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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 below

Timeline

Screening ~ 2 days
Treatment ~ 1 day
Follow Up ~24 months
This trial's timeline: 2 days for screening, 1 day for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HbA1C ≤ 7% or a ≥ 2.5 decrease from baseline (before transplant)
Increased (≥ 1x) unstimulated serum c-peptide (corrected to glycemia) compared to baseline before transplant
Reduction (≥ 25%) in exogenous insulin requirements
+1 more

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

Media Library

Human Pancreatic Islet Transplantation (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02846571 — Phase 1 & 2
Type 1 Diabetes Research Study Groups: Human Pancreatic Islet Transplantation
Type 1 Diabetes Clinical Trial 2023: Human Pancreatic Islet Transplantation Highlights & Side Effects. Trial Name: NCT02846571 — Phase 1 & 2
Human Pancreatic Islet Transplantation (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02846571 — Phase 1 & 2
~3 spots leftby Dec 2026
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