Islet Cell Transplantation Alone and CD34+ Enriched Bone Marrow Cell Infusion in Patients With Diabetes Mellitus: Steroid-Free Regimen

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Overall Status

Completed

CT.gov ID

NCT00021801

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

The goal of islet cell transplantation in Type 1 diabetics is to provide those affected with constant normal blood glucose levels, thereby reducing or eliminating altogether the need for injected insulin. This normalization may prevent or slow progression of diabetic complications, result in a healthier lifestyle, and lead to a better quality of life.

Participants who meet the inclusion criteria will undergo an extensive screening process which typically includes a series of blood tests, EKG, chest x-rays, and a psychological evaluation, among others. Those who are eligible for and chose to participate in the trial will receive an islet cell transplant and bone marrow infusion from the same donor, together with following immunosuppressive medications: tacrolimus, sirolimus, daclizumab and infliximab. Because the bone marrow infusion may successfully prevent the transplanted islet cells from rejecting, some participants may be able to stop taking the immunosuppressive medications after a year.

The islet cell transplant is done under local anesthesia in a special procedure radiology room. Several days after the islet cell transplant, the participant is admitted to the hospital as an outpatient in order to receive bone marrow via a simple intra-venous infusion procedure.

All participants will need to be seen at the Diabetes Research Institute after the transplant for follow-up testing and post-islet cell transplant care.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Procedure: Islet Cell Transplantation	Phase 2

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pathways to Tolerance in Human Islet Transplantation

Study Start Date :

Mar 1, 2000

Study Completion Date :

Sep 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Candidates must be between the ages of 18 and 50.
Candidates must have had insulin-dependent diabetes mellitus (IDDM) for at least 5 years and been under physician care for at least 6 months prior to enrollment in trial.
Eligible candidates will have poorly controlled IDDM and manifest signs and symptoms severe enough to be incapacitating. These symptoms can include episodes of hypoglycemic unawareness (failure to recognize blood glucose levels < 54 mg/dl) or episodes requiring the assistance of others.
Candidates may have poor diabetes control despite intensive insulin therapy (HbA1c > 8.0%).
Creatinine clearance should be > 60 ml/min)
Body Mass Index should be less than 26
Women of child-bearing age must have a negative pregnancy test and agree to follow effective contraceptive measures for the duration of the trial.

Exclusion Criteria:

Previous or concurrent organ transplant
Previous or concurrent malignancy
Untreated proliferative diabetic retinopathy
Unstable cardiovascular status, including positive stress echocardiography (if > age

Active infections, including x-ray evidence of pulmonary infection
Peptic ulcer disease, gall stones, or portal hypertension
Abnormal liver function tests
Presence of panel reactive antibodies > 20%
Creatinine clearance < 60 ml/min
HbA1c > 12%
Serological evidence of HIV, HbsAg, or HCV
Anemia (hemoglobin < 12.0)
Any condition or circumstance, including psychogenic factors, that preclude therapeutic compliance or otherwise make it unsafe to undergo an islet cell transplant.
PSA > 4 in males