Tolerogenic Dendritic Cell Vaccine for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I trial investigates the side effects of PIpepTolDC vaccine in treating patients with type 1 diabetes who use insulin and don't have any other diabetes-related health complications. Type 1 diabetes is an autoimmune disease. This means that the immune system, which usually protects against foreign invaders like bacteria and viruses, attacks the body's insulin-producing betacells in the pancreas (autoimmune response). Overtime, the beta cells are destroyed by the immune system. To stay alive, people with type 1 diabetes must use insulin. PIpepTolDC vaccine is a type of immunotherapy (a treatment that uses a person's own immune system) that works like an allergy shot. The vaccine is made using one's own immune cells (dendritic cells) and a beta cell protein. The vaccine may teach the immune system to stop attacking the beta cells, which may help the beta cells recover and make enough insulin to control blood sugar levels. The vaccine may also help reduce future type 1 diabetes related complications.
Will I have to stop taking my current medications?
The trial requires participants to stop taking certain medications, such as systemic corticosteroids, systemic immunosuppressive therapy, and insulin sensitizers, before joining. Over-the-counter anti-inflammatory drugs like ibuprofen are generally allowed, but chronic use during study visits is not permitted.
Is the Tolerogenic Dendritic Cell Vaccine safe for humans?
How is the treatment PIpepTolDC different from other treatments for Type 1 Diabetes?
PIpepTolDC is unique because it uses tolerogenic dendritic cells to specifically target and inactivate the immune cells that mistakenly attack insulin-producing cells in the pancreas, potentially reducing the autoimmune response without affecting the rest of the immune system. This approach is different from standard treatments that mainly focus on managing blood sugar levels rather than addressing the underlying autoimmune cause.13678
What data supports the effectiveness of the treatment PIpepTolDC for Type 1 Diabetes?
Research shows that tolerogenic dendritic cells (tDC) can make the immune system less reactive to specific proteins involved in Type 1 Diabetes, potentially helping to control the disease. In studies, tDCs reduced the activity of immune cells that attack insulin-producing cells, suggesting they might be useful for some patients with Type 1 Diabetes.13678
Who Is on the Research Team?
Behrouz Salehian-Dardashti, MD
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for people with type 1 diabetes who use insulin, have stable blood sugar control, and no other diabetes complications. They must be willing to undergo a procedure to collect immune cells and not have certain genetic traits or previous severe allergic reactions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis
Participants undergo leukapheresis to collect CD14+ monocytes for vaccine preparation
Treatment
Participants receive a prime dose of PIpepTolDC intradermally on Day 0, followed by a boost dose on Day 28
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PIpepTolDC
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor