Archive for the ‘Bone repair’ Category

Tumor Surgeon James C. Wittig, MD Featured in New York Magazine’s Best Doctors Issue for 2012

New York, NY (PRWEB) June 29, 2012

Dr. James C. Wittig has again been named a top orthopedic surgeon in New York magazine’s latest guide to the “Best Doctors in New York.” Time and again, Dr. James Wittig has earned the distinction of being among the finest in the country – and that’s according to leading physicians in his field.    Dr. Wittig, an Orthopedic Oncologist at Mount Sinai Medical Center, dedicates his practice exclusively to limb-sparing surgery; pediatric and adult bone and soft tissue sarcomas; benign musculoskeletal tumors; metastatic cancers; as well as complex hip and knee replacement surgery. In addition to his office at Mount Sinai Medical Center, Dr. Wittig sees patients at offices in Hackensack and Morristown, New Jersey as well as in Long Island, NY.

On any given day, you will find Dr. Wittig in surgery, making rounds or conferring with colleagues on the next best option for his patients. It is this assiduous schedule that keeps Dr. Wittig at the forefront of his field, earning him accolades yearly and again this year. In addition, he recently co-authored “Operative Techniques in Orthopaedic Surgical Oncology,” a much needed resource and whose time had come. Co-authored also by Martin Malawar, MD and Jacob Bickers, MD, the book was produced to provide a comprehensive guide on the surgical treatment for bone and soft tissue sarcoma and a heavy emphasis on limb sparing surgery.

He takes this accolade as another motivating force to continue to seek out and explore both new and technologically advanced medical treatments as well as share his experiences. The desire to help others coupled with his educational endeavors has grown tremendously from his roots as a child in Paterson to receiving his first honor in 1990, a Biology Department Honors Citation for Superior Academic Achievement followed by Summa Cum Laude status upon graduation from Seton Hall University. Four years later he received his Medical Degree from New York University School of Medicine where he was elected to the prestigious Alpha Omega Alpha (AOA) Honor Society and also served as president of the society. During medical school, he also received “Most Outstanding Research Presentation on Medical Student Assembly Day, The Lange Medical Publication Award for Outstanding Achievement as a Medical Student and the Glover C. Arnold surgical Award for the Medical Student who excelled in Surgery. From NYU he interned in General Surgery at St. Luke’s-Roosevelt Hospital Center and did his residency in Orthopaedic Surgery at Columbia Presbyterian Medical Center in New York City where he was appointed Administrative Chief Resident received the ‘Orren D. Baab Award for Excellence in Orthopedic Surgery, Member of the Senior Resident Staff who Best Exemplifies those Qualities of Academic Excellence, Clinical Proficiency and Capacity for Leadership, New York Orthopedic Hospital.’ Dr. Wittig continued to fine tune his surgical skills as a Fellow in Orthopedic Oncology at Washington Cancer Institute, Washington Hospital Center, Children’s National Medical Center, Armed Forces Institute of Pathology in Washington, DC as well as serve as a Sarcoma Consultant, Surgical Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.

The experience and accolades he has received along his medical journey has continued to enrich his desire to teach fellow colleagues as well as secure the best treatment options available for both adults and children affected by orthopedic tumors. While an Assistant Professor of Orthopedic Surgery at NYU Medical Center he received ‘Teacher of the Year for Outstanding Leadership, Guidance and Selfless Dedication to the Residents of NYU Hospital for Joint Diseases Department of Orthopedic Surgery Class of 2007.’     His desire was also transparent when he joined Mount Sinai Medical Center and was asked to develop a multidisciplinary team to treat sarcomas and other musculoskeletal tumors. In a two year span, he has performed over 600 cases and has dramatically changed the lives of those who have met him. Dr. Wittig has been instrumental in recruiting a team of specialists who focus on diagnosing and treating sarcomas as well as other types of bone and soft tissue tumors that affect the extremities, pelvis and spine. Currently, the team consists of specialized Pathologist Dr. Roberto Garcia; Musculoskeletal Radiologist Dr. Darren Fitzpatrick; Pediatric Oncologist Dr. Birte Wistinghausen and Radiation Oncologist Dr. Vishal Gupta as well as three Physician Assistants, 2 administrative assistants, a second orthopedic oncologist, Dr. Ilya Iofin and Dr. Sheeraz Qureshi, a spine surgeon focusing on a collaborative approach for spine tumors. The newest member to join Dr. Wittig’s team is renowned sarcoma cancer researcher and medical oncologist Dr. Robert Maki. Dr. Maki is also Chief of Pediatric Oncology and the Medical Director of the Sarcoma Program at Tisch Cancer Institute of Mount Sinai Medical Center. His vast array of experience, particularly his expertise in novel therapies for treating these complex sarcoma cancers, will ensure continuous research and development in this field.

