Category Archives: Kansas Stem Cells

Emily Dumler, a 36-year-old mother of three, is petite, energetic and appears to be the very picture of health. To look at her, youd never know that four years ago she was at deaths door.

Her symptoms struck out of the blue in the middle of the day. It was lunchtime and her kids were with her. Her husband, a medical device salesman, was at work. Dumler called him and told him she needed to go to urgent care right away.

My blood wasnt clotting properly and so I went into urgent care and then ended up in the hospital for 43 days, Dumler says.

Initially, she was diagnosed with ITP, a disorder that leads to excessive bleeding caused by low levels of platelets. It turned out she had something else: non-Hodgkins lymphoma, a blood cancer.

Dumler wound up undergoing six rounds of outpatient chemotherapy, one round every three weeks. The initial results looked good. The cancer appeared to be gone. But it wasnt. It came roaring back.

In January 2015, she underwent a stem cell transplant using her own stem cells at M.D. Anderson Cancer Center in Houston.

They just basically wreck your body so much that you almost are basically dying, and then they give you your stem cells back just to keep you alive, Dumler says of the stem cell therapy.

She lost 20 pounds in a matter of weeks. And then came the bad news: the transplant failed. At that point, she was pretty much out of options. Her only hope was getting into a clinical trial at M.D. Anderson for an experimental treatment. It had just begun and luckily she qualified.

I was the third patient in the world to be in this trial, which is called CAR T-cell therapy, Dumler says.

Reengineering the body's own cells

CAR: Its a mouthful, but it stands for chimeric antigen receptors. The therapy involves removing a patients T cells, a type of white blood cell, and genetically engineering them to recognize and attack the patients tumors. The T cells are then put back into the patients body.

Dr. Joseph McGuirk is director of blood cancers and stem cell transplants at the University of Kansas Cancer Center. McGuirk oversaw a CAR-T clinical trial at KU that showed promising results.

When patients develop cancer, the T-cells have failed to do their job, because part of their job is surveillance for misbehaving cells or abnormally shaped cells recognize that and attack and destroy them, McGuirk explains.

Unlike traditional intensive chemotherapies or radiation, CAR-T re-arms patients immune systems, allowing them to do the work. It is, says McGuirk, a revolution in cancer medicine thats ongoing right now.

Just last week, the U.S. Food and Drug Administration for the first time approved a CAR-T therapy, in that case to treat kids and young adults with leukemia.

KUs clinical trial involved patients like Dumler with an extremely aggressive form of non-Hodgkins lymphoma. One of those patients, a 47-year-old Australian who traveled to KU to undergo CAR-T therapy in late 2015, died last year. But a significant percentage of patients nearly half achieved complete remissions.

It is a keyhole view into this extraordinary future thats coming down the line in cancer medicine, McGuirk says.

Costly treatment

The KU clinical trial is no longer accepting patients. But now that the FDA has approved CAR-T therapy, KU is expected to be one of the few facilities to offer it.

While CAR-T therapy has delivered impressive results and may eventually be approved for solid tumors, its extremely expensive.

When we talk about the cost of treatment, there's going to be the cost of the drug itself, there's going to be the cost, from the hospital side, of preparing the patient and then giving the treatment, and then there's going to be the cost of actually administering the treatment, says Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society.

In fact, Novartis, the drugmaker behind the FDA-approved treatment, has priced it at $475,000. And some patients, after showing promising results, have died from the side effects of CAR-T therapy.

Because as the CAR-T cells begin to get into the body, as they begin to attack the cancer, then there's the release of various proteins and other substances into the bloodstream that can actually cause, sometimes, fatal events, Lichtenfeld explains.

Emily Dumler got her CAR-T treatment on July 13, 2015, just over two years ago. And she did have side effects. One of them was neurotoxicity: basically her brain fogged up.

And it's just a little unnerving to be outside of what you can, I don't know, cognitively understand, so I did experience not knowing anything, Dumler says.

But the side effects eventually dissipated. And now, Dumler says, she feels great.

