Takeda, TiGenix stem cell therapy shows sustained effect – FierceBiotech

Takeda and TiGenix have presented 52-week data on their allogeneic expanded adipose-derived stem cells in Crohns disease patients with treatment-refractory complex perianal fistulas. The data show the Cx601 stem cells continue to outperform placebo one year after administration.

TiGenix presented the 24-week data from the successful phase 3 trial back in 2015, sparking a surge in its stock price and setting it up to land a deal with Takeda. Last year it followed up with the release of a first look at 52-week results confirming the efficacy outcomes seen in the earlier data drop.

Takeda and TiGenix have now shared another overview of the 52-week data at the 12th Congress of the European Crohns and Colitis Organisation (ECCO). The abstract includes treatment-related adverse event data that were absent from TiGenixs original release, but included in subsequent presentations.

Those 52-week data confirm the positive safety profile seen in the 24-week results. The rate of treatment-emergent adverse events was lower in the Cx601 cohort than the placebo plus standard of care arm at both time points. The same is true when only serious adverse events are analyzed.

The safety results complement the previously-released efficacy data. Among the 62% of patients who completed the 52-week follow-up, the results were comparable to those generated after 24 weeks. In the Cx601 arm, 56.3% of the modified intention-to-treat (mITT) population achieved combined remission after 52 weeks, compared to 51.5% after 24 weeks. The respective figures for the placebo cohort are 38.6% and 35.6%. The mITT population included all patients to undergo at least one post-baseline efficacy evaluation.

These data highlight that the efficacy and safety of a single administration of Cx601 were maintained during one year of follow up, TiGenix CMO. Marie Paule Richard said in a statement. It is important to also note that the definition of combined remission used in the ADMIRE-CD study, which includes both clinical and radiological assessment by MRI, is more stringent than the criteria commonly used in previous large scale, randomized clinical trials evaluating perianal fistulas in Crohns disease, based only on clinical assessment.

Relapse rates in the Cx601 group were rarer, too. Three-quarters of participants who responded to Cx601 after 24 weeks made it to 52 weeks without relapsing. The number falls to 55.9% among the placebo cohort.

TiGenix is hoping the data will prove compelling enough to secure a regulatory approval in Europe later this year. In parallel, TiGenix is setting up another phase 3 trial designed to deliver data to support approval in the U.S.. TiGenix expects the trial to start later this year.

Shares in TiGenix traded up 4% shortly after the stock exchange in Brussels opened for the day.

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Takeda, TiGenix stem cell therapy shows sustained effect - FierceBiotech

A.J. Foyt planning to undergo stem cell therapy | USA TODAY Sports – USA TODAY

A.J. Foyt during practice for the 2016 Indianapolis 500. (The Indianapolis Star)

Auto racing legend A.J. Foyt is hoping to find thefountain of youth for a body that has taken quite a beating over the years. And like a handful of athletes before him, its a journey that will take him outside the United States.

Foyt, 82, told IndyCar.com Saturday during a Verizon IndyCar Series test at Phoenix International Raceway that he plans to undergo stem cell therapy, likely in Cancun, Mexico, with injections into both ankles and shoulders as well as his blood.

Foyt suffered a broken back during a NASCAR race in 1964 and broken feet and legs during a 1991 IndyCar crash. In 2005, hewas stung more than 200 times by bees while trapped under his bulldozer at his Texas ranch. Hes had knee and hip replacements, and in 2014 underwent triple-bypass heart surgery.

Hes hopeful that stem cell therapy will help heal the lingering effects of some of those ailments.

They have to cut away some of the tissue from my stomach and it takes 8-10 weeks for it to grow back to produce the stem cells, Foyt told IndyCar. Ill probably have it done soon so that we can begin the treatment within the next two to three months.

Adult stem cells are able to grow and become a cell for a specific tissue or organ, according to the National Institutes of Health. They are different from embryonic stem cells, which come from fertilized eggs or aborted fetuses. Embryonic stem cells can turn into cells for nearly any tissue in the body.

