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Cell Therapy
Islet Transplantation for Type 1 Diabetes
Phase 1
Waitlist Available
Led By Fouad Kandeel, MD
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
No evidence of liver disease
Difficult to control Type 1 diabetes mellitus with documentation of negative basal and stimulated C-peptide and diagnosis of diabetes for at least 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, and 24 months
Awards & highlights
Study Summary
This trial will study whether islet cell transplantation can help people with type 1 diabetes who have trouble controlling their blood sugar, despite using standard insulin therapy and monitoring their blood sugar levels often.
Who is the study for?
This trial is for adults aged 18-65 with difficult to control Type 1 diabetes, experiencing severe blood sugar fluctuations despite using insulin and monitoring. Candidates must have had diabetes for at least 5 years, no chronic kidney or liver disease, and be able to follow a strict post-transplant regimen. Exclusions include significant heart disease, certain immune responses (high antibody levels), obesity (BMI over 30), active infections, substance abuse, psychiatric issues affecting treatment adherence, and any history of cancer except specific skin or cervical cancers.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of islet cell transplantation without steroids in managing Type 1 diabetes that's hard to control with standard treatments. It involves transplanting cells into patients who then receive an immunosuppressive drug regimen to prevent rejection of the new cells while avoiding glucocorticoids which can affect blood sugar levels.See study design
What are the potential side effects?
Potential side effects may include low blood sugar episodes immediately after transplant due to insulin-producing cell adjustment; risks associated with immunosuppression such as increased infection susceptibility; possible organ inflammation from immune response; surgical complications like bleeding or infection at the transplant site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is healthy.
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I have had Type 1 diabetes for over 5 years and it's hard to control.
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I check my blood sugar at least four times a day and keep detailed records.
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I often have low blood sugar episodes that I can't feel or that need help.
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I am between 18 and 65 years old.
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My kidneys are functioning well without significant protein loss.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12, and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12, and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of subjects who have achieved insulin independence post transplant.
Secondary outcome measures
HgAlc</= 6.5%
Insulin use </=0.2units/kg/day
Reduction/elimination of hypoglycemic episodes
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment2 Interventions
Islet cell transplantation alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Islet cell transplantation
2005
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,443 Total Patients Enrolled
2 Trials studying Diabetes
191 Patients Enrolled for Diabetes
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,571 Total Patients Enrolled
25 Trials studying Diabetes
64,177 Patients Enrolled for Diabetes
Fouad Kandeel, MDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
3 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high body mass index (BMI).I am on long-term medication for a chronic illness.I currently have an ongoing infection.You have a high level of preformed antibodies in your blood.My liver is healthy.I have had Type 1 diabetes for over 5 years and it's hard to control.I check my blood sugar at least four times a day and keep detailed records.I often have low blood sugar episodes that I can't feel or that need help.I am between 18 and 65 years old.I have a serious heart condition.I am not pregnant, breastfeeding, and I am willing to use effective contraception.I am at a higher risk of bleeding or I am on long-term blood thinners.I do not have an untreated mental health condition that could affect a transplant.I can follow the treatment plan after my transplant, including taking medications, using an insulin pump, and undergoing tests.My cholesterol levels are high despite treatment.You need to use a device that measures your blood sugar levels over time to see if you have episodes of low or high blood sugar often.I have struggled to follow strict blood sugar control and insulin pump guidelines recently.I have anemia or another blood disorder that needs treatment.You are currently using alcohol, drugs, or smoking cigarettes regularly.My kidneys are functioning well without significant protein loss.I have a serious liver condition.I have had cancer before, but it was only skin cancer or cervical cancer that did not spread.
Research Study Groups:
This trial has the following groups:- Group 1: 1
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.
Are there any vacancies available for volunteers in this experiment?
"This clinical trial, which was originally created on April 7th 2004 and last modified on July 6th 2022, is not presently recruiting. Despite this, a plethora of other trials are currently looking for applicants - 1250 to be exact."
Answered by AI
Does this research endeavor accept participants aged under 80?
"Patients seeking enrollment in this clinical trial must be between 18 and 65 years of age. If somebody is younger than 18 they can look at the 217 studies that cater to minors, while those older than 65 may find a more suitable fit amongst the 917 trials tailored for senior citizens."
Answered by AI
Has the FDA approved Islet cell transplantation for patient treatment?
"The team at Power has evaluated the safety of Islet cell transplantation as a 1, due to it being in its early phases and having only minimal data corroborating safety and efficacy."
Answered by AI
Could I be considered a suitable participant for this clinical research?
"To be eligible for this trial, individuals must have diabetes mellitus and fall within the ages of 18-65. Additionally, only 17 participants are needed for enrollment."
Answered by AI
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