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Cell Therapy

Human Pancreatic Islets for Type 1 Diabetes

Phase 1
Waitlist Available
Led By Amer Rajab, MD, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
First islet transplant
Demonstrate intensive efforts to manage diabetes for last 6 months (≥4 SMBG/day, ≥3 injections of insulin/day or use of pump and ≥3 contacts with diabetes care team in last 12 months)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 90, 120, 180, 270 and 365 days post-transplant
Awards & highlights

Study Summary

This trial will test the safety and feasibility of islet transplantation in people with type 1 diabetes. The goal is to see if it can help people with the disease manage their condition without exogenous insulin injections, potentially decreasing the development of diabetes-related complications.

Eligible Conditions
  • Type 1 Diabetes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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from a donor Doctors in the USA have carried out the world's first islet transplant from a donor
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The person has been trying very hard to manage their diabetes for the last 6 months
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In the past year, you have had ≥2 severe hypoglycemic events or ≥2 hospitalizations for diabetic ketoacidosis (DKA).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 90, 120, 180, 270 and 365 days post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 90, 120, 180, 270 and 365 days post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in measured creatinine clearance
Change in microalbumin level
Incidence of abnormalities in lipids
+7 more
Secondary outcome measures
Amount of daily insulin units required
Change in Quality of Life
Body Weight Changes
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subjects with prior kidney transplantExperimental Treatment1 Intervention
Subjects with renal failure secondary to diabetes who have received a prior kidney transplant at least 6 months previously and have stable renal function on a steroid-free immunosuppressive regimen will receive Human Pancreatic Islets (in the form of islets after kidney - IAK).
Group II: Subjects with preserved kidney functionExperimental Treatment1 Intervention
Subjects with preserved renal function that have not previously received a kidney transplant will be treated with Human Pancreatic Islets (in the form of islets alone - IA).

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
823 Previous Clinical Trials
501,183 Total Patients Enrolled
Amer Rajab, MD, PhDPrincipal InvestigatorOhio State University

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Georgia
Arkansas
Ohio
Other
How old are they?
18 - 65
What site did they apply to?
The Ohio State University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~7 spots leftby Oct 2033