Stem Cell Clinic

Mayo researcher Abba Zubair is sending stem cells for study on the … – Florida Times-Union

By Stem Cell Clinic

As a boy growing up in Nigeria, Abba Zubair dreamed of becoming an astronaut.

But as he prepared to apply to college, an adviser told him to find a different path.

He said it may be a long time before Nigeria sends rockets and astronauts into space, so I should consider something more practical, Zubair saud.

He decided to become a physician, and is currently the medical and scientific director of the Cell Therapy Laboratory at the Mayo Clinic in Jacksonville. And while hell almost certainly never get to make a journey outside the Earths atmosphere himself, if the weather stays good Saturday hell be sending a payload into space.

A SpaceX Falcon 9 rocket is scheduled to launch at 10:01 a.m. Saturday from the Kennedy Space Center on a cargo delivery mission to the International Space Station. Among the cargo it will be carrying are several samples of donated adult stem cells from Zubairs research lab.

Zubair believes adult stem cells, extracted from bone marrow, are the future of regenerative medicine. Currently at the Mayo Clinic in Jacksonville they are being used in clinical trials to treat knee injuries and transplanted lungs.

But a big problem with using stem cells to treat illnesses is that it may require up to 200 million cells to treat a human being and the cells take a long time to reproduce. Based on studies using simulators on Earth, Zubair believes that the stem cells will more quickly mass produce in microgravity.

Thats the hypothesis hell be testing as the stem cells from his lab spend a month aboard the space station. Astronauts will conduct experiments measuring changes in the cells. They will then be returned on an unmanned rocket and Zubair will continue to study them in his lab.

We want to understand the process by which stem cells divide so we can grow them at a faster rate and also so we can suppress them when treating cancer, he said.

Zubair became interested in the idea of sending stem cells into space four years ago, when he learned of a request for proposals that involved medicine and outer space. Hes been trying to arrange to send stem cells into space for three years.

In May 2015, he sent stem cells to the edge of space as a hot-air balloon carried a capsule filled with cells from his lab to about 100,000 feet then dropped the capsule. The idea was to test how the cells handled re-entry into the Earths atmosphere.

It turned out well, he said. The cells were alive and functioning.

Zubair was supported in that effort as he is being supported in sending cells to the space station by the Center for Applied Spacee Technology. Its chief executive is Larry Harvey, a retired Navy pilot and former astronaut candidate who lives in Orange Park.

While stem cells have myriad potential medical applications, one that particularly interests Zubair is the use of them in treating stroke patients. Its a personal cause to Zubair, whose mother died of a stroke in 1997.

Weve shown that an infusion of stem cells at the site of stroke improves the inflammation and also secretes factors for the regeneration of neurons and blood vessels, he said.

Zubair hasnt entirely given up on his old dream of being an astronaut. Hes applied for the civilian astronaut program. But he doesnt expect that to happen.

Im not sure I made the cut, he said. I just wanted to apply.

And he realizes what a long, strange trip hes made.

I have come so far from Africa to here, he said, and now Im sending stem cells into space.

Charlie Patton: (904) 359-4413

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Mayo researcher Abba Zubair is sending stem cells for study on the ... - Florida Times-Union

THON by the numbers: An anaylsis of the work done and the funds raised – The Daily Collegian Online

By Stem Cell Clinic

With THON merely hours away, lets take a look at the massive event by the numbers. One thing is certain: the statistics are remarkable.

Two-thirds of all money raised since THONs inception in 1977 has been raised in the past 10 years.

Since 2007, THON has raised over $93 million dollars for Four Diamonds, according to the Four Diamonds annual financial reports.

Four Diamonds provides financial and medical assistance to children with pediatric cancer and their families, specifically for care and treatment not covered by insurance or other means as well as additional expenses that disrupt the welfare of the children.

According to Four Diamonds website, 100 percent of all patients bills are covered.

However, the Four Diamonds does not just cover the treatment bills for kids with pediatric cancer. Four Diamonds also enables specialty care providers to be made exclusively available to patients and their families. These specialty care providers offer psychological care, nutritional care, social work such as transportation assistance, musical therapy to help cope with hospital settings and pastoral care for spiritual and religious needs.

