HA1C

The University of Miami is currently holding a clinical trial for a procedure known as Islet Cell Transplantation Alone in Patients With Type 1 Diabetes Mellitus: Steroid-Free Immunosuppression. This is one of the most popular hopeful future treatments for Type 1 Diabetes.

Criteria

In order to participate in this study you must first meet certain criteria. Look over each requirement carefully and make sure you meet all of them. If so, please check out the contact information below and do your part, and maybe even get cured in the process. Please also note, you may be required to fly to Miami.

Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:

1. Patients between 18 and 65 years of age

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

3. One or more of the following:

   • Hypoglycemia unawareness – judged by history of blood sugars <54 on glucometer without symptoms and/or hypoglycemic episodes requiring assistance from either family, glucagon administration or emergency services

4. Poor diabetes control (HbA1c>8% or >2 visits/yr to hospital for treatment of ketoacidosis) despite intensive insulin therapy

5. Progressive complications of type 1 diabetes mellitus

6. Body Mass Index (BMI) ?26

Exclusion Criteria:

1. c-peptide > 0.3ng/ml basal or stimulated;

2. untreated proliferative diabetic retinopathy;

3. HbA1C >12%;

4. creatinine clearance <60;

5. serum creatinine consistently >1.6 mg/dl;

6. macroalbuminuria >300mg albumin in 24 hours;

7. presence of panel reactive antibodies (PRA) >20%;

8. previous/concurrent organ transplantation (except previous unsuccessful islet cell transplant;

9. malignancy or previous malignancy (except non-melanomatous skin cancer);

10. x-ray evidence of pulmonary infection;

11. active infections;

12. active peptic ulcer disease, gall stones, hemangioma, or portal hypertension

13. serological evidence of HIV, HbsAg or HCV; serological evidence of active EBV (IgM>IgG) or EBV negative serology;

14. PPD conversion or positive PPD without historic completion of appropriate prophylactic treatment;

15. abnormal liver function test;

16. anemia (hemoglobin <12.0);

17. hyperlipidemia (fasting serum triglycerides >200mg/dl and/or fasting serum cholesterol >240 mg/dl and/or fasting LDL cholesterol >140 mg/dl);

18. BMI above 26;

19. unstable cardiovascular status; prostate specific antigen (PSA) >4;

20. pregnancy or breastfeeding;

21. sexually-active females who are not: a) post-menopausal, b) surgically sterile, or c) not using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices are acceptable; condoms used alone are not acceptable);

22. alcohol abuse, substance abuse or smoking within the previous 6 months; insulin requirement >1u/kg/day and any condition or any circumstance that makes it unsafe to undergo an islet cell transplant.

Interested? Here is who you need to contact:

Contact: Rodolfo Alejandro, M.D. 305-243-5324 ralejand@med.miami.edu

Contact: Camillo Ricordi, M.D. 305-243-6913 cricordi@med.miami.edu

I would do it today because the spots won’t last long.