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Cell Therapy

Islet Transplant for Type 1 Diabetes

Phase 2

Waitlist Available

Led By Rodolfo Alejandro, M.D.

Research Sponsored by Rodolfo Alejandro

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Progressive complications of type 1 diabetes mellitus

Patients with type 1 diabetes mellitus for more than 5 years duration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for the duration of islet graft function

Awards & highlights

Study Summary

This trial is aiming to improve the lives of those with Type 1 Diabetes Mellitus by transplanting islet cells to reverse the effects of the disease.

Who is the study for?

This trial is for adults aged 18-65 with Type 1 Diabetes Mellitus, BMI ≤26, experiencing severe hypoglycemia unawareness or poor diabetes control despite intensive insulin therapy. Candidates must have had diabetes for over 5 years and show progressive complications. Excluded are those with certain blood markers, untreated eye issues, kidney dysfunction, high insulin requirements or lipid levels, specific infections including HIV/HCV/EBV, history of malignancy (except some skin cancers), unstable heart conditions, pregnancy/breastfeeding without proper contraception use, recent substance abuse/smoking.Check my eligibility

What is being tested?

The study tests whether transplanting islet cells can reverse the need for insulin in Type 1 Diabetes patients while avoiding steroid-based immunosuppression. It also examines if this procedure prevents severe low blood sugar episodes and improves long-term health outcomes related to diabetes complications. The effects of infliximab and etanercept on early islet survival and exenatide on graft function/survival are being studied as well.See study design

What are the potential side effects?

Potential side effects may include immune system reactions due to the transplanted cells or medications like infliximab and etanercept used to prevent rejection; these could lead to inflammation or infection risks. Exenatide might cause digestive issues such as nausea or decreased appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My type 1 diabetes is getting worse.

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I have had type 1 diabetes for over 5 years.

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I have had low blood sugar episodes without noticing.

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My diabetes is not well-controlled despite using insulin regularly.

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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for the duration of islet graft function

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for the duration of islet graft function

This trial's timeline: 3 weeks for screening, Varies for treatment, and for the duration of islet graft function for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

a1c less than 6.5 without severe hypoglycemia

Secondary outcome measures

Secondary end-points will include: partial graft function, as evidenced by baseline C-peptide greater than 0.5 ng/ml

assessment of EXN to improve islet survival at time of islet transplantation - number of subjects achieving insulin independence with a single infusion

assessment of EXN to re-establish insulin independence or increase insulin secretion - reduction in insulin requirements with restoration of satisfactory glycemic control

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Islet transplantationExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rodolfo AlejandroLead Sponsor

9 Previous Clinical Trials

222 Total Patients Enrolled

Health Resources and Services Administration (HRSA)FED

84 Previous Clinical Trials

151,447 Total Patients Enrolled

1 Trials studying Diabetes

45 Patients Enrolled for Diabetes

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,548 Total Patients Enrolled

25 Trials studying Diabetes

64,177 Patients Enrolled for Diabetes

Media Library

islets (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00306098 — Phase 2

Diabetes Research Study Groups: Islet transplantation

Diabetes Clinical Trial 2023: islets Highlights & Side Effects. Trial Name: NCT00306098 — Phase 2

islets (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00306098 — Phase 2

Frequently Asked Questions

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

Has the FDA greenlit islets for medical use?

"While islets have shown some evidence of being safe in Phase 2 trials, there is currently no data supporting their efficacy."

Answered by AI

Could I be given the chance to join this research project?

"Up to 40 individuals that have been diagnosed with diabetes mellitus and are between the ages of 18-65 may be accepted into this study. It is worth highlighting that these patients must also meet the following conditions: having a Body Mass Index (BMI) ≤26."

Answered by AI

Can new patients sign up for this clinical trial at this time?

"The last update to this trial's posting on clinicaltrials.gov was on March 1st, 2022, which indicates that the study is not currently looking for patients. This particular trial was first made public on December 1st, 2000. There are 1304 other trials presently recruiting participants at this time."

Answered by AI

Are patients who are octogenarians being recruited for this study?

"According to the inclusion criteria, patients participating in this trial must be aged 18-65. There are 225 trials for people under 18 and 964 for seniors."

Answered by AI