Guidelines for Neonatal Research Donors Being Developed by IIAM
Many families who receive a non-survivable diagnosis for their baby during pregnancy inquire about organ donation. Too often, they're told there are no options. In 2012, with the commitment of an exceptional couple, a team of OPO staff and medical professionals, IIAM helped shatter that perception.
Over the past four years, IIAM’s Neonatal Donor Program has given over 60 families an opportunity to create a lasting legacy for their baby. Through those gifts, more than 200 organs and tissues have been provided to researchers who have been able to gain unprecedented insights into how organs develop — right down to the cellular level.
However, many health care professionals are still unaware that neonates with fatal diagnoses such as anencephaly can become donors. IIAM has had an active presence at regional and national conferences that attract neonatologists, genetic counselors and NICU nurses, sharing information about donation possibilities for these tragic situations. Most recently, GDS presented "Families Considering Donation Options After Infant Loss" at the Neonatal Nursing Conference.
In order to ensure that the myriad legal and ethical issues surrounding these referrals are thoroughly addressed, IIAM and MTF established a multi-disciplinary Neonatal Steering Committee, comprised of respected ethicists, neonatologists, obstetricians, legal experts, OPO executives and donor family members. The goal of the steering committee is to establish protocols that will guide how best to manage neonatal and fetal demise referrals, and to publish the results of our work.
"In addition to making sure that families facing the loss of a baby with severe fetal deformities can consider donation, we aim to be diligent in making decisions that are legally and ethically sound," said Gina Dunne Smith, Executive Director of IIAM. "We want to play a leading role, and we want to do it right."
Members of the Neonatal Steering Committee are:
- Martha Anderson, Executive Vice President, Donor Services, MTF
- Kavita Shah Arora, MD, Case Western Reserve University
- Jennifer Birmingham, General Counsel, MTF
- Maggie Coolican, RN, CFC
- Aaron Goldenberg, PhD, Case Western Reserve University
- Sarah Gutin, CNP, Case Western Reserve University
- Dan Lebovitz, MD, Lifebanc
- Jeff Orlowski, CEO, LifeShare of Oklahoma
- Rick Rodriguez, MD, Cleveland Clinic Foundation
- Joe Roth, President/CEO, NJ Sharing Network
- Gina Dunne Smith, Executive Director, IIAM
- Stuart Youngner, MD, Case Western Reserve University
IIAM Welcomes Three New Placement Coordinators
IIAM is pleased to introduce the newest additions to our Placement Coordinator team, all of whom were hired in 2016. With the volume of referrals from OPOs steadily increasing, this expansion ensures that IIAM can offer full service and eliminate lag time by promptly activating screening and placement of organs and tissue for research.
Brian Bush, hired in March, spent 10 years with Mid-America Transplant Services, St. Louis, MO (and the IL region), in nearly every role — Organ/Tissue Recovery Coordinator, Hospital Development, Public Relations and Call Center Manager. Shortly thereafter, he began his career with the Illinois Secretary of State Office's Organ/Tissue Donor Program and more recently served as Community Outreach Coordinator. Brian, who graduated from Southern Illinois University of Carbondale with a degree in Mortuary Science and Funeral Service, is a licensed funeral director and embalmer. He has served on the Donate Life America Donor Designation Collaborative and is currently the state team leader for Donate Life Illinois. Brian comes to IIAM with over 19 years of experience in the donation and transplant field.
Nancy Eckerd, hired in April, spent 10 years with Finger Lakes Donor Recovery Network, Rochester, NY, as Organ Recovery Coordinator and then as Team Leader. As a licensed practical nurse, Nancy spent many years prior to and after her tenure with the OPO working in hospitals — devoting 20 years to dialysis patients. This experience enabled her to develop expertise in relationship integration with doctors and administrative staff of varying levels. Nancy is also is well versed in electronic medical records and systems — which will be a great benefit to her new role with IIAM as a Placement Coordinator.
Jennifer Evans joined IIAM in August with a decade of experience in the transplant field. She started her career at the Utah Lion's Eye Bank as a Recovery Technician, and after a move across the country, was a Tissue Donor Coordinator at Lifebanc in Cleveland, Ohio. More recently, Jennifer had served as a Donor Coordinator for the Musculoskeletal Transplant Foundation, our parent organization, as well as Intermountain Donor Services in Salt Lake City, Utah. She has a degree in Health Administration, and is CTBS certified.
Hiring these three Placement Coordinators from OPOs is no coincidence. "Coming from the donor management side, their learning curve is minimal," said Gina Dunne Smith, Executive Director of IIAM. "In the time-critical, high-pressure environment of a call center, they know our clients, they come in with the required skill sets and it doesn't take long for them to get up to speed. With Brian, Nancy and Jennifer on the team, IIAM doesn't just talk the talk, we walk the walk!"
Growth Is in This OPO's "DNA"
Over the past year, Donor Network of Arizona (DNA) has seen a dramatic increase in referrals for non-transplantable organs and tissue for research. As of the end of August, the OPO, located in Phoenix, AZ, had referred 198 organs. At that rate, DNA would reach 300 referrals, compared to 203 in all of 2015.
