is the current CAGR of the Global Cell Isolation Market?

Which product is expected to show the highest market growth?

Which application is projected to gain a lions share of the Global Cell Isolation Market?

Which region is foretold to create the most number of opportunities in the Global Cell Isolation Market?

Will there be any changes in market competition during the forecast period?

Which are the top players currently operating in the global market?

How will the market situation change in the coming years?

What are the common business tactics adopted by players?

What is the growth outlook of the Global Cell Isolation Market?

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Restore your crowning glory with recombinant DNA tech – The New Paper

By daniellenierenberg

Hair care is being taken to the next level, by utilising recombinant DNA technology to restore one's confidence and crowning glory.

Such hair restoration products or treatments are made using recombinant DNA - or DNA cloning - where selected pieces of DNA from different organisms are combined to construct artificial DNA.

At Ageless Medi-Aesthetics, its latest AnteAge MD Hair Treatment is a non-invasive procedure that involves applying the AnteAge MD Hair Growth Factor solution or serum - made from potent recombinant growth factors and cytokines - onto skin prepared with microneedling.

Dr Lam Bee Lan, director of Ageless Medi-Aesthetics, told The New Paper: "Recombinant DNA technology is more efficient in producing large amounts of artificial messenger proteins effective for skin and hair renewal compared with stem cells derived from plants."

Methods of hair restoration are often divided into two broad categories - invasive techniques and topical and/or oral solutions. They can either be expensive or linked to side effects such as erectile dysfunction, ejaculatory dysfunction and loss of libido.

But Dr Lam cautioned that before treatments are prescribed, patients must consult with a physician to ascertain if they are suitable for them.

"Treatments based on recombinant DNA technology should be worked in as a first-line treatment when you start to experience more hair loss than usual, or as part of a regular routine in maintaining a full head of hair.

"For more severe hair loss, patients should consider a hair transplant," she said.

While there are minimal side effects such as occasional soreness and redness that will resolve within one to two hours, Dr Lam noted that most patients will experience slowing down of hair loss after the first session, while new hair will grow after the second session.

Home-grown scalp specialist PHS Hairscience has also explored stem cell technology and cell signalling technology since 2014 to treat hair loss or greying hair on the cellular level.

Ms Anita Wong, its chief executive and founder, told TNP: "As the body ages or changes due to reasons such as stress or lifestyle choices, cell functions can deteriorate, and cell activity that directly impacts new hair growth or melanin (hair pigment) production becomes less than optimal."

PHS Hairscience's marquee treatment, Miracle Stem Cell Solution, leverages on stem cell science and cell signalling to reactivate dormant follicle cells to promote hair growth. At $297 a session, it can be complemented with the FEM/HOM Thickening range of products.

She said: "These active botanical stem cells also work to increase the life span of hair follicles so your hair can remain in the anagen (growth) phase of the hair growth cycle for a longer period of time.

"Keeping the hair in this growth phase will maximise the length and thickness of new hair, as well as stop the existing strands from shedding."

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Delivering the promise of regenerative medicine – PMLiVE

By daniellenierenberg

The question remains unanswered as to whether a peer-to-peer collaborative model will prosper where medtech companies that are in some instances one step ahead of big pharma in terms of drug development are happy to be a third- party provider to big pharma that have the budgets and networks to truly deliver the regenerative medicine revolution.

In a recent document published by the UK government in response to the Regenerative Medicine Inquiry by the House of Commons Science and Technology Committee, policymakers stressed the importance of commercialising new therapies to meet the changing needs of the health sector.

In the UK, the Regenerative Medicine Expert Group (RMEG) has been tasked with developing an NHS regenerative medicine strategy to ensure the NHS is fully prepared to deliver innovative treatment and that regulations support and not hinder its delivery.

The Cell and Gene Therapy Catapult is also continuing to work to bridge the gap between translational research and commercialisation.

However, for the UK to be well-positioned to offer safe and effective regenerative therapies, a strategy is needed that covers the whole value chain from academic research, commercial development and clinical application.

The effect of Brexit on the UKs regenerative medicine sector remains unclear, but the UK has the opportunity to develop an independent framework outside the EU regulatory system to accelerate the development of new therapies and its economic potential while upholding the highest patient safety standards.

