Islet Transplantation + Immune Cell Therapy for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if people with brittle type 1 diabetes, who struggle to control their blood sugar, benefit more from islet transplantation when they also receive special immune cells. Participants will receive either their own regulatory T cells (a type of immune cell that helps control the immune response) or cells from the bone marrow of the islet donor (Donor Derived Vertebral Bone Marrow infusion). Those who have had type 1 diabetes for at least 5 years and experience frequent episodes of severe low blood sugar might be a good fit for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Do I need to stop my current medications for the trial?
The trial requires that you stop taking any anti-diabetic medication other than insulin within 4 weeks of enrollment. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that stem cells from bone marrow, like those used in certain bone marrow infusions, are generally safe. They are often used in studies because most patients tolerate them well. Although no major safety issues have emerged, further research is needed to fully understand their effects.
Similarly, studies on regulatory T cell infusions have shown they are mostly safe. In one study, most patients experienced no serious problems, though one person developed a fever after treatment. This indicates that while these treatments are generally safe, mild side effects can occur.
Both treatments are in early trial stages, so researchers focus primarily on ensuring their safety for people.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for Type 1 Diabetes because they offer a novel approach to managing the condition. Unlike standard treatments that typically focus on insulin replacement, these therapies aim to address the underlying immune dysfunction. The donor-derived vertebral bone marrow infusion introduces new stem cells that could help regenerate healthy islets and immune tolerance, while the recipient T regulatory cell infusion works to modulate the immune system, potentially reducing the autoimmune attack on insulin-producing cells. These innovative strategies could lead to more durable and effective management of Type 1 Diabetes, shifting the focus from symptom management to addressing root causes.
What evidence suggests that this trial's treatments could be effective for type 1 diabetes?
This trial will compare two experimental treatments for type 1 diabetes. One treatment arm uses donor-derived vertebral bone marrow cells. Research has shown that stem cells from bone marrow might help treat type 1 diabetes, with studies in rats finding that these cells can help control blood sugar levels. In humans, some early tests suggested possible benefits, but more proof is needed.
The other treatment arm involves the infusion of recipient T regulatory cells. These special immune cells help manage the body's immune response. Previous research has found challenges with their long-term effectiveness, but they have shown some promise in managing type 1 diabetes. The idea is that these cells might help protect transplanted islets and improve blood sugar control. More research is needed to confirm these findings in humans.14678Who Is on the Research Team?
Stephan Busque, MD, MS
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
Adults aged 18-70 with brittle type 1 diabetes, not suitable for pancreas transplant, under intensive diabetes management, and experiencing severe hypoglycemia unawareness. Must be mentally stable to follow the study protocol and use dual contraception if of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive islet transplantation along with either regulatory T cells or donor-derived vertebral bone marrow cells
Follow-up
Participants are monitored for safety, glucose control, and adverse events post-islet transplantation
Long-term monitoring
Continued monitoring of glucose variability, hypoglycemia, and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Donor Derived Vertebral Bone Marrow infusion
- Recipient T regulatory cell infusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
University of California, San Francisco
Collaborator