I actually just had my two-year scans in Houston a couple of weeks ago and Im still in remission today, Dumler says.

Before her brush with death, Dumler had been a stay-at-home mom. Now shes director of religious education at the Catholic church she attends.

She says she might have wound up taking the job anyway. But having gone through what shes gone through, she now says she felt called to do it.

Dan Margolies is KCURs health editor. You can reach him on Twitter @DanMargolies.

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Shawnee Woman Was Among First In The World To Undergo New FDA-Approved Cancer Therapy - KCUR

A virus feared for its effect on the brains of the unborn might hold a key to treating a deadly form of adult brain cancer.

The Washington University School of Medicine in St. Louis on Tuesday said the Zika virus has shown it may be useful in attacking glioblastoma cancer cells.

The university collaborated with the University of San Diego School of Medicine in the research that shows the Zika virus kills brain cancer stem cells.

Zika attacks the brains of developing fetuses, leading to small and misshapen heads. The research indicates that ability can also be directed against cancer cells.

We showed that Zika virus can kill the kind of glioblastoma cells that tend to be resistant to current treatments and lead to death, Michael S. Diamond at Washington University said in a release announcing the findings, which were published Tuesday in The Journal of Experimental Medicine.

Glioblastoma is the most common form of brain cancer, afflicting about 12,000 people a year, according to the university. U.S. Sen. John McCain of Arizona is one of them.

Glioblastomsa stem cells are often resistant to standard treatment. The study injected glioblastoma tumors with two strains of the Zika virus, and both were effective in killing the stem cells, stopping them from producing more cancer cells. The study suggests that using the virus in conjunction with chemotherapy and radiation has a complementary effect. Chemo and radiation alone leaves stem cells to produce more tumors.

We see Zika one day being used in combination with current therapies to eradicate the whole tumor, Milan D. Chheda of Washington University said in the announcement.

The studys experiments were conducted on mice with tumors. The ones injected with Zika lived significantly longer than mice injected with a placebo.

The BBC and futurism.com also reported on the medical findings.

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Feared Zika virus kills brain cancer stem cells, new research shows - Kansas City Star

Jack Massey is ready to go back to school.

Only this time, the University of Florida senior will head back to campus with his mom and a new outlook on life.

Massey suffered a spinal cord injury in a pool accident in March and is paralyzed from the chest down. After months of rehab, he's eager to get back into a familiar routine.

"It's definitely boring," the 21-year-old said at his parents' home in Niceville. "There's not a lot to do. I want to go back to school. I still have my brain. I still have everything I need to be successful."

After the accident March 17, Massey was treated at the University of Florida Shands Hospital and then was transferred to Shepherd Center, a spinal cord and brain injury rehab center in Atlanta. At Shepherd Center he met with a peer mentor, counselors and physical therapists to help him find a new normal.

Jack has remained positive throughout the past six months.

"Jack has been a fighter through all of this," said his mother, Julie. "I think he's done well. I only saw him break down once."

Before the accident, Jack was a well-rounded athlete who playing baseball and basketball and ran. He was a star on the track and field team at Niceville High School, with his 4 X 800 relay winning state his senior year.

He says the biggest challenge now is not being able to do the same things he could before.

"I can't get up and go," he said. "It didn't really start to set in until after I got out of rehab."

Jack has had to find enjoyment in other things, like reading or playing with the dogs. His friends have learned to transfer him from his wheelchair to a car so they can take him to the movies or out to eat. When they recently took a trip to the beach, Julie said five of Jack's friends carried him out to the sand a lesson on how hard it is to navigate the world in a wheelchair.

Jack said he believes technology one day will advance enough that he won't be paralyzed forever. He also volunteered to do stem cell surgery to allow doctors to study the effects of stem cells on his spine for the next 15 years. Instead of wallowing in self-pity, he's moving forward. But he'll need help.

"I'm appreciating everything in the now," he said.