In any case, EU and UK regulators need to prioritise the standardisation of regulations governing manufacturing, quality control and the supply chain to keep up with advancements made by the FDA in the US.

Establishing an efficient supply chain for regenerative medicine

The promise of regenerative medicine requires an innovative look at the complete product life cycle, including the development of an efficient distribution network.

Once these novel drugs become mainstream, the entire healthcare ecosystem will have to adapt. Regulatory approval for any drug relies on it safely and successfully fulfilling its medical intent.

As such, information about supply chain management needs to be submitted to the regulator after the completion of phase 3 clinical trials, including packaging, labelling, storage and distribution.

The clinical supply chains required to deliver these therapies are arguably the most complex the industry has seen so far. Regenerative medicine is either personalised or matched to the donor-recipient. They are also highly sensitive to exogenous factors like time and temperature.

Advanced IT solutions and monitoring systems are being developed and employed to ensure end-to-end traceability. These are giving clinicians access to view the progress of therapies and their distribution in real-time and allow users to automatically schedule or amend material collections in line with manufacturing capacity, helping to keep the supply chain as agile as possible.

The live tissues and cells which form the basis of regenerative medicine products are highly sensitive and some have a shelf life of no more than a few hours.

Therefore, materials need to be transported from the site of harvest to manufacturing facilities, and from manufacturing facilities to medical institutions under strictly controlled conditions, within certain times and temperatures, according to cell and tissue requirements.

Temperature-controlled logistics solutions are vital to ensure a safe, effective and financially viable supply chain network for these high-value shipments. Cryopreservation is one technique increasingly being used to deliver medicines at optimum temperature using vapour phase nitrogen; however, many clinical settings remain ill-equipped to handle such equipment.

On-site production is an alternative manufacturing arrangement, particularly for autologous products which are derived from a patients own cells.

However, this throws up a number of compliance and infrastructure challenges, as the hospital would need to comply with a host of regulations including installing a Good Manufacturing Practice (GMP)-licensed clean room.

As a first-generation technology, stakeholders will have a greater tolerance for higher pricing... but only for a limited time period. By streamlining the currently very expensive manufacturing process and improving supply chain management, yields will automatically get larger and costs will slowly come down.

While there are many challenges in the road ahead, 2019 certainly appears to be the start of regenerative medicines move to the big time.

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Stem Cell Therapy Market Trends, Secondary Research With Geron Corporation, Vericel Corporation, Pluristem Therapeutics, Cytori Therapeutics, Fate…

By daniellenierenberg

Stem Cell Therapy Market research analysis and insights displayed in this report are very thoughtful for the businesses to make enhanced decisions, to build up better strategies about production, marketing, sales and promotion of a particular product. Stem Cell Therapy market report also takes into consideration several major factors such as revenue, cost, gross and gross margin while analysing market data. Various markets at local, regional and international level are thought of in this Stem Cell Therapy report. All this helps in extending their reach towards the success. The use of advanced tools and techniques applied for this report makes it the premium in the class. By understanding clients needs precisely, this report merges business and product information for the sustainable growth in the market. Geron Corporation, Vericel Corporation, Pluristem Therapeutics, Cytori Therapeutics, Fate Therapeutics are some players grooming the market.

Stem Cell Therapy Market is expected to reach USD 15.63 billion by 2025, from USD 7.72 billion in 2017 growing at a CAGR of 9.2% during the forecast period of 2018 to 2025. The Stem Cell Therapy market report contains data for historic year 2016, the base year of calculation is 2017 and the forecast period is 2018 to 2025 (Updated values listed in sample report).

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Stem cell therapy is the therapy which uses stem cells for the treatment or prevention of a disease. Bone marrow transplant is the widely applicable therapy which is followed by umbilical cord blood. Research is going on to develop various sources (such as cord blood cells, bone marrow and skin) to use these cells for treatment of various disorders like neurodegenerative diseases and conditions such as heart disease, diabetes and other conditions. Some of the major players operating in the global stem cell therapy market are

Others: ViaCyte, Inc, AbbVie, Mesoblast Ltd., Roslin Cells, Regeneus Ltd, ReNeuron Group plc,, International Stem Cell Corporation, Aastrom Biosciences, Inc., Advanced Cell Technology, Cryo Cell International, Cytori Therapeutics, Inc., Geron Corporation, and Invitrogen and others. The global stem cell therapy market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of the global stem cell therapy market for global, Europe, North America, Asia Pacific and South America.