James C. Wittig, MD specializes in limb-sparing surgery; pediatric and adult bone and soft tissue sarcomas; melanoma; benign musculoskeletal tumors; metastatic cancers; as well as complex hip and knee replacement surgery. He also has special expertise with regard to tumors that affect the shoulder girdle and scapula. In addition to his office at Mount Sinai Medical Center located at 5 East 98th Street, New York, NY, Dr. Wittig has satellite offices affiliated with Hackensack University Medical Center, at Continental Plaza, 433 Hackensack Avenue, 2nd Floor, Hackensack, NJ and Morristown Memorial Hospital, at NJ Advanced Musculoskeletal Center, PA, 131 Madison Avenue, Suite 130, Morristown, NJ and ProHealth in Long Island. Currently, Dr. Wittig is Associate Professor of Orthopedic Surgery, Chief of Pediatric and Adult Orthopedic Oncology and the Sarcoma Program at Mount Sinai Medical Center in New York City as well as Chief, Orthopedic Oncology and Director, Sarcoma Section of the Cancer Center, Hackensack University Medical Center. He is a member of the American Academy of Orthopedic Surgeons; New York State Society of Orthopedic Surgeons, Inc.; and the Medical Society of New Jersey. He has published over 90 educational materials ranging from original reports, abstracts, videos and articles in the following publications: Clinical Orthopedics and Related Research, The Journal of the American College of Surgeons, American Family Physician, Journal of Arthroplasty, Radiology and Journal of Bone and Joint Surgery. He is also a prominent lecturer in the field of Orthopedic Surgery throughout the nation.

For more information about this or other related topics, or to schedule an appointment, please call (212) 241-1807, visit http://www.TumorSurgery.org or email Dr. Wittig at drjameswittig(at)gmail(dot)com.

Read the full story at http://www.prweb.com/releases/2012/6/prweb9650840.htm

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At 5 years old, Jasmine Williams is fighting rare cancer

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Posted 22 Oct 2011 — by James Street
Category Age and osteosarcoma, Bone repair, Cost, Finance and Politics of cancer research and treatment, Osteosarcoma

Published: Friday, October 21, 2011

By Caitlin Fertal
CFertal@News-Herald.com

Just prior to four months ago, 5-year-old Jasmine Williams was as healthy as could be.

Her parents Dixie and Michael Williams of Chardon never had to worry about her getting sick; she was even described as “freakishly healthy.”

It was her 8-year-old brother Anthony who typically caught colds — but that all changed in July.

Jasmine was taken to the hospital when her mom discovered that she may have had an abscessed tooth. Upon examination, doctors told the family to head to University Hospitals Rainbow Babies Children’s Hospital right away.

Cancer was the diagnosis.

Originally, doctors thought that the then 4-year-old had rhabdomyosarcoma, a cancer that affects connective tissues such as muscle, fat, membranes that line the joints or blood vessels.

While a devastating diagnosis, it was only about to get worse.

The family soon was told that Jasmine actually had a rare, more aggressive form of cancer — osteosarcoma.

While osteosarcoma itself is the most common type of cancer that starts in the bone, the exact type that Jasmine has is something that her doctors are not familiar with, Dixie Williams said.

Typically this cancer affects the arm or leg bones, however, for Jasmine it started near her jaw, which can lead to a less favorable outcome, according to The American Cancer Society.

Jasmine has already undergone an extensive, 13-hour surgery to remove a large tumor from her jaw area, as well as daily chemotherapy treatment.

Her mother explained the surgery:

“(They) removed all of her baby and adult teeth in the left upper jaw, all the bone is gone; the cheek bone is gone, part of the orbit of her eye is gone — and part of her nasal on the left side, the whole left roof or her mouth and everything. They took a graft and cut from her knee to her hip and reconstructed that side of her face with all soft tissue because she’s still growing.”

She is currently receiving three different types of chemotherapy, which kill every rapidly growing cell in the body. This type of treatment has unpleasant side effects, but aggressively goes after cancer cells.

Due to the treatments, only the fine, baby hair that lines Jasmine’s head remains, which her mother said was probably the hardest part for the little girl.

“She had really long hair that she loved.”

The therapy also makes Jasmine nauseous and at times, she completely loses her appetite. She has a feeding tube that her parents will use when she refuses to eat, her mother said.

“It enables us to give her the nutrients and stuff that she needs when she won’t eat because there are times when she won’t,” she said. “Originally they put it in because of the procedure, she had so much swelling and they had done so much work they didn’t want to jeopardize their grafts with all the sutures.”

The family spends about 20 days per month in the hospital in order for Jasmine to keep up with all of her chemotherapy as well as the eight to 10 different prescriptions she needs.

As can be imagined, the family’s medical expenses have totalled close to $750,000 so far.

Dixie left her job as at University Hospitals Geauga Medical Center temporarily in the very beginning, and Michael stopped work completely in order to care for their daughter.

Anthony was pulled out of school and now often learns in between happenings at the hospital.

The first week in November she will undergo additional cat scans. If no regrowth is found, then they will continue the schedule of chemotherapy that Jasmine is currently on. The same process will occur in February, and if there is still no regrowth, Jasmine will be considered in remission.

“But the chemo — there’s always a risk of developing another type of cancer like leukemia,” Dixie Williams said. “It’s cancer, so it’s never over.”

