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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years post-transplant
Awards & highlights
TCD Trial 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.Check my eligibility
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.See study design
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.
TCD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 68 years old.
Select...
I have had Type 1 diabetes for 5 years or more.
TCD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 1 year post-transplant
Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 2 years post-transplant
Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 5 years post-transplant
Secondary outcome measures
Proportion of subjects who are free of severe hypoglycemic episodes AND have a hemoglobin A1c < or = 7.0%
Other outcome measures
Change in average daily insulin use compared to baseline
Decline in insulin intake/100,000 IEQ infused
Duration of insulin independence
+13 moreTCD 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
1,528 Previous Clinical Trials
10,276,841 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,450 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some common uses for Immunosuppressive Agents?
"Immunosuppressive Agents are most often used in anti-platelet therapies. They can also help treat peptic ulcers, gastric ulcers, and gastroesophageal reflux disease."
Answered by AI
How many people are taking part in this experiment at most?
"Yes, as denoted by the clinicaltrials.gov website, this study is looking for 20 more participants and is being conducted at 1 location. The trial was first posted on October 16th, 2013 and updated February 17th, 2022."
Answered by AI
Are we still enrolling patients in this research project?
"That is correct, the online information hosted on clinicaltrials.gov affirms that this study is searching for subjects to participate. The trial was first posted on October 16th 2013 and updated February 17th of this year. They are looking for a total of 20 individuals at a single location."
Answered by AI
Do you know of any other research that has looked at Immunosuppressive Agents?
"There are 4 ongoing clinical trials studying the effects of Immunosuppressive Agents. None of these studies have advanced to Phase 3 yet. Most of the research is being conducted in Duarte, California; however, there are also active trials taking place at 4 other locations."
Answered by AI
Are elderly people barred from participating in this experiment?
"People eligible for this particular clinical trial must be aged 18-68. There are 165 trials available for those under 18 and 192 for seniors."
Answered by AI
What is the official position of the FDA on Immunosuppressive Agents?
"While there is some evidence of safety for Immunosuppressive Agents, it is still in Phase 2 of clinical trials and has not yet been proven effective. Consequently, our team rates its safety as a 2."
Answered by AI
Which type of person is better suited for this test?
"20 patients will be enrolled in this clinical trial that is testing a new diabetes mellitus treatment. To qualify, interested individuals must have type 1 diabetes and be between 18-68 years old."
Answered by AI
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