Doctors have said Jack has adapted faster than expected, but there are still some everyday essential tasks that are out of his reach. He cannot write or cook. He can shower himself but can't dry himself or transfer himself in and out of his wheelchair. The Massey family hopes to secure a personal care attendant for Jack at school, but until then Julie will be in Gainesville to help him transition. An occupational therapy student from the university will also help Jack on a temporary basis.

Finding proper care for her son has proven to be a learning experience for Julie and her husband, Lance.

"I don't know how people do it," she said. "We have good health care, but then there's hidden costs. There's travel expenses. ... It's kind of humbling. Nobody should have to go to GoFundMe for medical help."

Jack wants to spend his final year as an undergrad as independent as possible. After months of helping him recover, Julie said it will be hard to let her son go. Jack is the oldest of three; his brother Lance is 19 and a student at UF and his sister Alina is 14 and attends Ruckel Middle School.

"It's like letting him go off to kindergarten again," she said.

As for life after college, Jack said he doesn't feel limited in career choices. One of his professors in the geology department encouraged him by saying that there were plenty of opportunities he could pursue in that field. Jack said he may also consider law school. One thing he's learned through this life-altering experience is that there are no limits to what he can achieve.

"I haven't done that much deep thinking. I just go with the flow," he said. "But I learned I have more perseverance. I'm more mentally tough than I thought I was. I'm appreciative for life in general. That's one of the big things."

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Paralyzed after pool accident, student heads back to college - Kansas City Star

In July 2013, the Midwest Stem Cell Therapy Center (MSCTC) was created by Kansas Legislature with the mission to facilitate existing research and therapy on a global level, as well as to establish a frontier for other research and therapies for patients suffering from diseases.

Funded initially through State appropriation, the Center also operates off the generosity of donors through the University of Kansas Endowment Association. The 15-member advisory board is composed of members appointed by the governer, the House, Senate, Board of Regents and several other stakeholder entities.

The law creating the center took effect on July 1, 2013. KU Medical Center Executive Vice Chancellor Douglas Girod, M.D. appointed Buddhadeb Dawn, M.D., to serve as the center's executive director. A 15-member advisory has been assembled, with members appointed by the governor, the House, the Senate, the Board of Regents and several other stakeholder entities throughout the state.

Adult stem cell treatments have been used clinically to successfully treat leukemia and related bone/blood cancers using bone marrow transplantation. KU Medical Center has been involved in research using the solid part of the umbilical cord (Wharton's jelly).

Besides KU Medical Center, other institutions around the state have also initiated adult stem cell research projects. However, before the MSCTC, there was no systematic mechanism for Kansans to receive adult stem cell therapy (other than bone marrow transplants for a few conditions) in the state or in the region, nor was there a coordinated center to translate basic stem cell research findings into clinical applications. The MSCTC is also working to educate the public, as well as medical professionals about adult stem cell therapeutic options, currently available or in development, that could benefit patients in need.

In addition to bone marrow transplantation, additional therapies with adult stem cells - including organ repair - have been the focus of intense attention in the scientific community in recent years.

As adult stem cell therapy is becoming more effective, many patientswill benefit. Kansas is well-positioned tocontribute to this burgeoning new field of medicine. Kansas has the opportunity to focus on development of specific areas of adult stem cell research and patient treatment, with the potential to become a world leader in patient therapies for specific diseases or conditions.

Last modified: Aug 01, 2016

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About Us, Midwest Stem Cell Therapy Center - KUMC

The LA Galaxy Foundation has teamed up with Gift of Life Marrow Registry, a club community partner curing blood cancer through marrow and stem cell donation, to co-host Kick Blood Cancer at The Grove in Los Angeles on Sunday, Aug. 13 from 1-4p.m. The event will feature family-friendly games, activities and LA Galaxy appearances in the effort to recruit potential donors to the worldwide marrow registry.

LA Galaxy goalkeeper Jon Kempin, LA Galaxy Star Squad and LA Galaxy mascot Cozmo will be in attendance. Kempin joined LA Galaxy in the off-season and is one of the brightest young talents in the organization, who earned his first MLS shutout earlier this season. He signed his first MLS contract with Sporting Kansas City at the age of 17.

