Improving Islet Transplantation Outcomes With Gastrin
Status:
Recruiting
Trial end date:
2026-02-01
Target enrollment:
Participant gender:
Summary
This clinical study will evaluate the safety and effectiveness of Gastrin treatment with
islet transplantation to help patients with difficult to control type 1 diabetes make insulin
again and improve blood sugar control.
This study involves two investigational (experimental) products not yet approved by the U.S.
Food and Drug Administration (FDA) as a treatment for any disease:
1. Human allogenic islet cells (islet cells from a deceased, unrelated human donor)
2. Gastrin-17 (Gastrin) - a hormone secreted by the gut
Islet cell transplantation involves transplanting the cells that make insulin from a pancreas
of deceased organ donor to a patient with diabetes. Because there is a limited supply of
donor islet cells available, this study is testing whether Gastrin injections can help make a
fewer number of transplanted islets work better.
Gastrin is a natural gut hormone that is present in the pancreas during its development in
the embryo but not after birth, and is believed to participate in the formation of the normal
pancreas. Several studies have tried to use gastrin to help grow insulin making islet cells
in laboratory experiments or after transplanting islets in laboratory animals. In early
clinical trials, diabetic patients treated with gastrin and other growth factors required
less insulin after 4 weeks of gastrin treatment and the effect lasted more than 12 weeks
after stopping treatment, suggesting that gastrin may have increased the number of cells that
make insulin.
This study will evaluate whether taking Gastrin injections following a single islet
transplantation is safe, improves how well the islet transplant works and/or helps increase
the number of insulin-making cells in the islets.
Qualified participants will receive treatment with a single islet transplant, followed by two
rounds of gastrin treatment (twice daily injections for 30 days) just after transplant and
again 6 months later. Study participants will also take anti-rejection medications (to
prevent the body from rejecting the islet cells) and other medications to guard against
infection and support their health and/or the health of the transplanted islets. Participants
will need to return to City of Hope in Duarte, CA for frequent follow-up visits for one year
after transplant.