Transplantation of beta cells in patients with long-term diabetes

In type 1 diabetic patients the insulin producing beta cells are destroyed by the patient's own immune system. Therefore, these patients have to inject insulin daily. In the long-term, the beta cells fail to produce any insulin at all. The patient needs to continually increase the insulin dose. Unfortunately, these injections cannot always maintain a good control of blood glucose levels, which often results in important fluctuations of glucose levels. Very low levels (?hypoglycaemia?) can cause dangerous diabetic coma. High glucose levels (?hyperglycaemia?) can, at long-term, lead to chronic complications such as heart attack, blindness, renal failure and amputations.

Aim of the study

• The aim of this treatment is to inject donor beta cells in sufficient numbers to restore insulin production. This could result in a significant improvement of blood glucose levels and delaying long-term complications. Temporarily, insulin injections might be decreased or even stopped.

Who can participate

• type 1 diabetic patients on insulin
• age between 18 and 65 years
• hypoglycaemia unawareness or complications to eyes or kidneys
• body weight below 80 kg
• non smoker
• no previous history of tuberculosis or cancer
• no wish to become pregnant

A first series of tests should prove the absence of insulin production. After that, additional tests will determine if the patient is eligible for transplantation.

Once the patient is eligible, he or she is placed on a waiting list. The number of transplantations per year is limited and depends on the number of donor organs available and the blood type of the patient.

What does this study imply

• Beta cells are isolated from organs of deceased donors (e.g. after a road accident).
• If the number and quality of the cells is good, they are injected into a blood vessel of the liver. This is performed during a short hospital stay.
• After transplantation, patients have to take medication that suppresses the immune system. This is essential to prevent rejection of beta cells.
• The aim is to gradually decrease this medication to prevent long-term side effects of continuous administration.
• After transplantation, tests are performed regularly to determine whether insulin production is restored. When control of blood sugar levels has markedly improved, daily insulin dose can be decreased or even stopped.