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Cell Therapy
Islet Cell Transplant for Type 1 Diabetes (TCD Trial)
Phase 2
Waitlist Available
Led By Fouad Kandeel, MD, PhD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-68 years
Type 1 diabetes mellitus for at least 5 years
Must not have
Anemia or other blood disorders that require medical treatment
Increased risk of bleeding, other chronic hemostasis disorders, or treatment with chronic anticoagulant therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying islet cell transplantation as a possible treatment for type 1 diabetes.
Who is the study for?
Adults aged 18-68 with Type 1 diabetes for at least 5 years, willing to follow a strict post-transplant regimen including anti-rejection meds, frequent clinic visits, and contraception use. Excludes those with significant heart or kidney issues, high BMI (>33), substance abuse, certain infections or blood disorders, pregnancy/breastfeeding women, and untreated psychiatric illnesses.
What is being tested?
The trial is testing if transplanting insulin-producing cells into the liver can help control blood sugar in Type 1 diabetes patients. It involves anti-rejection drugs (ATG or alemtuzumab) plus other medications to protect the transplanted cells. Participants may get up to three transplants and are monitored for five years.
What are the potential side effects?
Possible side effects include immune system suppression leading to increased infection risk; reactions related to infusion of immunosuppressive agents; potential organ inflammation; and complications from long-term use of anti-rejection medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 68 years old.
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I have had Type 1 diabetes for 5 years or more.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have anemia or another blood disorder that needs treatment.
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I have a high risk of bleeding or I am on long-term blood thinners.
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I have serious kidney problems.
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I have a serious liver or gallbladder condition.
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My high blood pressure is not controlled despite treatment.
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My cholesterol/triglycerides are high despite treatment.
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I am on long-term medication for a chronic illness that cannot be used with certain treatments.
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I am not pregnant, not planning to become pregnant, and willing to use contraception if of childbearing potential.
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I have had a gastric bypass surgery.
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I have a serious heart condition.
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I use more than 1.2 units of insulin per kilogram of my body weight daily.
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I have an active eye condition where new blood vessels are growing abnormally.
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I have had an organ or tissue transplant.
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm StudyExperimental Treatment3 Interventions
Allogenic Human Islet Cell Transplant with immunosuppression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Immunosuppressive Agents
2014
N/A
~3240
Find a Location
Who is running the clinical trial?
University of California, Los AngelesOTHER
1,564 Previous Clinical Trials
10,262,623 Total Patients Enrolled
13 Trials studying Diabetes
106,977 Patients Enrolled for Diabetes
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,570 Total Patients Enrolled
2 Trials studying Diabetes
191 Patients Enrolled for Diabetes
Fouad Kandeel, MD, PhDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have anemia or another blood disorder that needs treatment.I have a high risk of bleeding or I am on long-term blood thinners.I have serious kidney problems.I have a serious liver or gallbladder condition.My high blood pressure is not controlled despite treatment.My cholesterol/triglycerides are high despite treatment.You have a mental illness that is not being treated, or may make it hard for you to follow the study's rules even with treatment.I have not received any live vaccines in the last 2 months.I am on long-term medication for a chronic illness that cannot be used with certain treatments.You are currently using alcohol, drugs, or smoking cigarettes regularly.I am not pregnant, not planning to become pregnant, and willing to use contraception if of childbearing potential.I have had a gastric bypass surgery.I am between 18 and 68 years old.I have had cancer before, but it was either skin cancer that was completely removed or a cervical cancer that did not spread.I have a serious heart condition.You are allergic to both rATG and alemtuzumab.I use more than 1.2 units of insulin per kilogram of my body weight daily.You do not have antibodies for the Epstein-Barr Virus.Your white blood cell count is less than 3,000 per microliter.I have been following my medical treatments and can manage strict blood sugar and insulin therapy.Your body mass index (BMI) is greater than 33.I have an active eye condition where new blood vessels are growing abnormally.I have had an organ or tissue transplant.I am committed to following a strict post-transplant care plan, including medication, contraception, and regular health monitoring.I have had Type 1 diabetes for 5 years or more.I do not have any ongoing serious infections.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm Study
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.
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