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Category Archives: Cell Therapy

AJ Foyt undergoes stem cell therapy, toe surgery – USA TODAY

Posted: April 29, 2017 at 5:50 pm


USA TODAY
AJ Foyt undergoes stem cell therapy, toe surgery
USA TODAY
Foyt, whose list of injuries is almost as long as that of his legendary racing achievements, had right foot toe surgery Wednesday just days after stem cell therapy in Mexico. So the winner of Phoenix Raceway's debut event in 1964 won't be at ...

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Banking Teeth for Stem Cell Therapy – HealthCentral.com

Posted: April 28, 2017 at 1:50 am

Banking Teeth for Stem Cell Therapy

Banking baby teeth or wisdom teetha practice thats been around for about 10 yearsis becoming more widely accepted in developed areas of the world, according to researchers. It involves cryopreserving teethand the dental stem cells they containfor potential stem cell therapy in the future.

Most research surrounding dental stem cells and tooth banking is still in the experimental stage and, at this time, scientists disagree about whether its worthwhileunlike cord blood banking, which has proven benefits for stem cell therapy. Some research suggests preserved dental stem cells could one day be used to regenerate healthy tissue and help fight complex diseases. But many experts remain less convinced of the potential benefits, as so much of the research is preliminary.

So far, the research has centered around dentinthe innermost hard layer of the tooth, below the enameland soft tissue beneath the dentin called pulp. The pulp contains the tooths nerve and blood supplies. In studying how teeth repair themselvesfrom a cavity, for exampleresearchers discovered that teeth contain stem cells. More studies are needed to determine if these dental stem cells can be harvested, preserved, stored, and someday used for stem cell therapy.

Image Credit: iStock

Sourced from: CNN

A new study suggests that cardiovascular decompensationa life-threatening drop in blood pressure caused by serious injuries involving significant blood lossmay be treated temporarily at the scene or during transport to the hospital simply by applying a bag of ice water to the injured persons face. Decompensation, which remains a dangerous complication even after bleeding has stopped, reduces the delivery of oxygen to the brain, heart, and other vital organs.

For the study, ten healthy volunteers were placed in a special chamber that simulates blood circulation after a person has lost one-half to one liter of blood and a tourniquet has been applied to stop the bleeding. Researchers applied bags of ice water or bags of room-temperature water to the study participants faces for 15 minutes while they continuously monitored cardiovascular function. They discovered that participants treated with bags of ice water experienced significant increases in blood pressure, suggesting that applying ice water can improve cardiovascular function after blood loss and prevent a dangerous drop in blood pressure.

Researchers expect to begin clinical trials soon. The hope is that this simple technique can be used by first responders or medics in the field of combat to improve survival rates after injuries involving blood loss by providing extra time for transport to a hospital or other medical facility.

Image Credit: iStock

Sourced from: ScienceDaily

Cooking dinner at homerather than eating outis a good way to eat healthier and save money, according to researchers at Oregon State University and the University of Washington. Historically, people with a higher socioeconomic status are generally healthier than those with lower incomes, but this study suggests otherwiseIF more money means dining out more often and less money means eating at home.

The study involved about 400 adults in the Seattle-area. Study participants were surveyed about their cooking and eating behaviors for one week and provided various socioeconomic information. Their weekly food intake was graded using the Healthy Eating Index (HEI)a scale that ranges from 0 to 100, with higher scores indicating a healthier diet.

According to researchers, cooking at home three times per week produced an average score of about 67 on the Healthy Eating Index, and cooking at home six times per week resulted in an average score of 74. Results of the study suggest that home-cooked dinners are associated with a diet lower in calories, sugar and fat, overall than dining out regularly.

Image Credit: iStock

Sourced from: Oregon State University

Daily Dose Index

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First-Of-Its-Kind Cancer Treatment Developed By Santa Monica Company Helps Save Lives – CBS Los Angeles

Posted: April 28, 2017 at 1:50 am

April 25, 2017 11:23 PM By Andrea Fujii

SANTA MONICA (CBSLA)An Orange Countywoman given only months to live is now cancer free, thanks to a one-of-a-kind treatment developed by a Santa Monica company.

In 2015, Denise Delatorre was diagnosed with aggressive lymphoma. Chemotherapy failed towork. She was given six months to live.

That day I went home and told my son I was going to die. I actually pulled him out of work and told him that I wasnt going to make it,Delatorre recalled as tears welled up in her eyes.