Gift of Life believes every person battling blood cancer deserves a second chance at life and they are determined to make it happen. They are singularly passionate about engaging the public to help get everyone involved in curing blood cancer, whether as a donor, a volunteer or a financial supporter. It all begins with one remarkable person, one life-changing swab and one huge win finding a match and a cure.

For many patients who suffer from leukemia, lymphoma, or other types of blood cancer, transplantation of bone marrow or peripheral blood stem cells donated by unrelated volunteers offers the hope of a cure.

WHAT

Kick Blood Cancer

WHEN

Sunday, Aug. 13

1-4 p.m.

WHERE

The Grove

189 The Grove Drive

Los Angeles, CA 90036

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Join Jon Kempin, LA Galaxy Foundation and Gift of Life Marrow Registry for Kick Blood Cancer on August 13 - LA Galaxy

LONDON--(BUSINESS WIRE)--According to the latest market study released by Technavio, the regenerative medicine market in the US is expected to grow at a CAGR of almost 24% during the forecast period.

This research report titled Regenerative Medicine Market in the US 2017-2021 provides an in-depth analysis of the market in terms of revenue and emerging market trends. This market research report also includes up to date analysis and forecasts for various market segments and all geographical regions.

The regenerative medicine market in the US is expected to grow at a rapid pace during the forecast period. The major factors that are driving the demand for regenerative products are increasing investments in R&D activities and the rising incidence of chronic diseases. Leading vendors have increased their R&D investments to develop innovative medical therapies, which is driving the overall growth of the market. M&A and strategic alliances among vendors will have a significant impact on the market growth.

This report is available at a USD 1,000 discount for a limited time only: View market snapshot before purchasing

Buy 1 Technavio report and get the second for 50% off. Buy 2 Technavio reports and get the third for free.

Technavios healthcare and life sciences research analysts categorize the regenerative medicine market in the US into the following segments by end-user. They are:

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Technavios sample reports are free of charge and contain multiple sections of the report including the market size and forecast, drivers, challenges, trends, and more.

Hospitals

Hospitals are the key end users in the market, which form a partnership with regenerative medicine manufacturing companies to provide cell therapy and tissue scaffolds to improve patient care and treatment. The increasing number of wound treatment, craniomaxillofacial surgery, knee replacement cases, and soft tissue repair has increased the demand for cell therapy and tissue scaffolds in the market.

According to Srinivas Sashidhar, a lead orthopedics and medical devices research analyst from Technavio, Hospitals provide cell therapy in outpatient settings to reduce the cost burden on the patient. The Centers for Medicare and Medicaid Services provides reimbursement to the hospitals based on the Current Procedural Terminology code and the type of cell or tissue scaffold product. A minimal amount is paid to the physician who performs the procedure. Most of the hospitals have budget constraints and are required to reduce medical expenses. This has made many hospitals to avoid purchasing the high-cost regenerative medicines.

ASCs

There is an increased need for monitoring chronic conditions outside hospitals. The growing focus toward offering more consumer-friendly outpatient services and locations has increased the demand for ASCs. Individuals who have received vital signs monitoring in emergency rooms will step into urgent care centers. ASCs have a limited number of suppliers.

The government in the US focuses on reducing overall hospital costs. Governments pay low reimbursements in these centers compared with hospitals, which helps in making profits. In addition, these centers offer better patient care, and people can go through the same services offered in hospitals at a lower cost, which will lead to an increase in surgical procedures in these centers, adds Srinivas.

Regenerative medicine centers

Regenerative medicine centers are certified clinics that offer healthcare services to people. These centers have specialized departments for regenerative medicine, which offer care and treatment. For instance, the Regenerative Medicine Clinic at the Cedars-Sinai Heart Institute offers treatment and consultation for heart patients. For such patient pool, the clinic investigates the effect and efficiency of stem cell therapy.

Kansas Regenerative Medicine Center in the US provides stand-alone stem cell therapy. It offers autologous adipose-derived stem cell treatments. It contains multidisciplinary physicians to provide treatment to the patients. The skilled professionals conduct mini liposuction procedures to isolate and implant patients source of regenerative cells from the fat tissue.