But the procedure Foyt seeks has not yet been approved by the FDA for use in the United States, so he will head south of the border where several former football players have received these treatments.

MORE:Companies offer athletes hope with questionable stem cell treatments

It used to be you would have to go to Germany to get this procedure, but now its available in Cancun and that is probably where Ill have it done, Foyt said. Dan Pastorini (the former NFL quarterback) did it and it helped him. Peyton Manning (the former Indianapolis Colts and Denver Broncos quarterback) did it for his neck and it really helped him. Tony Dorsett (the former Dallas Cowboys running back) did it, so I think we should try it.

Dorsett underwent a procedure where stem cells were extracted from his own stomach fat then cultured and multiplied with the help of a serum derived from cattle. The cells were then purified and injected back into him, about 200 million at a time, in Cancun.

When I was taking the stem cells, I was able to figure things out a little better and not get as frustrated, Dorsett told USA TODAY Sports in November of 2015. But Dorsett also admitted the effects of the therapy faded over time.

Stem cell treatments are largely untested and unproven by U.S. standards. In general, the FDA has a critical threshold for adult stem cell therapies.

If the cells are more than minimally manipulated when extracted from a patients body, they are classified as biological drugs that must go through long and costly testing to make sure they are safe and effective for widespread use in the USA.

Contributing:Brent Schrotenboer and Jarrett Bell

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Paralyzed Easton Teen Seeking Stem Cell Treatment In Bid To … – Wilton Daily Voice

EASTON, Conn. --Hope is a big word in the Standen household in Easton these days.

Through a procedure at the Cell Medicine Institute in Panama, there is a 60 percent to 70 percent chance that Zach Standen a 17-year-old who became paralyzed from the waist down after a car accident last summer may regain some feeling and movement in his legs.

In the procedure, The stem cells are taken from your own bone marrow and human umbilical cords and are re-injected into your body," Zachs mother, Christine Standen, said in a phone interview.

The ultimate goal is for the stem cells from Zach's body to regenerate the nerves and neural connections for him to regain some feeling and function in his legs.

It's extremely important that Zach gets the treatment as soon as possible, his mother said. "He should get the stem cell therapy within a year of the accident since this is when the most healing occurs and before scar tissue is laid down," Christine Standen said. Once this happens, she said, muscle mass is lost and muscles begin to atrophy.

Related story: Easton teen is left paralyzed after car crash.

Zach's family has set up a GoFundMe page to raise the nearly $40,000 needed to pay for the treatment. So far, the page has been shared 687 times. With 313 donations, it has raised $18,194 out of a $100,000 goal.

The family is hoping to raise enough money to get Zach two stem cell treatments, which would greatly increase his chances for recovery.

In addition, a fundraiser has been established to benefit the cause for Zach. Through Feb. 28, a total of 15 percent of the cost of the Arbonne products from this page will be donated to Zach Standens Stem Cell Therapy Fund.

Zach and his mother, as well as Zachs girlfriend, Constance Rude, plan on taking the month-long trip to Panama.

We are hoping that Zach [who attends Joel Barlow High School in Redding] will get his homework assignments ahead of time," she said, adding that he will most likely have to take summer classes or make up some timein the fall.

In a post on Zachs GoFundMe Page, his mother wrote, As of right now, there has been very little progress physically and I can't see him being like this for the rest of his life. No walking, no bowel or bladder control, no sexual function, no feeling. This is no way to live if we can help it, especially for a 17 year old."

She said Zach's spirits are waning. "He is finding it difficult to study and is trying to maintain hope."

Aside from his medical issues, Zach has the life of a typical teenager he goes to school and hangs out with his friends.

Related story: A family seeks support for treatment for paralyzed son.

Zach goes twice a week to physical therapy at Gaylord Hospital in Wallingford. "He is working really hard, every day," said his mother.

