Category Archives: Stem Cell Clinic

Hiltzik: The battle against unlicensed stem cell clinics – Los Angeles Times

In 2017, the Food and Drug Administration closed a loophole exploited by clinics pitching unproven, ineffective and potentially hazardous stem cell therapies directly to consumers.

Those treatments were illegal, the FDA ruled. That was the good news. The agency, however, suspended its enforcement for three years to give these operators time to get right with its regulations. During the pandemic, the FDA added six months to the deadline, so its period of regulatory forbearance expired on May 31.

What happened in the meantime? Instead of stem cell purveyors reaching out to the FDA to work out how to meet federal regulations, a torrent of shady operations poured into the field so many that the task of protecting the public from them may now exceed the FDAs capabilities.

Dont believe the hype.

The FDAs warnings against unlicensed stem cell clinics

Thats the concern of Leigh Turner, a public health expert at UC Irvine, longtime critic of stem cell treatment claims and author of a new study that tracked the explosion of businesses offering purported stem cell treatments and cures during the FDAs hands-off period.

The paper is essentially a follow-up to a seminal study Turner conducted with Paul Knoepfler of UC Davis in 2016, which identified 351 businesses hawking stem cell treatments directly to consumers through 540 clinics.

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Turners new study, which was published Thursday in the peer-reviewed journal Cell Stem Cell, identified 1,480 businesses operating 2,754 clinics nationwide.

That hardly seems like progress, Turner told me. Now the problem the FDA faces is four times larger than what existed in 2016. The FDA only has so many employees and so many inspectors. They dont really have enough inspectors to send them to 1,480 businesses.

The FDA hasnt been entirely inactive. Over the last 3 years it issued more than 400 warning letters to stem cell marketers, clinics and healthcare providers, notifying them that they may be operating outside the law. But it hasnt done much more than that.

The proliferation of stem cell claims points to a major breakdown in Americas healthcare regulatory system generally.

Given the size of this clinic industry the risk to the public is huge, Knoepfler says. The industry threatens the authority of the FDA itself. It might be one of the largest and most serious noncompliance challenges that the FDA has ever faced in its history. What would the FDA do if pharmaceutical firms were selling unapproved drugs at 2,700 clinics all over the country? It would be considered a national emergency.

State medical boards, which have at least nominal authority to ride herd on the practices of licensed physicians in this field, have done little of note. The Medical Board of California, a state that with 347 clinics is the largest center of facilities in Turners database, created a two-member Stem Cell and Regenerative Therapy Task Force in 2018.

The task force hasnt met since 2019, according to a board spokesman, and hasnt issued any reports. Board records indicate that it received 33 complaints about stem cell treatments from 2018 through this year, and has taken no disciplinary or administrative actions in response.

California hasnt done much to rise to the challenge, Turner says.

A few words may be useful about the regulatory environment. The chief targets of the FDAs enforcement program, such as it is, have been clinics that extract fat cells from customers through liposuction and then supposedly extract stem cells from the fat and inject them back into the customers bodies as treatments. Some purportedly extract stem cells from customers bone marrow.

The conditions for which these treatments are commonly offered include pain, sports injuries, heart and lung disease, multiple sclerosis, Parkinsons, Alzheimers, autism, diabetes, vision loss and erectile dysfunction.

No scientifically validated evidence exists for any of these claims, the FDA notes. The only stem cell products approved by the FDA are a few derived from umbilical cord blood, and then only for a very limited category of blood system diseases.

Beyond that, the agency advises consumers, Dont believe the hype.

The purveyors of unproven and unlicensed treatments identified by Turner charge as much as $28,000 for their services, with an average of more than $5,000 often ponied up by unwary customers seduced by advertising and irresponsibly credulous reports in the press.

The treatments typically are not covered by insurance, so customers are paying out of pocket.

Under FDA regulations, most stem cell treatments being sold to customers are illegal. Thats because the products are deemed to be unlicensed drugs. Exceptions exist for some surgical procedures and in cases in which almost identical cells are reinjected into patients, but the FDA says few of the targeted clinics qualify.

The FDAs position was endorsed by a federal judge in Miami in 2019, when she shut down a clinic that the FDA had sued for offering unapproved stem cell procedures. The clinic lost an appeal of her ruling in June. A separate lawsuit the FDA filed against California Stem Cell Treatment Center and associated businesses is awaiting a verdict from U.S. Judge Jesus G. Bernal in Riverside following a trial he conducted in May.

The offered treatments are not only unproven, but potentially hazardous. Reports of adverse outcomes from unlicensed treatments have proliferated, some of them gruesome. In a report issued in June, researchers at the Pew Charitable Trusts documented reports of adverse outcomes from 360 patients between 2004 and mid-2020.

These figures are almost certainly conservative, as clinics operating outside the law are highly unlikely to follow rules mandating that they report adverse reactions among their customers. Indeed, the FDA in its lawsuit against the California defendants asserted that numerous adverse outcomes experienced by their patients were not reported to the agency.

A note cited by the FDA from the file of one patient who was unable to walk for six months after receiving a stem cell injection in her knee from a clinic associated with the defendants, read, Not all treatments are successful. Not really adverse event due to the treatment. At trial, defendant Mark Berman said the clinics product has had very rare adverse events.

