UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Basic Study for Pancreatic islet-like cells derived from iPS cells: Establishment of Stable Cellular Delivery System
Title of the study (Brief title)	A Basic Study for Pancreatic islet-like cells derived from iPS cells
Region	Japan

Condition
Condition	Pancreatic diseases which are needed pancreatectomy
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We plan these preclinical studies described below for utilizing pancreatic islet-like cells derived from iPS cells in clinical setting. Delivering islet-like cells derived from iPS cells from DefiniGEN (England) to Tohoku University and evaluating the endocrinal function of the cells before and after delivery, and certifying the safety of the cells using transplant animal models. Making islet-like cells via iPS cells which are differentiated from blood samples taken from persons in health and patients who receive pancreatectomy. The endocrinal function and safety are evaluated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Comparing insulin releasing function by glucose stimulation between pre- and post-derivery 2) Comparing viability defined as ratio between viable cells and total cells between pre- and post-derivery 3) Evaluating safety in tumogenesis using transplant animal model
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	taking blood sample
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

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Persons in health and patients who need pancreatectomy. Candidates as persons in health are defined as persons who receive explanation about this study, understand the theme, and sign the consent form. The consents are provided under their will. There are no matters about the disease for pancreatectomy in the case of patients who need pancreatectomy.
Key exclusion criteria	Patients in emergency Patients who cannot have a consent by themselves (i.e.persons under 18 years old) Patients in difficult hemostasis condition
Target sample size	10

Research contact person
Name of lead principal investigator	Naoaki Sakata
Organization	Tohoku University School of Medicine
Division name	Surgery
Address	1-1 Seiryomachi, Aobaku, Sendai
TEL	022-717-7205
Email	n-sakata@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	Naoaki Sakata
Organization	Tohoku University School of Medicine
Division name	Surgery
Address	1-1 Seiryomachi, Aobaku, Sendai
TEL	022-717-7205
Homepage URL
Email	n-sakata@surg1.med.tohoku.ac.jp

Sponsor
Institute	Department of Surgery, Tohoku University School of Medicine
Institute
Department

Funding Source
Organization	National Cancer Center
Organization
Division
Category of Funding Organization	Other
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	2016 Year 03 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 01 Month 19 Day
Anticipated trial start date	2016 Year 01 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 03 Month 31 Day

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

Management information
Registered date	2016 Year 02 Month 18 Day
Last modified on	2018 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024266