Another fundraiser for Zachwill be a concert by the Grayson Hugh & The Moon Hawks & The Bobby Paltauf Band on March 11 at 7 p.m. at the Fairfield Theatre Company. A total of 25 percent of ticket sales will go toward Zach's Stem Cell Therapy Fund.

Christine Standen said she feels extreme gratitude toward for the support the family has received through this tough time. "We are so grateful to the entire community," she said.

For previous Daily Voice articles on Zach Standen, click here and here .

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Paralyzed Easton Teen Seeking Stem Cell Treatment In Bid To ... - Wilton Daily Voice

Paralyzed Easton Teen Seeking Stem Cell Treatment In Bid To Move Legs Again – Westport Daily Voice

EASTON, Conn. --Hope is a big word in the Standen household in Easton these days.

Through a procedure at the Cell Medicine Institute in Panama, there is a 60 percent to 70 percent chance that Zach Standen a 17-year-old who became paralyzed from the waist down after a car accident last summer may regain some feeling and movement in his legs.

In the procedure, The stem cells are taken from your own bone marrow and human umbilical cords and are re-injected into your body," Zachs mother, Christine Standen, said in a phone interview.

The ultimate goal is for the stem cells from Zach's body to regenerate the nerves and neural connections for him to regain some feeling and function in his legs.

It's extremely important that Zach gets the treatment as soon as possible, his mother said. "He should get the stem cell therapy within a year of the accident since this is when the most healing occurs and before scar tissue is laid down," Christine Standen said. Once this happens, she said, muscle mass is lost and muscles begin to atrophy.

Related story: Easton teen is left paralyzed after car crash.

Zach's family has set up a GoFundMe page to raise the nearly $40,000 needed to pay for the treatment. So far, the page has been shared 687 times. With 313 donations, it has raised $18,194 out of a $100,000 goal.

The family is hoping to raise enough money to get Zach two stem cell treatments, which would greatly increase his chances for recovery.

In addition, a fundraiser has been established to benefit the cause for Zach. Through Feb. 28, a total of 15 percent of the cost of the Arbonne products from this page will be donated to Zach Standens Stem Cell Therapy Fund.

Zach and his mother, as well as Zachs girlfriend, Constance Rude, plan on taking the month-long trip to Panama.

We are hoping that Zach [who attends Joel Barlow High School in Redding] will get his homework assignments ahead of time," she said, adding that he will most likely have to take summer classes or make up some timein the fall.

In a post on Zachs GoFundMe Page, his mother wrote, As of right now, there has been very little progress physically and I can't see him being like this for the rest of his life. No walking, no bowel or bladder control, no sexual function, no feeling. This is no way to live if we can help it, especially for a 17 year old."

She said Zach's spirits are waning. "He is finding it difficult to study and is trying to maintain hope."

Aside from his medical issues, Zach has the life of a typical teenager he goes to school and hangs out with his friends.

Related story: A family seeks support for treatment for paralyzed son.

Zach goes twice a week to physical therapy at Gaylord Hospital in Wallingford. "He is working really hard, every day," said his mother.

Another fundraiser for Zachwill be a concert by the Grayson Hugh & The Moon Hawks & The Bobby Paltauf Band on March 11 at 7 p.m. at the Fairfield Theatre Company. A total of 25 percent of ticket sales will go toward Zach's Stem Cell Therapy Fund.

Christine Standen said she feels extreme gratitude toward for the support the family has received through this tough time. "We are so grateful to the entire community," she said.

For previous Daily Voice articles on Zach Standen, click here and here .

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Paralyzed Easton Teen Seeking Stem Cell Treatment In Bid To Move Legs Again - Westport Daily Voice

INDYCAR legend Foyt plans to have stem cell therapy – IndyCar.com – INDYCAR

(This story originally appeared as exclusive content on the Verizon INDYCAR Mobile app. To download the app for smartphones, click here.)

AVONDALE, Ariz. At 82, A.J. Foyt's body has literally been beaten beyond his years.