FDA officials have said that their expectations that stem cell treatment purveyors would engage with the agency during the forbearance period to work out how to come into compliance with its regulations proved wildly optimistic. We have been very disappointed in the number of clinics that have come in, Wilson Bryan, a top FDA official, told a law conference in June.

The FDA may not have recognized that the clinics they were targeting never had any intention of meeting its regulations.

Were talking about a huge number of businesses that are failing to comply with federal law, but have no reasonable prospects of coming into compliance, Turner says. They dont have clinical research programs. They dont have qualified stem cell researchers. Theyre just peddlers putting out a shingle on the internet.

Instead of using that three-year period to change their practices and comply with the law, lots of businesses stayed in the marketplace and did nothing to change what they were doing, and a huge number of other operators poured into the marketplace.

Over the last five years or so, or since Turner and Knoepfler published their original report, stem cell treatment claims have become just one more offering by practitioners advertising other services of dubious effectiveness.

Stem cell treatment has become just a routine claim, Turner says, from all kinds of orthopedic clinics, sports medicine clinics, podiatrists, chiropractors, naturopaths, wellness clinics. They market an array of services and stem cells are just something else they can sell, like cryotherapy or acupuncture.

Its unclear whether some of these operations really even use stem cells some may be offering just costly placebos, Turner conjectures.

The threat to public health from unlicensed and unproven stem cell claims will only get worse if the FDA fails to act forcefully.

People make the mistake of thinking that these are businesses that will go under if they get a bit of a push from the FDA or FTC [Federal Trade Commission] Turner says. The truth is that some of them are quite well capitalized and have the resources to go out and join these battles.

The FDA may be waiting for Judge Bernals ruling before taking the next step but thats dependent on his finding in the FDAs favor. It could seek mass injunctions, admittedly a big practical challenge, Knoepfler says. He adds, Looking ahead, the agency should take quick, large-scale, and even creative actions if it has any hope to make a dent in this clinic industry.

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Hiltzik: The battle against unlicensed stem cell clinics - Los Angeles Times

Cell therapy biotech PlateletBio reels in $75M as it looks ahead to first clinical test – MedCity News

PlateletBio, a company developing a new class of cell therapies based on the biology of platelets, has raised $75.5 million to advance its drug pipeline, including a lead candidate for a rare bleeding disorder on track to reach the clinic next year.

Platelets are components of blood best known for their role forming clots that stop bleeding. But Watertown, Massachusetts-based PlateletBio notes that platelets have other properties, including a role delivering growth factors and proteins throughout the body. PlateletBio is developing therapies that take advantage of these properties, but rather than using platelets from a patient or healthy donors, the startup makes them.

In the body, platelets are formed in bone marrow. PlateletBio produces its platelet-like cells, or PLCs, inside a bioreactor that mimics bone marrow conditions. The source material for its PLCs are stem cells, which have the ability to become almost any cell or tissue in the body.

Platelets are technically not cells. They dont have a nucleus, but thats an advantage for therapeutic applications. Since a PlateletBio therapy wont introduce DNA into a patients body, the potential risks that come from introducing foreign genetic material are avoided. PlateletBio says it can produce PLCs with new features and therapeutic payloads that include antibodies, signaling proteins, therapeutic proteins, and nucleic acids.

PlateletBios lead cell therapy candidate is being developed to treat immune thrombocytopenia, a blood disorder in which the immune system mistakenly sees a patients platelets as foreign and destroys them. Immune thrombocytopenia patients have dangerously low platelet counts that make them susceptible to bleeding.

There is no FDA-approved treatment for the underlying cause of immune thrombocytopenia, but corticosteroids are used to try to dampen the immune systems attack on platelets. Platelet transfusions are another option, but the National Organization for Rare Disorders notes that these treatments are usually reserved for emergencies because the platelets are likely to be destroyed by antibodies produced by the patient.

Patients who have not responded to earlier treatments have two FDA-approved small molecule options: Tavalisse, from Rigel Pharmaceuticals, and the Swedish Orphan Biovitrum drug Doptelet. Sanofi aims to treat the disease with a small molecule called rilzabrutinib. That drug is designed to block Brutons tyrosine kinase, a protein that plays a role in the development of a B cells, a type of immune cell. Sanofi acquired the molecule last year via its $3.7 billion acquisition of Principia Biopharma.

The lead disease target for the Principia drug was multiple sclerosis. In September, Sanofi reported that rilzabrutinib failed that Phase 3 study. A separate Phase 3 test in immune thrombocytopenia is ongoing, as is a mid-stage clinical trial in another autoimmune condition called IgG4-related disease.

PlateletBio isnt the only company trying to turn a component of the blood into a new type of cell therapy. Cambridge, Massachusetts-based Rubius Therapeutics is developing cell therapies based on red blood cells. After disappointing early clinical trial results in the rare disease phenylketonuria last year, Rubius shifted its focus to cancer and immune system disorders. PlateletBios PLCs would represent an entirely new approach to treating immune thrombocytopenia. According to PlateletBios website, the company plans to file an investigational new drug application for its therapeutic candidate in the first half of next year.

PlateletBio is based on the research of Harvard University scientist Joseph Italiano, who co-founded the company under the name Platelet BioGenesis. When the startup emerged in 2017, it was developing platelets that could address the platelet shortage problem facing blood donation centers. Two years ago, the startup expanded its Series A round with $26 million in additional financing and plans to make its platelets into cell therapies. Besides immune thrombocytopenia, other diseases the biotech aims to treat include osteoarthritis and liver fibrosis.

