Clinical Study of Allogeneic Islet Transplantation for Treatment of type 1 diabetes

Clinical Study of Allogeneic Islet Transplantation for Treatment of type 1 diabetes - Clinical Study of Allogeneic Islet Transplantation for Treatment of type 1 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014381

Enrollment

Registered

2014-06-26

Start date

2014-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Interventions

Allogeneic Islet Transplantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Involvement in intensive diabetes management Absent basal c-peptide (<0.1ng/mL) At least one episode of severe hypoglycemia in the 12 months prior to study enrollment

Exclusion criteria

Exclusion criteria: Body mass index (BMI) >25 kg/m2 or patient weight >80kg. Insulin requirement of >0.8 IU/kg/day or >55 U/day. HbA1c >10%. Untreated proliferative diabetic retinopathy. Blood Pressure: SBP >160 mmHg or DBP >100 mmHg. eGFR <60 mL/min/1.73m^2 Presence or history of macroalbuminuria (>1g/day). Presence or history of panel-reactive anti-HLA antibodies above background by flow cytometry.

Design outcomes

Primary

Measure	Time frame
The proportion of subjects with an HbA1c <7.0% at Day 365 AND free of severe hypoglycemic events from Day 28 to Day 365 inclusive following the first islet transplant, with the day of transplant designated Day 0	—

Countries

Japan

Contacts

Public ContactMasayuki Shimoda

Research Institute, National Center for Global Health and Medicine Pancreatic islet cell transplantation

mshimoda@hosp.ncgm.go.jp03-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026