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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

Patient with at least one eye with extensive loss of vision from hand motion to no light perception

Normal cornea with good visualization of the anterior segment

Timeline

Screening 2 days

Treatment 1 days

Follow Up 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have severe vision loss in at least one eye.

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My cornea is healthy and the front part of my eye can be seen clearly.

Timeline

Screening ~ 2 days1 visit

Treatment ~ 1 days24 visits

Follow Up ~ 24 months24 visits

Screening ~ 2 days

Treatment ~ 1 days

Follow Up ~24 months

This trial's timeline: 2 days for screening, 1 days for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

0 / 4Eligibility criteria met

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

177 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to enroll in this clinical examination?

"This trial necessitates that participants suffer from diabetes and are younger than 70 years old, with the upper age limit set at 18. Approximately ten individuals will be selected to take part in this research project."

Answered by AI

Does this research encompass individuals older than 35 years old?

"The minimum age of consent is the cutoff for this trial, while individuals over 70 years old cannot be admitted."

Answered by AI

How many participants are currently engaged in this clinical trial?

"Affirmative. Clinicaltrials.gov currently reflects that this research, which was initially posted on December 5th 2019, is presently recruiting participants. A total of 10 individuals must be found from 2 medical centres for the trial to proceed."

Answered by AI

Are any new participants being accepted at this time for the clinical trial?

"Affirmative, according to clinicaltrials.gov the medical experiment has commenced recruitment since December 5th 2019 and was recently updated on February 23rd 2022. The trial aims to enroll 10 patients split between two locations."

Answered by AI

Who else is applying?

What site did they apply to?

Bascom Palmer Eye Institute

Diabetes Research Institute, University of Miami Miller School of Medicine

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I need to find out more about my diabetes that results in my eyes being blurry.

PatientReceived 2+ prior treatments

I’ve been T1for 66 years and have been diligent with maintaining an A1C of 4.8 ! I’ve achieved every goal I’ve set for myself including giving birth to 5 healthy children and earning 3 college degrees and working a 38 year teaching career! I’d like to contribute to a cure for T1 diabetes! I’m capable of traveling and paying for accommodations!

PatientReceived 1 prior treatment