New islet cell product (VX-880) transplantation
for patients with T1DM
A Phase 1/2 Study to Evaluate the Safety,
Tolerability, and Efficacy of VX-880 in Subjects
Who Have Type 1 Diabetes Mellitus with Impaired
Hypoglycemic Awareness and Severe Hypoglycemia
for Clinical Islet Transplantation.
Funded by Vertex
If, after reading the Brief Description of this study, you are still interested in participating in this study, please proceed to the pre-screening questions below:
Let's check first, if you qualify for the study:
- Have you had Type 1 diabetes for over 5 years?
- Are you over 18 and under 65 years old?
- Have you been suffering from sudden and unpredictable drops of blood glucose leading to confusion or passing out despite the best medical treatment of insulin under the guidance of an experienced diabetologist?
If one of the answers is no, you do not qualify and we would like to thank you for your interest and time.
If you answered yes to all 3 questions, please proceed to the Step 2 below.
Now, let's check if you might have a condition, which does not allow you to participate in the study:
- Is your Body Mass Index (BMI) >30kg/m2?
-Do you have a kidney dysfunction with a serum creatinine over 2mg/dl?
-Female: Are you pregnant, planning on being pregnant in the next 4 years, or breastfeeding?
-Male: Do you intend to procreate during the duration of the study or within 4 months after discontinuation?
-Have you encountered a presence or history of an active infection including hepatitis B, hepatitis C, HIV, or Tuberculosis?
-Have you had an invasive Aspergillus, Histoplasmosis, or Coccidioidomycosis infection within the last year?
-Do you have a history or malignancy/cancer (except for completely resected squamous or basal cell carcinoma of the skin)?
-Do you have any alcohol or substance abuse (except cigarettes)?
-Have you had a previous islet transplant?
If one of the answers is YES, we are sorry but you cannot participate in the study.
If you are unsure, you can always contact us with additional questions for clarification:
Lindsay.Basto@uchospitals.edu or fax 773-926-0671.
If all answers are NO to all questions above, please proceed to the step 3.
Please download, fill out the questionnaire:
and send it by email to Lindsay.Basto@uchospitals.edu or fax 773-926-0671.