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Assistant Professor of Biomedical Engineering, Zhen Xu received the 2015 Frederic Lizzi Early Career Award from the International Society of Therapeutic Ultrasound (ISTU). Every year, Lizzi Award is given to a researcher at early stage of career who has achieved significant accomplishment and contribution to the field of therapeutic ultrasound.
Allison Powell (BSE) and Kyle Bettinger (BSE) co-founded a startup called “PuffBarry” to develop a device aiding people living with ALS, multiple sclerosis, and muscular dystrophy. Born out of their BME 458 team project the PuffBarry device uses puffs of air as code that a computer can interpret and translate into speech as an alternative communication device for those who have lost the ability to speak. Their passion for helping those with ALS came after a family friend of Allison passed away during her college career. Allison and Kyle took their idea to the U-M Center for Entrepreneurship competition “The StartUp” and came away with $3000 in seed funding among 16 others in the field of 60 and eventually won the grand prize of $15,000 and entry into TechArb. They also received an additional $1000 by winning the TedXUofM prize. Allison will attend TedXTraverseCity in May as one of the invited speakers.
ANN ARBOR, Mich. — Kaiba was just a newborn when he turned blue because his little lungs weren’t getting the oxygen they needed. Garrett spent the first year of his life in hospital beds tethered to a ventilator, being fed through his veins because his body was too sick to absorb food. Baby Ian’s heart stopped before he was even six months old.
Three babies all had the same life-threatening condition: a terminal form of tracheobronchomalacia, which causes the windpipe to periodically collapse and prevents normal breathing. There was no cure and life-expectancies were grim.
The three boys became the first in the world to benefit from groundbreaking 3D printed devices that helped keep their airways open, restored their breathing and saved their lives at the University of Michigan’s C.S. Mott Children’s Hospital. Researchers have closely followed their cases to see how well the bioresorable splints implanted in all three patients have worked, publishing the promising results in today’s issue of Science Translational Medicine.
“These cases broke new ground for us because we were able to use 3D printing to design a device that successfully restored patients’ breathing through a procedure that had never been done before,” says senior author Glenn Green, M.D., associate professor of pediatric otolaryngology at C.S. Mott Children’s Hospital.
“Before this procedure, babies with severe tracheobronchomalacia had little chance of surviving. Today, our first patient Kaiba is an active, healthy 3-year-old in preschool with a bright future. The device worked better than we could have ever imagined. We have been able to successfully replicate this procedure and have been watching patients closely to see whether the device is doing what it was intended to do. We found that this treatment continues to prove to be a promising option for children facing this life-threatening condition that has no cure.”
The findings reported today suggest that early treatment of tracheobronchomalacia may prevent complications of conventional treatment such as a tracheostomy, prolonged hospitalization, mechanical ventilation, cardiac and respiratory arrest, food malabsorption and discomfort. None of the devices, which were implanted in then 3-month-old Kaiba, 5-month-old Ian and 16-month-old Garrett have caused any complications.
The findings also show that the patients were able to come off of ventilators and no longer needed paralytics, narcotics and sedation. Researchers noted improvements in multiple organ systems. Patients were relieved of immunodeficiency-causing proteins that prevented them from absorbing food so that they no longer needed intravenous therapy.
Kaiba Gionfriddo made national headlines after he became the first patient to benefit from the procedure in 2012, and the procedure was repeated with Garrett Peterson and Ian Orbich. Using 3D printing, Green and his colleague Scott Hollister, Ph.D., professor of biomedical engineering and mechanical engineering and associate professor of surgery at U-M, were able to create and implant customized tracheal splints for each patient. The device was created directly from CT scans of their tracheas, integrating an image-based computer model with laser-based 3D printing to produce the splint.
The specially- designed splints were placed in the three patients at C.S. Mott Children’s Hospital. The splint was sewn around their airways to expand the trachea and bronchus and give it a skeleton to aid proper growth. The splint is designed to be reabsorbed by the body over time. The growth of the airways were followed with CT and MRI scans, and the device was shown to open up to allow airway growth for all three patients.