The first four-time winner of the Indianapolis 500 has experienced everything from a broken back at a 1964 NASCAR race in Riverside, California, to two badly broken feet and legs in a horrible crash at Road America in a 1991 Indy car race.

Foyt retired from racing on pole qualifying day at the 1993 Indianapolis 500, but retirement hasn't been much easier. He was stung more than 200 times from an attack of killer bees in 2005, trapped under an overturned bulldozer on his Texas ranch in 2007 and had knee replacements and a hip replacement. In November 2014, Foyt underwent triple-bypass heart surgery and remained in the hospital for weeks afterward because of complications.

Foyt has survived it all but not without a struggle. He now is looking for a fountain of youth and told the Verizon INDYCAR Mobile App that he will undergo stem cell therapy in Cancun, Mexico.

They have to cut away some of the tissue from my stomach and it takes 8-10 weeks for it to grow back to produce the stem cells, Foyt said in an exclusive interview. I'll probably have it done soon so that we can begin the treatment within the next two to three months.

Adult stem cells are able to grow and become a cell for a specific tissue or organ, according to the National Institutes of Health. They are different from embryonic stem cells, which come from fertilized eggs or aborted fetuses. Embryonic stem cells can turn into cells for nearly any tissue in the body.

The procedure is not performed in the United States, so Foyt has found a medical facility in Mexico that can do the treatment that regenerates newer and younger cells. He said he will have stem cells injected into each ankle and shoulder, as well as into his blood.

It used to be you would have to go to Germany to get this procedure, but now it's available in Cancun and that is probably where I'll have it done, Foyt said Saturday during the Verizon IndyCar Series open test at Phoenix Raceway. I'm not in good health like I used to be and, if my son Larry hadn't taken over (running) the team four years ago, I would have had to shut it down. It's something he likes to do and I'm backing him 100 percent.

Foyt said he feels good to be his age after all the crap that I've been through.

I feel better this year than I did last year, Foyt continued. If I get to feeling bad, I probably won't show up at the race. But I'm going to do that stem cell deal. My wife, Lucy, has been pretty sick lately. Dan Pastorini (the former NFL quarterback) did it and it helped him. Peyton Manning (the former Indianapolis Colts and Denver Broncos quarterback) did it for his neck and it really helped him. Tony Dorsett (the former Dallas Cowboys running back) did it, so I think we should try it.

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INDYCAR legend Foyt plans to have stem cell therapy - IndyCar.com - INDYCAR

Foyt to undergo stem cell treatment for pain – Racer

For an 82-year-old legend who has broken countless bones, been set on fire a few times, attacked by killer bees, survived a heart bypass and a bout with sepsis, A.J. Foyt looks pretty damn good.

But the first four-time winner of the Indianapolis 500 is tired of hurting, so he's going to Mexico to undergo stem cell treatment.

"I'm going to try it so my ankles and shoulder don't hurt so bad all the time," Foyt said Tuesday afternoon from his ranch in Houston. "I feel better than I have in a long time, and I've lost 20 pounds and I need to lose about 20 more.

"I'm getting better every day but I'd just like to take away some of this constant pain."

His shattering crash at Road America in 1990 has made walking a challenge over the past two decades, and he injured his rotator cuff after falling off his bulldozer a few years ago.

"Hell, I've had my knee and hip replaced so I figure I might as well try this too," he said with a laugh. "I've talked to two or three people that had it done and they said it was great and I talked to Dr. [Terry] Trammell over the weekend and he thinks it's got some merit.

"Peyton Manning, Dan Pastorini and Tony Dorsett all had it done, so why not try it?"

Foyt will go to Cancun for his procedure, but will probably wait until Junebecause he's not about to miss the month of May. He was happy with the first test with his new drivers, Conor Daly and Carlos Munoz, last weekend at Phoenix and watched all four sessions.

"I'm still kicking," he declared, "and cussing when I have to."