Based on the information aggregated from Four Diamonds annual financial and impact reports, Four Diamonds on average takes in and provides funding for treatment for about 93 new patients per year and provides funding for treatment for about 558 patients per year total.

The funding Four Diamonds has received has allowed them to fund researchers and research initiatives for fighting and treating cancer. Specifically, funds from THON have allowed for the creation of stem cell transplant clinic, a pediatric cancer experimental therapeutics research program.

Gil Pak, the Operations Director for the Hershey Childrens Hospital, said the fundraising from

THON is one of the primary contributors to research funding.

The original goal of the Millards, when they founded Four Diamonds was to assist families, but with the fundraising success of THON and Mini-THONs we can go beyond that and invest in research, Pak said. Providing assistance to families will always be the main goal, but now we can go beyond just helping families and help find a cure.

From 2007 to 2014 the funds raised by THON increased steadily. In 2007 THON raised $4,497,001, but by 2012 THON was raising eight figure sums and in 2014 THON raised a record breaking $13.3 million in funds.

However, the last couple years saw a dip in funds raised by THON.

Despite Four Diamonds receiving record of $20 million in 2015, THON actually experienced a slight drop in fundraising from the previous year.

In 2015 THON raised $12,732,897, about $60 thousand less than 2014 when THON raised a record breaking $13,336,675.

Funds raised for the Four Diamonds by THON 2016, $10,262,256 was the lowest since THON 2011 when it raised, $9,266,841.

The cutbacks on canning in 2015 to 2016 (THON 2016 but the 2015-2016 Annual Financial Report), following the death of Vitalya Tally Sepot, a sophomore at Penn State, in September of 2015, may have been one of the factors that led to THON raising less money that year.

Sepots death sent shockwaves through the Penn State community and caused THON to evaluate the safety of canning trips. Several canning trips were cancelled by THON organizers due to concerns about less than ideal weather or other safety concerns.

Other factors could be at play as well. The drop in funds raised could also be that it is just difficult for those canning and participating in other fundraising events to continue raising money that will top the previous years eight figure sums. One student quoted in a previous report by The Daily Collegian said that the number of people canning in the same areas made it more competitive.

However, as reported previously by The Daily Collegian, many of those participating THON do not see topping the previous year's funds as important as how much the funds are benefiting kids with childhood cancer.

Even though funds raised by THON have decreased over the last couple years, the funds raised by Mini-THONs have steadily increased each year.

In 2007, Mini-THONs which are as events similar to THON that are held in elementary schools, middle schools, high schools and colleges, raised $624,246, but by 2016 though less than a decade later funds the funds raised were $5,497,215, about 8.8 times the funds raised by Mini-THONs in 2007.

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THON by the numbers: An anaylsis of the work done and the funds raised - The Daily Collegian Online

New Nanofiber Matrix Enhances Stem Cell Production – Drug Discovery & Development

By Embryonic Stem Cells

A new nanofiber-on-microfiber matrix could lead to more and better quality stem cells for disease treatment and regenerative therapies.

The matrix, produced by researchers from Kyoto University in Japan, is made of gelatin nanofibers on a synthetic polymer microfiber mesh and may provide a better way to culture large quantities of healthy human stem cells.

Researchers have been developing 3D culturing systems to allow human pluripotent stem cells (hPSC) to grow and interact with their surroundings in all three dimensions, as they would inside the human body, rather than in two dimensions like they do in a petri dish.

Pluripotent stems cells can differentiate into any type of adult cell and have potential for tissue regeneration therapies, treating diseases and for research.

The majority of 3D culturing systems have limitations and result in low quantities and quality of cultured cells.

The research team was able to fabricate gelatin nanofibers onto a microfiber sheet made of synthetic, biodegradable polyglycolic acid. They then seeded human embryonic stem cells onto the matrix in a cell culture medium.

The matrix allowed for an easy exchange of growth factors and supplements from the culture medium to the cells.

The stem cells also adhered well to the matrix, resulting in robust cell growth. After four days of culture more than 95 percent of the cells grew and formed colonies.