A concern for the family is that the cancer could easily spread or metastasize to other organs or bone tissue.

“I think the hardest thing for us is that there’s no statistics. There’s no set way to treat it because they’ve never seen it before,” Dixie Williams said. “It’s something we just take day by day because the overall picture is just too much to bare.”

A family member partnered with the fund raising website GiveForward in an effort to help alleviate the financial burden on the Williams family.

To see pictures of Jasmine, or to donate, visit www.giveforward.com/jasminesjourney.

Recreating human livers, in mice

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Posted 16 Jul 2011 — by James Street
Category Bone repair, Limb and organ Regeneration, Liver
‘Humanized’ mice could help scientists study the side effects of new drugs before they reach clinical trials.

Anne Trafton, MIT News Office
July 12, 2011

Alice Chen
Photo – Photo courtesy of the Lemelson-MIT Program
‘Humanized’ mice could help scientists study the side effects of new drugs before they reach clinical trials.

Anne Trafton, MIT News Office

July 12, 2011

Although scientists commonly use mice for biomedical research, they are not always helpful for pharmaceutical testing. Because mouse livers react to drugs differently than human livers, they often can’t be used to predict whether a potential drug will be toxic to people. That means that a drug that harms the liver could make it all the way to human clinical trials before researchers discover its risks.

Now, Alice Chen, a graduate student in the MIT-Harvard Division of Health Sciences and Technology (HST), has developed a way to overcome that problem. By growing human liver tissue inside mice, she has created “humanized” mouse livers that respond to drugs the same way a human liver does.

The humanized mice, described in Proceedings of the National Academy of Sciences (PNAS) the week of July 11, could also be used to study the liver’s response to infectious diseases such as malaria and hepatitis.

“What’s exciting to researchers is this idea that if we can create these mice with human livers, we can basically create a slew of human-like patients to do drug-development screens, or to … develop new therapies,” says Chen, who works in the lab of Sangeeta Bhatia, the John and Dorothy Wilson Professor of HST and Electrical Engineering and Computer Science.

Bhatia, who is a member of MIT’s David H. Koch Institute for Integrative Cancer Research, is senior author of the PNAS paper.

In March, Chen won the $30,000 Lemelson-MIT Student Prize for her research, including this work; she also won the 2010 Collegiate Inventors Competition in the graduate student category.

A new scaffold

One obstacle to creating mice with human livers is that liver cells tend to lose their function rapidly after being removed from the body. Another challenge is that until now, creating mice with humanized livers required starting with mice with severely compromised immune systems — which limits their use for studying the immune response to infectious agents such as the hepatitis C virus, or drugs to combat those agents. Furthermore, those approaches rely on liver injury to create an environment in which implanted human liver cells can proliferate.

The process of breeding such mice is very time-consuming: It can take months to produce a single mouse with the right characteristics, Chen says.

To overcome those issues, Chen and Bhatia developed a tissue scaffold that includes nutrients and supportive cells, which preserve liver cells after they are taken from the body. The tissue scaffold is the size, shape and texture of a contact lens, and can be implanted directly into the mouse abdominal cavity.

Using this approach, the researchers can rapidly implant scaffolds in up to 50 mice in a day; it takes about a week for the implanted liver tissue to integrate itself into the mice. The gel that forms the scaffold also acts as a partial barrier to the mouse’s immune system, preventing it from rejecting the implant.

In the PNAS paper, the researchers demonstrated that the implanted liver tissue integrates into the mouse’s circulation system, so drugs can reach it, and proteins produced by the liver can enter the bloodstream. (The mice also retain their own livers, but the researchers have developed a method to distinguish the responses of mouse and human liver tissue.) Unlike existing approaches, this technique can be used on mice with no liver injury and intact immune systems.

To test the function of the humanized livers, the team administered the drugs coumarin and debrisoquine and found that the mice broke them down into byproducts normally generated only by human livers.

Chen and her colleagues are now studying how the humanized livers respond to other drugs whose breakdown products, or metabolites, are already known. That will pave the way to exploring the effects of untested drugs. “The idea that you could take a humanized mouse and identify these metabolites before going to clinical trials is potentially very valuable,” Chen says.

The team is also working toward miniaturizing the implants to the point where hundreds or thousands could be implanted in a single mouse. If successful, that could make the drug development process more efficient and reduce the number of mice needed for drug studies, Chen says.

Inder Verma, a professor of molecular biology at the Salk Institute, says the new technology is not only an improvement over existing humanized mouse livers, it could be a step toward creating artificial livers from induced pluripotent stem cells derived from a patient’s own tissues.

“What you really want is to be able to do this with cells from a patient, so you can put them back in,” says Verma, who was not involved in this research.

Lab-Made Trachea Saves Man

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Posted 08 Jul 2011 — by James Street
Category Artificial Knees and implants, Bone repair, Limb and organ Regeneration

Tumor-Blocked Windpipe Replaced Using Synthetic Materials, Patient’s Own Cells

By GAUTAM NAIK

Doctors have replaced the cancer-stricken windpipe of a patient with an organ made in a lab, a landmark achievement for regenerative medicine. The patient no longer has cancer and is expected to have a normal life expectancy, doctors said.

