FDA Challenges Stem Cell Companies As Patients Run Out Of Time

Scientists have seen promise in the potential of stem cells, but not everyone agrees stem cell replacement therapy is ready for prime time.

Americans seeking stem cell replacement therapy hope the process can heal them of myriad diseases, and a 2011 report by the Baker Institute estimated the industry could bring in $16 billion in revenue by 2020.

But the Food and Drug Administration has expressed concerns. The agency sued to stop treatments at a Regenerative Sciences clinic in Colorado and closed the lab of another company, Celltex Therapeutics, in Texas.

While patients in dire situations are willing to try the therapy (and pay the hefty costs), there's concern the research doesn't support broad practice just yet.

Running Out Of Options

SammyJo Wilkinson remembers the day 18 years ago when she suddenly couldn't stand. She was a young, ambitious computer programmer, launching an Internet startup.

Her doctor told her it was secondary progressive multiple sclerosis.

Now, at 48, Wilkinson is in a wheelchair. She's tried every available FDA-approved drug and two experimental therapies, including a two-year course of chemotherapy. Nothing worked.

Over time, she started researching adult stem cell replacement, but it was available only abroad. The U.S. opened its doors to the treatment two years ago.

Wilkinson had to see a doctor first, but then she paid Celltex $28,000 for stem cell replacement. In a nutshell, the company promises to remove good, healthy stem cells; store them; make more; and put them back into her body where they can help her heal.

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FDA Challenges Stem Cell Companies As Patients Run Out Of Time

Beauty Innovation: Young-looking skin with stem cell therapy

Admit it or not, as you age your skin starts showing signs that you would rather hide. Spots, wrinkles, and even crow's feet are just some of those signs that you would camouflage with makeup and skin creams to make them disappear-temporarily. But fear not, for beauty experts have discovered that stem cell treatment can also help in maintaining youthful skin.

According to Ma Fe Doria, a skin care expert, stem cell therapy is an intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury. As many may be aware, the most popular stem cell treatment is in Germany, where lots of celebrities and personalities (i.e. politicians) have flown to have stem cell injections for their ailments, using cells mostly harvested from the sheep. According to those who have undergone the procedure, the treatments have improved their body and the pains they've experienced have disappeared.

Today, many medical researchers continue to do experiments to determine if stem cell can help in curing various types of ailments from cancer to diabetes, which doctors have said may not be far behind. Aside from its healing benefits, stem cell is now being used by the beauty industry. Many cosmetic and beauty centers have started offering stem cell injections for the face, which is said to regenerate the skin where the cells are injected. While some continue to use sheep cells, plant and fat stem cells are now becoming the popular alternatives, with the fat stem cells being used to heal wounds, improve scars, and rejuvenate the skin.

But stem cell treatment is not cheap. Those who can afford it need to fly out of the country to avail of the treatment. Realizing the need in the market, Flawless Facial Center partnered with a local industry leader to produce Flawless' Stem Cell line, which uses the potent power of plant stem cells. Dubbed as the "superfood for the skin," Flawless' Stem Cell line is the epitome of skin nutrition.

"This new range of products allowed us to mark several milestones not just for Flawless but for the local beauty industry. Once again, we have taken something that, for the longest time, has remained exclusive to celebrities and other influential people, and made it affordable for the regular Juan and Juana," says Flawless ceo Ruby Sy.

For P2,500, the line includes a cleanser, day cream, and night serum. Flawless' Stem Cell line utilizes the plant stem cell technology to achieve the skin's youthful appearance by protecting it against oxidative stress and boosting the skin's repair and rejuvenation systems. "Times have really changed. No thanks to free radicals that are present in almost everything around us-from the food we eat to the air we breathe-people today age so much faster. This is especially true for people who like to spend late nights partying or spend too much time in front of the [TV/computer] monitor. Various studies have proven time and again the harmful effects such activities have on our skin," Sy said.

But with Flawless' latest baby, you can say goodbye to those ugly marks on your face. The Stem Cell line promises to solve all these, and more, by providing your skin with the right amount of nutrition and protection. Indeed, youthful glow is not only safe and available in a bottle, it's also now within reach of your pocket.

Go to http://www.flawless.com.ph for

store locations

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Kan. kangaroo gets stem cell treatment

SALINA, Kan. (AP) - A kangaroo at a central Kansas wildlife refuge has undergone a stem cell treatment to repair an injured leg.

The Salina Journal reports (http://bit.ly/WDe3ar ) that vets at Rolling Hills Wildlife Adventure performed the procedure Wednesday on the 6-year-old female red kangaroo.

