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Cell Therapy
Islet Transplantation for Type 1 Diabetes
Verified Trial
Phase 1 & 2
Recruiting
Led By Midhat Abdulreda, Ph.D.
Research Sponsored by Midhat H. Abdulreda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have you been diagnosed with Type 1 Diabetes?
Have you been diagnosed with Type 2 Diabetes?
Timeline
Screening 2 days
Treatment 1 day
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment for diabetes which involves transplanting islets into the eye.
Who is the study for?
This trial is for individuals with Type 1 Diabetes who have severe vision loss in at least one eye and are legally blind. They must have a normal cornea, stable intraocular lens if applicable, and no response to a mixed meal tolerance test. People can't join if they've had certain immune reactions, uveitis, narrow iris angle, recent investigational drug use, history of most cancers or substance abuse.
What is being tested?
The study tests transplanting human pancreatic islet cells into the eye's anterior chamber to help manage diabetes in those with low vision. The procedure involves placing cells through the cornea and requires patients to lie flat afterwards to ensure cell attachment.
What are the potential side effects?
Potential side effects may include discomfort or complications from the corneal incision, inflammation within the eye (uveitis), increased intraocular pressure, bleeding inside the eye (hyphema), or rejection of transplanted cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 2 days1 visit
Treatment ~ 1 day24 visits
Follow Up ~ 24 months24 visits
Screening ~ 2 days
Treatment ~ 1 day
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Absence of ocular complications
Absence of sympathetic ophthalmia
Confirmation of intraocular islet graft survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Human Pancreatic Islet TransplantationExperimental Treatment1 Intervention
Islet transplantation into the anterior chamber of the eye single arm
Find a Location
Who is running the clinical trial?
Bascom Palmer Eye InstituteOTHER
11 Previous Clinical Trials
1,177 Total Patients Enrolled
Midhat H. AbdulredaLead Sponsor
Diabetes Research Institute FoundationOTHER
9 Previous Clinical Trials
84 Total Patients Enrolled
Midhat Abdulreda, Ph.D.Principal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blind eye has a stable lens implant.My cornea is healthy and the front part of my eye can be seen clearly.You have not taken any experimental drugs in the past 4 weeks.I have had cancer before, but it was completely removed except for skin cancer.I have severe vision loss in at least one eye.You currently have a problem with drinking alcohol or using drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Human Pancreatic 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 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 Days
- Follow Ups: You may be asked to continue sharing information regarding the trial for 24 Months after you stop receiving the treatment.