WINDPIPE1

David GreenA lab-made windpipe was implanted June 9 into a 36-year-old patient whose own windpipe was obstructed by a tumor.

WINDPIPE1

WINDPIPE1

“He was condemned to die,” said Paolo Macchiarini, a professor of regenerative surgery who carried out the procedure at Sweden’s Karolinska University Hospital. “We now plan to discharge him [Friday].”

The transplantation of an entirely synthetic and permanent windpipe had never been successfully done before the June 9 procedure. The researchers haven’t yet published the details in a scientific journal.

The patient’s speedy recovery marks another milestone in the quest to make fresh body parts for transplantation or to treat disease. More immediately, it offers a possible treatment option for thousands of patients who suffer from tracheal cancer or other dangerous conditions affecting the windpipe.

WINDPIPE2

Associated PressPaolo Macchiarini, a professor of regenerative surgery, carried out the procedure.

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WINDPIPE2

“It’s yet another demonstration that what was once considered hype [in the field of tissue engineering] is becoming a life-changing moment for patients,” said Alan Russell, director of the McGowan Institute for Regenerative Medicine in Pittsburgh, who wasn’t involved in the latest operation.

In 2006, researchers disclosed how they had implanted lab-grown bladders into children and teens with spina bifida, a birth defect. And in 2008, members of a team that included Dr. Macchiarini said they had given a patient a new windpipe made partly from her own cells, and partly from “scaffolding” material taken from a cadaver.

The latest experiment shows that a fully functioning windpipe can be manufactured in the lab without the need for a cadaver.

WINDPIPE
WINDPIPE

WINDPIPE

“It makes all the difference,” said Dr. Macchiarini. “If the patient has a malignant tumor in the windpipe, you can’t wait months for a donor to come along.”

The patient in this case is a 36-year-old Eritrean man, identified by doctors as a father of two studying geology in Iceland. Surgery and radiation treatments failed to stem a cancerous growth in his windpipe.

When the tumor reached about six centimeters in length, it almost completely blocked the trachea, or windpipe, making it hard for the patient to breathe.

With no suitable donor windpipe available, the final option was to try to build one from scratch. Dr. Macchiarini had good reason to feel emboldened: He had successfully transplanted cadaver-based windpipes in 10 patients.

WINDPIPE3

David GreenThe patient is expected to be released from the hospital Friday.

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WINDPIPE3

The windpipe is a hollow tube, about 4.5 inches long, leading to the lungs. A key part of it is a scaffold—which functions like a skeleton for the organ—consisting of tissues such as cartilage and muscle. As a first step, a team led by Alexander Seifalian of University College London used plastic materials and nanotechnology to make an artificial version of the scaffold in the lab. It was closely modeled on the shape and size of the Eritrean man’s windpipe.

Meanwhile, researchers at Harvard Bioscience Inc. of Holliston, Mass., made a bioreactor, a shoe-box-size device similar to a spinning rotisserie machine. The artificial scaffold was placed on the bioreactor, and stem cells extracted from the patient’s bone marrow were dripped onto the revolving scaffold for two days.

With the patient on the surgery table, Dr. Macchiarini and colleagues then added chemicals to the stem cells, persuading them to differentiate into tissue—such as bony cells—that make up the windpipe.

Related

In a notable advance in organ transplants, surgeons at UC Davis Medical Center have restored the voice of a woman who couldn’t speak on her own through a transplant of the larynx, thyroid and trachea. Avery Johnson has details.

About 48 hours after the transplant, imaging and other studies showed appropriate cells in the process of populating the artificial windpipe, which had begun to function like a natural one. There was no rejection by the patient’s immune system, because the cells used to seed the artificial windpipe came from the patient’s own body.

Dr. Russell of the McGowan Institute sounded a note of caution about using this technique to build more-complex organs. For example, while tissue engineering can help to build hollow organs such as a windpipe, it will likely prove a bigger challenge to use the technique for creating the heart, which has much thicker tissue.

Dr. Macchiarini said he planned to use the same windpipe-transplant technique on three more patients, two from the U.S. and a nine-month-old child from North Korea who was born without a trachea.

Write to Gautam Naik at gautam.naik@wsj.com

Synthes and Lilly Sign Development and Collaboration Agreement

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Posted 09 Jun 2011 — by James Street
Category Bone repair, Limb and organ Regeneration, Methotrexate, Osteosarcoma surgery

WEST CHESTER, Pa. and INDIANAPOLIS, June 9, 2011 /PRNewswire/ — Synthes, Inc. (SIX: SYST.VX) and Eli Lilly and Company (NYSE: LLY) today announced the signing of an exclusive worldwide collaboration agreement to address the needs of patients who are cared for by orthopedic surgeons, including those with osteoporosis and those with bone fractures.