The operation was performed by Dr. Danelle Okeson, the zoo's veterinarian, and Dr. Larry Snyder, veterinarian from the University Bird and Small Animal Clinic in Topeka.

The procedure was intended to regenerate a damaged joint that was causing the kangaroo to hobble around on one leg and her tail.

Snyder says stem cell therapy has been a viable treatment for humans for decades but has only recently been used on animals, mostly house pets and horses.

A refuge official says it may take days for zoo officials to notice any improvement.

Information from: The Salina (Kan.) Journal, http://www.salina.com

Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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Health Canada Approves ADCETRIS® (Brentuximab Vedotin) for the Treatment of Relapsed or Refractory Hodgkin Lymphoma …

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced that Health Canada has issued a Notice of Compliance with conditions (NOC/c), authorizing marketing of ADCETRIS for two lymphoma indications: (1) the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen. The indications for ADCETRIS were authorized based on promising response rates demonstrated in single-arm trials. No data demonstrate increased survival with ADCETRIS.

We are focused on making ADCETRIS available globally to all eligible patients with relapsed HL and sALCL. The approval of ADCETRIS in Canada, as well as the recent approval in the European Union, are important milestones to accomplish this goal, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. Now that Health Canada has approved ADCETRIS, we are committed to working closely with public and private insurers to secure reimbursement coverage for patients in Canada.

The approval of ADCETRIS in Canada marks a significant milestone for patients with relapsed HL or sALCL who have had few new treatment options in several decades, Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for Lymphoid Cancer at BC Cancer Agency in Vancouver, Canada.

Health Canada grants NOC/c, a form of market approval, on the basis of promising evidence of clinical effectiveness, for products intended for the treatment of serious, life-threatening or severely debilitating illnesses that meet a serious unmet medical need or demonstrate a significant improvement in the benefit/risk profile over existing therapies. Conditions associated with market authorization under the NOC/c policy include a requirement that Seattle Genetics conduct clinical trials designed to confirm the anticipated clinical benefit of ADCETRIS in these patients. Two confirmatory phase III clinical trials evaluating ADCETRIS in the front-line treatment setting of HL and mature T-cell lymphoma (MTCL), including sALCL, are currently underway and enrolling patients.

ADCETRIS (brentuximab vedotin) was issued marketing authorization under the NOC/c policy based on results from a single-arm, phase II pivotal trial in HL patients with relapsed or refractory disease following an ASCT and a single-arm, phase II pivotal trial in relapsed or refractory sALCL patients. ADCETRIS is administered in hospitals through IV infusion over 30 minutes every three weeks and patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately one year).

ADCETRIS is the first in a new class of antibody-drug conjugates (ADCs) to be approved in Canada. Using Seattle Genetics proprietary technology, the ADC consists of a monoclonal antibody directed to an antigen called CD30. The monoclonal antibody is connected to a cell-killing agent by a linker system that is designed to be stable in the bloodstream but to release the cell-killing agent into CD30-expressing cells, resulting in target cell death. The CD30 antigen is known to be expressed on the Reed-Sternberg cells of HL and on sALCL, an aggressive type of T-cell non-Hodgkin lymphoma.

Health Canadas approval of ADCETRIS is the first step in getting patients access to this important therapy, said Sue Robson, Executive Director of Lymphoma Foundation Canada. The Lymphoma Foundation is committed to working with Canada provincial governments to ensure that appropriate patients have access to this new therapy.

About Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell generally expresses CD30. Systemic ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that also expresses CD30.

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Health Canada Approves ADCETRIS® (Brentuximab Vedotin) for the Treatment of Relapsed or Refractory Hodgkin Lymphoma ...

Controversial Stem-Cell Company Moves Treatment out of U.S.

Celltex Therapeutics of Houston ceased treatment patients in the U.S. last year after a warning from regulators, and will now send patients for treatments to Mexico

By David Cyranoski and Nature magazine

Relations have soured between Celltex and RNL Bio since December 2011 when they launched their stem-cell bank in Sugar Land, Texas. Pictured: human neural stem cells from fetal cortex. Image: Flickr/GE Healthcare

US citizens who had pinned their hopes on a company being able to offer stem-cell treatments close to home will now need to travel a little farther. Celltex Therapeutics of Houston, Texas, stopped treating patients in the United States last year following a warning from regulators. A 25 January e-mail to Celltex customers indicates that the firm will now follow in the footsteps of many other companies offering unproven stem-cell therapies and send its patients abroad for treatment but only to Mexico.