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Major Market Drivers and Restraints:

Drivers:

Restraints:

Segmentation:

The global stem cell therapy market is segmented based on

Type

Product

Application

End Users

Geographical Segments

On the basis of type, the market is segmented into

Allogeneic stem cell therapy

Autologous stem cell therapy

The allogeneic stem cell therapy segment is expected lead the market because of commercialization of allogeneic stem cell therapy products and wide application with easy scale up process.

Based on products, the market is segmented into

Adult stem cells

Human embryonic stem cells

Induced pluripotent stem cells and others

The adult stem cells accounts highest share in market due to ability to generate trillions of specialized cells which may lower the risks of rejection and repair tissue damage.

Based on application, the market is segmented into

Musculoskeletal disorders

Wounds and injuries

Cardiovascular diseases

Surgeries

Gastrointestinal diseases, and other applications

The musculoskeletal disorders segment leads the market due to availability of stem cell-based products for the treatment of musculoskeletal disorders, high prevalence of musculoskeletal disorders and bone & joint diseases.

Based on end users, the market is segmented into

Therapeutic companies

Cell and tissues banks

Tools and reagent companies

Service companies

The growing number of stem cell donors, improved stem cell banking facilities and because of the research and development therapeutic companies held the largest share in stem cell therapy.

By Geography

North America (U.S., Canada, Mexico)

South America (Brazil, Argentina, Rest of South America)

Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Turkey, Belgium, Netherlands, Switzerland, Rest of Europe)

Asia-Pacific ( Japan, China, South Korea, India, Australia, Singapore, Thailand, Malaysia, Indonesia, Philippines, Rest of Asia Pacific)

Middle East & Africa (South Africa, Egypt, Saudi Arabia, United Arab Emirates, Israel, Rest of Middle East & Africa)

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Stem Cell Therapy Market Trends, Secondary Research With Geron Corporation, Vericel Corporation, Pluristem Therapeutics, Cytori Therapeutics, Fate...

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Thought Leadership & Innovation Foundation to Expand Its Regenerative Medicine Program Through New Collaboration with RenovaCare – Yahoo Finance

By daniellenierenberg

MCLEAN, Va.--(BUSINESS WIRE)--

The Thought Leadership & Innovation Foundation (TLI) announces today plans to build on its existing Regenerative Medicine Program through a research collaboration with cellular therapy industry leader RenovaCare. As part of TLIs efforts to conduct vital research in regenerative medicine and chronic disease, this initiative aims to innovate methods for reducing complications from burn and diabetic wounds across large populations.

Our research base, collaborative institutions and long history of innovation align with RenovaCares commitment to breakthrough biomedical technologies, says Bill Oldham, founder and chairman of the Board, TLI. The patented RenovaCare SkinGun technology and its ability to ultra-gently spray stem cells could present a special opportunity for investigations and applications in a wide range of regenerative therapies. Working together, our overall goal is to improve the quality, efficiency and effectiveness of patient care by not only developing new treatment methods, but also by making thoughtful and systematic changes to healthcare and health systems.

TLIs Regenerative Medicine program seeks to adapt new strategies based upon sound scientific evidence, utilizing its infrastructure to support the continuation of scientific and medical work, as well as the development of grant-funded research and other initiatives.

Dr. Robin A. Robinson, who is a TLI Fellow, Vice President of Scientific Affairs, RenovaCare, and named one of the top 100 innovators in medicine by Medicine Maker in 2018, states, This exciting collaboration between RenovaCare and TLIs Regenerative Medicine Program is the first step toward the development of meaningful and quality therapeutic treatments that will benefit patients around the world.