But then the Laguna Beach mother read about a study at UCLA involving a unique immunotherapy called CAR-T cell therapy. She became the first patient to be involved in the clinical trial.

Your body is a miraculous thing. Its supposed to heal itself. Our immune systems are meant to heal disease,Delatorresaid.

And that is exactly what biopharmaceutical company,Kite Pharma, hopes to do with its development of the first-of-its-kind therapy, which uses a patients own cells to fight cancer.

T-cells are extracted from the patients blood, modified to fight and kill the cancer cells and then injected back into the patients body.

John Timmerman is a UCLA oncologist and member of the Jonsson Comprehensive Cancer Centertumor immunology program. He studied five patients. including Delatorre.

These are the patients own cells that have now been re-engineered to fight cancer in a way that the normal T-cells cannot do, UCLA Timmerman explained.These are patients that have failed all other therapies and have really had few options up until now.

So far, the results are promising.Kite Pharma studied 101 patients across the country.

After an average of nearly nine months,82 percent saw their tumors shrink during the study while39 percent, including Delatorre, were in complete remission.

I had no hope when I entered in clinical trials. So I feel extremely blessed, Delatorre said.

Before treatment, she hadmore than 30 tumors. After the treatment, those tumors were gone, a scan showed.

However, there are risks. Some of the patients developed a condition in which their immune system overreacted to the therapy. Two of those patients died.

Since then, doctors said they have adapted.Theres been a learning curve associated with using this therapy in myself and with other doctors around the country,Timmerman said. I think we know how to use this therapy much more safely now.

The hope is that even if cancer re-emerges in Delatorre, her engineered cells will continue to fight.

The T-cells should just pop back up and take care of that cancer, so I believe that is the true miracle of this, the 57-year-old said.

In remission now for a couple of months, Delatorre said was finally feeling like herself again.

I started buying more clothes, and I started a new job. Im starting to live my life again, she said with a big smile.

Kite Pharma hopes to have the CAR-T cell therapy approved by the FDA by November.

CBS2/KCAL9 reporter Andrea Fujii was born and raised in Honolulu, Hawaii. She received a B.A. in Business from the University of Washington and a law degree from Santa Clara University. She took an unusual road to journalism, which, in her words,...

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Global CAR T Cell Therapy Market & Clinical Trials Insight 2022 … – PR Newswire (press release)

Posted: April 28, 2017 at 1:50 am

The report highlights the ongoing clinical and non-clinical advancement in the field of Car T Cell Therapy. As per report findings, the promise of CAR modified T cell therapy derives from its combined immunologic benefits and include the specificity of a targeted antibody, the ability to expand the T cell population and the potential for long term persistence to facilitate the ongoing tumor surveillance. The success in early phase trials, assess the feasibility of evaluating the treatment modality across the multiple centers and in larger patients. Currently, there are 99 CAR T Cell based therapies in clinical pipeline and most of them belong to Phase-I and Phase-I/II clinical trials.

In recent years, researchers have identified the chimeric antigen receptor as a potential target for molecular genetics to insert a new epitopes on the receptor region which allows a degree of control of the immune system. CAR T cell therapy satisfy the need to explore new and efficacious adoptive T cell therapy. The gene transfer technology could efficiently introduce the genes encoding CARs into the immune effector cells. The transferring of engineered T cells provides the specific antigen binding in a non-major histocompatibility complex. The promise of CAR modified T cell therapy derives from its combined immunologic benefits and include the specificity of a targeted antibody, the ability to expand the T cell population and the potential for long term persistence to facilitate the ongoing tumor surveillance. The success in early phase trials, assess the feasibility of evaluating the treatment modality across the multiple centers and in larger patients.

Companies Mentioned

Key Topics Covered:

1. Chimeric Antigen Receptor (CAR) T Cell Therapy - Next Era in Immuno Oncology

2. Evolution of Chimeric Antigen Receptor (CAR) T-Cell Design

3. Principle of Chimeric Antigen Receptor Design

4. CAR T Cell Therapies Delivery Pipeline & Mechanism of Action

5. Approaches to Improve the CAR T Cell Therapy

6. Global CAR T Cell Therapy Clinical Trials for Cancer Treatment

7. Global CAR T Cell Therapies Clinical Pipeline by Company, Indication & Phase

8. Global Market Scenario of CAR T Cell Therapy

9. Global Market Size of CAR T Cell Therapy

10. Global CAR T Cell Therapy Market Dynamics

11. Global CAR T Cell Therapy Market Future Prospects

12. Competitive Landscape

For more information about this report visit http://www.researchandmarkets.com/research/q57z4j/global_car_t_cell

