Status:
ACTIVE_NOT_RECRUITING
Islet Cell Transplant for Type 1 Diabetes
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
University of California, Los Angeles
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-68 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Three different categories of patients with Type 1 Diabetes will be considered for study participation:
- Naïve islet transplant alone (nITA) candidates: T1D patients complicated by frequent/severe hypoglycemia, hypoglycemia unawareness, AND/OR otherwise unstable blood glucose control who have not received a previous transplant (except for a failed pancreas more than 6 months prior to screening)
- Repeat transplant (RT) candidates: T1D patients who have received two or fewer previous islet transplants \> 1 month prior to screening, but continue to require exogenous insulin treatment or have an HbA1c \> 6.5%
- Islet after kidney transplant (IAK) candidates: T1D patients with a history of successful renal transplant \> 3 months prior to screening
- Inclusion criteria for all candidates:
- Age 18-68 years
- Type 1 diabetes mellitus for at least 5 years
- Ability and willingness to comply with post-transplant regimen, including taking anti-rejection medications, use of reliable contraception, frequent clinic visits, lab tests, careful recording of blood glucose values, insulin doses and medications, and completing detailed follow-up studies
- Additional Inclusion Criteria nITA Candidates Only
- Unstable blood sugar control characterized by:
- Frequent hypoglycemia (blood glucose ≤ 54 mg/dl more than once per week) -AND/OR- Hypoglycemia unawareness (Clarke score of 4 or more) -AND/OR- One or more severe hypoglycemic episodes in 12 months preceding enrollment. -AND/OR- Erratic blood glucose levels that interfere with daily activities -AND/OR- One or more hospital visits for diabetic ketoacidosis in the 12 months preceding enrollment
- Additional Inclusion Criteria for RT Candidates Only
- One or two or previous islet transplants \> 1 month prior to screening with continuing insulin requirements and/or HbA1c \> 6.5%
- Additional Inclusion Criteria for IAK Candidates Only
- Successful kidney transplant \> 3 months prior to screening
- Stable maintenance immunosuppression consisting of tacrolimus alone or in conjunction with sirolimus, mycophenolate mofetil, myfortic or azathoprine; or cyclosporine in conjunction with sirolimus, mycophenolate mofetil, or myfortic +/- ≤ 10 mg/day corticosteroids
- No history of acute rejection related to kidney graft in last 12 months and low risk of rejection
- Under continuing care of physician for kidney graft, who has provided letter in support of candidate's consideration for study participation
- Exclusion Criteria:
- Body Mass Index (BMI) \> 33
- Insulin requirements \> 1.2 units/kg/day
- Known sensitization to both rATG -and- alemtuzumab
- Significant kidney dysfunction
- Significant liver/gall bladder disease
- Significant cardiovascular disease
- Active proliferative retinopathy
- High blood pressure despite appropriate treatment
- High cholesterol/triglycerides despite appropriate treatment
- Anemia or other blood disorders that require medical treatment
- WBC \<3,000/ul
- Increased risk of bleeding, other chronic hemostasis disorders, or treatment with chronic anticoagulant therapy
- Recent unresolved acute infection (except for mild skin infection or nail fungal infection), or chronic infection
- Epstein-Barr Virus (EBV) IgG negative
- Any history of malignancy, except for completely resected squamous or basal cell carcinoma of the skin or in situ cancer of the cervix
- Recent history of non-adherence to medical treatment, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin therapy
- Psychiatric illness that is untreated, or likely to interfere significantly with study compliance despite treatment
- Previous organ/tissue transplant, except as noted above
- Administration of live attenuated vaccines within 2 months of enrollment
- Presence of a chronic disease that must be chronically treated with a contraindicated agent
- Use of investigational agents within four weeks of enrollment
- Active alcohol or substance abuse, including cigarette smoking
- 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
- Individuals without health insurance
- History of gastric bypass
- Any medical condition that in the opinion of the investigator will interfere with safe participation in the trial
Exclusion
Key Trial Info
Start Date :
October 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01909245
Start Date
October 16 2013
End Date
September 22 2026
Last Update
November 7 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010