PlateletBios latest financing, a Series B round, adds new investors SymBiosis, K2 HealthVentures, and Oxford Finance. Earlier investors Ziff Capital Partners and Qiming Venture Partners also participated in the new round.

This is a major milestone for PlateletBio, adding capital and resources needed to advance our innovative platelet-like cell therapy science and manufacturing platform and support key corporate initiatives over the next 18 to 24 months, Sam Rasty, the startups president and CEO, said in a prepared statement.

Photo by Flickr user Marco Verch via a Creative Commons license

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Cell therapy biotech PlateletBio reels in $75M as it looks ahead to first clinical test - MedCity News

VDH: Cases surge again to third-worst on record – Vermont Biz

Vermont Business MagazineThe Vermont Department of Healthis reporting today that COVID-19 cases surged again to 376 cases, the third highest on record. This was an increase of 114 from Saturday.Cases Friday were377 and there were 487 cases on Thursday, which was the all-time record. The 12worst days have all come since mid-September, following fromthe Delta variant surge that began in July. There were no additional COVID-related death, which stand at384 statewide.

Based on record high cases this past week, Governor Phil Scott issued a statement Thursday afternoon urging Vermonters to get vaccinated. He said in part, "The simple fact is, this pandemic is being driven by the unvaccinated, including 53,000 eligible adults. The three lowest vaccinated counties account for 25% of todays cases, yet they only make up 10% of our state population. Unvaccinated Vermonters are up to 5 times as likely to contract COVID in Vermont and they account for 70-85% of our hospitalizations and ICU stays. Unvaccinated adults are directly contributing to the strain on our hospital capacity. Enough is enough, its time to step up and get vaccinated something over 90% of your fellow Vermont adults have done."

Cases have been especially high in the Northeast Kingdom, which has had elevated case rates in recent weeks. Chittenden County had the most cases with 83 and Washington County had51.

Meanwhile, the CDC gave final approval late Tuesday for Pfizer vaccines for children 5-11 and parents could start signing up their kids starting Wednesday morning (for vaccine information or to registerCLICK HERE). Shots for 5-11 are available starting Friday at some state clinics and as early as Sunday at some pharmacies.

There are about 44,000 kids in the 5-11 age band in Vermont. Human Services Secretary Mike Smith said there will be plenty of first and second doses available for all who sign up. The doses are a third of the strength of the adult dose and like the adult Pfizer regimen will require a followup shot for full immunity.

See locations of vaccine clinics and case dashboards below.

There are 45 people hospitalized (up thrtee) with 12in the ICU (downtwo).Hospitalizations are high but have been stable.

Recent fatalities have all been amongVermonters 50 and older, with most in the oldest age band, which has been the case since the beginning of the pandemic.

There were 39 COVID-related deaths in Vermont in October, which is the third-worst month on record. There are nine so far in November.

The 11 worst days for cases have all come since mid-September,as the Delta variant has taken oversince early July.

Financial Regulation Commissioner Michael Pieciak said both the case counts and fatalities have not shown dramatic reductions, as they have in other parts of the nation, particularly the South, or even in southern New England.

While the health experts do not understand exactly why this is, given Vermont's high vaccination rate, Pieciak said the three Northern New England states are all showing a similar pattern.

In addition, Health Commissioner Mark Levine, MD, continues to urge Vermontersto get their booster dose, especially if they're over 65. The immunity appears to wane over time and older Vermonters and those immunocompromised were among the first vaccinated last winter.

The elderly have been especially vulnerable to COVID, with the vast majority of fatalities coming among those 80 and over (206total deaths, while having by far the fewest number of infections for any age band.). One death Saturday for 80+.

Thestate announced last Thursday nightthat boosters for Moderna (like already approved Pfizer, six months after second dose) and Johnson & Johnson (two months after first dose)would begin immediately. The CDC is also allowing people to change/ mix and match vaccines.

TheFDA Tuesdayapproved the low-dose Pfizer vaccine for children5-11. Human Services Secretary Mike Smith said if the CDC approves it tonight then the state will allow parents to sign up their kids as early as 8 am tomorrow morning with doses being available as early as Thursday.

He said that in addition to the usual vaccination clinics, the state will also be bringing the vaccine directly to 112 schools around the state, especially to those in outlying areas where transportation or fewer pharmacies could make it more difficult for kids to get their shots.

Dr Rebecca Bell, President, Vermont Chapter of the American Academy of Pediatrics, at the governor's press conference Tuesday, sought to alleviate parents' fears.

She said the efficacy of this lower dose children's vaccine is still 91 percent. And unlike with adults, children in the control group did not show any of the flu-like symptoms that some adults have experienced.

Parents should also take comfort that a vaccinated child would no longer have to quarantine if they were a close contact to someone that tested positive. This issue has kept many kids out of school even though they never contracted COVID.

The Northeast Kingdom has the highest case rate of any region of the state, with Orleans County having the highest county rate, with over 1,000 cases per 10,000 residents. Bennington has the second highest rate with over 900 per 10,000.

Smith said the state will reinstitutepop up vaccination sitesin the NEK to increase vaccination rates, which are the lowest in the state. See list of upcoming NEK clinicsHEREand see below for statewide list of clinics.

