Islet Cell Transplant for Type 1 Diabetes

Phase 2

Active, not recruiting

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Biological: Allogenic Human Islet Cells; Drug: Immunosuppressive Agents; Drug: Gastrin 17

• Registration Number: NCT01909245
• Lead Sponsor: City of Hope Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-22
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-26
• Study Start: 2013-10-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-10-16
• Study Completion: 2025-10-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

1. Body Mass Index (BMI) > 33
2. Insulin requirements > 1.2 units/kg/day
3. Known sensitization to both rATG -and- alemtuzumab
4. Significant kidney dysfunction
5. Significant liver/gall bladder disease
6. Significant cardiovascular disease
7. Active proliferative retinopathy
8. High blood pressure despite appropriate treatment
9. High cholesterol/triglycerides despite appropriate treatment
10. Anemia or other blood disorders that require medical treatment
11. WBC <3,000/ul
12. Increased risk of bleeding, other chronic hemostasis disorders, or treatment with chronic anticoagulant therapy
13. Recent unresolved acute infection (except for mild skin infection or nail fungal infection), or chronic infection
14. Epstein-Barr Virus (EBV) IgG negative
15. Any history of malignancy, except for completely resected squamous or basal cell carcinoma of the skin or in situ cancer of the cervix
16. Recent history of non-adherence to medical treatment, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin therapy
17. Psychiatric illness that is untreated, or likely to interfere significantly with study compliance despite treatment
18. Previous organ/tissue transplant, except as noted above
19. Administration of live attenuated vaccines within 2 months of enrollment
20. Presence of a chronic disease that must be chronically treated with a contraindicated agent
21. Use of investigational agents within four weeks of enrollment
22. Active alcohol or substance abuse, including cigarette smoking
23. Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures prior to study entry and for as long as they are on immunosuppression medication, and women presently breast feeding are excluded
24. Individuals without health insurance
25. History of gastric bypass
26. Any medical condition that in the opinion of the investigator will interfere with safe participation in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Study	Allogenic Human Islet Cells	Allogenic Human Islet Cell Transplant with immunosuppression
Single Arm Study	Immunosuppressive Agents	Allogenic Human Islet Cell Transplant with immunosuppression
Single Arm Study	Gastrin 17	Allogenic Human Islet Cell Transplant with immunosuppression

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 2 years post-transplant	2 years post-transplant
Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 5 years post-transplant	5 years post-transplant
Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 1 year post-transplant	1 year post-transplant

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who are free of severe hypoglycemic episodes AND have a hemoglobin A1c < or = 7.0%	+75 days, +6 months, +12 months, and +2, +3, +4 and +5 years post islet transplant

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States