The top vendors highlighted by Technavios research analysts in this report are:

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About Technavio

Technavio is a leading global technology research and advisory company. Their research and analysis focuses on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions.

With over 500 specialized analysts, Technavios report library consists of more than 10,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavios comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

If you are interested in more information, please contact our media team at media@technavio.com.

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Regenerative Medicine Market in the US - Forecasts, Segmentation, and Opportunity Assessment by Technavio - Business Wire (press release)

Washington, DC - infoZine - After a six-hour spaceflight, NASA astronaut Randy Bresnik, Sergey Ryazanskiy of Roscosmos and Paolo Nespoli of ESA (European Space Agency) arrived at the International Space Station at 5:54 p.m. EDT Friday to continue important scientific research in the orbiting laboratory.

The three crewmates launched aboard the Soyuz MS-05 spacecraft from the Baikonur Cosmodrome in Kazakhstan at 11:41 a.m. (9:41 p.m. Baikonur time), orbited Earth four times, and docked at the space station. Following standard pressurization and leak checks, the hatches between the spacecraft and station will be opened.

The newly-expanded Expedition 52 crew soon will conduct new science investigations arriving on SpaceXs 12th NASA-contracted commercial resupply mission targeted to launch in August. Investigations the crew will work on include a study developed by the Michael J. Fox Foundation of the pathology of Parkinsons disease to aid in the development of therapies for patients on Earth. The crew will use the special nature of microgravity in a new lung tissue study to advance understanding of how stem cells work and pave the way for further use of the microgravity environment in stem cell research. Expedition astronauts also will assemble and deploy a microsatellite investigation seeking to validate the concept of using microsatellites in low-Earth orbit to support critical operations, such as providing lower-cost Earth imagery in time-sensitive situations such as tracking severe weather and detecting natural disasters.

During their expedition, the crew members also are scheduled to receive an Orbital ATK Cygnus spacecraft launched from NASAs Wallops Flight Facility in Virginia and a Russian Progress resupply mission, each delivering several tons of food, fuel, supplies and research such as an investigation to demonstrate the merits of manufacturing fiber optic filaments in microgravity.

Whitson, Fischer and Yurchikhin are scheduled to remain aboard the station until September. Shortly after their departure, NASA astronauts Mark Vande Hei and Joseph Acaba and Russian cosmonaut Alexander Misurkin will join the Expedition 53 crew. Bresnik, Ryazanskiy and Nespoli are scheduled to return in December.

For more than 16 years, humans have lived and worked continuously aboard the International Space Station, advancing scientific knowledge and demonstrating new technologies, making research breakthroughs not possible on Earth that will enable long-duration human and robotic exploration into deep space. A global endeavor, more than 200 people from 18 countries have visited the unique microgravity laboratory that has hosted more than 1,900 research investigations from researchers in more than 95 countries.

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International Space Station's Crew Restored to Six People - Kansas City infoZine

At Jef Boeke's lab, you can whiff an odor that seems out of place, as if they were baking bread here.

But he and his colleagues are cooking up something else altogether: yeast that works with chunks of man-made DNA.

Scientists have long been able to make specific changes in the DNA code. Now, they're taking the more radical step of starting over, and building redesigned life forms from scratch. Boeke, a researcher at New York University, directs an international team of 11 labs on four continents working to "rewrite" the yeast genome, following a detailed plan they published in March.

Their work is part of a bold and controversial pursuit aimed at creating custom-made DNA codes to be inserted into living cells to change how they function, or even provide a treatment for diseases. It could also someday help give scientists the profound and unsettling ability to create entirely new organisms.

The genome is the entire genetic code of a living thing. Learning how to make one from scratch, Boeke said, means "you really can construct something that's completely new."

The research may reveal basic, hidden rules that govern the structure and functioning of genomes. But it also opens the door to life with new and useful characteristics, like microbes or mammal cells that are better than current ones at pumping out medications in pharmaceutical factories, or new vaccines. The right modifications might make yeast efficiently produce new biofuels, Boeke says.