COVID cases reported today were high in southern Vermont, with Bennington County alone reporting 34 and Rutland County 24.

But with all three boosters now available, vaccines for kids available and cases apparently declining, Governor Scott said Tuesday,"I'm more hopeful today than I have been in weeks."

Education Secretary Dan French announced Tuesday that the state was once again delaying the roll out of the 80 percent rule for ending school mask mandates. It will not happen go into effect until January 18, 2022, when students return to school after the Martin Luther King Holiday break.

The governor and his staff reiterated that these are recommendations only, because there is no State of Emergency, not mandates. The local school districts, like local businesses and individuals, must make their own rules.

As the Delta variantcontinues to be active in Vermont, Governor Scottiscalling on all Vermonters to act responsibly.

The new school guidance reads:

"To allow school districts time to calculate the percentage of currently eligible students who have received two doses of a two-dose vaccine, schools should require universal masking for all students and staff when indoors until January 18, 2022.

"Currently, all Vermonters ages 12 and older are eligible to be vaccinated.

"After January 18, 2022, masks should no longer be required for all those eligible for vaccination when the vaccination rate (two doses of a two-dose vaccine) among students is equal to or greater than 80% of the schools currently eligible population.

"Masks should be required indoors for students younger than 12, who are not eligible to be vaccinated at this time.

"Masks, when required, may be removed when needed for instructional or operational purposes.

"Masks are currently required for all passengers on buses per federal regulation, regardless of age or vaccination status.

"Masks should not be required outdoors. Guidance will be updated when vaccine eligibility expands."

The state also released school sports guidance Tuesday.

See Vaccination & COVID-19 Dashboards & Vaccination Sites TableBelow

Addison County

New Cases:5

Recent Cases 14 days:91

Bennington County

New Cases:20

Recent Cases 14 days:352

Caledonia County

New Cases:30

Recent Cases 14 days:204

Chittenden County

New Cases:83

Recent Cases 14 days:651

Essex County

New Cases:8

Recent Cases 14 days:90

Franklin County

New Cases:48

Recent Cases 14 days:301

Grand Isle County

New Cases:2

Recent Cases 14 days:26

Lamoille County

New Cases:15

Recent Cases 14 days:134

Orange County

New Cases:14

Recent Cases 14 days:169

Orleans County

New Cases:42

Recent Cases 14 days:334

Pending Validation

New Cases:4

Recent Cases 14 days:6

Rutland County

New Cases:15

Recent Cases 14 days:412

Washington County

New Cases:51

Recent Cases 14 days:283

Windham County

New Cases:6

Recent Cases 14 days:176

Windsor County

New Cases:33

Recent Cases 14 days:261

Most cases in Vermont are in the younger age groups with the 20-29 reporting the most, with nearly 7,300 total cases out of 37,100+, but only one death. The over 79 demographic has the fewest cases (just over 1,200) but by far the most fatalities with 188, or more than half the state total.

Financial Commissioner Michael Pieciak said Tuesday (SEE HIS FULL SLIDE DECK HERE) cases across the nation are falling fast and that the seven-day and 14-day averages in Vermont and the Northeast also are falling but at a slower rate. Vermont's seven-day infection rate is down15 percent. For the 14-day average, while overall it is down 2 percent for those who are fully vaccinated, it's up 9percent for those who are not fully vaccinated (which includes the unvaccinated).

Cases in high vaccination regions of the country are not displaying the typical Delta variant pattern, as in India, of a spike followed by a steep drop off after a couple months.

In Vermont, Delta has shown slow growth and a long plateau. Health Commission Mark Levine suggested that the drop off here could be another couple of weeks off, but he frankly was not sure.

He and Governor Scott and Human Services Secretary Mike Smith all urged that everyone who is eligible to get a vaccine to get one now, to get a booster now and to wear a mask while at an indoor gathering.

Governor Scott said the data shows that virus transmission with Delta is occurring at things like weddings and baby showers and birthday parties, sort of small and medium events where people are gathered for a period of time. It is not happening while visiting a convenience store or other type place where you are in an out, he said. Nor is it happening at outdoor gathering events.

Pieciak,in his COVID-19 Modeling presentation, said deaths seem to have slowed down a little as Delta has taken its toll. There have been 23 in October so far (as of the 21st)

Still, September was the second worst month for COVID-related deaths in Vermont since the beginning of the pandemic, with 45.

December 2020 was the worst with 71 and April 2020 was third worst with 35.

Meanwhile, the state is ramping up antigen testing in schools to keep kids in school who otherwise would be sent home if there were a close contact of someone who tests positive. Children now have a higher rate of infection than adults.

Governor Scott and state officials are urging all those who are eligible now to get vaccinated or get a booster shot, to do so, in order to reduce community transmission of the novel coronavirus (see clinic sites below).

As of October 1, many more Vermonters can now schedule and receive their Pfizer vaccine booster shots. He said there is plenty of vaccine supply.

We know vaccines are safe and effective, and these additional doses add even more protection. So, I encourage anyone who is eligible to register for your booster today, said Governor Scott. At the same time, we continue to urge those who have not yet gotten their first dose to get vaccinated. The data shows we are now in a pandemic of the unvaccinated, and vaccines are the best way to protect yourself, friends and family, and to make sure we continue moving forward from the pandemic.