The agreement allows for the joint development and licensing of early stage compounds from Lilly to Synthes for use within orthopedic trauma, spine, craniomaxillofacial and reconstructive areas. These compounds have pre-clinical and in some cases clinical data packages and have the potential to aid in the local treatment and regeneration of the skeleton. The two companies will jointly develop site-specific osteoinductive (i.e. bone healing) products based on Synthes’ biomaterials combined with Lilly’s biologics or pharmaceuticals.

Within a second development program, Synthes and Lilly will jointly conduct and fund the evaluation of additional orthopedic uses for Lilly’s osteoporosis drug Forteo® (teriparatide [rDNA origin] injection), marketed as Forsteo® in some countries outside of the United States).  Building upon a Phase II study that Lilly has already completed, Lilly and Synthes will collaborate on additional clinical studies to evaluate potential future indications for Forteo, including fracture healing.

In addition to the development component of the agreement, the collaboration also includes the U.S. co-promotion of Forteo to orthopedic surgeons, an important segment of physicians who treat patients with a fracture due to osteoporosis. The companies will also co-promote Forteo in select countries and regions outside of the United States.

“I am very excited about this unique collaboration that will utilize the complementary clinical, development and operational strengths of each partner,” said Michel Orsinger, president and CEO of Synthes. “Osteoporosis is one of the most significant unsolved clinical problems in orthopedics. Addressing the osteoporosis disease as well as the resulting fracture and bone defect is a significant strategic priority of both organizations,” he continued. “Strategic collaborations between medtech and pharma companies represent a new and promising avenue to develop and market true innovations in a changing, dynamic market environment.”

“We believe that patients worldwide will benefit from this collaboration because together we will be able to look for new ways to treat osteoporosis and bone fractures,” said Bryce Carmine, executive vice president and president, Lilly Bio-Medicines, Eli Lilly and Company. “At Lilly, we are always exploring new opportunities to bring innovative medicines to people with unmet medical needs and improve outcomes for individual patients.”

“Many orthopedic surgeons are in the position to diagnose and treat osteoporosis when their patients present with fractures, and we believe it is imperative to treat the underlying cause of the initial fracture,” said Johnston Erwin, Bone/Muscle/Joint global development platform leader, Lilly Bio-Medicines, Eli Lilly and Company. “Our collaboration will also explore ways to treat fractures with Forteo in older patients and/or those who have osteoporosis and, longer term, will look for new ways to deliver medicine locally to the fracture site.”

Financial terms of the agreement have not been disclosed.

Forteo, an FDA-approved osteoporosis therapy to help build new bone, is a treatment for postmenopausal women with osteoporosis who are at high risk for fracture(1) and to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.(2) Individuals at high risk for having broken bones include men and women with either a history of broken bones due to osteoporosis, who have several risk factors for fracture, or who cannot use other osteoporosis treatments.(1) Forteo is also approved to treat men and women with osteoporosis associated with sustained, systemic glucocorticoid therapy at high risk for fracture.(3) Forteo is a prescription medicine given as a 20 mcg once daily dose(4) available in a 2.4 mL prefilled delivery device for subcutaneous injection over 28 days.(5)

During the drug testing process, the medicine in Forteo caused some rats to develop osteosarcoma, which, in humans, is a serious but rare bone cancer. Osteosarcoma has been reported rarely in people who took Forteo, and it is unknown if people who take Forteo have a higher chance of getting the disease. Before patients take Forteo, patients should tell their healthcare provider if they have Paget’s disease of bone, are a child or young adult whose bones are still growing or have had radiation therapy.(6) For more information about Forteo, please see the important safety information, including Boxed Warning regarding osteosarcoma, below.

About Eli Lilly and Company

Eli Lilly and Company, a leading innovation-driven company, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers — through medicines and information — for some of the world’s most urgent medical needs. Information about Lilly is available at www.lilly.com.

Synthes: A leading medical device company

Synthes is a leading global medical device company, specialized in the development, manufacturing and marketing of instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the human skeleton and its soft tissues.

Important Safety Information about FORTEO

What is the most important information I should know about FORTEO?

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

During the drug testing process, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has been reported rarely in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma. Before you take FORTEO, you should tell your healthcare provider if you have Paget’s disease of bone, are a child or young adult whose bones are still growing, or have had radiation therapy

Who should not take FORTEO?

  • You should not take FORTEO for more than 2 years over your lifetime.

 

  • Do not use FORTEO if you are allergic to any of the ingredients in FORTEO. Serious allergic reactions have been reported.

 

What should I tell my healthcare provider before taking FORTEO?

  • Before you take FORTEO, you should tell your healthcare provider if you have a bone disease other than osteoporosis, have cancer in your bones, have trouble injecting yourself and do not have someone who can help you, have or have had kidney stones, have or have had too much calcium in your blood, take medications that contain digoxin (Digoxin, Lanoxicaps, Lanoxin), or have any other medical conditions.

 

  • You should also tell your healthcare provider, before you take FORTEO, if you are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby. If you are breastfeeding or plan to breastfeed, it is not known if FORTEO passes into your breast milk. You and your healthcare provider should decide if you will take FORTEO or breastfeed. You should not do both.

What are the possible side effects of FORTEO?

