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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014381
Receipt No. R000016734
Official scientific title of the study Clinical Study of Allogeneic Islet Transplantation for Treatment of type 1 diabetes
Date of disclosure of the study information 2014/06/26
Last modified on 2014/06/25

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Basic information
Official scientific title of the study Clinical Study of Allogeneic Islet Transplantation for Treatment of type 1 diabetes
Title of the study (Brief title) Clinical Study of Allogeneic Islet Transplantation for Treatment of type 1 diabetes
Region
Japan

Condition
Condition Type 1 Diabetes
Classification by specialty
Endocrinology and Metabolism Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the safety and efficacy of islet transplantation for the treatment of Type 1 Diabetes in subjects with hypoglycemia
unawareness and a history of severe hypoglycemic episodes
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Allogeneic Islet Transplantation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key 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
Key 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.
Target sample size 3

Research contact person
Name of lead principal investigator Masayuki Shimoda
Organization Research Institute, National Center for Global Health and Medicine
Division name Pancreatic islet cell transplantation
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655 Japan
TEL 03-3202-7181
Email mshimoda@hosp.ncgm.go.jp

Public contact
Name of contact person Masayuki Shimoda
Organization Research Institute, National Center for Global Health and Medicine
Division name Pancreatic islet cell transplantation
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655 Japan
TEL 03-3202-7181
Homepage URL
Email mshimoda@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 26 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 03 Month 07 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 06 Month 26 Day
Last modified on
2014 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016734


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