Your session is about to expire
← Back to Search
Cell Therapy
Islet Cell Transplant for Type 1 Diabetes
Phase 1 & 2
Waitlist Available
Research Sponsored by Rodolfo Alejandro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female patients age 18 to 65 years of age
Type 1 diabetes with onset of disease at <40 years of age, insulin-dependence for > 5 years at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new way to transplant islets (pancreas cells) in people with type 1 diabetes. The current method has many limitations, including the need for immunosuppression and loss of function over time. The new method is being tested to see if it leads to better outcomes.
Who is the study for?
This trial is for adults aged 18-65 with Type 1 diabetes, who have had the disease since before age 40 and been insulin-dependent for over 5 years. They must experience severe low blood sugar without awareness and be mentally stable to follow the study protocol. Exclusions include severe heart disease, certain cancers, high HbA1c levels (>10%), previous pancreas or islet transplants, obesity (BMI >30), heavy alcohol use, and other specific health conditions.Check my eligibility
What is being tested?
The trial tests transplanting islet cells onto the omentum (a part of the abdomen) instead of into the liver to manage blood sugar in Type 1 diabetes patients. This method aims to avoid complications like liver inflammation and improve cell function compared to current transplantation sites.See study design
What are the potential side effects?
Potential side effects may include immune system reactions due to foreign cells being introduced into the body, surgical risks from implantation procedure such as infection or bleeding, possible need for immunosuppressive drugs which can increase infection risk and cause organ toxicity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I have had Type 1 diabetes since before I was 40 and have been on insulin for over 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
A1c </= 6.5% and no severe hypoglycemia
procedural complications
Side effects data
From 2014 Phase 2 trial • 3 Patients • NCT00315627100%
Overt Proteinuria
100%
Lymphopenia
100%
Memory deficit
100%
Other
67%
Cough
67%
Urinary tract infection
67%
Nausea
67%
Muscle cramps
33%
Sinusitis
33%
Flu like symptoms
33%
Right foot injury
33%
Cataract
33%
Fatigue
33%
Edema
33%
Pulpitis
33%
Menorrhagia
33%
Dyspnea
33%
Thrombophlebitis Right arm
33%
Gastroenteritis
33%
Capsular opacity
33%
Gallblader polyp
33%
Bronchitis
33%
Rinorrhea
33%
Ovarian Cyst
33%
Microalbuminuria
33%
Anemia
33%
Hypersensitivity
33%
Hair loss
33%
Displastic Nevus
33%
Acne/Folliculitis
33%
Pruritus
33%
Toe sprain
33%
Yeast infection
33%
Uterine fibroids
33%
Hot Flashes
33%
Abnormal Papsmear
33%
Tremors
33%
Headaches
33%
Paresthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Islet Transplantation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Islet transplantationExperimental Treatment1 Intervention
Transplantation of at least 5000 islet equivalents/kg of body weight onto the omentum.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Islet transplantation
2005
Completed Phase 3
~30
Find a Location
Who is running the clinical trial?
Rodolfo AlejandroLead Sponsor
9 Previous Clinical Trials
256 Total Patients Enrolled
Diabetes Research Institute FoundationOTHER
9 Previous Clinical Trials
181 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,743 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body does not produce enough c-peptide when given a meal.I haven't taken any diabetes medication except insulin in the last 4 weeks.I have had cancer before, but it was completely removed except for skin cancer.I am a man and understand the need for birth control during the study.I have or had specific infections.I am between 18 and 65 years old.Your blood pressure is higher than 160 over 100.Your kidney function is below a certain level, as measured by a calculation.I need long-term blood thinners for a clotting disorder.I regularly take steroids in pill or injection form.I am not on any immunosuppressive treatments currently.I have not had a fungal infection in the past year.I have painful gallstones.I have had blockages in my intestines before.I have been diagnosed with inflammatory bowel disease.I have had major surgery in my abdomen before.I have had Type 1 diabetes since before I was 40 and have been on insulin for over 5 years.I am actively managing my diabetes with a detailed plan.I use more than 1.0 IU/kg/day or less than 15 units of insulin daily.I have pancreatitis.I have a serious heart condition.Your liver tests show that your liver may not be working as it should.Your HbA1c level is higher than 10%.I have not received any live vaccines in the last 2 months.You had a very low blood sugar episode in the past year.I have had a pancreas transplant.I am mentally stable and can follow the study's procedures.You do not have Epstein-Barr Virus (EBV) based on a blood test.You weigh more than 30 kilograms for every square meter of your height, or you weigh less than 50 kilograms.I have stomach or intestine problems that could affect how I absorb pills.You have a history of having a lot of albumin in your urine.I have had peritonitis before.You have a decreased ability to recognize when your blood sugar gets too low, as determined by specific guidelines.I have had an islet transplant before.You have antibodies against certain proteins in the body that could cause a reaction.You are currently abusing alcohol or drugs.I have symptoms of an active stomach ulcer.My high cholesterol hasn't improved with medication.I have diabetic eye disease that hasn't been treated.I have abnormal blood counts or a history of Factor V deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Islet transplantation
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 people with the target condition able to enroll in this trial at this time?
"This particular trial, as shown on clinicaltrials.gov, is not currently looking for new patients to enroll. This research was originally posted September 1st, 2014 and updated March 1st, 2022. Even though this study isn't taking any more participants, there are 444 other trials with open enrollment at the moment."
Answered by AI
Would this research be appropriate for individuals outside of the age group 25-35?
"The age range this study is looking at is people who are older than 18 and below 65."
Answered by AI
How do I sign up for the clinical study?
"This clinical study is recruiting 6 individuals aged 18-65 who have hypoglycemia. Furthermore, to be eligible for this trial participants must meet the following requirements: Subjects screening data from 20053135 protocol will be accepted for subjects eligible for this study. If 20053135 visit was 12 months prior to enrollment, Visit 2 laboratory should be repeated., Male and female patients age 18 to 65 years of age., Ability to provide written informed consent., Mentally stable and able to comply with the procedures of the study protocol., Type1 diabetes with onset of disease at <40 years of age, insulin-dependence for > 5 years at the"
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger