"I feel so fortunate to be able to benefit from such an exceptional program that’s right here in Nebraska. I’m here today because of them."
Surviving Against All Odds
Stephanie Haines is in the prime of her life. But at just 25 years old, Haines will tell you that she is just happy to be alive – everything else is just frosting on the cake.
During her first year of college, Haines was diagnosed with pancreatitis due to a condition called pancreatic divisum. While many patients with pancreatic divisum experience no symptoms at all, such was not the case for Haines. Haines suffered repeated attacks. In the end, it almost took her life.
Pancreatitis is an inflammation of the pancreas that can cause severe abdominal pain and other complications. Pancreatic divisum is a congenital abnormality of the pancreas in which the two ducts of the pancreas fail to fuse together before birth. One of the jobs of the pancreas is to produce enzymes for digesting food in the intestine. These enzymes drain from the pancreas via the pancreatic duct. In Haines' case, the major duct was not connected to the pancreas and the smaller duct was so narrow that the enzymes kept backing up into her pancreas, causing acute episodes of pancreatitis.
For four years, Haines staged an aggressive battle against this unrelenting condition. Fourteen surgeries later, with little or no progress, Haines' options were running out. She was told that removal of her pancreas combined with an autologous islet transplant was her last option. That's when she landed at the Transplant Center, a joint program of Nebraska Medicine and the University of Nebraska Medical Center (UNMC).
Haines had heard about the world-class organ transplant program at Nebraska Medicine. When she contacted the Transplant Center, she was connected to Jean Botha, MB, BCh, a transplant surgeon at UNMC and Nebraska Medicine, who is known for his innovative surgeries including autologous islet transplants, liver and pancreatic resections and liver transplants.
Autologous islet transplant, a procedure that is performed at just a few medical centers in the country, involves removing the pancreas, then harvesting the islet cells from the pancreas and transplanting them back into the liver. This allows the liver to take over the pancreas's job of producing insulin. Autologous islet cell transplantation can prevent diabetes or reduce the severity of diabetes after removal of the pancreas.
This procedure was possible, in part, due to Nebraska Medicine's experience and capabilities in harvesting and storing the islet cells which requires an isolated and extremely sterile environment as well as strict environmental and quality control standards. Several suites at Nebraska Medicine's new Biologics Production Facility were specifically designed to facilitate this type of processing. The role of staff at the Biologics Facility is to enzymatically digest the excised organ, isolate and purify the islet cell tissue and prepare it for infusion all in one continuous event from pancreatectomy in the operating room to transplantation.
The Biologics Production Facility has opened new opportunities to further advance Nebraska Medicine's world-class organ transplant program and our pioneering work in the use of pancreatic islets and liver cells.
The facility was designed to support scientific and clinical investigators in using the most modern medical techniques to develop and test promising new medical therapies to treat cancer, diabetes, degenerative diseases, serious injuries and other life-threatening disorders. Many of these therapies involve the collection, isolation, processing, modification, cryopreservation and/or storage of cells, tissues, or cellular and tissue-derived products. This is an area of research that is growing rapidly but is limited to select institutions because of the expertise, comprehensive quality management, process controls and the stringent environmental controls required for such work to take place.
"The Biologics Production Facility allows us to take the most recent findings from a laboratory to the development of a product that potentially benefits patients," says Dr. Warkentin. "Much of biologics medicine is still investigational, but the results have been very promising. I foresee that there will be many more diseases in the future that we will be able to treat with products or vaccines that can be produced here. We are only limited by our creativity and our imagination."
For Haines, an autologous islet transplant was her last option. According to Dr. Botha, "she was the perfect candidate. If the patient is well-selected, they can do very well with this procedure and live a long time. By using a patient's own islet cells, there is no risk of rejection which eliminates a lot of complications."
On Aug. 11, 2008, Haines successfully underwent the 12-hour surgery. Nebraska Medicine physicians continue to play an integral role in Haines' care to ensure her insulin and blood sugar levels are managed properly.
Haines considers herself a beneficiary of the positive results that can occur when you let "great things happen." "The Transplant Center is amazing," she says. "I feel so fortunate to be able to benefit from such an exceptional program that's right here in Nebraska. I'm here today because of them."
Taking Back Life
Stored in a liquid nitrogen freezer at temperatures below -150°C (-238 F) at Nebraska Medicine’s Biologic Production Facility, are several thousand small bags of human hematopoietic stem cells. They are the link to life and a possible cure for many patients with cancer or other life-threatening illness.