Media Contact:

Laura Wood, Senior Manager press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-car-t-cell-therapy-market--clinical-trials-insight-2022-pipeline-analysis-by-company-indication--phase---research-and-markets-300447325.html

SOURCE Research and Markets

http://www.researchandmarkets.com

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Lonza US cell therapy plant slapped with FDA warning letter – FiercePharma

Posted: April 27, 2017 at 10:44 am

Swiss CDMO leader Lonza has had its cell therapy facility in the U.S. slapped with a warning letter after halting some production there two months ago because of sterility problems with a product it was producing for a client.

The company acknowledged the FDA action in its first-quarter earnings report Tuesday, saying that the warning letter was issued Monday for its facility in Walkersville, Maryland. The FDA had concerns about issues including validation and aseptic process simulations, the drugmaker said.

Lonza takes this issue seriously, and has already started to address all issues raised by the FDA, the company said.

Lonza first learned about the issue in December after product end-user notified the FDA of the issue, Lonza spokeswoman Constance Ward said in an email Tuesday. Lonza opened an investigation after confirming the sterility issue. She said the plant halted production of the product in the affected manufacturing area in early February, while also quarantining the inventory it had on hand.

"After inspecting both the customer of the product and the Walkerville operations, the FDA issued Lonza a warning letter that identified issues involving validation, aseptic process simulations, corrective and preventive actions, and environmental monitoring, Ward explained.

She said the company expects to have the problems resolved and FFM media manufacturing back online by mid-2017. The company had already begun a $7.6 million manufacturing upgrade at the facility, which Ward said is slated to be finished in 2018.

While the drugmaker said it expects the latest FDA action to have minimal impact on revenues of its Pharma & Biotech segment, it reported sales in the segment were softer in the first quarter because of the action. Without providing specific numbers, the contract manufacturer Tuesday reported that growth in that segment was driven by demand in mammalian manufacturing, as well as in clinical development and licensing.

This is not the first time that Lonza has faced FDA concerns about its biologics operations in the U.S. An API plant it had in Hopkinton, Massachusetts, was cited in 2011 over a plethora of problems, creating supply problems for a drug it manufactured there at the time for French drugmaker Ipsen. After struggling to get issues resolved, Lonza simply closed the plant and concentrated its biologics work at its extensive site in Visp, Switzerland.

Lonza is preparing to expand its Visp biologics capability further. It will break ground in the second half of the year on a new large-scale biologics production facility that it is building in partnership with Frances Sanofi. The companies announced in February that they would share the cost, and capacity, of a 270 million ($286.3 million) plant at Lonzas site in Visp.

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HemaCare Will Attend International Society of Cell Therapy in … – Business Wire (press release)

Posted: April 27, 2017 at 10:44 am

LOS ANGELES--(BUSINESS WIRE)--HemaCare Corporation (OTCBB: HEMA), a leader in cell and tissue collection, processing and cell therapy solutions, will be exhibiting at the annual meeting of the International Society of Cell Therapy (ISCT) in London, UK, May 3-6, 2017. This year marks the 25th anniversary of the ISCT, a global society that unites clinicians, researchers, regulators, technologists and industry partners with a shared vision to translate cellular therapy into clinical practice. HemaCare will meet with its customers and European distributors at the conference and showcase its growing portfolio for cell therapy developers around the world.

Attending this meeting enables us to capture the latest developments in cell therapy and better serve our customer needs, said Pete van der Wal, Chief Executive Officer for HemaCare.The field of cell therapy is rapidly evolving. Our products and services are embedded in some of the most critical phases of translational research, enabling scientists to work with high quality human cells from our well-characterized donor pool.

The conference is being held at ExCel London Conference Center. Look for us there, or view our products and services at http://www.hemacare.com.

About HemaCare

HemaCare specializes in the customization of human-derived biological products and services for customers research and cell therapy protocols. HemaCares network of FDA-registered, GMP/GTP-compliant collection centers ensures donor material is available for fresh shipment to customers, as well as for internal use within HemaCares isolation laboratory. In this laboratory, human biological material such as peripheral blood, bone marrow, and cord blood from donor and patient subjects is isolated into various primary cell types for distribution to customers in fresh and frozen formats. HemaCare's extensive registry of well-characterized repeat donors provides consistent primary human cells and biological products for advanced biomedical research and cellular therapy process development.