Governor Scott said that the state will take a very broad interpretation of eligibility.

"We've reflected on this," Scott said. "We'regoing to be quitelenientin terms of whoshould beincluded and if they'd like tohave a booster we'd like to find a wayfor them to have it. So Iexpect that number is substantiallyhigherat this point. So our interpretation ofthis will be,again, quite broad."

Addition of Rapid Testing Tools Will Help Keep More Kids in School

When a student or staff member with COVID-19 is present in school during their infectious period, the school may implement Test to Stay for unvaccinated close contacts.

Unvaccinated, asymptomatic students (ages 5 and up) and staffwho areclosecontacts of a positiveCOVID-19case.

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VDH: Cases surge again to third-worst on record - Vermont Biz

Blood and bone marrow stem cell donation – Mayo Clinic

Overview

If you are planning to donate stem cells, you have agreed to allow doctors to draw bone marrow stem cells from either your blood or bone marrow for transplantation.

There are two broad types of stem cells: embryonic and bone marrow stem cells. Embryonic stem cells are studied in therapeutic cloning and other types of research. Bone marrow stem cells are formed and mature in the bone marrow and are then released into the bloodstream. This type of stem cell is used in the treatment of cancers.

In the past, surgery to draw bone marrow stem cells directly from the bone was the only way to collect stem cells. Today, however, it's more common to collect stem cells from the blood. This is called peripheral blood stem cell donation.

Stem cells can also be collected from umbilical cord blood at birth. However, only a small amount of blood can be retrieved from the umbilical cord, so this type of transplant is generally reserved for children and small adults.

Every year, thousands of people in the U.S. are diagnosed with life-threatening diseases, such as leukemia or lymphoma, for which a stem cell transplant is the best or the only treatment. Donated blood stem cells are needed for these transplants.

You might be considering donating blood or bone marrow because someone in your family needs a stem cell transplant and doctors think you might be a match for that person. Or perhaps you want to help someone else maybe even someone you don't know who's waiting for a stem cell transplant.

Bone marrow stem cells are collected from the posterior section of the pelvic bone under general anesthesia. The most serious risk associated with donating bone marrow involves the use and effects of anesthesia during surgery. After the surgery, you might feel tired or weak and have trouble walking for a few days. The area where the bone marrow was taken out might feel sore for a few days. You can take a pain reliever for the discomfort. You'll likely be able to get back to your normal routine within a couple of days, but it may take a couple of weeks before you feel fully recovered.

The risks of this type of stem cell donation are minimal. Before the donation, you'll get injections of a medicine that increases the number of stem cells in your blood. This medicine can cause side effects, such as bone pain, muscle aches, headache, fatigue, nausea and vomiting. These usually disappear within a couple of days after you stop the injections. You can take a pain reliever for the discomfort. If that doesn't help, your doctor can prescribe another pain medicine for you.

For the donation, you'll have a thin, plastic tube (catheter) placed in a vein in your arm. If the veins in your arms are too small or have thin walls, you may need to have a catheter put in a larger vein in your neck, chest or groin. This rarely causes side effects, but complications that can occur include air trapped between your lungs and your chest wall (pneumothorax), bleeding, and infection. During the donation, you might feel lightheaded or have chills, numbness or tingling around your mouth, and cramping in your hands. These will go away after the donation.

If you want to donate stem cells, you can talk to your doctor or contact the National Marrow Donor Program, a federally funded nonprofit organization that keeps a database of volunteers who are willing to donate.

If you decide to donate, the process and possible risks of donating will be explained to you. You will then be asked to sign a consent form. You can choose to sign or not. You won't be pressured to sign the form.

After you agree to be a donor, you'll have a test called human leukocyte antigen (HLA) typing. HLAs are proteins found in most cells in your body. This test helps match donors and recipients. A close match increases the chances that the transplant will be a success.

If you sign up with a donor registry, you may or may not be matched with someone who needs a blood stem cell transplant. However, if HLA typing shows that you're a match, you'll undergo additional tests to make sure you don't have any genetic or infectious diseases that can be passed to the transplant recipient. Your doctor will also ask about your health and your family history to make sure that donation will be safe for you.

A donor registry representative may ask you to make a financial contribution to cover the cost of screening and adding you to the registry, but this is usually voluntary. Because cells from younger donors have the best chance of success when transplanted, anyone between the ages of 18 and 44 can join the registry for free. People ages 45 to 60 are asked to pay a fee to join; age 60 is the upper limit for donors.

If you're identified as a match for someone who needs a transplant, the costs related to collecting stem cells for donation will be paid by that person or by his or her health insurance.

Collecting stem cells from bone marrow is a type of surgery and is done in the operating room. You'll be given an anesthetic for the procedure. Needles will be inserted through the skin and into the bone to draw the marrow out of the bone. This process usually takes one to two hours.

After the bone marrow is collected, you'll be taken to the recovery room while the anesthetic wears off. You may then be taken to a hospital room where the nursing staff can monitor you. When you're fully alert and able to eat and drink, you'll likely be released from the hospital.

If blood stem cells are going to be collected directly from your blood, you'll be given injections of a medication to stimulate the production of blood stem cells so that more of them are circulating in your bloodstream. The medication is usually started several days before you're going to donate.