The stem-cell treatments offered by Celltex involved extracting adult stem cells from a patient, culturing them and then reinjecting them in a bid to replenish damaged tissue. It had been offering the treatment for more than a year with one of its high-profile customers being Texas governor, Rick Perry when the US Food and Drug Administration (FDA) wrote to the company on 24 September 2012 advising it that the stem cells it harvested and grew were more than minimally manipulated during Celltex's procedures. As such, the FDA regarded the cells as drugs, which would require the agency's approval to be used in treatments. The FDA also warned that Celltex had failed to address problems in its cell processing that inspectors from the agency had identified in an April 2012 inspection of its cell bank in Sugar Land, Texas. Shortly after it received the letter, Celltex stopped injecting stem cells into patients.

For customers who still had cells banked at Celltex and were wondering how to get them out, things became more chaotic when Celltex and RNL Bio, a company based in Seoul, South Korea, which operated the processing center and bank in Sugar Land, sued each other over financial disagreements. Celltex had to issue a restraining order just to gain access to the cells.

The January e-mail from Celltex reassures customers that their cells are safely stored in a facility in Houston and adds: We anticipate that we will be able to offer our stem cell therapy services to physicians in Mexico starting very soon! The e-mail also says that the company is building a new laboratory in Houston, to be opened in March.

Celltex adds that it will carry out an FDA-approved clinical trial, to start shortly after a March meeting with the FDA, pending a positive review from the regulator. However, the company had said in a 25 October e-mail to patients that it would start such a trial within two months and that patient enrolment could begin in late November.

Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, says that the move to Mexico is "not surprising", given the companys difficulties in the United States.

As Celltex's stem culturing and banking technology was licensed from RNL Bio, it is also not clear whether it has the expertise needed to launch a clinical trial on its own, says Turner. "It would have to build a stem-cell company from the ground floor up. I wouldnt say it is anywhere near the starting line."

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Controversial Stem-Cell Company Moves Treatment out of U.S.

Researchers Study Link Between Exercise and Recovery Time in Stem Cell Transplantation

Newswise Researchers at the University of Illinois at Chicago College of Nursing have received a four-year grant to determine whether exercise can shorten recovery time for patients who undergo high-dose chemotherapy and stem cell transplantation.

High-dose chemotherapy followed by marrow or stem cell transplantation can cure blood-borne cancers like lymphoma and leukemia but poses a high risk of severe complications or even death during the first 100 days post-treatment, says Eileen Danaher Hacker, UIC associate professor of biobehavioral health science and lead researcher of the study.

Severe fatigue often accompanies chemotherapy, which can lead patients to decrease their physical activity, Hacker said. She developed an exercise program called Strength Training to Enhance Early Recovery, or STEER, that uses elastic resistance bands to increase muscle mass and functional ability and improve patients' quality of life.

She will recruit about 75 patients being treated by stem cell or marrow transplantation at the University of Illinois Hospital & Health Sciences System for the new study. They will either use the STEER program or participate in a health education program while continuing with their usual rest, activity and exercise.

Patients will exercise three times a week -- once supervised by health care professionals in a clinical setting, and twice at home, Hacker said. They will be assessed three times during the study for amount of physical activity, fatigue, muscle strength, functional ability, quality of life, and frailty.

Strength training, in comparison to other exercises, is most effective at building muscle mass, Hacker said, but few studies have focused on patients undergoing high-dose chemotherapy.

Muscle strength is needed for physical activity and for a body to function properly, she said. Without it, frailty and long-term disability may occur, even though the transplant survivors are cancer-free.

"Strength training is possible during the early recovery period if it is tailored to the individuals capabilities.

Hackers research-scholar grant from the American Cancer Society (RSG-13-054-01 PCSM) is for about $720,000 over four years.

UIC ranks among the nation's leading research universities and is Chicago's largest university with 27,000 students, 12,000 faculty and staff, 15 colleges and the state's major public medical center. A hallmark of the campus is the Great Cities Commitment, through which UIC faculty, students and staff engage with community, corporate, foundation and government partners in hundreds of programs to improve the quality of life in metropolitan areas around the world.For more information about UIC, please visit http://www.uic.edu.

