Transformational cell therapies for patients with pancreatic disease

FAQs: FREQUENTLY ASKED QUESTIONS

1. What are the benefits of TP-IAT with Kyslecel?

TP-IAT with Kyslecel is very likely to provide a transformative and long-term relief from pancreatitis pain (80-90% of patients); allow you to substantially reduce or eliminate your need for pain medication (up to 82% of patients are narcotic-free after one year); and improve your quality of life. Most patients (about 90%) who undergo TP-IAT will achieve some level of insulin production for some period of time. With Kyslecel, your pancreas and islets will be handled by one of the most experienced teams in the world. Dr. Balamurugan Appakalai, who runs Koligo’s production lab, has more than 30 years of experience in the field and is a world-renowned expert in islet technologies.

2. Who is eligible for TP-IAT with Kyslecel?

Children and adults with chronic pain due to CP and whose islets produce insulin.  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.  Kyslecel contains human albumin, heparin, and ciprofloxacin – you should tell your doctor if you have an allergy or sensitivity to these agents.  Koligo may be able to prepare Kyslecel with alternative additives.

3. When is TP-IAT NOT recommended?

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 Kyslecel 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.

4. What tests are done before TP-IAT?

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.

5. What happens after my pancreas is removed?

You can live a full life without a pancreas so long as you diligently monitor your blood sugar and take daily enzyme replacements.  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 shipped to Koligo’s production facility by a specialized courier according to the same procedures used for organ donation.  Koligo will promptly make Kyslecel from your own pancreatic islets and send it back to your doctor – usually the next day.  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.

6. How long can I expect to be insulin independent after TP-IAT?

The outcomes for insulin independence vary widely from patient-to-patient.  Some patients who receive Kyslecel 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.  Koligo’s experience demonstrates that about 50% of patients who receive Kyslecel (and who were not diabetic prior to TP-IAT) are insulin independent after six months.   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.

7. Why will I be given insulin during and after TP-IAT?

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 in Kyslecel 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.

8. What is the safety record for 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, 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.

Kyslecel personalized cell therapy for chronic pancreatitis. Because pain should not define your life.