For 39 years, HemaCare has provided human-derived primary blood cells and tissues for biomedical research, supported cell therapy clinical trials and commercialization with apheresis collections, and provided a wide range of consulting services. HemaCare directly supports benchtop immunology and oncology research, compound screening for drug discovery, and assay development and qualification, as well as enables customers to advance both autologous and allogeneic cellular therapies. For more information, please visit http://www.hemacare.com.

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Kelly Osbourne campaigning to make stem cell therapy affordable in America – Hollywood.com

Posted: April 26, 2017 at 3:41 pm

Singer-turned-TV personality Kelly Osbourne wants to help cure fellow Lyme disease sufferers by making stem cell therapy available for all in the U.S. Ozzy and Sharon Osbournes daughter contracted the condition after she was bitten by a tick during a party for the rockers 56th birthday back in 2004, when her mother had a reindeer sanctuary installed at their Los Angeles home. However, Kelly wasnt properly diagnosed until 2014, months after suffering a seizure while filming an episode of E!s Fashion Police show in 2013, when doctors claimed her collapse had been caused by epilepsy. She did some research into her ailments and discovered she was actually struggling with Lyme disease, and promptly sought out alternative treatment to help her overcome the illness. I started to actually do the one thing doctors tell you not to do and thats to go online and look it up, she explained on U.S. breakfast show Good Morning America, and all roads pointed to Lyme disease so I found a doctor through my mum. I went to Frankfurt, Germany, and I did stem cell (therapy) and I got cured, Kelly claimed. The 32-year-old is lucky to have been in a position to afford the treatment, which involves the transplant of stem cells to heal those damaged by the disease, and now she is looking to get involved in making the therapy more widely available and affordable to others less fortunate. It sickens me that thats not available to everyone and that you have to be considered lucky or privileged to get that sort of treatment, she said. I want to make sure and I will do anything that I can do to make sure that that treatment is available in this country. Kelly details her experience with the bacterial infection in her new memoir There Is No F**king Secret: Letters from a Bada** B**ch. She isnt the only celebrity to open up about her struggles with Lyme disease pop star Avril Lavigne, and veteran model Yolanda Hadid and her runway star kids Bella and Anwar Hadid have also been battling the illness.

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Cellectis to Present at the American Society of Gene & Cell Therapy … – Yahoo Finance

Posted: April 26, 2017 at 3:41 pm

NEW YORK--(BUSINESS WIRE)--

Regulatory News:

Cellectis (ALCLS.PA) (CLLS) (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells, today announced that data on its gene-edited allogeneic off-the-shelf CAR T-cell immunotherapies (UCART) will be presented at the ASGCT 20th Annual Meeting. The meeting will be held from May 10th to 13th, 2017 in Washington, D.C., USA.

Oral presentation:

Development of Gene Edited Allogeneic CAR T-Cell Therapy Philippe Duchateau, PhD. Chief Executive Officer, Cellectis

Session: 300 - Clinical Advancement of Gene Editing-Moving New Science to the Clinic - Organized by the Clinical Trials and Regulatory Affairs Committee

Friday, May 12, 2017 from 8:35 AM to 9:10 AM EST Lincoln 2, 3, 4

Poster presentations:

176 - Genome-Wide Analysis of TALEN Activity in Primary Cells Brian Busser, Sonal Temburni, Aymeric Duclert, Philippe Duchateau and Laurent Poirot

Session: Gene Targeting and Gene Correction I Wednesday May 10, 2017 at 5:30 PM EST Exhibit Hall A & B South

114 - UCART22: An Allogeneic Adoptive Immunotherapy for Leukemia Targeting CD22 with CAR T-cells Anne-Sophie Gautron, Ccile Schiffer-Mannioui, Alan Marechal, Severine Thomas, Agnes Gouble, Laurent Poirot, Julianne Smith

Session: Cancer-Immunotherapy, Cancer Vaccines I Wednesday May 10, 2017 from 5:30 PM to 7:30pm EST Exhibit Hall A & B South

372 - Manufacturing of Gene-Modified Mouse CAR T-Cells Laurent Poirot, Brian Busser, Sonal Temburni, Philippe Duchateau

Session: Gene Targeting and Gene Correction II Thursday May 11, 2017 from 5:15 PM to 7:15 PM EST Exhibit Hall A & B South

About Cellectis

Cellectis is a biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART). The companys mission is to develop a new generation of cancer therapies based on engineered T-cells. Cellectis capitalizes on its 17 years of expertise in genome engineering - based on its flagship TALEN products and meganucleases as well as its pioneering electroporation PulseAgile technology - to create a new generation of immunotherapies. CAR technologies are designed to target surface antigens expressed on cells. Using its life-science-focused, pioneering genome-engineering technologies, Cellectis goal is to create innovative products in multiple fields and with various target markets.