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Researchers Study Link Between Exercise and Recovery Time in Stem Cell Transplantation

Lichen Sclerosus (LS) Patients Find Immediate Relief with Dr. Nathan Newman’s Stem Cell Lift®

BEVERLY HILLS, Calif.--(BUSINESS WIRE)--

Nathan Newman, MD, Board Certified Dermatologist, Cosmetic Surgeon and innovator of the Stem Cell Lift, is on the cutting-edge of the revolutionary advancements in stem cell therapy. He is providing an array of new, safe and effective treatment options for many conditions, such as Lichen Sclerosus et atrophicus (LS). LS is an auto immune skin disease that attacks male and female genital area, and usually causes severe pain, burning and itching to the vagina and male genitals. Until the application of the Stem Cell Lift, there has been no known effective treatment, which would provide any long term relief to the debilitating symptoms of LS. http://www.stem-cell-lift.com

The Stem Cell Lift is showing promising results in often providing immediate relief to patients suffering from LS. Dr. Newmans proprietary Stem Cell Lift delivers an enhanced amount of stem cells found in the patients own fat to the affected areas. The stem cells have the ability to reduce inflammation, improve circulation, and repair damaged cells and tissue, thereby providing almost immediate relief to this devastating condition.

Many women who have LS cant, or are afraid to have intercourse, as it is often too painful. Paula, a 34-year old female LS patient, endured 7 years of unending suffering and countless visits to numerous specialists. They merely prescribed her topical treatments that only gave her temporary relief from her devastating symptoms. Then she met Dr. Newman and had the Stem Cell Lift. Thrilled with the immediate, positive results, Paula remarks, The constant, intense, sensitive burning that I had had every single day for a year or more, was gone the very next morning. It was gone and its never come back.

While prevalent in women of all ages, LS appears more prominently in post-menopausal women (1 in 30), as well as men and some children. The disease is often misdiagnosed, enabling the symptoms to progress and worsen, often for many years. Even with a correct diagnosis, to date medical treatments for LS have been limited to strong corticosticosteroid ointments, which merely provide temporary relief of the itching and discomfort similar to a chronic yeast infection.

The Stem Cell Lift offers new hope for relief, often immediate, from the painful symptoms of this condition. LS patients from around the world are seeking out Dr. Newman and his Stem Cell Lift procedure because, after years of suffering, they are feeling free of the pain and discomfort of LS by using their own bodies' stem cells. The stem cells may also help stop the progression of the disease through their ability to inhibit the bodys immune system from attacking itself.

Patients treated with the Stem Cell Lift confirm that they experience fewer flare ups, which are shorter in duration. Post-Stem Cell Lift, most patients are able to discontinue the use of topical steroids and hormones and may be able to resume intimacy.

States Dr. Newman, "I hope to raise public awareness of this debilitating disease and inform patients that with the advent of the Stem Cell Lift, new treatment options are now available to LS patients."

For more information regarding Dr. Nathan Newman, The Stem Cell Lift and treatment for LS, please visit http://www.stem-cell-lift.com and his blog at http://newmansbeautyspot.blogspot.com/ or call 310-273-3344.

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Lichen Sclerosus (LS) Patients Find Immediate Relief with Dr. Nathan Newman’s Stem Cell Lift®

1 Millionth Blood Stem Cell Transplant Marks Major Medical Milestone

BERN, Switzerland, Jan. 30, 2013 (GLOBE NEWSWIRE) -- The collaborative work of medical scientists and physicians across the globe has resulted in a major medical milestone: the world's 1 millionth blood stem cell transplant, a procedure that has become a proven and essential therapy for many patients battling blood cancers like leukemia and lymphoma, as well as other critical diseases.

The Worldwide Network for Blood and Marrow Transplantation (WBMT) announced the landmark achievement today. The WBMT--a nonprofit scientific organization whose mission is promoting excellence in stem cell transplantation, stem cell donation and cellular therapy--said the 1 millionth transplant occurred in late December 2012. The finding is based on data collected by WBMT international member organizations involved in blood stem cell transplantation, which were analyzed and verified by the WBMT.

"One million transplants is a milestone that may surprise many people, because blood stem cell transplants were viewed as a rare procedure until the last decade or so," said Dietger Niederwieser, M.D., president of the WBMT and professor of medicine in the division of hematology and medical oncology at the University Hospital of Leipzig, Germany. "But important discoveries--and the vital cooperation of many scientists and physicians around the world--have dramatically improved outcomes for patients who undergo stem cell transplantation."

The first blood stem cell transplant was reported by Dr. E. Donnall Thomas in 1957, who received the Nobel Prize in 1990 for pioneering the use of this innovative approach to treatment of leukemia and other life-threatening diseases.

By the late 1960s, as knowledge of the requirements for matching patients with donors evolved, physicians were performing successful allogeneic transplants, using blood-forming stem cells from sibling donors (among the first in U.S., Holland and France). In 1973, the first successful transplant between two unrelated people occurred in New York, when a young boy received a transplant from a donor identified as a match through a blood bank in Denmark. In 1988, the first successful umbilical cord blood transplant was performed in Paris.