Jennifer Muriett, MSN, RN, CPTC, Director of Organ Recovery Services at DNA, identified two reasons to explain this growth. "First, we are focusing on making sure we offer every family interested in donating the research option if transplantation isn't viable," she said. "In addition, we've experienced a spike in volume due to a significant increase in organ donor designations through motor vehicle and other registries."
Both Muriett and Mike Vara, IIAM's Midwest and West Coast Regional Director, are just as proud of our close partnership in research since 2010. DNA's staff regularly attends IIAM's semiannual Research Recovery Workshops, which train surgical/tissue and perfusion techs how to recover non-transplantable organs for medical research.
"As we train people from OPOs, we see a marked increase in successful recoveries, which enables us to provide researchers with more acceptable organs," said Vara. Muriett added, "It was an active decision on our part to commit to IIAM's Research Recovery Workshops, a valuable way to practice skills and stay current with best practices."
According to Muriett, IIAM's call center makes the entire referral process smooth. "Their Placement Coordinators are knowledgeable, responsive, polite and easy to work with, and it's a pleasure to collaborate with Mike and Gina (Executive Director Gina Dunne Smith). I appreciate our partnership with IIAM, as well as their relationships with medical researchers. After all, medical research is a key component to advances in medicine that lead to saving lives."
Next-Generation Liver Research
Advances Organ and Tissue Engineering
Not long ago, the prospect of creating artificial organs bordered on science fiction. Due to the efforts of bioengineering research companies like Samsara Sciences and Organovo, that fantasy is coming closer to reality.
Samsara develops high-quality primary human liver cells for research applications. Organovo designs and creates functional human tissues for research and therapeutic applications using proprietary three-dimensional bioprinting technology.
Based in San Diego, CA, the two "sister" companies are collaborating on two projects: (1) generating 3D human liver tissues that can be used to develop and test new drugs, study liver diseases and test methods of implanting such tissues into patients with liver diseases; and (2) developing an accurate 3D bioprinted kidney model to be used for pharmacology/toxicology, drug metabolism, drug screening and kidney disease studies.
IIAM provides hepatic and renal tissue to Samsara, which then provides the cells and tissue reagents to Organovo to enable the work. "A key aspect of generating 3D human tissues is reconstructing native tissue architecture, which means utilizing most or all of the cell types that are normally present in a tissue," said Sharon Presnell, PhD, President of Samsara and Chief Scientific Officer of Organovo.
"Most providers of liver cells focus on the hepatocytes, the metabolic workhorse cells of the liver, but the functionality of that very important cell type is heavily influenced by and dependent on the presence and support of several other cell types (stellate cells, endothelial cells, macrophages, etc.)," she said. "For bioprinting or other next-generation tissue-engineering efforts, it's important to incorporate all cell types. Our techniques enable each cell type to be isolated and characterized separately and then recombined to create a full suite of valuable cellular reagents."
Samsara recently provided Organovo with a matched set of cellular reagents that were all isolated from the same liver donor. "While donor-matched cells may not be required for in vitro applications, it may prove exceptionally important to be able to build tissues for use in regenerative medicine using cells originating from a single donor," said Presnell. "Because of our close geographic proximity and our mutual commitment to generating and using the full suite of cell types from each organ system, Samsara is uniquely able to partner with Organovo and guide our product development toward their needs."
Later this fall, Samsara plans to release renal proximal tubular epithelial cells as the company begins to expand its portfolio of human kidney cellular products.
Eric David, MD, JD, Chief Strategy Officer and Executive Vice President of Preclinical Development at Organovo, explained his organization's role in the process. "We use the liver cells we obtain through Samsara to make small pieces of liver tissue, which we are designing and implanting into animals with the goal of getting into clinical trials for human implantation in the coming years. While Organovo cannot yet make full livers, we believe we can make enough functional liver tissue to be curative in certain pediatric liver diseases. And for other adult liver diseases, we believe we can make enough tissue to bridge patients a few more years before they need a transplant."
Presnell explained how collaborating with IIAM advances Samsara's and Organovo's initiatives. "Our goal is to provide customers with a full suite of options to support their research efforts — not only multiple, well-characterized cell types from each organ, but also cells isolated from a broad spectrum of both healthy and diseased donors. The IIAM team does a great job of taking time to understand the needs of the researchers they support and to provide tissues that serve those needs. Very good listeners and strong communicators, they are willing to partner in servicing a wide range of challenging research goals."
Although Samsara and Organovo are involved in technology-driven research, both principals emphasize the human aspect of their work and the benefits that work is creating. "The demand for liver transplants far outpaces the donor supply, and I've seen that dire need first hand," said Dr. David. "Our company has the tools and processes that have the potential to alleviate the situation and a passionate team that's dedicated to making it happen."
Presnell said, "The primary goal for any tissue should be to save a life on that day — but when that is not possible, I believe donor families appreciate that one donated tissue may go on to make tens or hundreds of regenerative medicine products that could save many lives... or lead to new cures for life-threatening diseases."
(l to r): Ken Dorko, Associate Director of Lab Operations at Samsara Sciences; Sharon Presnell, President of Samsara Sciences and Chief Scientific Officer of Organovo; and Gina Dunne Smith, Executive Director of IIAM