One of these bags contain Nessie Swedlund’s stem cells. In March of 2008, Swedlund was diagnosed with multiple myeloma, a cancer of the plasma in the bone marrow. Less than a year later, she received a life-saving stem cell transplant at Nebraska Medicine. During the stem cell procurement process, extra stem cells were collected and frozen and now serve as a back-up for Swedlund in case her cancer cell percentage should increase. In this cryopreserved state, cellular products, such as stem cells, can remain stable for a minimum of 10 years, and probably longer.
While Swedlund knows that there is no cure for multiple myeloma, she takes comfort in knowing that she is receiving care at one of the leading medical centers in the country for multiple myeloma and stem cell transplantation. She is also comforted by the fact that she has another dose of her own stem cells frozen and carefully preserved in the region’s only biologics production facility should she need a second transplant.
"I feel so fortunate to have access to this type of expertise right here in Omaha," says Swedlund.
The Biologics Production Facility, which opened in November of 2010, allows Nebraska Medicine to take medicine to the next level in stem cell transplantation, as well as other cutting edge areas of cellular therapy.
Jointly operated by Nebraska Medicine and the University of Nebraska Medical Center (UNMC), it is designed to support scientific and clinical investigators in using the most modern medical techniques to develop and test promising new medical therapies to treat cancer, diabetes, degenerative diseases, serious injuries and other life-threatening disorders. Many of these therapies involve the collection, isolation, processing, modification, cryopreservation and/or storage of cells, tissues, or cellular and tissue-derived products. This is an area of research that is growing rapidly but is limited to select institutions because of the expertise, comprehensive quality management, process controls and the stringent environmental controls required for such work to take place.
For instance, in Swedlund’s case, while the storage of stem cells has become more common, it is a procedure that must be performed according to detailed written procedures to prevent damaging the functionality of the cells. First, the collected cells are mixed with a cryoprotectant consisting of dimethyl sulfoxide (DMSO), saline, and albumin at a specified concentrations. The cell suspension is then transferred into special cryobags designed to withstand liquid nitrogen temperatures. The product is then slowly cooled at a slow controlled rate (about 1°C per minute) down to -90°C. At that point, the cell suspension is frozen solid, and the bags are transferred to a monitored liquid nitrogen storage freezer, which averages a temperature of about -190°C. Each step in the process is controlled, documented, and reviewed by a member of the Quality Unit before the product is approved for release to the patient.
"This facility gives us the ability to do almost anything from a manufacturing perspective," says Phyllis Warkentin, MD, medical director of the Biologics Production Facility. "For many years, we’ve been able to process and preserve minimally manipulated products such as hematopoietic stem and progenitor cells. In this facility, we will be able to isolate, select and potentially expand selected cell populations and manufacture vaccines and other cellular products for our own patients or patients elsewhere. Such products can potentially improve patient outcomes, decrease complications and treat diseases that were previously resistant. We are very excited about the potential of these therapies, as well as the types of clinician investigators, scientists and projects this facility will attract to Nebraska. The possibilities are limitless."
When Swedlund thinks about the last few years of her life, she chuckles quietly, "like the movie, it could have been ‘two weddings and a funeral.’ But I was lucky. For me, it was two weddings and a stem cell transplant."
While receiving treatment to prepare her body for the stem cell transplant, Swedlund helped plan her son’s wedding, which she attended in September of that year. She underwent a stem cell transplant in October. Four months later and still recovering, she celebrated her daughter’s wedding. It was a challenging year, but Swedlund says she fought through it with prayer, family support, by seeking out something positive everyday and by putting her trust in her physician, Julie Vose, MD, hematologist/oncologist, one of the country’s leading experts on lymphoma, leukemia and multiple myeloma.
"The transplant was the best thing I’ve ever done," says Swedlund. "Since then, I’ve had no more bone pain and my bone lesions have stopped progressing. It feels so good to get back to doing many of the things I was doing before."
There are a few things that doctors have asked Swedlund to avoid, but in her positive way of living life, Swedund always finds something to replace it with. For instance, when they told her not to downhill ski, she learned to cross country ski. When they said no more water skiing, Swedlund took up kayaking. "My goal is to stay as fit and active as possible," she says.
In March, Swedlund celebrated the three-year anniversary of her diagnosis. "When I was first diagnosed, the first doctor I saw only gave me three years to live," she recalls. "I intend to make it at least another 15. Every day I’m here there is new research going on. I owe so much to Dr. Vose, Nebraska Medicine and the Biologics Production Facility."