UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021090
Receipt number R000024266
Scientific Title A Basic Study for Pancreatic islet-like cells derived from iPS cells: Establishment of Stable Cellular Delivery System
Date of disclosure of the study information 2016/03/01
Last modified on 2018/02/19 14:49:30

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Basic information

Public title

A Basic Study for Pancreatic islet-like cells derived from iPS cells: Establishment of Stable Cellular Delivery System

Acronym

A Basic Study for Pancreatic islet-like cells derived from iPS cells

Scientific Title

A Basic Study for Pancreatic islet-like cells derived from iPS cells: Establishment of Stable Cellular Delivery System

Scientific Title:Acronym

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

1st name
Middle name
Last name Naoaki Sakata

Organization

Tohoku University School of Medicine

Division name

Surgery

Zip code


Address

1-1 Seiryomachi, Aobaku, Sendai

TEL

022-717-7205

Email

n-sakata@surg1.med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoaki Sakata

Organization

Tohoku University School of Medicine

Division name

Surgery

Zip code


Address

1-1 Seiryomachi, Aobaku, Sendai

TEL

022-717-7205

Homepage URL


Email

n-sakata@surg1.med.tohoku.ac.jp


Sponsor or person

Institute

Department of Surgery, Tohoku University School of Medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2016 Year 01 Month 19 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024266


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name