  • FORTEO can cause serious side effects including a decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking FORTEO and goes away within a few hours. For the first few doses, take your injections of FORTEO in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking FORTEO and call your healthcare provider. FORTEO may also cause increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.

 

  • Common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions including injection site pain, swelling and bruising.  These are not all the possible side effects of FORTEO.  You are encouraged to report negative side effects of Prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call             1-800-FDA-1088 begin_of_the_skype_highlighting 1-800-FDA-1088 end_of_the_skype_highlighting .

 

Additional safety information about FORTEO

  • There is a voluntary patient registry for people who take FORTEO. The purpose of the registry is to collect information about the possible risk of osteosarcoma in people who take FORTEO. For information about how to sign up for this patient registry, call             1-866-382-6813 begin_of_the_skype_highlighting 1-866-382-6813 end_of_the_skype_highlighting or go to www.forteoregistry.org.

 

  • The FORTEO Delivery Device has enough medicine for 28 days. It is set to give a 20-microgram dose of medicine each day. Before you try to inject FORTEO yourself, a healthcare provider should teach you how to use the FORTEO Delivery Device to give your injection the right way. Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). Do not inject all the medicine in the FORTEO Delivery Device at any one time. Do not transfer the medicine from the FORTEO Delivery Device to a syringe. This can result in taking the wrong dose of FORTEO. If you take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness.

 

How should I store FORTEO?

  • Keep your FORTEO Delivery Device in the refrigerator between 36 degrees F to 46 degrees F (2 degrees C to 8 degrees C). Do not freeze the FORTEO Delivery Device. Do not use FORTEO if it has been frozen. Do not use FORTEO after the expiration date printed on the delivery device and packaging. Throw away the FORTEO Delivery Device after 28 days even if it has medicine in it (see the User Manual).

 

For more safety information, please see Medication Guide (http://pi.lilly.com/us/forteo-medguide.pdf) and Prescribing Information, including Boxed Warning (http://pi.lilly.com/us/forteo-pi.pdf).  Please see full user manual that accompanies the delivery device.

TE Con ISI  07Mar2011

This press release contains certain forward-looking statements about the collaboration between Synthes and Lilly and about Forteo for the treatment of osteoporosis in patients who are at high risk for a fracture. It reflects Synthes’ and Lilly’s current beliefs. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that the product will be commercially successful. There is also no guarantee that the collaboration will be successful. For further discussion of these and other risks and uncertainties, see Lilly’s filing with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

The securities of Synthes have been offered and sold outside the United States and have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”). Such securities may not be offered, sold or transferred in the U.S. or to U.S. Persons (as defined in the regulations of the Securities Act), except pursuant to a registration statement filed under the Securities Act or under an applicable exemption under the Securities Act. Hedging transactions involving such securities may not be conducted unless in compliance with the Securities Act. The Synthes securities are deemed “Restricted Securities” as that term is defined in Rule 144 under the Securities Act.

FORTEO® and FORSTEO® are registered trademarks of Eli Lilly and Company.

P-LLY

(Logo:  http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

(Logo:  http://photos.prnewswire.com/prnh/20110609/DE15577LOGO )

(1)  FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 2, Section 1.1. Accessed on April 21, 2011.

(2)  FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 2, Section 1.2. Accessed on April 21, 2011.

(3)  FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 2, Section 1.3. Accessed on April 21, 2011.

(4)  FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 2, Sections 2.1, 2.2, 2.3. Accessed on April 21, 2011.

(5)  FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 3, Section 3. Accessed on April 21, 2011.

(6)  FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 3, Section 5.1. Accessed on April 21, 2011.

SOURCE Eli Lilly and Company

Leg attached backward lets teen Dugan Smith return from cancer treatment to ballfield

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Posted 09 May 2011 — by James Street
Category Artificial Knees and implants, Artificial limbs, Bone repair, Osteosarcoma surgery
Published: Monday, May 09, 2011, 3:46 PM     Updated: Monday, May 09, 2011, 4:30 PM

By Plain Dealer staff

FOSTORIA, Ohio — A rare and radical surgery is helping a 13-year-old Fostoria boy survive bone cancer and keep up an active life with the healthy parts of his right leg, doctors told his hometown paper.

In 2008, when he was 10, Dugan Smith was diagnosed with osteosarcoma, the most common bone cancer in children. His knee and part of his thigh had to be amputated. But rather than have his movements limited, Dugan opted for “rotationplasty,” which turned his lower leg around, attached it to the remainder of his thigh and allowed his ankle to take over in place of his knee.

The Tiffin Advertiser-Tribune began the story in 2008.

In April, the Columbus Dispatch picked up the tale:

Less than three years after doctors from Ohio State University Medical Center amputated much of his right leg to remove a softball-size tumor from above his right femur (thighbone), Dugan plays baseball and basketball, went skiing last week, and plans to go out for freshman football in the fall.

The Fostoria Review-Times explained more last week:

“The foot fits into a prosthetic and allows him to expend much less energy walking than if he had opted to simply amputate the diseased portion of his leg.”

But the leg does look strange.