During the donation, blood is usually taken out through a catheter in a vein in your arm. The blood is sent through a machine that takes out the stem cells. The unused components are returned to your bloodstream. This process is called apheresis. It typically takes up to two hours and is done as an outpatient procedure. You'll typically undergo two to four apheresis sessions, depending on how many blood stem cells are needed.

Recovery times vary depending on the individual and type of donation. But most blood stem cell donors are able to return to their usual activities within a few days to a week after donation.

Recovery times vary depending on the individual and type of donation. But most blood stem cell donors are able to return to their usual activities within a few days to a week after donation.

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Blood and bone marrow stem cell donation - Mayo Clinic

Global Stem Cell and Primary Cell Culture Medium Market 2021 Trends and Leading Players Analysis 2027 Merck, STEMCELL Technologies, Irvinesci, Cell…

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Global Stem Cell and Primary Cell Culture Medium Market 2021 Trends and Leading Players Analysis 2027 Merck, STEMCELL Technologies, Irvinesci, Cell...

Resilience commits $30M to launch new biotechs out of Harvard with focus on therapeutics, biomanufacturing – FierceBiotech

National Resilience is not running in circles these days. The manufacturing and tech shop appears to have its ducks in a row, and the latest high-profile move is a $30 million commitmentto forming new companies with Harvard researchers.

First up is Circle Therapeutics. The biotech willbring forth a Harvard professor's technology platform with "promising applications in skeletal muscle disorders," the company said Friday.

Resilience might ring a bell: the San Diego-based company will helpModerna manufacture its mRNA COVID-19 vaccine in Canada. It will also produceDNA products for newly launched gene therapy biotech Intergalactic Therapeutics and recently contributed to stem cell startup Garuda's $72 million series A last month.

As part of the $30 million commitment, Resilience has inked a five-year research and development license with the Ivy League school to develop biologics, vaccines, nucleic acids and cell and gene therapies.

RELATED:Moderna taps National Resilience's new Canadian manufacturing site for COVID-19 vaccine production duties

Resilience's money will go toward faculty-initiated research dedicated to new therapeutic and biomanufacturing technologies formed in Harvard's labs. In turn, Resilience has the option to license technologies that come out of the projects.

Circle will likely be just the first in a clutch of companies formed under the collaboration to bring the new technologies into the clinic and onto the market. The new biotechcomes from the lab of Lee Rubin, Ph.D., whose group has identified targets for spinal muscular atrophy and amyotrophic lateral sclerosis and is also studying Parkinson's, Alzheimer's and autism.

For six decades since the discovery of the satellite cell, it has not been possible to expand therapeutic numbers of satellite cellsin vitro, until we made real headway on it at Harvard, Rubin said in a statement. Were truly excited for the possible therapeutic impact of our innovations.

Aside from Harvard, Resilience also teamed up with the Children's Hospital of Philadelphia on biomanufacturing tech and development of new cell, gene and nucleic acid therapies. Terms of the deal, disclosedearlier this week, were kept under wraps.

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Resilience commits $30M to launch new biotechs out of Harvard with focus on therapeutics, biomanufacturing - FierceBiotech

Selma Blair Shares That Shes Now in Remission 3 Years After MS Diagnosis – Self

Three years after actor Selma Blair received her multiple sclerosis (MS) diagnosis, her treatment is working well and her prognosis is positive.

"My prognosis is great. I'm in remission. Stem cell put me in remission," Blair said at a TCA panel in support of the upcoming Introducing Selma Blair documentary, per People. "It took about a year after stem cell for the inflammation and lesions to really go down."

Multiple sclerosis is thought to be an autoimmune condition that occurs when the body's immune system begins attacking the protective myelin sheaths that coat and protect nerve fibers. That can cause communication issues along the nerves and, over time, lead to permanent nerve damage.

People who have MS can have a range of symptoms such as fatigue, dizziness, tingling, balance issues, muscle weakness, and changes in vision (like blurred vision or double vision). The symptoms typically come and go, and someone may experience a flare of their symptoms (that can last days, weeks, or months) or they might be in a period of remission when their symptoms wane (but don't necessarily disappear completely).

Although there is no cure for MS, there are a variety of medications and treatment options that can help manage the symptoms. Experts are still researching and developing stem cell therapy for MS, the type of treatment Blair mentioned. To use stem cells to manage more aggressive forms of MS, doctors will typically perform an autologous stem cell transplant, the Mayo Clinic says, meaning they'll take a patient's own stem cells and use them to replenish their bone marrow. This type of stem cell transplant is most commonly used in the treatment of conditions such as myeloma, Hodgin's lymphoma, and non-Hodgkin's lymphoma, the Mayo Clinic says.

Blair was first diagnosed with MS in 2018 after dealing with symptoms like falling, dropping things, chronic pain, and a foggy memory, she revealed in an Instagram post. At first, Blair said she attributed her symptoms to a pinched nerve, but received her diagnosis after undergoing an MRI.

She told the panel that, for the past few months, she's been feeling noticeably better. But she was reluctant to talk about her improvements publicly because she felt like she still needed to be more healed and more fixed, People reports. "I've accrued a lifetime of some baggage in the brain that still needs a little sorting out or accepting. That took me a minute to get to that acceptance. It doesn't look like this for everyone."