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Foyt to undergo stem cell treatment for pain - Racer

Can banking baby teeth treat diabetes? – Fox News

When she was just 11 months old, Billie Sue Wozniaks daughter Juno was diagnosed with type 1 diabetes, an autoimmune disease that affects 1.25 million people and approximately 200,000 children under age 20 in the United States.

The disease had affected several members of Billie Sues family, including her uncle, who passed away at the age of 30.

My first thought was, Her life is going to be short, the 38-year-old from Reno, Nevada recalled. The more that I learned, the more I found that many people with type 1 live longer and the treatment advances are really exciting.

While looking for treatments, Wozniak learned about encapsulation therapy, in which an encapsulated device containing insulin-producing islet cells derived from stem cells is implanted under the skin. The encapsulation device is designed to protect the cells from an autoimmune attack and may help people produce their own insulin.

After learning of the therapy through JDRF, Wozniak saw an ad on Facebook for Store-A-Tooth, a company that offers dental stem cell banking. She decided to move forward with the stem cell banking, just in case the encapsulation device became an option for Juno.

In March 2016, a dentist extracted four of Junos teeth, and sent them to a lab so her stem cells could be cryopreserved. Wozniak plans to bank the stem cells from Junos molars as well.

Its a riskI dont know for sure if it will work out, Wozniak said.

Dental stem cells: a future of possibilities

For years, stem cells from umbilical cord blood and bone marrow have been used to treat blood and bone marrow diseases, blood cancers and metabolic and immune disorders.

Although there is the potential for dental stem cells to be used in the same way, researchers are only beginning to delve into the possibilities.

Dental stem cells are not science fiction, said Dr. Jade Miller, president of the American Academy of Pediatric Dentistry. I think at some point in time, were going to see dental stem cells used by dentistson a daily practice.

Dental stem cells have the potential to produce dental tissue, bone, cartilage and muscle. They may be used to repair cavities, fix a tooth damaged from periodontal disease or bone loss, or even grow a tooth instead of using dental implants.

In fact, stem cells can be used to repair cracks in teeth and cavities, according to a recent mouse study published in the journal Scientific Reports.

Theres also some evidence that dental stem cells can produce nerve tissue, which might eliminate the need for root canals. A recent study out of Tufts University found that a collagen-based biomaterial used to deliver stem cells to the inside of damaged teeth can regenerate dental pulp-like tissues.

Dental stem cells may even be able to treat neurological disorders, spinal cord and traumatic brain injuries.

I believe those are the kinds of applications that will be the first uses of these cells, said Dr. Peter Verlander, Chief Scientific Officer for Store-A-Tooth.

When it comes to treating diseases like type 1 diabetes, dental stem cells also show promise. In fact, a study in the Journal of Dental Research found that dental stem cells were able to form islet-like aggregates that produce insulin.

Unlike umbilical cord blood where theres one chance to collect stem cells, dental stem cells can be collected from several teeth. Also, gathering stem cells from bone marrow requires invasive surgery and risk, and it can be painful and costly.

The stem cells found in baby teeth, known as mesenchymal cells, are similar to those found in other parts of the body, but not identical.

There are differences in these cells, depending on where they come from, Verlander said.

Whats more, mesenchymal stem cells themselves differ from hematopoietic, or blood-forming stem cells. Unlike hematopoietic stem cells, mesenchymal stem cells can expand.

From one tooth, we expect to generate hundreds of billions of cells, Verlander said.

Yet the use of dental stem cells is not without risks. For example, theres evidence that tumors can develop when stem cells are transplanted. Theres also a chance of an immune rejection, but this is less likely if a person uses his own stem cells, Miller said.

The process for banking stem cells from baby teeth is relatively simple. A dentist extracts the childs teeth when one-third of the root remains and the stem cells are still viable. Once the teeth are shipped and received, the cells are extracted, grown and cryopreserved.

Store-A-Tooths fees include a one-time payment of $1,749 and $120 per year for storage, in addition to the dentists fees for extraction.