“Initially, they were just like any one would be when you describe the surgery, they were taken aback,” Dr. Joel Mayerson, an orthopedic oncologist at the Arthur G. James Cancer Hospital told the R-T. “But, they understood it would bring Dugan back to the most functional state.”

“… For Dugan, it was a no-brainer.”

Now an unusually determined seventh-grader, Dugan pitches and plays first base for the Fostoria Junior Redmen, and continues to work to strengthen his hip and leg.

An Ohio State Medical Center oncologist talks about the case:

Cancer Patient’s Lower Body Rebuilt With Bone Autografts and Titanium

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Posted 08 May 2011 — by James Street
Category Artificial Knees and implants, Artificial limbs, Bone repair, experimental treatments

Posted By Scott Jung On May 6, 2011 @ 12:00 am In in the news… | No Comments

What is being hailed as the first of its kind surgery here in the United States, a multi-disciplinary team of oncologists, urologists, neurosurgeons, plastic surgeons and general surgeons from The Ohio State University Comprehensive Cancer Center have successfully rebuilt the pelvis of a cancer patient out of bones from his own amputated leg. Even more remarkable than the sheer engineering complexity of the pelvic device is the fact that the patient, now considered a cancer survivor, is almost able to walk without any assistance.
Mike Prindle was an Ohio mail carrier who developed a chondrosarcoma tumor on his pelvis and sacrum that necessitated the removal of the malignant part of his pelvis, and the amputation of his left leg. However, instead of discarding the amputated limb, doctors kept the femur, fibula, and their surrounding blood vessels, muscles, and skin, which were unaffected by the cancer. They then engineered a custom device consisting of the salvaged leg bones, two large rods and a couple of smaller rods fixed to the pelvis and spine with 14 screws to help provide support.
Most patients who receive a similar device made of cadaver bones or artificial materials are confined to wheelchairs for the rest of their lives because the reconstructed pelvis does not heal strongly enough to support a person’s body weight. However, Prindle’s own bones fused together to create a pelvic ring strong enough to allow him to walk again using a prosthetic leg. The prosthetic leg, a C-Leg [1] from Germany based Otto Block, contains mini-computers at the hip joint, knee joint and foot to analyze his gait, reducing the amount of strain on the prosthetic and allowing him to walk with greater ease.

Article from OSUCCC: Ohio State Surgeons Rebuild Pelvis Of Cancer Patient… [2]
Medgadget’s Otto Bock archives… [3]

Ohio State Performs Rare ‘Rotation’ Surgery On Cancer Patient

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Posted 01 Apr 2011 — by James Street
Category Artificial Knees and implants, Bone repair, Limb and organ Regeneration, Surgery

By Ohio State University Comprehensive Cancer Center
Apr 1, 2011 – 7:08:26 AM

(HealthNewsDigest.com) – COLUMBUS, Ohio– Two years ago, Dugan Smith, an athletic and active fourth-grader, fell and broke his femur, revealing a softball-sized tumor just above his knee. Now, after undergoing a unique surgery in which his lower leg was amputated, the tumor removed, and the leg rotated and reattached so that his ankle now functions as his knee, Smith, 13, is cancer-free and back to the activities he loves – playing basketball and baseball.

After the shock of learning their son had osteosarcoma, a rare cancer that attacks the bones, his parents opted for the unusual surgical procedure to increase his chance not only of survival, but to help him return to an active lifestyle. Fewer than 12 rotationplastysurgeries are performed each year in the United States.

“For an active child, the rotationplasty surgery can be the best option,” said Dr. Joel Mayerson,Smith’s orthopaedic oncologist at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richad J. Solove Research Institute. “The fact that he is out playing baseball and living his life like a normal teen-ager, speaks to the success of the surgery and his determination to overcome all odds to do something he truly loves.”

The rotationplasty procedure allows doctors to remove the diseased portion of the patient’s leg, in Smith’s case, the middle section including his knee. The lower leg is turned backwards and reattached to the area just above where the tumor had been removed. By rotating the leg, Smith’s calf muscle now serves as his thigh, while his ankle and foot act as his knee and shin. He has been fitted with a prosthetic leg that fits over his foot and ankle, allowing him to walk, run and play sports. Smith is now the star pitcher of his middle school baseball team in Fostoria, Ohio.

“Unlike adults, children can re-train their body to make their foot work like a knee, enabling them to run and participate in athletic activities,” said Mayerson, who is one of only 125 fellowship-trained musculoskeletal oncologists nationwide. “Having this procedure also eliminates the need for follow-up surgeries as the child continues to grow, because the bone will grow on its own as the child ages, and there aren’t any artificial parts to break or become damaged with wear.”

While the procedure is rare and may be considered extreme, research shows that patients report a high level of quality of life and psychological satisfaction.

The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (cancer.osu.edu) is one of only 40 Comprehensive Cancer Centers in the United States designated by the National Cancer Institute. Ranked by U.S. News & World Report among the top cancer hospitals in the nation, The James is the 205-bed adult patient-care component of the cancer program at The Ohio State University. The OSUCCC – James is one of only five centers in the country funded by the NCI to conduct both phase I and phase II clinical trials.