The research team also scaled up the process by designing a gas-permeable cell culture bag in which multiple cell-loaded, folded fiber-to-fiber matrices were placed.

The system was designed so that minimal changes were needed to the internal environment, which reduced the amount of stress placed on the cells. This also yielded a large number of cells compared to conventional 2D and 3D culture methods.

Our method offers an efficient way to expand hPSCs of high quality within a shorter term, the research team wrote in a statement. Additionally, as nanofiber matrices are advantageous for culturing other adherent cells, including hPSC-derived differentiated cells, FF matrix might be applicable to the large-scale production of differentiated functional cells for various applications.

According to the study, clinical-grade scaffolds and high-quality hPSCs are required for cell expansion as well as easy handling and manipulation of the products.

Current hPSC culture methods do not fulfill these requirements because of a lack of proper extracellular matrices (ECM) and cell culture wares.

The layered nano-on-micro fibrous cellular matrix mimicking ECM enables easy handling and manipulation of cultured cells.

The results show that the matrix supports effective hPSC culture with maintenance of their pluripotency and normal chromosomes over two months, as well as effective scaled-up expansion with fold increases of 54.115.6 and 40.48.4 in cell number per week for H1 human embryonic stem cells and 253G1 human induced pluripotent stem cells, respectively.

The study was published in Biomaterials.

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New Nanofiber Matrix Enhances Stem Cell Production - Drug Discovery & Development

How does the Catholic Church resolve new bioethical questions? – Catholic Free Press

By Embryonic Stem Cells

Father Tadeusz Pacholczyk

By Father Tadeusz Pacholczyk

A number of years ago, I participated in a debate at Harvard on embryonic stem cell research which also included a Jewish rabbi, an Episcopalian clergyman, and a Muslim imam. The debate went smoothly and cordially, although I was the only voice in the group who defended the human rights of individuals who happen still to be embryos. After the debate, the Episcopalian clergyman pulled me aside and told me how he thought Catholics should consider themselves fortunate to have such an authoritative reference point in the Church and the Vatican, particularly when it comes to resolving new bioethical questions. With surprising candor, he shared how he had sat on various committees with others from his own faith tradition where they had tried to sort through the ethics of embryonic stem cells, and he lamented, we just ended up discussing feelings and opinions, without any good way to arrive at conclusions.

Many people, indeed, appreciate that the Catholic Church holds firm and well-defined positions on moral questions, even if they may remain unsure about how or why the Church actually arrives at those positions, especially when it comes to unpacking new scientific developments like embryonic stem cell research.

So how does the Church arrive at its positions on bioethics? For one thing, it takes its time, and doesnt jump to conclusions even in the face of media pressure for quick sound bites and rapid-fire news stories.

I once had a discussion with a journalist for a major newspaper about the ethics of human-animal chimeras. He mentioned that a leading researcher working on chimeras had met the pope and afterwards implied that the pope had given his blessing to the project. I reminded him that its quite common for the pope to offer general encouragement and blessings to those he meets, though that wouldnt be the same thing as sanctioning new and morally controversial techniques in the biosciences. As a rule, the Catholic Church does not address important bioethical questions that way, through chance encounters with the pope as you are strolling through the hallways of the Vatican.

Instead, the Church may reflect for months, years, or even decades, to identify important considerations and guiding principles when new moral dilemmas arise in the biosciences. Even with this slow and deliberative process, I think its fair to say that the Church generally stays ahead of the curve. By the time of the successful cloning of Dolly the sheep in 1996, for example, the Catholic Church had already been reflecting on the question of human cloning for many years, and concluded, nine years prior to Dolly, that human cloning would be morally unacceptable in an important document called Donum Vitae (On the Gift of Life).

This same document also identified key moral problems with doing human embryonic stem cell research 11 years before it was even possible to destructively obtain those cells from human embryos. When the first test tube baby was born in 1978, the serious moral concerns raised by the procedure had already been spelled out twenty-two years earlier, by Pope Pius XII, in his 1956 Allocution to the Second World Congress on Fertility and Human Sterility wherein he concluded: As regards experiments of human artificial fecundation in vitro, let it be sufficient to observe that they must be rejected as immoral and absolutely unlawful.