For families who are interested in banking dental stem cells, they should know that theyre not necessarily a replacement for cord blood banking or bone marrow stem cells.

Theyre not interchangeable, we think of them as complementary, Verlander said.

Although the future is unclear for Junowho was born in 2008her mom is optimistic that shell be able to use the stem cells for herself and if not, someone else.

Ultimately, however, Wozniak hopes that if dental stem cells arent the answer, there will be a biological cure for type 1 diabetes.

I hold out hope that somewhere, someone is going to crack the code, she said.

Julie Revelant is a health journalist and a consultant who provides content marketing and copywriting services for the healthcare industry. She's also a mom of two. Learn more about Julie at revelantwriting.com.

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Can banking baby teeth treat diabetes? - Fox News

Stem cell treatment for baldness showing signs of success – WLS-TV

Americans spend between one and four billion dollars a year treating hair loss. Now, four surgeons in the U.S. are testing a stem cell treatment in a non-surgical procedure, and overseas trials in Japan and Egypt are already showing some success.

"It's been thirty years of concern," said Roy Woelke.

Doctor Kenneth Williams may have new hope for Roy and millions of others. He's running a clinical trial that uses stem cells and platelet-rich plasma, or PRP, to treat baldness.

"The study is taking cells that are in our body that help to regenerate or stimulate inactive or dormant hair follicles. That is the theory behind what we're doing this procedure on," said Dr. Williams.

Dr. Williams takes fat from the abdomen, emulsifies it and separates the stem cells, mixes it with the patient's own plasma which has been spun down to be super concentrated. Then, with 300 shots, injects the mixture into the scalp, twice over a three-month period. Roy hopes to get into the trial, which has five participants so far. Dr. Williams already does the procedure for paying patients who've had promising results.

Dr. Williams hopes to publish results in two years.

Doctor Williams' trial is supported by NIH, but not by a major pharmaceutical company yet. That means his trial is patient-funded, meaning they'll pay a reduced cost of the $2,500 to $5,800 procedure, depending on which arm of the trial is chosen. Contact the Irvine Institute of Medicine and Cosmetic Surgery at (949) 333-2999 or visit http://www.straandstudy.com for more information.

If you would like more information, check out the medical breakthroughs on the web at http://www.ivanhoe.com.

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Stem cell treatment for baldness showing signs of success - WLS-TV

Genetic profiling can guide stem cell transplantation for patients with myelodysplastic syndrome, study finds – Science Daily

Genetic profiling can guide stem cell transplantation for patients with myelodysplastic syndrome, study finds Science Daily "Although donor stem cell transplantation is the only curative therapy for MDS, many patients die after transplantation, largely due to relapse of the disease or complications relating to the transplant itself," said the study's lead author, R. Coleman ... and more »

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Genetic profiling can guide stem cell transplantation for patients with myelodysplastic syndrome, study finds - Science Daily

‘Economical stem cell treatment will revolutionise medicine’ – The Hindu

Cost-effective stem cell treatment has to be the next revolution to transform personalised treatment of patients, said Hunterian Professorship Awardee A.A.Shetty. Speaking at a felicitation function, Dr. Shetty said there is a need to create awareness about stem cells and patient-specific treatment specifically designed for individuals.

It is going to be simple, with minimal complications. Our role is to make it cost effective. Once it happens, it will revolutionise treatment, said Dr. Shetty.

Surgery using stem cell technology is developing at a rapid pace and the role of stem cell therapy in Orthopaedics is gaining importance, said Trauma and Orthopaedic Speciality Hospital (TOSH) Managing Director S.H. Jaheer Hussain. The ability of stem cells to transform into bone and cartilage has given a new dimension in the treatment of osteoarthritis, fracture non union, ligament tears. Stem cells have shown significant clinical results in osteoarthritis and cartilage defects. Recent advances in stem cells centrifuging techniques have lead to the introduction of the new concept of single- stage knee cartilage regeneration.

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'Economical stem cell treatment will revolutionise medicine' - The Hindu