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Islet Transplantation + Immune Cell Therapy for Type 1 Diabetes
Phase 1
Waitlist Available
Led By Stephan Busque, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 6, 12 and 24 months post-islet transplantation
Awards & highlights
Study Summary
This trial will test if adding either regulatory T cells or immune cells from the islet donor can help patients with brittle type 1 diabetes get better control of their sugars. #diabetes #clinicaltrial
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing whether adding immune cells (either the patient's own regulatory T cells or donor bone marrow cells) to an islet cell transplant helps better control blood sugar in people with brittle type 1 diabetes.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, increased risk of infection due to immune system suppression by the transplanted cells, and possible complications related to immunosuppressive medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at 6, 12 and 24 months post-islet transplantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 6, 12 and 24 months post-islet transplantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who receive Treg infusions (Arm1) or Donor Derived Vertebral Bone Marrow (Arm2) and islet transplantation (feasibility)
Occurrence of Grade 3 to 5 cytokine release syndrome / acute infusion reaction after Treg administration infusion reaction after Treg administration
Occurrence of grade 4 or greater adverse events of islet transplantation
Secondary outcome measures
Absence of severe hypoglycemic events
Basal C-peptide at levels e >0.5 ng/mL (>0.17 nmol/L) fasting or stimulated.
Clarke hypoglycemia severity (HYPO) score less than 2 (0 to >4, >4 indicate severe hypoglycemia unawareness)
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Recipient T Regulatory CellExperimental Treatment1 Intervention
T regulatory cells prior to islet transplantation, induction therapy with ATG and Belatacept and maintenance immunosuppression with Tacrolimus Extended-release tablets (Envarsus XR) and Mycophenolate Mofetil (MMF).
Group II: Donor Derived Vertebral Bone MarrowExperimental Treatment1 Intervention
Deceased donor vertebral bone marrow (VBM) cells, induction therapy with ATG and Belatacept and maintenance immunosuppression with Tacrolimus Extended-release tablets (Envarsus XR) and Mycophenolate Mofetil (MMF).
Find a Location
Who is running the clinical trial?
University of California, San FranciscoOTHER
2,507 Previous Clinical Trials
15,238,551 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,326 Total Patients Enrolled
Stephan Busque, MDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
59 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a serious fungal infection in the last year.I have pancreatitis.My BMI is over 30 or I weigh 50kg or less.I have severe heart issues, including a recent heart attack or poor heart function.I need long-term blood thinners or have a clotting disorder.I haven't taken any diabetes medication except insulin in the last 4 weeks.My liver tests are not higher than 1.5 times the normal limit.I do not have an active infection like hepatitis B, C, HIV, or TB.I am not pregnant and agree to use 2 forms of birth control during the study.I have a very low IgA level and am allergic to IgA.I have had cancer before, but it was completely removed except for skin cancer.I don't have harmful antibodies against a potential organ donor.I check my glucose 3+ times daily and use insulin injections or a pump, under specialist care.I have diabetic eye disease that hasn't been treated.I am not pregnant, breastfeeding, and willing to use contraception during and 4 months after the study. For males: I agree not to try for a child and will use contraception.I have had an islet transplant before.I have completed a 2-hour training on the Tandem X2 pump with Control IQ technology and understand how to use it.I use more than 1.0 IU/kg/day or less than 15 units/day of insulin.I haven't taken any diabetes medication except insulin in the last 4 weeks.I have not received any live vaccines in the last 2 months.I am between 18 and 70 years old.I haven't taken any experimental drugs in the last 4 weeks.I am mentally stable and can follow study instructions.I was diagnosed with Type 1 Diabetes before 45 and have been insulin-dependent for 5+ years.I had a kidney transplant and am on immunosuppressants but don't qualify for a pancreas transplant.My kidney function is reduced.
Research Study Groups:
This trial has the following groups:- Group 1: Donor Derived Vertebral Bone Marrow
- Group 2: Recipient T Regulatory Cell
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age range for enrolling in this research inclusive of those over 65?
"According to the stated enrollment parameters, potential participants must be at least 18 years old and no older than 70."
Answered by AI
How can I become a participant in this experiment?
"To be accepted into this research project, participants must have undergone islet transplantation and possess an age between 18 to 70 years old. The current target for the number of people enrolled in the trial stands at 24."
Answered by AI
Is this health study still actively seeking participants?
"Clinicaltrials.gov confirms that this trial, which was first posted on August 1st 2023 and last updated on July 25th 2023, is not enrolling participants at present. However, 87 other trials are actively recruiting patients right now."
Answered by AI
Has the FDA authorized application of Recipient T Regulatory Cell?
"Due to the limited amount of available evidence, Recipient T Regulatory Cell is assumed to carry a risk level of 1 on our scale. This is due to it being in Phase 1 trials with minimal data regarding its safety and efficacy."
Answered by AI
What outcomes are researchers hoping to achieve through this clinical experiment?
"This research project, set to be evaluated in a three-month period, seeks to measure the frequency of grade 4 or more serious adverse events related to islet transplantation. Secondary outcomes that will also be monitored include an absence of extreme hypoglycemia incidents necessitating external assistance, a 50% decrease in insulin daily dosage from pre-transplant levels, and improvement of the Clarke Hypoglycemia Severity Score (HYPO) below 2 points."
Answered by AI
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