Whenever definitive conclusions about medical ethics are reached or otherwise clarified by the Church, they are normally promulgated through official Church documents, like papal encyclicals and addresses, or, with the approval of the pope, documents and commentaries from the Congregation for the Doctrine of the Faith (CDF the Vatican office responsible for preserving and interpreting Catholic doctrine), or other congregations, councils or dicasteries of the Church.

Even today, certain bioethical controversies remain under active discussion within the Church, such as the question of whether it would be allowable to adopt abandoned frozen embryos by implanting and gestating them in volunteer mothers. While a 2007 CDF document expressed some reservations and concerns about the proposal, debate continues inside and outside the Vatican.

New medical discoveries and technological developments challenge us to careful moral reflection and discernment. These scientific developments can either be an opportunity for genuine human advancement or can lead to activities and policies that undermine human dignity. The U.S. Bishops in a recent document summed it up this way: In consultation with medical professionals, church leaders review these developments, judge them according to the principles of right reason and the ultimate standard of revealed truth, and offer authoritative teaching and guidance about the moral and pastoral responsibilities entailed by the Christian faith. While the Church cannot furnish a ready answer to every moral dilemma, there are many questions about which she provides normative guidance and direction.

Rev. Tadeusz Pacholczyk, Ph.D. earned his doctorate in neuroscience from Yale and did post-doctoral work at Harvard. He is a priest of the diocese of Fall River, MA, and serves as the Director of Education at The National Catholic Bioethics Center in Philadelphia. See http://www.ncbcenter.org

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How does the Catholic Church resolve new bioethical questions? - Catholic Free Press

Mayo researcher Abba Zubair is sending stem cells for study on the International Space Station – St. Augustine Record

By Uncategorized

As a boy growing up in Nigeria, Abba Zubair dreamed of becoming an astronaut.

But as he prepared to apply to college, an advisor told him to find a different path.

He said it may be a long time before Nigeria sends rockets and astronauts into space, so I should consider something more practical, Zubair saud.

He decided to become a physician, and is currently the medical and scientific director of the Cell Therapy Laboratory at the Mayo Clinic in Jacksonville. And while hell almost certainly never get to make a journey outside the Earths atmosphere, if the weather stays good Saturday hell be sending a payload into space.

A SpaceX Falcon 9 rocket is scheduled to launch at 10:01 a.m. Saturday from the Kennedy Space Center on a cargo delivery mission to the International Space Station. Among the cargo it will be carrying are several samples of donated adult stem cells from Zubairs research lab.

Zubair believes adult stem cells, extracted from bone marrow, are the future of regenerative medicine. Currently at the Mayo Clinic in Jacksonville they are being used in clinical trials to treat knee injuries and transplanted lungs.

But a big problem with using stem cells to treat illnesses is that it may require up to 200 million cells to treat a human being and the cells take a long time to reproduce. Based on studies using simulators on Earth, Zubair believes that the stem cells will more quickly mass produce in microgravity.

Thats the hypothesis hell be testing as the stem cells from his lab spend a month aboard the space station. Astronauts will conduct experiments measuring changes in the cells. They will then be returned on an unmanned rocket and Zubair will continue to study them.

Zubair became interested in the idea of sending stem cells into space four years ago, when he learned of a request for proposals that involved medicine and outer space. Hes been trying to arrange to send stem cells into space for three years.

In May 2015, he sent stem cells to the edge of space as a hot-air balloon carried a capsule filled with cells from his lab to about 100,000 feet then dropped the capsule. The idea was to test how the cells handled re-entry into the Earths atmosphere.

It turned out well, he said. The cells were alive and functioning.

Zubair was supported in that effort as he is being supported in sending cells to the space station by the Center for Applied Science Technology. Its chief executive is Lee Harvey, a retired Navy pilot and former astronaut candidate who lives in Orange Park.

While stem cells have myriad potential medical applications, one that particularly interests Zubair is the use of them in treating stroke patients. Its a personal cause to Zubair, whose mother died of a stroke in 1997.

