Koligo Therapeutics refers to its islet product solution as Kyslecel.
TP-IAT FOR THOSE SUFFERING FROM CHRONIC PANCREATITIS
Total Pancreatectomy with Islet Auto-Transplantation (TP-IAT) is a surgical procedure for patients suffering from chronic pancreatitis that can provide significant pain relief with long-term glycemic control. The first step is a total pancreatectomy in which the source of the chronic pain and inflammation (the pancreas) is surgically removed from the patient. The pancreas is then transported to a laboratory for processing and islet cell isolation. Islet cells are small clusters of cells within the pancreas that are responsible for metabolic functions, namely glycemic control via insulin production. Once the islets are isolated, they are formulated into an IV and infused back into the patient for the potential to maintain glycemic control after the pancreatectomy.
It is important to note that the removal of the pancreas is a significant operation, and the recovery process may take several months. The decision to undergo TP-IAT should only be made after careful consideration with your physician.
Children and adults with chronic pain due to CP and whose islets produce insulin are candidates for TP-IAT. Generally, eligibility for TP-IAT is determined by abdominal pain longer than six months, severely impaired quality of life, repeated hospitalizations, and a consistent need for narcotic pain medication.
Most chronic pancreatitis patients (nearly 80%) will eventually become diabetic as the disease progresses and their pancreas continues to degenerate. Consideration of TP-IAT earlier in the course of the disease can preserve islet viability and function, increasing the potential level of blood sugar control post-procedure. However, not every patient that undergoes TP-IAT will achieve sufficient blood sugar control and will require lifelong insulin therapy.
All patients will require lifelong enzyme replacement therapy once their pancreas is removed. TP-IAT is a major surgery that carries significant risks. It is essential to speak to your doctor about the potential risks and benefits of the procedure.
Your doctor will undertake tests to confirm the diagnosis of chronic pancreatitis. You will be tested for diabetes which may require fasting before the test. Your doctor may review your immunization status to ensure vaccination against certain organisms that may arise from surgery. You will be assessed for your nutritional status and any other potential concerns that may impact your recovery from TP-IAT.
TP-IAT can be performed by healthcare providers with the requisite surgical and endocrinology capabilities. Your physician may prefer to refer you to a specialized surgical center with an established TP-IAT program. If helpful, your physician can contact Koligo to discuss available programs.
The outcomes for insulin independence vary widely from patient-to-patient. Some patients can expect to be insulin free for many years. Most patients can expect to be insulin free for a period of time (6-18 months) before requiring supplemental insulin to manage blood sugar. Some patients will never achieve insulin independence after TP-IAT. Published studies indicate that 10-47% of patients who have undergone TP-IAT will be insulin independent. Importantly, even in patients who become dependent on insulin but retain partial islet function benefit from TP-IAT. Patients who achieve partial success will experience less dramatic swings in blood sugar and generally have a more controllable form of diabetes than patients who do not undergo an islet transplant.
During TP-IAT, your surgeon will carefully prepare your pancreas to assure that blood supply is maintained as long as possible to preserve the function of your pancreatic islets. Your pancreas will be transported to a cleanroom laboratory for isolation of the islets. The islets will be formulated into IV bags and transported back to the clinical facility for administration into your liver where they will be able to provide some level of glycemic control.
You can live a full life without a pancreas so long as you diligently monitor your blood sugar and take daily enzyme replacements. Because your pancreas has been permanently removed, you will need to take oral pancreatic enzymes for life. These enzymes are critical for our body to digest fats, proteins, and carbohydrates. They also play an important role in the absorption of many vitamins. Your doctor will start enzyme replacement therapy during the surgery.
Immediately after removal of your pancreas, your doctor will start continuous insulin infusions. This is an important part of the procedure to maintain control of your blood sugar and to give the islets the best chance for success when transplanted into your liver. Your doctor will continue insulin therapy in the hospital, and you will likely continue with insulin therapy at home after discharge. If your islets engraft successfully, your insulin treatment will be tapered down and potentially stopped altogether. You should stay in close contact with your doctor or nurse to carefully monitor your insulin and blood sugar after TP-IAT.
TP-IAT generally has a safety profile similar to other pancreatic surgeries, except that TP-IAT carries a higher risk of bleeding and need for blood infusions as compared to pancreatectomy alone. Potential complications that may occur up to 20% of the time include wounds, pneumonia, sepsis, thromboembolism (blockage created by a blood clot), and shock. Very rarely, as with all major surgery, some complications can lead to extended hospitalization or death. Usually, TP-IAT complications can be treated and resolved by your doctor. TP-IAT has been performed for over 40 years. The safety and efficacy profile of the procedure is constantly improving.
TP-IAT is a major surgery, so patients should be of sufficient health to undergo the procedure. Patients who suffer from active alcoholism, pancreatic cancer, illegal drug usage, poorly controlled psychiatric illness, or end stage cardiopulmonary disease are not appropriate candidates for TP-IAT. Sometimes TP-IAT can be considered after appropriate recovery from these conditions. Patients with C-peptide negative diabetes (no islets) will not benefit from TP-IAT because it is unlikely that your islets will regain function after transplant into the liver. Patients with liver disease such as portal hypertension, portal vein thrombosis, or cirrhosis may not be appropriate candidates, due to potential complications.
Tell your healthcare provider all of the medications you take.