About TLI Foundation:

TLI Foundation is a nonprofit foundation focused on driving innovative thinking and action on global issues relating to health, education and economic empowerment. The organization is committed to fostering transformative change and improving the health and well-being outcomes of communities around the world. Visit https://www.thoughtfoundation.org/

About RenovaCare:

RenovaCare, Inc. is a biotechnology company focused on developing first-of-their-kind autologous (self-donated) stem cell therapies for the regeneration of human organs. Initial products under development target the bodys largest organ, the skin. Investigative clinical use of their flagship technology has shown to be promising new alternatives for patients suffering from burns, and chronic and acute wounds. https://www.renovacareinc.com.

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Thought Leadership & Innovation Foundation to Expand Its Regenerative Medicine Program Through New Collaboration with RenovaCare - Yahoo Finance

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Neural Stem Cell Transplantation Crawls Toward the Clinic – The Scientist

By daniellenierenberg

Pelizaeus-Merzbacher disease is a genetic malady that leaves neurons without their myelin coating. This deficit has devastating consequences for the boysits X-linkedwho have it. These children have severe developmental delay, so they have inability to walk, inability to talk and perform self-care, says Nalin Gupta, a professor of neurological surgery and pediatrics at the University of California, San Francisco (UCSF). Their neurologic function typically does not improve, and usually they actually die during childhood.

About a decade ago, the biotech firm StemCells Inc. was looking for a neurosurgeon to try out an intervention that might finally offer some help for these children. Because Gupta had experience conducting surgical clinical trials in kids with disabilities, the company approached him to see if he could transplant neural stem cells into the brains of boys with Pelizaeus-Merzbacher disease (PMD)an approach that researchers had considered promising for a range of conditions, but which had yet to be proven effective in a clinical trial for any disease. He agreed.

In 2012, Gupta and colleagues reported that four boys with PMD who had received pluripotent neural stem cells in a Phase 1 clinical trial tolerated the procedure, and imaging techniques that indirectly detect myelin indicated they may have had myelination in their brains one year following the transplant. This August, the researchers reported the results of a long-term follow-up study of those patientsall four are still alive at ages 10, 11, 12, and 13. Patients like these who have symptoms of the disease starting at birth typically die in their teens.

Although the researchers could not directly examine myelinationthat would require autopsiesthe imaging evidence is promising. There were some clinical improvements, too, although with such a small number of patients and no control group in a trial designed to examine safety, its hard to know whether they are attributable to the transplant.

We dont actually have a product that we can use even if we wanted to do a Phase 2 study in this disease.

Nalin Gupta, UCSF

Guptas study is the latest report in a series of clinical trials on neural stem cell transplantation, in which pluripotent neural cells taken, in most cases, from the brains of aborted fetuses are expanded in the lab and then injected into the brains or spinal cords of patients with incurable neurological disorders. These include stroke, multiple sclerosis, ALS, spinal injury, and Parkinsons disease. But for all the effort that has gone in to testing these cells, none have been able to work themselves out of trials and into clinical practice.

When asked which of the human clinical trials have been most successful, Steven Goldman, a professor of neurology and neuroscience at the University of Rochester, replies, So far, none of them, right? To date, no Phase 2 trial to evaluate the efficacy of a neural stem cell treatment has been completed, he points out. And scientists, Gupta included, are less-than-ecstatic about the methods and outcomes of the clinical trials that have been done so far.

Goldman, who was not involved in the PMD experiment, calls it by far the most rigorous and well controlled. But that trial can go no further.

Gupta says he and his colleagues felt that there was sufficient evidence from the Phase 1 trial to justify a Phase 2. They cant proceed, however, because StemCells, the company that funded the research and provided the cells, closed in 2016. We dont actually have a product that we can use even if we wanted to do a Phase 2 study in this disease, he says.

Research on other potential uses for neural stem cells are also affected by a lack of momentum. Theres somewhat of a pause in what people are doing in terms of stem cell therapeutics, says Gupta. Treatments for conditions such as spinal cord injury and stroke hold the most interest for their potential societal benefit, he says, but the complexity of the changes that occur when the brain or spinal cord are injuredmeaning regions composed of multiple cell types and networks of connections are just wiped outmake for a challenging repair. Were probably a long way from being able to transplant a structure that will recapitulate the three-dimensional organization and structure of the brain and spinal cord, he says. Trials for diseases with more specific defects might be more successful, he adds, such as multiple sclerosis, which like PMD involves demyelination.

