New Islet Lab Brings All Facets of TPIAT Procedure In-house
On-site Islet Lab Improves TPIAT Patient Outcomes, Research Efforts
A new on-site islet laboratory at the Pancreas Care Center is launched to further improve care for pediatric patients who receive a total pancreatectomy with islet autotransplantation (TPIAT) procedure to treat pancreatitis.
The laboratory is the heart of the Cincinnati Human Islet Program (CHIP), which brings cell preparation in-house and provides many benefits, says Maisam Abu-El-Haija, MD, MS, medical director of the Pancreas Care Center and medical director of the CHIP initiative.
“This is the next step forward and upward for improving islet production and clinical outcomes for our patients,” Abu-El-Haija says.
Benefits of an In-House Lab
TPIAT eases the severe pain caused by relapsing pancreatitis. The procedure removes the pancreas and reconstructs the gastrointestinal tract. The operation also transplants islet cells isolated from the patient’s own pancreas into the liver to allow the body to make insulin when the cells engraft.
The Pancreas Care Center team along with key partners from cell therapy, spent more than a year preparing and building its islet lab to allow for on-site extraction of islet cells. The advantages the new facility provides include:
- Islet cell product of high quality
- Reduced operating time
- Faster recovery time for the patients
Published research studies that compare on-site and off-site islet cell isolation find that patients who receive TPIAT with on-site islet cell preparation show less dependence on exogenous insulin after surgery. “Having the TPIAT program and islet lab with quality assurance all in one place is really a dream come true,” Abu-El-Haija says.
Building CHIP
Cincinnati Children’s partnered with Imagine Pharma in Pittsburgh, a global leader in human islet cell isolations led by Rita Bottino, Ph.D. Bottino is a world-renowned expert in the field with more than two decades of experience using the highest quality standards. Bottino is also highly sought after as a trainer for islet biologists.
Bottino developed and optimized the protocols for the preparation of islet cells. She has vast experience in providing islets from clinical autologous islet transplantation for numerous programs around the country. Bottino and Imagine Pharma’s Islet Center were recently selected by the National Institutes of Health as one of only five isolation centers in the United States participating in the Integrated Islet Distribution Program. They partner with the Network for Pancreatic Organ Donors with Diabetes and Vanderbilt University, where they work to master the isolation of human islets from pancreatic donor organs with Type 1 and Type 2 diabetes.
Bottino consults with Cincinnati Children’s and is on-site during every islet isolation procedure.
Carolyn Lutzko, Ph.D., is the laboratory director for the CHIP program, as well as the director of Cell Manipulations in the Translational Core Laboratory at Cincinnati Children’s. She has 25 years of experience in the development and translation of cell- and gene-based therapies and used this expertise to establish the new CHIP Laboratory under the current Good Manufacturing Practices (cGMP).
She worked with Bottino and Abu-El-Haija, the rest of the transplant team, and the Translational Core Lab and CHIP teams to design and build the new islet isolation lab. The lab operates under cGMP to ensure all islet isolations occur under the highest levels of safety and quality.
The first patient treated through CHIP received care in January 2023. Six TPIAT procedures using the on-site lab have been completed to date, with more to come.
Personalized Protocol
The team developed methods that tweak islet cell isolation based on the patient’s age. The age of the patient dictates the degradation of the pancreas needed to get the islet cells. Each pancreatic organ is different. How the tissue responds to the digestion procedure varies and requires tailoring of the isolation approach to the specific characteristics of each organ. This translates to balancing enzymatic and mechanical digestion to recover as many islets as possible. Even if the isolation team follows rigorous qualitative standards, the best digestion approach must be decided “on the field” to achieve the best results. The CHIP team knows how to assess the health of pancreas tissue and adjust their process accordingly to provide the patients on the spot with the best yield possible.
Cincinnati Children’s has developed the expertise to determine which patients will get the most benefit from TPIAT.
“We strive to choose the best time for intervention,” Abu-El-Haija says. “We don’t always know, but we don’t want to operate too soon or wait too long and do multiple ERCPs [endoscopic retrograde cholangiopancreatographies], and then the islet cells could burn out. It is a fine line that we walk and a balance that we have to keep.”
“It’s critical that we get every islet cell that is there and give it back to the patient,” Abu-El-Haija says.
The Pancreas Care Center team works with families—many of whom come from outside of Cincinnati—to find the best time to schedule a TPIAT procedure. Abu-El-Haija says the goal is to minimize stress. Having the islet lab in-house increases the scheduling flexibility and options.
Research Opportunities
Abu-El-Haija describes the culture at Cincinnati Children’s as “deriving care through innovation.” It’s a model her team uses when building any new initiative.
The new islet lab provides opportunities for research and future care improvements.
The team will track data, outcomes, and protocols. These will highlight when research is needed to improve an outcome or a step in the process.
With just a few cases completed in the new model, the team is pleased by the high quality of cells they can extract. The Pancreas Care Center is proud to deliver the full care paradigm for children with chronic pancreatitis.