Doctors received emergency clearance from the FDA to do the procedures.
“We were pleased to find that all of our cases so far have proven to improve these patients’ lives,” Green says. “The potential of 3D-printed medical devices to improve outcomes for patients is clear, but we need more data to implement this procedure in medical practice.”
Authors say the recent report was not designed for device safety and that rare potential complications of the therapy may not yet be evident. However, Richard G. Ohye, M.D., head of pediatric cardiovascular surgery at C.S. Mott who performed the surgeries, says the cases provide the groundwork to potentially explore a clinical trial that could help other children with less-severe forms of tracheobronchomalacia in the future.
Kaiba, now a curious, active 3-year-old who loves playing with his siblings and who recently saw his favorite character Mickey Mouse at Disney World thanks to the Make-a-Wish Foundation, was back at Mott in April for a follow-up appointment.
The splint is dissolving just how it’s supposed to and doctors expect that eventually, his trachea will reflect that of his peers with no signs of the tracheobronchomalacia that nearly killed him as a newborn.
“The first time he was hospitalized, doctors told us he may not make it out,” Kaiba’s mom April Gionfriddo remembers. “It was scary knowing he was the first child to ever have this procedure, but it was our only choice and it saved his life.”
Now an energetic 2-and-a-half-year-old with a contagious laugh, Garrett is able to breathe on his own and spend his days ventilator-free. Ian, now 17 months old, is known for his huge grins, enthusiastic high fives and love for playing with his big brother, Owen. Ian had the splint procedure done at Mott exactly one year ago this month.
“We were honestly terrified, just hoping that we were making the right decision,” his mother Meghan Orbich remembers. “I am thankful every single day that this splint was developed. It has meant our son’s life. I am certain that if we hadn’t had the opportunity to bring Ian to Mott, he would not be here with us today.”
To learn more:
Support this important research by making a gift to the 3D-Printed Airway Splint Fund.
Watch a video demonstrating 3D printing
Read blog post from Dr. Glenn Green that goes behind the scenes on what led to the 3D printed devices to restore breathing in babies with tracheobronchomalacia.
See more on Kaiba’s story
See more on Garrett’s story
Additional Authors: Robert J. Morrison, Scott J. Hollister, Matthew F. Niedner, Maryam Ghadimi Mahani and Richard G. Ohye, all of U-M. Albert H. Park, of University of Utah; Deepak K. Mehta, of the Children’s Hospital of Pittsburgh of University of Pittsburgh Medical Center.
Funding: This work was funded in part by the National Institutes of Health (grant R21 HD076370-01) Morrison is supported by NIH grant T32 DC005356-12.
Disclosure: Hollister and Green have filed a patent application related to the device.
Reference: “Mitigation of Tracheobronchomalacia with 3D-Printed Personalized Medical Devices in Pediatric Patients,” Science Translational Medicine, April 29, 2015.
Each year, the Society For Biomaterials solicits nominations for outstanding work in the Clemson Award categories. The history of these awards reflects the strong traditional ties between the Society For Biomatierals and Clemson University since 1974.
Lonnie Shea, The William and Valerie Hall Chair and Professor of Biomedical Engineering, is the recipient of the 2015 Clemson Award for Contributions to the Literature for his significant contributions to the literature on the science and technology of biomaterials.
“Dr. Shea has a tremendous publication record for his career stage, and he publishes important papers. Dr. Shea has been actively involved in educational and service activities at many levels, and has made major contributions to the biomaterials field through these activities,” stated colleague David Mooney.
Dr. Shea has published over 168 papers in peer-review journals, and 11 book chapters in the biomaterials and tissue engineering fields. Dr. Shea’s awards and honors include the NSF New Century Scholar, NSF Career Award, and election as a Fellow to AIMBE in 2010.
