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NCT01909245 · ClinicalTrials.gov registry record · Phase 2
Islet Cell Transplant for Type 1 Diabetes
A Phase 2 study of Type 1 Diabetes Mellitus, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01909245 is a Phase 2 study of Type 1 Diabetes Mellitus that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 10 participants, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01909245, a Phase 2 study of Type 1 Diabetes Mellitus, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
City of Hope National Medical Center, located in Duarte, CA, is hosting a clinical study on islet cell transplantation, an experimental procedure being evaluated as a treatment for patients with type 1 diabetes. Islet cell transplantation involves taking insulin-producing cells from organ donors and transplanting them into the liver of a patient with diabetes. Once transplanted, the islets produce insulin, which can improve blood sugar control and eliminate the need to inject insulin or use an insulin pump. Anti-thymocyte globulin (ATG) and alemtuzumab (Campath) are anti-rejection medications that work by decreasing a patient's T-cells. T-cells are special white blood cells that recognize and destroy unwanted things like infections but can also attack transplanted cells and organs. Reducing the number of T-cells at the time of transplant may protect islets and improve long-term transplant success. In previous research studies, islet transplantation has been successful in reducing low blood sugar episodes, improving overall blood sugar control, and in some cases, allowing patients with type 1 diabetes to stop taking insulin. The purpose of this study is to determine if islet cell transplantation using ATG or alemtuzumab, along with additional medications to prevent the body from rejecting the transplanted cells, is a safe and effective treatment for type 1 diabetes. Study participants may receive up to three islet transplants and will be followed for five years to monitor blood sugar control, islet transplant function, and changes in quality of life.
Conditions Studied
Interventions
- BIOLOGICAL Allogenic Human Islet Cells
- DRUG Gastrin 17
- DRUG Immunosuppressive Agents
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-10-16 |
| Est. Completion | 2026-09-22 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01909245
The ClinicalTrials.gov registry entry for NCT01909245 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (93% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Allogenic Human Islet Cells is the first listed.
NCT01909245 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01909245 about?
NCT01909245 is a clinical study titled "Islet Cell Transplant for Type 1 Diabetes". City of Hope National Medical Center, located in Duarte, CA, is hosting a clinical study on islet cell transplantation, an experimental procedure being evaluated as a treatment for patients with type 1 diabetes. Islet cell transplantation involves taking insulin-producing cells from organ donors and...
What is the current status of trial NCT01909245?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2013-10-16. Estimated completion is 2026-09-22.
What conditions does trial NCT01909245 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT01909245?
The interventions under investigation include: Allogenic Human Islet Cells (BIOLOGICAL), Gastrin 17 (DRUG), Immunosuppressive Agents (DRUG).
Who is sponsoring clinical trial NCT01909245?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01909245 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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