Cellectis is listed on the Nasdaq market (CLLS) and on the NYSE Alternext market (ALCLS.PA). To find out more about us, visit our website: http://www.cellectis.com

Talking about gene editing? We do it. TALEN is a registered trademark owned by the Cellectis Group

Disclaimer

This press release and the information contained herein do not constitute an offer to sell or subscribe, or a solicitation of an offer to buy or subscribe, for shares in Cellectis in any country. This press release contains forward-looking statements that relate to the Companys objectives based on the current expectations and assumptions of the Companys management only and involve risk and uncertainties that could cause the Company to fail to achieve the objectives expressed by the forward-looking statements above.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170425006830/en/

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Are baby, wisdom teeth the next wave in stem cell treatment? – CNN

Posted: April 26, 2017 at 3:41 pm

It's based on experimental research that suggests stem cells extracted from the pulp of these teeth might someday regrow a lost adult tooth or offer other regenerative medicine benefits -- some potentially life-saving.

"So I'll try not to get emotional here, but my husband was diagnosed with acute myeloid leukemia in 2011," said Bassetto, of Naperville, Illinois, head of a sales team at a software company.

In 2012, her husband, James, had a stem cell transplant to restore his bone marrow and renew his blood.

"He was very fortunate. He was one of six kids, and his brother was a perfect match," she said. She noted that her two children, Madeline, 23, and Alex, 19, may not be so lucky if they develop health problems, since they have only each other; the chance of two siblings being a perfect stem cell match is only 25%.

Unfortunately, her husband's stem cell transplant was not successful. He developed graft-versus-host disease, where his brother's donated stem cells attacked his own cells, and he died shortly afterward.

However, she says, the transplant had given him a chance at a longer life.

Last year, when her son saw a dentist for wisdom tooth pain, a brochure for dental stem cell storage caught Bassetto's eye and struck a chord.

"I know stem cells have tremendous health benefits in fighting disease, and there's a lot ways they're used today," she said. "Had my husband had his own cells, potentially, his treatment could have been more successful."

Medical breakthroughs happen all the time, said Bassetto. "Who knows what potential there is 20 years, 40 years down the road, when my son is an adult or an aging adult?

"Almost like a life insurance policy, is how I viewed it," she said.

Some scientists see storing teeth as a worthwhile investment, but others say it's a dead end.

"Research is still mostly in the experimental (preclinical) phase," said Ben Scheven, senior lecturer in oral cell biology in the school of dentistry at the University of Birmingham. Still, he said, "dental stem cells may provide an advantageous cell therapy for repair and regeneration of tissues," someday becoming the basis for reconstructing bone tissue, retinas and even optic neurons.

Dr. Pamela Robey, chief of the craniofacial and skeletal diseases branch of the National Institute of Dental and Craniofacial Research, acknowledges the "promising" studies, but she has a different take on the importance of the cells.

"There are studies with dental pulp cells being used to treat neurological disorders and problems in the eye and other things," Robey said. The research is based on the idea that these cells "secrete factors that encourage local cells to begin the repair process."

"The problem is, these studies have really not been that rigorous," she said, adding that many have been done only in animals and so provide "slim" evidence of benefits. "The science needs a lot more work."

Robey would know. Her laboratory discovered dental stem cells in 2003.

"My fellows, Songtao Shi and Stan Gronthos, did the work in my lab," Robey said. "Songtao Shi is a dentist, and basically he observed that, when you get a cavity, you get what's called 'reparative dentin.' In other words, the tooth is trying to protect itself from that cavity, so it makes a little bit of dentin to kind of plug the hole, so to speak."

Dentin is the innermost hard layer of tooth that lies beneath the enamel. Underneath the dentin is a soft tissue known as pulp, which contains the nerve tissue and blood supply.