Weve shown that an infusion of stem cells at the site of stroke improves the inflammation and also secretes factors for the regeneration of neurons and blood vessels, he said.

Zubair hasnt entirely given up on his old dream of being an astronaut. Hes applied for the civilian astronaut program. But he doesnt expect that to happen.

Im not sure I made a cut, he said. I just wanted to apply.

And he realizes what a long, strange trip hes made.

I have come so far from Africa to here, he said, and now Im sending stem cells into space.

Charlie Patton: (904) 359-4413

The rest is here:
Mayo researcher Abba Zubair is sending stem cells for study on the International Space Station - St. Augustine Record

Local vet taking part in stem cell therapy study for dogs – WPTV.com

By Uncategorized

TARPON SPRINGS, Fla. - Cosby just doesnt get around like he used to.

We have six dogs and hes always the one thats the last to get up. The last to get out, said his owner Brian Cirillo.

And for Cirillo, its sad to see.

I hate it. Its always like he always on his tippy topes on his back legs. So its heartbreaking.

But a new trial study that is about to start at the St. Francis Pet Care Center in Tarpon Springs, could be just what Cosby needs.

Veterinarian Mike Amsberry is offering stem cell therapy for dogs.

They are seeing that its very, very safe. And very effective.

This study is focused specifically on four-legged friends with arthritis.

But in the past hes seen stem cell treatments work wonders for other ailments.

Its cells treating the body, rather than then some foreign substance. Some medication.

In this trial, the stem cells come from umbilical cords of donor dogs.

Not only can qualified pets get the treatment for free, but owners are paid too.

Cosby seems like the perfect candidate.

I think thats where everything seems to be going with regard to medicine. So to be on the leading edge of that to potential help him without having to put him on a bunch of medicine is definitely a plus, said Cirillo.

The hope is one day Cosby will be able to keep up with the rest.

And lead the way to help thousands of other dogs.

For more information on the trial study go to petstemcells.org.

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Local vet taking part in stem cell therapy study for dogs - WPTV.com

Mesoblast’s cell therapy candidate MPC-300-IV shows positive effect in mid-stage study in treatment-resistant … – Seeking Alpha

By Uncategorized

A Phase 2 clinical trial assessing Mesoblast's (NASDAQ:MESO) allogeneic cell therapy candidate MPC-300-IV in patients with rheumatoid arthritis (RA) who have not responded to anti-Tumor Necrosis Factor (TNF) therapy [e.g., AbbVie's Humira (adalimumab)] showed a durable improvement in symptoms, physical function and disease activity with no safety signals observed.

The study enrolled 48 patients with active RA who were on a stable regimen of methotrexate and had an inadequate response to at least one anti-TNF agent. 63% (n=30/48) has received 1 - 2 biologic agents. Participants were randomized to receive a single infusion of 1MMesenchymal Precursor Cells(MPCs)/kg (n=16), 2M MPCs/kg (n=16) or placebo (n=16). The primary study period was 12 weeks and the total study duration was 52 weeks.

Both doses of MPC-300-IV outperformed placebo at both week 12 and week 39 as measured by ACR20/50/70 (ACR20 = 20% improvement in RA symptoms). The 2M-cell cohort showed the greatest response. At week 12, for example, 27% of the 2M-cell group achieved ACR70 compared to 0% for placebo. The proportion was 36% in the subgroup (n=11) who had received 1 - 2 biologics. The treatment effect was maintained through week 39.

The clinical development of MPC-300-IV is ongoing.

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Mesoblast's cell therapy candidate MPC-300-IV shows positive effect in mid-stage study in treatment-resistant ... - Seeking Alpha

Capricor Drops Cenderitide to Focus on Cell and Exosome Therapies – Genetic Engineering & Biotechnology News

By Uncategorized

Capricor Therapeutics is dropping further development of its Phase II-stage heart failure drug Cenderitide and is terminating its license agreement with the Mayo Clinic for the natriuretic peptide receptor agonist program. "Our decision to return these rights is a strategic move as we prioritize our efforts to advance our core cell and exosome-based therapeutic development programs," said Linda Marbn, Ph.D., Capricor president and CEO.

