Diabetes Mellitus, Type 1 study: Allogenic islet cells
Official title Islet Transplantation in Patients With "Brittle" Type I Diabetes
ClinicalTrials.gov ID: NCT01630850
What this study is testing
What is Allogenic islet cells (human, U. Chicago)?
investigational cell therapy being studied for Type 1 diabetes mellitus is designed to replace lost insulin‑producing cells by transplanting donor islet clusters into the bloodstream
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if transplanting islet cells is safe for people with type 1 diabetes and could improve blood sugar control.
- Who it's for
- It is looking for adults who have type 1 diabetes and are not well controlled by insulin.
- What's involved
- Participants will receive islet cells from a deceased donor through a vein and will have follow‑up visits and tests to monitor safety and blood sugar levels.
- Time commitment
- The study lasts several months, with regular clinic visits and blood tests to track safety and effectiveness.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Male and female patients 18 to 70 years of age.
- people who are able to provide written informed consent and to comply with the procedures of the study protocol.
- Clinical history compatible with T1D with onset of disease at \< 40 years of age, insulin-dependence for ≥ 5 years at the time of enrollment, and a...
- Involvement in intensive diabetes management defined as self monitoring of glucose values no less than a mean of three times each day averaged over...
- Reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more OR a HYPO score greater than or equal to the 90th percentile (1047)...
You likely can't join if
- Body mass index (BMI) \>30 kg/m2 or patient weight \<50kg.
- Insulin requirement \>1.0 IU/kg/day or \<15 U/day.
- Untreated proliferative diabetic retinopathy.
- Blood Pressure: SBP \>160 mmHg or DBP \>100 mmHg.
- Measured glomerular filtration rate \ 1.73 m2.
- Presence or history of macroalbuminuria (\>300 mg/g creatinine).
See the full eligibility criteria
- Male and female patients 18 to 70 years of age.
- people who are able to provide written informed consent and to comply with the procedures of the study protocol.
- Clinical history compatible with T1D with onset of disease at \< 40 years of age, insulin-dependence for ≥ 5 years at the time of enrollment, and a sum of patient age and insulin dependent diabetes duration of ≥ 28 and...
- Involvement in intensive diabetes management defined as self monitoring of glucose values no less than a mean of three times each day averaged over each week and by the administration of three or more insulin injections...
- Reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more OR a HYPO score greater than or equal to the 90th percentile (1047) during the screening period and within the last 6 months
- Body mass index (BMI) \>30 kg/m2 or patient weight \<50kg.
- Insulin requirement \>1.0 IU/kg/day or \<15 U/day.
- Untreated proliferative diabetic retinopathy.
- Blood Pressure: SBP \>160 mmHg or DBP \>100 mmHg.
- Measured glomerular filtration rate \ 1.73 m2.
- Presence or history of macroalbuminuria (\>300 mg/g creatinine).
- Presence or history of panel-reactive anti-HLA antibodies above 30% or history/presence of donor specific anti-HLA antibodies in order to avoid unacceptable antigen(s) (Campbell PM 2007).
- For female people: Positive pregnancy test, presently breast-feeding, wishes to be pregnant at any time point in the future, which includes during or after the completion of the study even if study participation is...
- Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB).
- Known active alcohol or substance abuse.
- Severe co-existing cardiac disease
- Known hypercoagulative state.
- Symptomatic cholecystolithiasis.
- Acute or chronic pancreatitis. Other protocol related inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.