According to Evan Snyder, the director of the Center for Stem Cells and Regenerative Medicine at the Sanford Burnam Prebys Medical Discovery Institute in La Jolla, California, there havent been enough trials, and certainly not enough under ideal circumstances, to know whether neural stem cell transplantation can be an effective treatment in humans. I think the field is too young to know right now if theyre effective. I think the field can just say that theyre safe, says Snyder. To be able to know whether the cells are effective, you really need to be able to put them into an optimal setting where their mechanism of action is optimal, and that kind of trial has never been done yet, he adds.

The animal research that laid the foundation for the PMD study, and other studies on diseases involving the loss or absence of myelination, took place in a mouse model called shiverer. These animals have a mutation that prevents their oligodendrocytes from making myelin, such that their neurons are badly insulated and cannot efficiently conduct electrical signals. The shiverer mice have problems with motor functions and self-care along with seizures. They also have a tremor, hence their name.

In 1999, Snyders lab reported in PNAS that injecting mouse neural stem cells into the brains of shiverer mice led to the remyelination of neurons as well as some tremor reductionmeasured by dipping each mouses tail in ink and noting the size of the stain it left on a piece of graph paper.

Using the model, Goldmans team later transplanted human glial progenitor cellswhich are derived from neural stem cellsinto shiverer mice, generating chimeras in which mouse neurons became insulated with human myelin. The chimeric mice, as Goldman reported in Cell Stem Cell in 2008, survived longer and had improved neurological phenotypes, including fewer seizures, compared with untreated controls. In 2012, StemCells Inc., in collaboration with researchers at Oregon Health & Science University and elsewhere, reported in Science Translational Medicine that transplanting shiverer mice with human neural stem cells resulted in remyelination in the brain. Also in that issue, Gupta and StemCells described the one-year results from the PMD trial, which used the same cells for transplantation.

Neurons (green) and glia (red) differentiated from human neural stem cells in culture. Nuclei are stained blue.

Evan Snyder

The PMD study was not the first trial launched by StemCells Inc. In 2006, the company launched a Phase 1 trial of neural stem cell transplantation in children with Batten disease, a fatal condition in which children are missing a lysosomal storage enzyme. That study was the first study authorized by the FDA for transplantation with neural stem cells into the brain, says Stephen Huhn, a biotech consultant and the former chief medical officer of the company.

The trial, which was completed in 2009, revealed the treatment to be safe, the authors reported in Journal of Neurosurgery: Pediatrics. Autopies on the brains of several kids who died of the disease during the study suggested that in some patients donor cells had both survived and migrated away from the subcortical and ventricular injection sites and into the basal ganglia, among other locations, Huhn says.

The fact that we saw even glimmers of an effect was for us very promising that cellular therapy could well have a place in the treatment of some neurological disorders.

Stephen Huhn, formerly of StemCells Inc.

The stem cells used for this and other StemCells trials were isolated from the brain of a single aborted fetus, expanded as balls of cells called neurospheres, and frozen for later use. Before injection into patients, the cells were thawed, cultured for two weeks, and dissociated, so that what was injected was no longer a neurosphere but a cluster of cells, according to Huhn. Because the neural stem cells were donor-derived, patients were given immunosuppressant drugs for several months following the transplant to prevent rejection.

Using the same procedure and stock of cells, Gupta and colleagues transplanted neural stem cells into the brains of the four boys with PMD in a Phase 1 trial that began in 2009 and ran through 2012the same trial whose long-term follow-up results came out this summer. One year after transplantation, diffusion tensor imagingan MRI-based technique that lets researchers indirectly observe myelinated axonsof the boys brains suggested that myelination had occurred.

From 2012 to 2015, the company ran a Phase 1/2 trial of neural stem cell transplantation for age-related macular degeneration. The treatment proved safe, and there was also evidence of a treatment effecta slowing of the retinal damage called geographic atrophy and improvements in visual functionin some patients, says Huhn.

At the same time, the firm was engaged in a Phase 1/2 trial of stem cell transplantation for patients with injuries to the thoracic region of the spine. The treatment proved safe, and Huhn notes that several participants seemed to have sensory improvement below the level of injury, which would imply that the stem cells were having a treatment effect.

But the companys run of auspicious results did not last forever: Its Phase 2 trial of neural stem cells to treat cervical spinal cord injury, which began in 2014, terminated two years later after an independent review of the emerging data found that the study was unlikely to show a statistically significant treatment effect, Huhn says. For that same reason, a follow-up study on the same patients also ended in 2016, he adds.

At that point, StemCells Inc. shut down. STAT reported that the reason was disappointing results from the spinal cord study.

Despite stopping, the companys work was not in vain, says Huhn, as it demonstrated that the approach is safe and might be worth pursuing. These are challenging disorders, Huhn says, adding that the fact that we saw even glimmers of an effect was for us very promising that cellular therapy could well have a place in the treatment of some neurological disorders.

According to Snyder, who was not involved in the work, the PMD trial suffered from the limitations of the clinical trials system. The unfortunate thing is the way clinical trials are designed, you only get a patient who has failed every other intervention, is very deep into the disease, and almost has no chance of anything changing the course, he says. This problem is not unique to the PMD trial but applies to all neural stem cell clinical trials to date, Snyder says. In the Batten disease trial, for instance, the patients had little hope of recovery, Snyder notes. Three of the six participants had died of their disease by the time the researchers stopped collecting data. Where stem cells are going to be most useful, ultimately, is going to be the early stages of a disease where there are regions that can be rescued, and where the cells are placed in a position where they can distribute themselves throughout the region that needs to be fixed. And no clinical trial has ever met those [criteria].

Although the follow-up PMD study revealed some myelination, there was not a lot of it, notes Goldman, who was not involved in the work. Theres some evidence for local remyelination around the region of the transplants, but there was nothing that was dispersed or broad, and these patients need really widespread remyelination, he says.

Goldman says he believes that there was not more widespread and robust myelination in the PMD patients because of the cell type used. While neural stem cells can give rise to oligodendrocytes, astrocytes, and neurons, they not very efficient at making oligodendrocytes, he says. And, he adds, they do not migrate much, which is necessary for them to have widespread effects. In contrast, human glial progenitor cells, which are produced from neural stem cells and give rise to both oligodendrocytes and astrocytes, are more migratory, says Goldman, and for this reason, the field has shifted away from neural stem cells and toward glial progenitor cells for transplantation. Goldman has trials of his own in the works using a neural stem cell derivative to treat multiple sclerosis and PMD through a company he cofounded, Oscine Therapeutics.

Other trials are currently underway. Researchers at Emory University and the University of Michigan, with funding from the company Neuralstem, have completed a Phase 1 study of neural stem cells to treat ALS and, according to ClinicalTrials.gov, a Phase 2 clinical trial is ongoing. Theres a Phase 2/3 trial of nasally delivered neural stem cells to treat Parkinsons disease enrolling in China. And theres an active Phase 1 trial for Parkinsons disease in Australia using human parthenogenetic neural stem cells derived from unfertilized eggs, rather than fetal tissue.

This year, Snyder received a California Institute for Regenerative Medicine (CIRM) grant to do work leading up to cell-based therapies for babies who are at risk for developing cerebral palsy due to perinatal asphyxia, or oxygen and blood deprivation in the womb, he says. Within the first few days of life, the researchers plan to do brain imaging to identify babies with regions of the brain where cells are injured but not dead, he says, then transplant neural stem cells. The injurys still very fresh and cells are sort of teetering on a knife edge. They can either go on to die or they can go on to live, and the [transplanted] stem cells make factors that push them in the direction to live, Snyder says. If that happens, the prediction is the babies will do much better.

Theres only a short window, when cells are damaged but not dead, during which a neural stem cell transplant can work, he adds. Other trials in older patients with more advanced disease, he suggests, may have missed their optimal treatment windows. Snyder predicts that if the right patients are transplanted with the right neural stem cells at the right time, I think then, under those circumstances, now youre going to start seeing not just safety but real efficacy.

Ashley P. Taylor is a New Yorkbased freelance reporter. Follow her on Twitter@crenshawseedsand read her work atashleyptaylor.com.

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