Capricor said it expects to reach key clinical milestones with both the cell and exome therapy programs during 2017. Topline data from the Phase I/II HOPE clinical study with lead cell therapy candidate CAP-1002 (allogeneic cardiosphere-derived cells) is expected during Q2 2017. The trial is evaluating CAP-1002 in patients with Duchenne muscular dystrophy (DMD)-associated heart disease. The firm said it is separately planning a clinical trial, anticipated to start during 2017, to investigate whether CAP-1002 therapy can boost skeletal muscle function in men and boys with DMD.

We are also committing increased attention to our exosomes program, and we expect to file an IND application for CAP-2003 (cardiosphere-derived cell exosomes) in the second half of this year," added Dr. Marbn. Capricor is developing CAP-2003 for the potential treatment of ophthalmic disorders, including ophthalmic graft-versus-host disease (oGvHD).

CAP-1002 is an allogeneic cardiac cell therapy product manufactured from donor heart tissue. The treatment has been granted orphan drug designation by the FDA for the treatment of DMD. Capricor and partner Janssen Biotech are developing a commercial manufacturing process for CAP-1002 as part of their potentially $337.5 million collaboration, established in January 2014, to develop the cell therapy program for cardiovascular applications. In May of last year, Capricor received a $3.8 million grant from the California Institute for Regenerative Medicine to support the Phase I/II HOPE study.

CAP-2003 exosomes are obtained from CAP-1002 cardiosphere-derived cells (CDCs). The exosome technology is being developed under a 2014 license agreement with the Cedars-Sinai Medical Center. In October 2016, Capricor was granted up to $4.2 million from the NIH to evaluate CAP-2003 exosome therapy for treating hypoplastic left heart syndrome. The previous month the firm received a $2.4 million grant from the U.S. Department of Defense to establish a commercial manufacturing platform for CAP-2003.

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Capricor Drops Cenderitide to Focus on Cell and Exosome Therapies - Genetic Engineering & Biotechnology News

Stem cell therapy treatment gives new lease of life to 5-year-old – Avenue Mail

By Uncategorized

Stem cell therapy treatment gives new lease of life to 5-year-old Jamshedpur February 17, 2017 , by Desk 104

Ranchi : Till very recently, it was believed that brain damage is irreversible. However, now with emerging research; we understand that it is possible to repair the damaged brain tissue using cell therapy.

Again, today there are still many people in India who have not preserved their stem cells through cord blood banks. For all those patients, who have lost their hopes in finding a new treatment for neurological related disorders, adult stem cell therapy offers a new hope for such kind of patients.

Dr Alok Sharma, Director, NeuroGen Brain and Spine Institute, Professor and Head of Neurosurgery, LTMG Hospital & LTM Medical College, Sion said Stem cell therapy is emerging as one of the newer treatment options for conditions like Autism, Cerebral Palsy, Mental retardation, Muscular Dytrophy, Spinal Cord Injury, Paralysis, Brain Stroke, Cerebellar Ataxia and Other Neurological Disorders. This treatment has the potential to repair the damaged neural tissue at molecular, structural and functional level.

Dr. NandiniGokulchandran, Deputy Director, Neurogen Brain and Spine Institute saidStem Cell Therapy (SCT) done at NeuroGen Brain and Spine Institute is a very simple and safe procedure. Stem Cells are taken from patients own bone marrow with the help of one needle and are injected back in their Spinal Fluid after processing.

Since they are taken from the patients own body there is no rejection, no side effects, hence making SCT a completely safe procedure.

Today, we are presenting a case study of Ranchi based 5 yrs old Master Dhairya Singh. He is a known case of brain damage due to lack of oxygen but not during birth. Dhairya was born in a normal manner, cried immediately after birth also his birth weight was appropriate.

There were no immediate post-natal complications reported. Dhariya was a normal child till the age of one and half years old. Then one day he suffered from an episode of pneumonia for which he was hospitalized for 6 days.

Last updated:Friday, February 17, 2017

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Stem cell therapy treatment gives new lease of life to 5-year-old - Avenue Mail

Takeda, TiGenix stem cell therapy shows sustained effect – FierceBiotech

By Stem Cell Treatment

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

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