SELECTION AND EVALUATION PROCESS

he following information will give an overview of the selection and evaluation process of potential islet transplant candidates.

Phase 1: Over-the-phone evaluation

People seeking to undergo islet transplant can contact the Human Islet Isolation Laboratory.

He Secretary of the islet transplant team will gather initial information from patients and will also set up an additional meeting for further information.

Contact: Laboratory of Isolation of Human Islets

Tel number: +55 41- 3 271-2135

Phone/Fax number: +55 41-3026-2966

e-mail: ilhotas@pucpr.br

Address: Rua Imaculada Conceição, 1155 - Prado Velho - 80215-901 Curitiba, PR - Brazil

Phase 2: Live Informative Meeting

The patient will attend a meeting hosted by the transplant clinic´s coordinator, whose objective is to answer any and all questions about the human islet transplant project.

Information by Mail

In case patients are not able to attend the information/live meeting, they will receive an informational booklet on islet transplant as well as a questionnaire about their condition .

The informational booklet contains:

1. Questions and answers about the islet transplant
2. Explanation of research terms
3. Criteria for inclusion and exclusion
4. Notions on/Information about necessary immunosupressing and antiinflammatory medication.
5. Report from the Physician who is Following the Patient´s Diabetes
6. This report should be sent to the Islet Laboratory to be evaluated by the transplant team

Information on the Pro-Renal Foundation Site

The following information is available at our site:

1. Information on the islet transplant
2. Explanation of clinical research terms
3. Criteria for islet transplant inclusion or exclusion
4. A health report form, which must be filled out together with the patient´s doctor and sent to:

Laboratório de Engenharia e Transplante Celular - Núcleo de Células Humanas Produtoras de Insulina

(Cell Engineering and Transplant Laboratory - Center of Human Insulin-Producing Cells)

Rua Imaculada Conceição,1155 - Prado velho - 80215-901 Curitiba, PR - Brazil

Phase 2: Selection

After the patient fills out the health report form and sends it to the Islet Laboratory, the report will be analyzed by the islet transplant clinical team and if the patient meets the criteria for inclusion a patient-team appointment will be scheduled. On this occasion, the patient will be interviewed and will receive the consent form. After receiving all the relevant information on the project, if the patient feels comfortable with the situation, he or she will sign the consent form.

From then on the patient will be directed to the first part of the project, which consists of a thorough medical interview and physical examination, followed by requests for the following exams:

1. Peptide C level : to determine whether the patient produces any insulin at all
2. HbA1c (glycosilated hemoglobin): it helps track blood sugar levels over the last three months
3. Creatinine: evaluation of renal function
4. GAD 65 and IA2 Antibodies: to determine whether specific Type 1 diabetes mellitus- related antibodies are present
5. Lipidic profile
6. Hepatic function
7. Hepatitis and CMV (citomegalovirus) sorology
8. Urine: evaluation of renal function

Fase 3: Further Selection

After the pre-evaluation exams are performed, all the patients who meet the study´s criteria will be submitted to further evaluation, which includes:

1. Sustacal © stimulation test: the ultimate test to determine whether there is insulin production
2. 24 hour urine collection: evaluation of renal function
3. ECG (eletrocardiogram)
4. HIV blood test
5. PPD: teste para tuberculose
6. Abdominal ultrasound
7. Chest X-ray
8. Stress echocardiogram : for patients over 35
9. HDE (high digestive endoscopy): to determine a history of gastric ulcer
10. Medical report of the last 12 months containing:

• Ophtalmologic evaluation
• Gynecological evaluation: Pap smear and endocervical culture
• Odontological evaluation
• Mamography if patient is over 40 or with a family history of breast cancer

Fase 4: Patient Selection for the Wait List

Patients whose exams meet the study´s criteria for inclusion will be placed on a waiting list. They must provide more than one phone number for contact when there is a transplant-ready pancreas available. Patients must send daily fax reports on their blood glucose levels, as well as insulin dosage. The laboratory will contact patients on a monthly basis for information on the state of their health. While on the waiting list, patients must keep the following exams updated:

1. Every two months: collection of serum (blood sample)
2. Every three months: HbA1c
3. Every six months: lipidic profile

Hepatic and renal function

24 hour-old urine collection

1. Every year: physical exam and history

ECG

Sorology: HIV, hepatitis, CMV

PPD: tuberculosis test

Ultrassom abdominal

Chest X-ray

Stress echocardiogram, for patients over 35

HDE (high digestive endoscopy): to determine a history of gastric ulcer

Ophtalmological evaluation

Gynacological evaluation: Pap smear and endocervical culture

Dental evaluation

Mamography, if patient is over 40 or has a family history of breast cancer

Notification of Compatible Donor

Our laboratory will select the patient who is most compatible with the donated pancreas. This selection will be based on blood type, sorology, histocompatibility test, number of viable islets and time on the waiting list. The likely recipient will be notified only after all the aforementioned tests have been carried out, and should go to the hospital as soon as possible.

Hospital admission

The selected transplant patient will be admitted at the Hospital Irmandade Santa Casa de Misericórdia de Curitiba where pregnancy, chest X-ray, blood and urine exams will be performed. If transplant-ready, he or she will undergo the procedure within the following 24 hours and will remain in the hospital for at least 2 days.

Transplant follow-up

The patient must remain in the Curitiba area during the first 4 weeks after the transplant for follow-up care as an outpatient. For the following six months, the patient will be seen every month, and after that, every three months.