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Cell Therapy
Islet Transplantation for Type 1 Diabetes
Phase 1
Waitlist Available
Led By Andrew M Posselt, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Absent stimulated c-peptide (< 0.3 ng/mL) in response to a (Boost® 6 mL/kg BW to a maximum of 360 mL; another equivalent product), measured at 60 and 90 min after start of consumption
Clinical history compatible with T1D (onset < 40 yrs old and insulin dependent for > 5 yrs at enrollment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new way to transplant islets in people with type I diabetes who have received a kidney transplant. Up to 6 patients will be enrolled and followed for 3 years.
Who is the study for?
This trial is for adults aged 18-70 with Type 1 Diabetes who have had a kidney transplant and are on specific immunosuppression drugs. They must have stable renal function, a history of severe hypoglycemia despite intensive diabetes management, and no production of c-peptide. Exclusions include active infections like hepatitis or HIV, recent use of other anti-diabetic drugs or investigational agents, certain cardiovascular conditions, untreated hyperlipidemia, pregnancy or unwillingness to use contraception.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of transplanting islet cells into the stomach's lining in people with Type 1 Diabetes who've had a kidney transplant. Six patients will be enrolled to receive this treatment and monitored for up to three years post-transplant.See study design
What are the potential side effects?
Potential side effects may include complications from surgery such as infection or bleeding at the transplantation site, immune reactions against the transplanted cells leading to inflammation or organ damage, and possible medication-related issues due to immunosuppressants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My c-peptide levels are very low after a special drink test.
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I was diagnosed with Type 1 Diabetes before 40 and have been on insulin for over 5 years.
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I am between 18 and 70 years old.
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I am between 18 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insulin independence
Secondary outcome measures
Changes (reduction) in insulin requirements
Changes in HbA1c
Incidence of adverse events
Trial Design
1Treatment groups
Experimental Treatment
Group I: Islet TransplantExperimental Treatment2 Interventions
Islet transplantation into the gastrointestinal submucosa
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,503 Previous Clinical Trials
15,236,652 Total Patients Enrolled
Andrew PosseltLead Sponsor
1 Previous Clinical Trials
1 Total Patients Enrolled
Andrew M Posselt, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is still high despite taking medication.I have an active stomach ulcer, symptomatic gallstones, or high blood pressure in the liver.I use more than 1.0 IU/kg/day or less than 15 units/day of insulin.I have had an organ transplant other than a kidney, or a failed pancreatic graft removed over 6 months ago.My c-peptide levels are very low after a special drink test.I haven't had fungal infections like Aspergillus, Histoplasmosis, or Coccidioidomycosis in the last year.I have serious heart problems, including a recent heart attack or weak heart muscle.I am not pregnant, breastfeeding, and willing to use effective birth control during and 4 months after the study.I do not have an active infection like hepatitis or HIV.I have high levels of certain antibodies against transplant tissues.I am using glucocorticoids for reasons other than a transplant.I was diagnosed with Type 1 Diabetes before 40 and have been on insulin for over 5 years.I had a kidney transplant over 3 months ago and am on specific immune-suppressing drugs.My kidney function has been stable for the last 3 months.I've had severe low blood sugar and manage my diabetes intensively.I weigh over 100 kg or my BMI is over 30.I have pancreatitis.I have developed proteinuria after my kidney transplant.I am between 18 and 70 years old.My cholesterol and triglycerides levels are high and untreated.You currently have a problem with drinking alcohol or using drugs.I have not received any live vaccines in the last 2 months.I am between 18 and 70 years old.I do not have any active infections, except for mild skin or nail fungus.I have had cancer before, but it was completely removed except for skin cancer.You do not have antibodies for the Epstein-Barr virus.I haven't taken any diabetes medication except insulin in the last 4 weeks.My kidney function is low, with a GFR of 40 mL/min/1.73 m2 or less.You have a positive test for BK virus in your blood when screened for the trial.I have untreated or worsening eye damage due to diabetes.Your liver function tests have been consistently higher than normal limits, which means your liver may not be working properly.
Research Study Groups:
This trial has the following groups:- Group 1: Islet Transplant
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.
Has the FDA sanctioned the utilization of Islet transplantation into the gastrointestinal submucosa?
"The safety of Islet transplantation into the gastrointestinal submucosa has been rated a 1 by Power as this is currently in Phase 1, meaning there are only limited data verifying its efficacy and safety."
Answered by AI
Does this experiment permit participation from individuals under 35 years of age?
"The primary inclusion criterion for this research is a patient's age, which must fall between 18 and 70 years old. For those younger than 18 or older than 65, there are 217 studies available as well as 916 respectively."
Answered by AI
Are researchers currently enrolling participants in this experiment?
"The information on clinicaltrials.gov indicates that the trial is no longer open for recruitment, having been posted initially in March of 2016 and last updated in August 2022. While enrollment has ceased, 1249 other trials are seeking patients at present."
Answered by AI
Does this research undertaking have any prerequisites for enrolment?
"For this research, a total of 3 individuals who have diabetes and an autoimmune disorder aged 18-70 are desired. Notably, both genders may apply to the study with no age restrictions beyond the previously mentioned boundaries."
Answered by AI
Who else is applying?
What state do they live in?
Arkansas
How old are they?
18 - 65
What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
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