Contact: Gabe Cherry, 734-647-7085, firstname.lastname@example.org
ANN ARBOR – New research in mice offers evidence that a drug being developed to treat osteoporosis may also be useful for treating osteogenesis imperfecta or brittle bone disease, a rare but potentially debilitating bone disorder that that is present from birth.
Previous studies have shown the drug to be effective at spurring new bone growth in mice and in humans with osteoporosis, and a University of Michigan research team believes that it may spur new growth in brittle bone disease patients as well. This would be a significant improvement over current treatments, which can only reduce the loss of existing bone.
The new drug is an antibody to a protein called sclerostin, which normally signals the body to stop producing new bone. Previous studies have shown that inhibiting sclerostin through antibody therapy is effective at increasing bone formation and strength.
The new U-M study focused on the effects of the antibody in very young and very old mice with genetic features that mimic brittle bone disease. Researchers were particularly interested in studying the effects of the drug on young mice, which are still growing new bone and have much lower levels of sclerostin.
“The dynamics of bone growth in young mice and in children are very different from those in adults,” explains Ken Kozloff, a U-M associate professor of orthopaedic surgery and biomedical engineering. “Their bone structures are still forming, so it’s important to understand how inhibiting sclerostin may affect that. We were also concerned that the benefits of the drug would reverse themselves after treatment stopped.”
The results of the study were encouraging, with no reduction in mid-shaft bone strength or mass in young mice six weeks after treatment stopped. While there was some loss in newly formed spongy bone, the researchers found that this could be remedied by using the sclerostin antibody in combination with other therapies.
Osteogenesis imperfecta is a genetic disease that affects an estimated 20,000 to 50,000 people in the United States, about 1 in 20,000 live births. It reduces the body’s ability to form new bone and weakens the bone that does form. This leads to bones that fracture easily in everyday activities, causing a cycle of repeated fractures and hospitalizations. There is no cure and current treatment options are limited. They include the use of bisphosphonate drugs to reduce the weakening of bone and the surgical implantation of steel rods in the bones to improve their strength.
“I envision a treatment that uses a precise combination of sclerostin antibodies to grow new bone, followed by bisphosphonates to lock in that bone growth. The rodent studies we’re doing right now are giving us a better understanding of how to optimize the timing and amounts of the two drugs,” said Michelle Caird, an associate professor of orthopaedic surgery at the U-M medical school who specializes in brittle bone disease. “We have years of hard work ahead of us, but I think this could really improve quality of life for kids with this disease.”
The research team still has an estimated two years of rodent studies to complete. They’re hopeful that patients may have a new treatment option within the next five to six years. Amgen, the manufacturer of the drug and the provider of the drugs used in the U-M study, is currently testing the drug on osteoporosis patients. Caird says the data gained from that testing may help a new treatment for brittle bone disease get through the testing and approval process more quickly. The team is also working on new study methods that may enable them to test the new drug in the lab on small samples of bone cells taken from patients.
“There are always special concerns about using drugs on young patients,” she said. “How will it affect long-term bone growth? Are there concerns about girls and childbearing? These are all questions that need to be addressed, but we’re optimistic.”
Researchers believe that the therapy may also be useful for treating children who suffer from disuse osteopenia, a bone disorder that can result when bones don’t bear normal amounts of weight. This is common among children who use wheelchairs as a result of diseases like cerebral palsy and spina bifida.
“Disuse osteopenia is the same disease that astronauts get when they’re in microgravity environments for long periods of time,” Caird said. “It affects many more children than brittle bone disease, so we’re very hopeful that sclerostin antibody therapy will be a useful treatment for them as well. But we’re focusing on brittle bone disease first because it’s particularly debilitating and because there are so few other options for those kids.”
An abstract titled “Single Dose of Bisphosphonate Preserves Long-term Gains in Bone Mass Following Cessation of Sclerostin Antibody in Osteogenesis Imperfecta Model” will be presented on March 31 at the annual meeting of the Orthopaedic Research Society in Las Vegas, Nevada. The research was funded by the National Institutes of Health. Drugs for the study were provided by Amgen and UCB.
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