In grappling with her diagnosis, Blair has found that being open with how she's feeling and what her life looks like now have been helpfulfor herself and others. "To hear even just me showing up with a cane or sharing something that might be embarrassing, it was a key for a lot of people in finding comfort in themselves and that means everything to me," she said.

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Third dose of COVID-19 vaccine to be offered to certain residents – Martins Ferry Times Leader

Coronavirus

Aug 18, 2021

WOODSFIELD Local health departments will offer a third dose of the COVID-19 vaccine to immunocompromised residents in an effort to help further protect those individuals from the virus.

The Centers for Disease Control and Prevention and the Ohio Department of Health announced a recommendation for a third dose of Moderna or Pfizer for immunocompromised individuals who have been fully vaccinated more than 28 days ago. Those who qualify include:

Individuals undergoing active treatment for cancer (solid tumor and hematologic malignancies);

Individuals who have received a solid-organ transplant and are taking immunosuppressive therapy;

Individuals who have received a CAR-T-cell or hematopoietic stem cell transplant (within two years of transplant or taking immunosuppression therapy);

Individuals with moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome);

Individuals with advanced or untreated HIV infection;

Individuals undergoing active treatment with high-dose corticosteroids (i.e., =20mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory.

The Monroe County Health Department will hold a third dose clinic Aug. 26 at the health department in Woodsfield. Amanda Sefert, public information officer of the county health department, said the clinic will be by appointment only. For more information on whether a person may qualify or to make an appointment for the third dose, call 740-472-4299 and leave your name, number and birthdate.

She said a staff member will return the call to answer questions.

Sefert said the third dose is needed to help further build the immune system of immunocompromised people. According to the CDC, severely compromised immune systems do not always build the same level of immunity compared to people who are not immunocompromised. Receiving the third dose will help prevent those individuals from contracting the virus or lessen the symptoms if they do, she said.

The health department is also offering youth clinics for ages 12-17. With school set to begin soon, Sefert said they wanted to help ensure students have access to the vaccine. She said there has been a fairly positive response for the clinics and she is hoping for a good turnout. The next youth clinic is set for 9:30-11:30 a.m. and 1:30-3:30 p.m. Thursday at the health department, with another set for 11 a.m. to 1 p.m. Aug. 27 at the EMS Pavilion during the county fair.

With the information from the delta variant coming out, I think more people are concerned, she added.

The Harrison County Health Department will offer third doses to residents who meet the qualifications and have received a recommendation from a doctor. Garen Rhome, administrator of the county health department, said there is only a small population who meet the qualifications so a clinic will not be necessary in his county.

What we want people to do is to get documentation from their providers. We just want to make sure they are part of that very select group that is currently recommended for the third dose of the series, so we want to know that their doctor recommends that they get it and then we can help them from there, he said.

To schedule an appointment for a third dose, call the health department at 740-942-2616.

Belmont County Deputy Health Commissioner Robert Sproul said his department is planning a third dose specific clinic. He said they are still working on a day and location. The department is currently only administering first and second doses out of the health department office. The department frequently posts upcoming clinics on its Facebook page.

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Third dose of COVID-19 vaccine to be offered to certain residents - Martins Ferry Times Leader

Friends, family continue Jocelyn’s drive to increase stem cell donors – Chatham This Week

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The importance of stem cell donation became a key part of Jocelyn McGlynns fight against leukemia.

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An aspiring doctor, the Chatham woman may have lost the battle, but she has inspired friends and family to continue her mission to increase the number of potential stem cell donors across Canada.

A total of 135 units of blood were collected during a blood donation clinic held in Jocelyns memory at the Chatham YMCA on Aug. 10, just days before those who loved the Western University medical science student will mark the first year of her death at age 23.

People at the clinic were also encouraged to join Canadas national stem cell registry.

Family friend Megan Canniff, who helped organize the event, said the clinic was a rewarding experience.

Jocelyn was just such an inspiration. I feel very blessed to be able to continue doing what she started, Canniff said. Its a good feeling and it makes you feel a little closer to her as well, being part of something she was so passionate about.

Canniff said a good number of people donated blood for the first time because they were inspired by Jocelyns passion.

Its really great to see. Hopefully, the impact is going to be continued in the future, she said.

Not long after Jocelyn was diagnosed with leukemia in the fall of 2018, she and her family dedicated themselves to promoting stem cell donor registration.

I think its so important because it was so important to our Jocey, said her mother, Jacquelyn McGlynn.

Jocelyns father, Peter McGlynn, said its heartening to know this kind of effort is helping someone else because so many people helped us.

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He said Jocelyn received numerous blood products because of people that were thinking, perhaps, of somebody else that had issues.

Having seen what his daughter started, he said it was critical to continue advocating for the things that she thought were important.

It brings sad memories, but this is what she would have wanted us to do, he said.

However, McGlynn said the clinic also brought happiness to the family knowing Jocelyns friends have embraced her cause.

Its lovely to see them and to know that they still think about her and love her, he said. Were very proud of these young folks.

A single donation of blood is equal to one unit of blood, and a leukemia patient can require up to eight units of blood per week.

As McGlynn wrote: Everybody join the team, theres a cure in your bloodstream.

Maureen Macfarlane, event co-ordinator with Canadian Blood Services, said there is an increased need for blood donations as hospital procedures, which were previously on hold during the COVID-19 pandemic, are being scheduled.