***

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LA BioMed And CellSeed To Launch Joint Research Project On Regenerative Medicine Technology

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Posted 09 Mar 2011 — by James Street
Category Bone repair, Limb and organ Regeneration

01 Mar 2011

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed) and CellSeed Inc., a Japanese biotechnology firm, have entered into a two-year research agreement to study CellSeed’s proprietary core technology in regenerative medicine, “Cell Sheet Engineering,” LA BioMed President and CEO David I. Meyer, PhD, announced today.

“LA BioMed is working to accelerate the pace of discovery and development so that new therapies and treatments can safely reach the patients who need them as quickly as possible,” said Dr. Meyer. “We look forward to conducting studies to determine the safety and efficacy of the novel cellular therapies developed by CellSeed and to expanding the possibilities of regenerative medicine.”

CellSeed has developed a method for taking small quantities of a patient’s own progenitor cells and culturing them in a special cell culturing dish. When the cells have grown sufficiently to create a sheet of cells, they are transplanted back into the patient. If the transplant is successful, the cells will differentiate to replace the damaged cells and restore the functions that have been lost. By using the patient’s own cells, this technology reduces the risk of tissue rejection and avoids the need to wait for a donor. CellSeed is testing this technology to repair corneal and other tissues damaged by disease.

“For CellSeed, this is a golden opportunity to collaborate with one of the nation’s leading biomedical research institutes, where many cutting-edge biomedical and biotechnological innovations have emerged. We believe that the studies with LA BioMed will enable us to bring our successful results in Europe to America. We also anticipate that such studies would give birth to a breakthrough that further advances Cell Sheet Engineering,” said Yukio Hasegawa, PhD, CellSeed president and CEO.

CellSeed’s clinical trial of its regenerative cornea technology in France is nearing completion, and the necessary paperwork to seek the European Medicines Agency’s authorization for commercialization of the process is being completed. The company is also broadening its range of commercial opportunities for regenerative medicine with Cell Sheet products to treat severe heart failure and periodontal disease, regenerate endoscopy-dissected cancerous esophagus and damaged cartilage, and treat other conditions.

“LA BioMed will be participating in a potentially revolutionary technology that, in clinical trials, has restored the vision of blind patients in Europe,” said Yutaka Niihara, MD, LA BioMed principal investigator who will lead the research team. “With this agreement, we can conduct the studies needed to meet the requirements for the Food and Drug Administration’s approval to bring this promising new technology to American patients.”

Source:
LA BioMed
CellSeed

Colorado State University’s Withrow Honored with Lifetime Achievement Award

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Posted 04 Feb 2011 — by James Street
Category Artificial Knees and implants, Bone repair, Cat osteosarcoma, Dog Osteosarcoma, Osteosarcoma, Surgery

FORT COLLINS – Dr. Steve Withrow, professor of surgical oncology and founder and associate director of the Animal Cancer Center at Colorado State University, recently was honored with the Theilen Tribute Award for Lifetime Achievement at the 30th Annual Veterinary Cancer Society conference.

Withrow received the Theilen Tribute Award for Lifetime Achievement for setting the foundation for veterinary oncology, initiating pioneering research and for advancing clinical veterinary oncology.

Withrow was cited for the brilliance of his surgical skills, passion for teaching veterinary students and graduate veterinarians, the inspiration of his leadership and the visionary spirit of developing one of the first medical oncology residency and surgical oncology fellowship programs. He also was recognized for his humanity and compassion in helping cancer patients – animal or human – get the information, diagnostics and treatment they need.

Withrow, considered one of the founding fathers of modern veterinary oncology, was introduced at the conference as the “most influential and accomplished living veterinary oncologist.” His contributions to cancer research, especially in the area of bone cancer diagnostics and treatment, have been noteworthy.

Withrow pioneered a treatment that may prevent amputation in bone cancer patients. The alternative treatment to amputation removes cancerous bones in the limbs of cats and dogs and replaces them with bones from another animal. The treatment was developed in parallel and collaboratively with human limb-sparing research. The procedure has been adopted by cancer treatment centers across the nation and has been highly successful in preventing amputations in children diagnosed with osteosarcoma.

Withrow has worked to secure the future growth of veterinary oncology by working with others to establish the Veterinary Cooperative Oncology Group and the Veterinary Society of Surgical Oncology. Withrow and fellow pioneer radiation oncologist, Dr. Ed Gillette, and others established the first true comprehensive cancer center in veterinary medicine, the Colorado State University Animal Cancer Center.

Withrow has been with the Colorado State Veterinary Teaching Hospital since 1978. He was recently named the director of the CSU Academic Cancer Supercluster and the chief scientific officer of NeoTREX, the enterprise arm of the Supercluster. He also is a Colorado State University Distinguished Professor, Stuart University Chair in Oncology and is the only veterinarian admitted as a member of the Musculoskeletal Tumor Society.

Withrow also presented a keynote address at the conference, held in October in San Diego, in which he reflected on his career and privilege of being a veterinarian.