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Cell Therapy
Islet Transplantation for Type 1 Diabetes
Phase 3
Waitlist Available
Led By Jose Oberholzer, MD
Research Sponsored by CellTrans Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Type 1 diabetes mellitus for more than 5 years complicated by reduced awareness of hypoglycemia
Type 1 diabetes mellitus for more than 5 years complicated by at least one episode of severe hypoglycemia in the past 3 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year after islet transplant
Awards & highlights
Study Summary
This trial is testing whether islet transplantation is safe and effective in improving glycemic control in Type 1 diabetic patients.
Who is the study for?
This trial is for Type 1 diabetes patients who've had the disease for over 5 years and experienced severe hypoglycemia or have reduced hypoglycemia awareness. Exclusions include those with pancreatitis, kidney issues, substance abuse, certain infections like hepatitis or HIV, pregnancy/breastfeeding without contraception use, some heart conditions, and other specific health concerns.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of transplanting islet cells to control blood sugar in Type 1 diabetes using the UIC protocol. This follows a successful earlier phase where this method showed promise without using steroids for immunosuppression.See study design
What are the potential side effects?
Potential side effects may include reactions to immunosuppressants such as increased infection risk, possible organ inflammation due to immune response, digestive issues from medication absorption problems, and complications related to underlying health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had Type 1 diabetes for over 5 years and often don't notice when my blood sugar is low.
Select...
I have had Type 1 diabetes for over 5 years and experienced a severe low blood sugar episode in the last 3 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year after islet infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after islet infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Subjects Reaching the Efficacy Goal
Treatment Emergent Adverse Events
Secondary outcome measures
Hypoglycemic Episodes by HYPO Score
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
Reduction in Hypoglycemic Severity Measured by %Reduction in HYPO Score
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.
Find a Location
Who is running the clinical trial?
CellTrans Inc.Lead Sponsor
1 Previous Clinical Trials
Jose Oberholzer, MDPrincipal InvestigatorUniversity of Illinois at Chicago
2 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a large amount of protein in your urine.I have had Type 1 diabetes for over 5 years and often don't notice when my blood sugar is low.My family has a history of MEN2 or MCT.I have had Type 1 diabetes for over 5 years and experienced a severe low blood sugar episode in the last 3 years.I have not had a stroke in the last 6 months.I have Addison's disease.I need to take steroids regularly for a health condition.You smoke cigarettes.I have painful gallstones.I have symptoms of an active stomach ulcer.I have not taken diabetes medication other than insulin in the last 4 weeks.I have had cancer before, but not skin cancer.I am either younger than 18 or older than 75.You had a previous organ transplant, or your body has a high chance of rejecting transplanted organs.I am not pregnant, not planning to become pregnant, not breastfeeding, and willing to use contraception.I have an untreated eye condition where blood vessels grow abnormally.You have a history of not following your doctor's instructions for taking medication.Your C-peptide response to glucagon stimulation is higher than 0.3 ng/mL.I have severe ongoing stomach issues that could affect how I absorb medication.Your liver function tests are not in the normal range before starting the study.I have or am being treated for tuberculosis.My mental health condition is stable on medication.You have high levels of cholesterol or triglycerides in your blood after fasting.My hemoglobin level is below the normal range for my gender.I do not have active infections like hepatitis C, B, or HIV.You are currently using alcohol, drugs, or smoking cigarettes. If you smoke, you must stop for at least six months.I have not had any live vaccines in the last 2 months.I am taking blood thinners or have a PT-INR greater than 1.5.Your HbA1c level is higher than 12%.I use more than 0.7 units of insulin per kilogram of my body weight daily.You have a body mass index (BMI) higher than 27 kg/m2.You are allergic to the dye used for medical imaging.I have had a heart attack in the last 6 months or have heart disease that can't be fixed with surgery.My kidney function, measured by creatinine clearance, is below normal.Your serum creatinine level is consistently higher than 1.5 mg/dL.I have pancreatitis.I have Factor V deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 4 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT00679042 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project allowing people who are over 25 to participate?
"The age bracket for people that this trial is recruiting starts at 18 years old and finishes at 75 years old."
Answered by AI
Are there any ongoing research projects concerning Islets of Langerhans transplantation?
"There are currently 329 clinical trials studying Islets of Langerhans transplantation, 44 of which are still actively enrolling patients. Most research is conducted in San Antonio, Texas; however, there are 2401 locations worldwide running these types of trials."
Answered by AI
Does the FDA sanction islet cell transplantation as a treatment method?
"Islets of Langerhans transplantation is considered safe, as it has reached Phase 3 status. This means that not only does some data support its efficacy, but multiple rounds of testing have confirmed its safety."
Answered by AI
How often is Islets of Langerhans transplantation used to help patients?
"The most frequent reason for islets of Langerhans transplantation is to treat immunosuppressive disorders. However, this procedure can also help patients with dermatitis, atopic rejections, kidney transplants, and psoriasis."
Answered by AI
What are the necessary qualifications for participants of this clinical trial?
"The prerequisites for this study are having type 1 diabetes mellitus and being between 18-75 years old. At the moment, the team is looking to recruitment 21 patients in total."
Answered by AI
Are we still looking for candidates to take part in this experiment?
"This study is not recruiting patients at the current moment. This study was posted on September 5th, 2007 and edited for the last time on July 21st, 2022. For individuals searching for other studies, there are 1306 trials actively recruiting patients with type 1 diabetes mellitus and 329 involving Islets of Langerhans transplantation."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Illinois
How old are they?
18 - 65
What site did they apply to?
University of Illinois at Chicago Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I want to be a part of this research.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long do screening visits take?
PatientReceived 2+ prior treatments
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