Islet Cell Transplantation Clinical Trials

Islet Cell Transplantation Treatment Clinical Trials
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Learn more about our ongoing islet cell transplant clinical trial/s:

IRB# 18156:  Improving Islet Transplantation Outcomes with Gastrin (NCT03746769) 
Principal Investigator: Fouad Kandeel, MD, PhD

Interested in participating?
If you are interested in learning more about available islet cell transplant clinical trial/s, call our toll-free patient screening line 866-44-ISLET (47538) or e-mail us at [email protected].

Long Term Follow-Up (LTF) Clinical Trial
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Study Purpose
The purpose of this protocol is to collect medical information from islet transplant recipients after they have completed (or withdrawn) from participation in their original islet transplant protocol.  This allows continued assessment of the safety and effectiveness of the procedure and for continued reporting to the islet transplant registries.

Who Can Participate?
Adults (age 18 yrs old or greater) with type 1 diabetes previously treated with islet transplantation who are no longer participating in the original islet transplant treatment study can be considered for study participation.

What Will be Done?
Subjects will continue to be followed by their primary medical team with visits to COH every 6 months for follow-up assessment.  If subjects are unable or unwilling to attend in-person follow-up visits to COH, they may choose to participate in telephone interviews conducted by a COH study staff member. Six month visits/phone calls are scheduled based on the date of the subject’s last islet transplant.

Subjects who return to City of Hope for follow-up will be monitored for:

1) Diabetic Complications
Participants are evaluated for complications related to their diagnosis of diabetes. They are asked to provide their blood sugar/insulin records, complete a symptom checklist, undergo a physical exam, including testing of the feet for diabetic neuropathy and testing eyes for retinal function. A small amount of blood is also drawn for routine lab tests.  Collection of a 24-hour urine sample is performed annually to monitor kidney function.

2) Islet Transplant Function
Specialized blood tests are performed which measure how well the transplanted islets are working, including:

  • Hemoglobin A1c measures average blood sugar levels over the previous 2-3 months.
  • Continuous glucose monitoring involves wearing a small pager-like device connected to a tiny sensor inserted just under the skin. The sensor measures sugar levels continuously for 3 days and results are downloaded to a computer for analysis by the islet cell transplant team.
  • C-peptide to glucose, creatinine ratio testing requires fasting overnight.  Blood is drawn in the morning to measure the C-peptide, glucose, creatinine insulin and proinsulin levels, to determine how much insulin the transplanted islets are producing.
  • Glucagon stimulation also requires overnight fasting and involves taking a blood sample to measure glucose levels before and after a glucagon injection. Glucagon stimulates the liver to release stored sugars which should cause the transplanted islets to make insulin.
  • Intravenous (through the vein) glucose tolerance test (IVGTT) involves measuring how effective the transplanted islets are in reducing blood sugar levels in response to a sugar (glucose) injection. Multiple blood samples are taken before and for 30 minutes after the injection to measure blood sugar levels.

3) Immune System Monitoring
The immune system consists of organs, tissues, and cells that normally fight infections or respond to the presence of other foreign substances. After a transplant, this process may lead to rejection of the islets. Several biological markers are measured from blood samples to monitor for signs of rejection including islet autoantibodies and a panel of common tissue types to which antibodies may have formed (PRA). The presence or absences of these antibodies help doctors determine if the body’s immune system is reacting to the islet transplant.  If positive results are detected, additional blood samples may be requested for further testing.

4) Quality of Life
To find out how quality of life is affected after islet transplant, patients are asked to complete a set of questionnaires every 12 months. The questions ask subjects to rank their feelings about their overall health, being diagnosed with diabetes, their diabetes treatment, the impact diabetes has on their work, relationships and life, the frequency with which they experience diabetes-related symptoms and how bothersome they are.

Subjects who are NOT able to return to City of Hope:
Subjects who are not able to come to City of Hope for check-ups will be contacted by City of Hope a study staff member by telephone every six months to obtain information about their health.  Telephone interviews are expected to last 10-20 minutes.  Subjects are asked about their health and to list any illnesses, severe low blood sugar episodes, hospitalizations, surgery or other health problems that he/she might have experienced since last contact.  Subjects contacted by phone will also be asked to provide detailed blood sugar and insulin records as well as copies of recent laboratory tests drawn by their treating physician.

Possible Complications
Although uncommon, complications may occur with blood draws and specific metabolic studies:

  • Blood Draw: The risks of drawing blood include temporary discomfort, bleeding or bruising from the needle stick, anemia, dizziness, and very rarely, an infection where the needle was inserted.
  • Glucagon stimulation: The risks of glucagon stimulation testing include temporary nausea, vomiting, abdominal pain and rash.
  • IVGTT: Risks related to IVGTT are temporary pain and bruising at the IV site, pain from the injection of the sugar water solution, and potential temporary high blood sugar levels.

If you have questions about this Long-Term Follow-Up Study, contact the ICT Coordinator at (626) 256-HOPE (4673) ext. 60057.