Some scientists look further into the future and see things like trees that purify water supplies and plants that detect explosives at airports and shopping malls.

Also on the horizon is redesigning human DNA. That's not to make genetically altered people, scientists stress. Instead, the synthetic DNA would be put into cells, to make them better at pumping out pharmaceutical proteins, for example, or perhaps to engineer stem cells as a safer source of lab-grown tissue and organs for transplanting into patients.

Some have found the idea of remaking human DNA disconcerting, and scientists plan to get guidance from ethicists and the public before they try it.

Still, redesigning DNA is alarming to some. Laurie Zoloth of Northwestern University, a bioethicist who's been following the effort, is concerned about making organisms with "properties we cannot fully know." And the work would disturb people who believe creating life from scratch would give humans unwarranted power, she said.

"It is not only a science project," Zoloth said in an email. "It is an ethical and moral and theological proposal of significant proportions."

Rewritten DNA has already been put to work in viruses and bacteria. Australian scientists recently announced that they'd built the genome of the Zika virus in a lab, for example, to better understand it and get clues for new treatments.

At Harvard University, Jeffrey Way and Pamela Silver are working toward developing a harmless strain of salmonella to use as a vaccine against food poisoning from salmonella and E. coli, as well as the diarrhea-causing disease called shigella.

A key goal is to prevent the strain from turning harmful as a result of picking up DNA from other bacteria. That requires changing its genome in 30,000 places.

"The only practical way to do that," Way says, "is to synthesize it from scratch."

The cutting edge for redesigning a genome, though, is yeast. Its genome is bigger and more complex than the viral and bacterial codes altered so far. But it's well-understood and yeast will readily swap man-made DNA for its own.

Still, rewriting the yeast genome is a huge job.

It's like a chain with 12 million chemical links, known by the letters, A, C, G and T. That's less than one-hundredth the size of the human genome, which has 3.2 billion links. But it's still such a big job that Boeke's lab and scientists in the United States, Australia, China, Singapore, and the United Kingdom are splitting up the work. By the time the new yeast genome is completed, researchers will have added, deleted or altered about a million DNA letters.

Boeke compares a genome to a book with many chapters, and researchers are coming out with a new edition, with chapters that allow the book to do something it couldn't do before.

To redesign a particular stretch of yeast DNA, scientists begin with its sequence of code letters nature's own recipe. They load that sequence into a computer, then tell the computer to make specific kinds of changes. For example one change might let them rearrange the order of genes, which might reveal strategies to make yeast grow better, says NYU researcher Leslie Mitchell.

Once the changes are made, the new sequence used as a blueprint. It is sent to a company that builds chunks of DNA containing the new sequence. Then these short chunks are joined together in the lab to build ever longer strands.

The project has so far reported building about one-third of the yeast genome. Boeke hopes the rest of the construction will be done by the end of the year. But he says it will take longer to test the new DNA and fix problems, and to finally combine the various chunks into a complete synthetic genome.

Last year, Boeke and others announced a separate effort, what is now called Genome Project-write or GP-write . It is chiefly focused on cutting the cost of building and testing large genomes, including human ones, by more than 1,000-fold within 10 years. The project is still seeking funding.

In the meantime, leaders of GP-write have started discussions of ethical, legal and social issues. And they realize the idea of making a human genome is a sensitive one.

"The notion that we could actually write a human genome is simultaneously thrilling to some and not so thrilling to others," Boeke said. "So we recognize this is going to take a lot of discussion."

___

Follow Malcolm Ritter at @MalcolmRitter. His recent work can be found here.

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Scientists build DNA from scratch to alter life's blueprint - Kansas City Star

Your or a donor provides stem cells for transplant

Stem cell collection is a relatively painless procedure. It takes three to five days to collect your stem cells for an autologous transplant. It takes one to two days to collect donor stem cells for an allogeneic transplant. For either type of transplant, it takes four or five hours for each day's collection.