Since then, a near-exponential rise in all types of blood stem cell transplants, particularly from unrelated donors, has occurred. This is largely thanks to the willingness of now more than 20 million voluntary stem cell donors worldwide. Today, unrelated transplants are often as successful as those that use family donors.

International partners will help make this continued growth possible. Already, data from the World Marrow Donor Association (WMDA), a WBMT partner, show that nearly half of the transplants performed with unrelated donors cross an international border. International donor registries not only expand the pool of potential donors, they help advance the global science of transplantation through the exchange of information.

Founding partners of the WBMT include the Center for International Blood and Marrow Transplant Research(R) (CIBMTR), the Asia-Pacific Blood and Marrow Transplantation Group (APBMT), the European Group for Blood and Marrow Transplantation (EBMT) and the WMDA. Other regional and national organizations that participate and contribute data include the Australasian Bone Marrow Transplant Recipient Registry (ABMTRR), the Canadian Blood and Marrow Transplant Group (CBMTG), the Eastern Mediterranean Blood and Marrow Transplant Group (EMBMT) and the Sociedade Brasileira de Transplante de Medula Ossea (SBTMO), among others.

"It must be especially emphasized that WBMT has contributed to the advances of blood stem cell transplants in emerging countries in the Asia-Pacific region and in the other areas of the world, where the awareness to this medical procedure is sharply increasing," said Yoshihisa Kodera, vice president of WBMT, chairman of APBMT and professor of Aichi Medical University, Japan.

The World Health Organization (WHO) has recognized transplantation as an important global task, recently recognizing the WBMT as a non-governmental organization (NGO). "Transplantation has extended the lifespan of hundreds of thousands of patients worldwide and enhanced their quality of life," said Luc Noel, M.D., of WHO. "It has become the standard of care for many patients, and should no longer be restricted to affluent countries or individuals."

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1 Millionth Blood Stem Cell Transplant Marks Major Medical Milestone

Controversial stem-cell company moves treatment out of the United States

Celltex had hoped to culture and bank cells with its partner RNL Bio, before the two became embroiled in legal action.

Tyler Rudick

US citizens who want to have stem-cell treatments without travelling overseas may soon be able to get them south of the border. Celltex Therapeutics of Houston, Texas, ceased treating patients in the United States last year following a warning from regulators. A 25 January e-mail to Celltex customers indicates that the firm will now follow in the footsteps of many other companies offering unproven stem-cell therapies and send its patients abroad for treatment but no farther than Mexico.

Celltex had been offering stem-cell treatments for more than a year starting with Texas Governor Rick Perry in July 2011 when the US Food and Drug Administration (FDA) wrote to the company on 24 September advising it that the stem cells it harvested and grew from customers were more than minimally manipulated during Celltex's procedures. As such, the FDA regarded the cells as drugs, which would require the agency's approval to be used in treatments. The FDA also warned that Celltex had failed to address problems in its cell processing that the inspectors from the agency had identified in an April 2012 inspection of its cell bank in Sugar Land, Texas. Shortly after the letter, Celltex stopped injecting stem cells into patients.

For customers who still had cells banked at Celltex and were wondering how to get them out, things became more chaotic when Celltex and RNL Bio, a company based in Seoul, which operated the processing centre and bank, sued each other. Celltex had to issue a restraining order just to access the cells.

The January e-mail from Celltex reassures customers that their cells are safely stored in a facility in Houston and adds, We anticipate that we will be able to offer our stem cell therapy services to physicians in Mexico starting very soon! The e-mail adds that the company is constructing a new laboratory, to be opened in March.

Celltex also says it will carry out an FDA-approved clinical trial, to start shortly after a March meeting with the FDA. However, the company had said in a 25 October e-mail to patients that it would start such a trial within two months and that patient enrolment could begin as early as 30 days after that.

University of Minnesota bioethicist Leigh Turner says the move to Mexico is "not surprising", given the companys difficulties in the United States.

As Celltex's stem culturing and banking technology was licensed from RNL Bio, it's also not clear whether on its own it will still have the expertise needed to launch a clinical trial, says Turner. "It would have to build a stem-cell company from the ground floor up. I wouldnt say they are anywhere near the starting line."

Celltex did not respond to questions about how it would ship stem cells to Mexico or how it would perform the clinical research needed to seek FDA approval.

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Controversial stem-cell company moves treatment out of the United States