Another blood donor clinic is being held in Chatham on Aug. 31 from 1 p.m. to 7 p.m. at the Retro Suites Hotel.

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Friends, family continue Jocelyn's drive to increase stem cell donors - Chatham This Week

Calidi Biotherapeutics Announces Exclusive License Agreement with City of Hope and the University of Chicago for Novel Oncolytic Virotherapy…

Details Category: DNA RNA and Cells Published on Monday, 16 August 2021 17:11 Hits: 487

LA JOLLA, CA, USA I August 16, 2021 I Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company with novel allogeneic stem cell platforms for delivery of oncolytic viruses, together with the University of Chicago and City of Hope, a world renowned NCI-Designated Comprehensive Cancer Center, based in Duarte, California, have entered into an exclusive worldwide licensing agreement for patents covering cutting edge therapies using an oncolytic adenovirus in combination with a clinical grade allogeneic neural stem cell line.

City of Hope (COH) scientists, led by Dr. Karen Aboody in collaboration with Dr. Maciej Lesniak's team at University of Chicago, and later Northwestern University, have used COHs exclusive GMP grade immortalized, clonal human neural stem cell line, to selectively deliver an oncolytic adenovirus to tumor sites. Dr. Aboody and Dr. Lesniak, together with Dr. Rachael Mooney at COH, have spent 13 years in a passionate effort to translate promising pre-clinical results into the clinic, attaining FDA approval for commencing a first-in-human Phase-1 trial in recurrent glioma patients.

We are very excited about the partnership and collaboration with Calidi Biotherapeutics. Their deep understanding and expertise using allogeneic stem cells as a delivery platform to protect, deliver, amplify, and potentiate oncolytic virotherapy, can potentially result in a significantly more effective treatment for cancer patients with invasive tumors, commented Dr. Karen Aboody, Professor, Department of Developmental and Stem Cell Biology, City of Hope National Medical Center & Beckman Research Institute.

The first wave of Oncolytic Viruses were novel, but lacked the ability to efficiently deliver the virus to tumor sites, due to the human complement immune system inactivating the viruses, usually within one hour of patient injection, thus resulting in a lack of efficacy, stated Allan Camaisa, Co-Founder, Chairman and CEO of Calidi Biotherapeutics. We believe this collaboration with City of Hope will allow us to implement Calidis proprietary techniques together with City of Hopes novel approach to glioblastoma and other malignant tumors, using neural stem cells combined with an oncolytic adenovirus. This FDA approved Investigational New Drug (IND), planned for patient trials in the first quarter of 2022, increases Calidis drug pipeline and gives our company a tumor-tropic stem cell line to use for oncolytic virus delivery in cancer patients.

This exclusive license agreement, which was executed by the University of Chicagos Polsky Center for Entrepeneurship and Innovation, transferred the COH/University of Chicago IND to Calidi for the commercial development of a licensed product. The agreement grants to Calidi commercial exclusivity in using neural stem cells with the adenovirus known as CRAd-pk-S-7 for oncolytic virotherapy.

Calidis scientific and medical teams are very excited to contribute in the development of this promising technology that has significant potential to help many patients with advanced tumors, said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi Biotherapeutics. We are delighted to collaborate with the outstanding researchers and clinicians who developed this novel oncolytic virotherapy approach.

About Calidi Biotherapeutics

Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the effective delivery of oncolytic viruses protected by stem cells for targeted therapy against difficult-to-treat cancers. Calidi Biotherapeutics is advancing a potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications. Calidis off-the-shelf, universal cell-based delivery platform is designed to protect, amplify, and potentiate oncolytic viruses currently in development leading to enhanced efficacy and improved patient safety. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit http://www.calidibio.com.

About University of Chicago

The University of Chicago is a leading academic and research institution that has driven new ways of thinking since its founding in 1890. As an intellectual destination, the University draws scholars and students from around the world to its campuses and centers around the globe. The University provides a distinctive educational experience and research environment, empowering individuals to challenge conventional thinking and pursue field-defining research that produces new understanding and breakthroughs with global impact.

The Polsky Center for Entrepreneurship and Innovation applies world-class business expertise from the University of Chicago Booth School of Business to bring new ideas and breakthrough innovations to market. Home of the Universitys technology transfer office, the Polsky Centers dedicated team of professionals with deep technical expertise enabling technology commercialization perform market analysis, manage intellectual property, identify partners, and negotiate partnerships and licenses for discoveries and inventions developed by faculty, researchers, and staff. Learn more at polsky.uchicago.edu and follow us on Twitter @polskycenter.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy. City of Hopes translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies, and numerous breakthrough cancer drugs are based on technology developed at the institution. Translational Genomic research (TGen) became a part of City of Hope in 2016. AccessHope, a wholly owned subsidiary, was launched in 2019, dedicated to serving employers and their health care partners by providing access to City of Hopes exceptional cancer expertise. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nations Best Hospitals by U.S. News & World Report. Its main campus is located in Pasadena, California, near Los Angeles, with additional locations throughout Southern California and in Arizona. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, or Instagram.

SOURCE: Calidi Biotherapeutics

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Calidi Biotherapeutics Announces Exclusive License Agreement with City of Hope and the University of Chicago for Novel Oncolytic Virotherapy...