Islet Cell Transplant for Type 1 Diabetes

Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Age Range:18 - 68
Start Date:October 2013
End Date:July 2021
Contact:Islet Cell Transplant Program
Phone:1-866-44-ISLET (1-866-444-7538

Use our guide to learn which trials are right for you!

Islet Transplantation Using a T-Cell Depleting Immunosuppression Induction Regimen

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.

Three different categories of patients with Type 1 Diabetes will be considered for study

- 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:

1. Age 18-68 years

2. Type 1 diabetes mellitus for at least 5 years

3. 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

4. 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

5. 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

6. Successful kidney transplant > 3 months prior to screening

7. 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

8. No history of acute rejection related to kidney graft in last 12 months and low risk
of rejection

9. Under continuing care of physician for kidney graft, who has provided letter in
support of candidate's consideration for study participation

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

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
We found this trial at
Duarte, California 91010
Principal Investigator: Fouad Kandeel, MD, PhD
Phone: 866-444-7538
Duarte, CA
Click here to add this to my saved trials