Observing dentin perform reparative work, Shi hypothesized that this must mean there's a stem cell within the tooth that's able to activate and make dentin. So if you wanted to grow an adult tooth instead of getting an implant, knowing how to make dentin would be the start of the process, explained Robey.

Pursuing this idea, Shi, Gronthos and the team conducted their first study with wisdom teeth. They discovered that pulp cells in these third molars did indeed make dentin, but the cells found in baby teeth, called SHED (stem cells from human exfoliated deciduous teeth), had slightly different properties.

"The SHED cells seem to make not only dentin but also something that is similar to bone," Robey said. This "dentin osteogenic material" is a little like bone and a little like dentin -- "unusual stuff," she said.

There is a meticulous process for extracting stem cells from the pulp.

"We very carefully remove any soft tissue that's adhering to the tooth. We treat it with disinfectant, because the mouth is not really that clean," Robey said, laughing.

Scientists then use a dental drill to pass the enamel and dentin -- "kind of like opening up a clam," said Robey -- to get to the pulp. "We take the pulp out, and we digest it with an enzyme to release the cells from the matrix of the pulp, and then we put the cells into culture and grow them."

According to Laning, even very small amounts of dental pulp are capable of producing many hundreds of millions of structural stem cells.

Harvesting dental stem cells is not a matter of waiting for the tooth to fall out and then quickly calling your dentist. When a baby tooth falls out, the viability of the pulp is limited if it's not preserved in the proper solution.

American Academy of Pediatric Dentistry President Dr. Jade Miller explained that "it's critical that the nerve tissue in that pulp tissue, the nerve supply and blood supply, still remain intact and alive." Typically, the best baby teeth to harvest are the upper front six or lower front six -- incisors and cuspids, he said.

For a child between 5 and 8 years of age, it's best to extract the tooth when there's about one-third of the root remaining, Miller said: "It really requires some planning, and so parents need to make this decision early on and be prepared and speak with their pediatric dentist about that."

Bassetto found the process easy. All it involved was a phone call to the company recommended by her dentist.

"They offer a service where they grow the cells and save those and also keep the pulp of the tooth without growing cells from it," she said. "I opted for both." From there, she said, the dentist shipped the extracted teeth overnight in a special package.

Bassetto said she paid less than $2,000 upfront, and now $10 a month for continued storage.

So is banking teeth something parents should be doing?

In a policy statement, the American Academy of Pediatric Dentistry "encourages dentists to follow future evidence-based literature in order to educate parents about the collection, storage, viability, and use of dental stem cells with respect to autologous regenerative therapies."

"Right now, I don't think it is a logical thing to do. That's my personal opinion," said Robey of the National Institute of Dental and Craniofacial Research. As of today, "we don't have methods for creating a viable tooth. I think they're coming down the pike, but it's not around the corner."

Science also does not yet support using dental pulp stem cells for other purposes.

"That's not to say that in the future, somebody could come up with a method that would make them very beneficial," Robey said.

Still, she observed, if science made it possible to grow natural teeth from stem cells and you were in a car accident, for example, and lost your two front teeth, you'd probably be "very happy to give up a third molar to use the cells in the molar to create new teeth." Third molars are fairly expendable, she said.

Plus, Robey explained, it may not be necessary to bank teeth: Another type of stem cell, known as induced pluripotent stem cells, can be programmed into almost any cell type.

"It's quite a different story than banking umbilical cord blood, which we do know contains stem cells that re-create blood," Robey said.

"So cord blood banking -- and now we have a national cord blood bank as opposed to private clinics -- so there's a real rationale for banking cord blood, whereas the rationale for banking baby teeth is far less clear," Robey said.

And there's no guarantee that your long-cryopreserved teeth or cells will be viable in the future. Banking teeth requires proper care and oversight on the part of cryopreservation companies, she said. "I think that that's a big question mark. If you wanted to get your baby teeth back, how would they handle that? How would they take the tooth out of storage and isolate viable cells?"

Provia's Laning, who has "successfully thawed cells that have been frozen for more than 30 years," dismissed such ideas.

"Cryopreservation technology is not the problem here," he said. "Stem cells from bone marrow and other sources have been frozen for future clinical use in transplants for more than 50 years. Similarly, cord blood has a track record of almost 40 years." The technology for long-term cryopreservation has been refined over the years without any substantial changes, he said.

Despite issues and doubts, Miller, of the pediatric dentistry academy, said parents still need to consider banking baby teeth.