If your donor is related, we will evaluate him or her before the stem cell collection. This will include an electrocardiogram, chest X-ray and blood tests. The evaluation and collection process will take seven to 10 days.

We match patients with unrelated donors who are registered with the National Marrow Donor Program. These donors are evaluated in their home cities before they donate.

This type of transplant has become more common than bone marrow stem cell transplants. Peripheral stem cells are easier to collect because donors don't require general anesthesia during collection.

During the collection procedure, called apheresis, we draw donor blood into a vessel and separate the stem cells. The remaining blood is returned to the donor.

Before and during collection, the donor will have injections of protein growth factors. Called mobilization, this stimulates the bone marrow to increase the number of stem cells in the blood.

We collect bone marrow stem cells from the pelvic bone and freeze them until the time of transplant. Because this requires general anesthesia, donors may stay in the hospital overnight.

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Stem Cell Collection - University of Kansas Hospital

Patients with severe critical limb ischemia (CLI) have an exciting new treatment option autologous stem cell therapy. Karl Stark, MD, FACS, with Kansas City Vascular, PC, is currently running two clinical trials with "incredible results," he says.

"This new stem cell therapy is a game changer for patients at high risk for losing a limb and for whom nothing else works," says Dr. Stark. "We have been looking for a viable treatment for a long time, and these new trials show the greatest promise." He has been involved in four clinical trials. The first two involved IV infusion of prostaglandins and the second was hyperbaric oxygen therapy but the results were not as profound as what his patients are experiencing with the two current stem cell trials.

CLI is the most severe form of peripheral artery disease. Its differentiated from acute limb ischemia in the duration of the process and the underlying etiology. Acute limb ischemia is usually embolic or thrombotic occlusion of the arteries of the leg.

Of patients with CLI, 25% will die within one year; 40% within 5 years. The one-year amputation rate is 25%, with the mortality risk 5-10% for BKA and 10-15% for AKA. In addition, quality of life and the ability to live independently decrease with an amputation.

Surgical revascularization involves using bovine carotid artery conduit when autologous vein is not available for bypass. It restores blood flow to the affected limb, and gives patients a better chance of survival than amputation. The same holds true for CLI patients, Dr. Stark reports.

Nondirect revascularization treatment options for patients with no reconstructable arteries include hyperbaric oxygen therapy. Clinical trial results included higher limb salvage rates and lower mortality rates. Patients were also twice as likely to heal their ischemic wounds.

Survival of patient with CLI and non-reconstructable arterial disease

For a specific group of patients, cell therapy appeared to be an option when other modalities proved inadequate or not possible:

The goal of cell therapy is angiogenesis. In Dr. Starks clinical trials, adult or autologous stem cells are used, which are harvested from bone marrow. Differentiated centrifugation separates cells into subgroups and then further separates them into tissue specific-types . An intra-arterial and/or intramuscular injection protocol then deposits cells in the neurovascular bundle.

Lifecells has developed the protocol Dr. Stark is using for harvesting and selecting the most effective stem cells. And because the work is with autologous stem cells, the process is safer, avoids moral issues and has fewer complications.

It takes 4 to 6 weeks to see results. Since limbs must be healthy enough to withstand this time period, seeing patients early in their disease is important. Early results show improved limb salvage rates at 60%. There is also improved limb perfusion as measured by ankle brachial index and TC02. Interim data also show improvement in ischemic rest pain and ulcer healing.

"We are seeing a lot of interest from around the country in our stem cell clinical trials," Dr. Stark noted. "North Kansas City Hospital is at the forefront of this research, and its an honor to work with referrals from some of the leading vascular surgery centers."

Dr. Starks presentation

Dr. Stark earned his medical degree from the University of Missouri-Kansas City. He completed his residency in general surgery at Truman Medical Center and a fellowship in vascular surgery at Middlesex General University Hospital, New Jersey. Dr. Stark is the Midwest medical director for Healogics and director of the Wound Healing Center at North Kansas City Hospital.

To learn more call, 816.872.1598.

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Stem Cell Therapy - North Kansas City Hospital, Kansas ...