A grandparent, he is making the decision for his own family.

"It's really at its infancy, much of this research," he said. "There's a very strong chance there's going to be utilization for these stem cells, and they could be life-saving."

He believes that saving baby teeth could benefit not only his grandchildren but also their older siblings and various other family members if their health goes awry and a stem cell treatment is needed.

"The science is strong enough to show it's not science fiction," Miller said. "There's going to be a significant application, and I want to give my grandkids the opportunity to have those options."

Aside from cost, Miller said there are other considerations: "Is this company going to be around in 30, 40 years?" he asked. "That's not an easy thing to figure out."

Having taken the leap, Bassetto doesn't worry.

"In terms of viability, you know, if something were to happen with the company, you could always get what's stored and move it elsewhere, so I felt I was protected that way," she said. She feels "pretty confident" with her decision and plans to store her grandchildren's baby teeth.

Still, she concedes that her circumstances may be rare.

"Not everybody's going to be touched by some kind of disease where it just hits home," Bassetto said. "For me, that made it a no-brainer."

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SAVSU and TrakCel announce collaboration to integrate Cell … – PR Newswire (press release)

Posted: April 26, 2017 at 3:41 pm

TrakCel's Cellular Orchestration platform facilitates efficiency and compliance to quality standards in cell therapy manufacturing by enabling program-critical information to be collated, tracked and and documented. Detailed processes and managed workflows for every participant in the value chain enable safe and efficient scaling outward and upward as production increases. Conditional logic workflows for all participants including clinicians, logistics and manufacturing partners ensure standardization andcompliance with validated procedures.

Bruce McCormick, President of SAVSU Technologies, remarked, "Our optimized technologies represent the next generation of integrated, cloud-connected cold chain technologies. We are very pleased to collaborate with TrakCel and look forward to integrating our respective data platforms to provide even more value to our mutual customers. We are committed to driving a paradigm shift away from traditional, risk-laden cold chain practices based on the use of poor performing shipping containers and disconnected data systems."

Ravi Nalliah, CEO at TrakCel, commented, "We scoped the packaging and cold chain technologies space to identify best of breed ecosystem partners. SAVSU is so far ahead of traditional container and data logger suppliers, and we are very keen to integrate their innovations into our Cell Orchestration Platform. The timing of this collaboration is perfect as the cell therapy market continues to mature and awareness is peaked on the need to use better tools to enable clinical trial success, commercial scale-out, and reimbursement supported by evidence of compliance throughout manufacturing, distribution and patient administration."

Chain Link Research and Pharmaceutical Commerce market research estimate that there are 80 million to 130 million annual temperature sensitive pharmaceutical shipments requiring cold chain management, resulting in $12 billion spent annually on cold chain logistics, with $9 billion for transportation and $3 billion for specialized tertiary packaging and instrumentation such as insulated boxes, blankets, phase change materials, temperature sensors and data loggers. The use of currently available cold technologies results in $15 billion to $35 billion spent annually replacing products lost due to temperature excursions.

About SAVSU Technologies SAVSU is a leading designer and manufacturer of innovative, high performance, cloud-connected passive storage and transport containers for temperature-sensitive biologics and pharmaceuticals. Our mission is to improve global health by greatly reducing the waste and risks associated with the improper freezing and overheating of thermal-sensitive medicines and biologics. SAVSU has developed proprietary state-of-the-art technology to ultimately lower costs and improve delivery of these most essential materials.

For more information please visit http://www.savsu.com.

About TrakCel TrakCel's cell, gene and immunotherapy management solution improves clinical study efficacy and accelerates global scale-up and scale-out by implementing communications technology to integrate the delivery path from needle-to-needle. The technology provides interactive instructions to professionals across the supply chain and gives stakeholders on-demand visibility of procedural results and chain-of-custody data for immediate traceability, validation and compliance audits.

TrakCel technology is increasingly being adopted by leaders in the cell, gene and immunotherapy industry. TrakCel is headquartered in Cardiff, Wales with a U.S. offices in Newport Beach, California and Bridgewater, NJ.

For more information please visitwww.trakcel.com.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/savsu-and-trakcel-announce-collaboration-to-integrate-cell-therapy-manufacturing-and-cold--chain-data-management-platforms-300444497.html

SOURCE SAVSU Technologies

http://www.savsu.com

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SAVSU and TrakCel announce collaboration to integrate Cell ... - PR Newswire (press release)

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