UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012534
Receipt number R000014592
Scientific Title Clinical application of corneal endothelial regenerative medicine by means of cultured human corneal endothelial cell transplantation
Date of disclosure of the study information 2013/12/09
Last modified on 2024/10/15 09:31:05

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Basic information

Public title

Clinical application of corneal endothelial regenerative medicine by means of cultured human corneal endothelial cell transplantation

Acronym

Clinical application of corneal endothelial regenerative medicine by means of cultured human corneal endothelial cell transplantation

Scientific Title

Clinical application of corneal endothelial regenerative medicine by means of cultured human corneal endothelial cell transplantation

Scientific Title:Acronym

Clinical application of corneal endothelial regenerative medicine by means of cultured human corneal endothelial cell transplantation

Region

Japan


Condition

Condition

Bullous Keratopathy

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the efficacy of human cultured corneal endothelial cell transplantation, and the safety of cultured corneal endothelial transplantation will be verified.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Corneal Endothelial Cell Density > 500 cells/mm2 (24W)

Key secondary outcomes

Corneal Thickness < 630 micro meter and no corneal epithelial edema
Improvement of visual acuity (24W)
Improvement of VFQ-25 (24W)


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

Medicine

Interventions/Control_1

ROCK inhibitor
caltivated human corneal endothelial cell

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

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

BSCVA under 0.5
Corneal thickness over 630 micro meter with corneal epithelial edema
corneal endothelial cell density unmesurable or under 500cells per mm2

Key exclusion criteria

corneal infection
pregnant
bleeding tendency
mental disability
uncontrolable glaucoma
uncontrolable diabetes
autoimmune disease
cancer patient
heart disease

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Shigeru
Middle name
Last name Kinoshita

Organization

Kyoto Prefectural University of Medicine

Division name

Frontier Medical Science and Technology for Ophthalmology

Zip code

6028566

Address

465 Kajii-cho, kamigyo-ku, Kyoto-shi,Kyoto

TEL

075-251-5578

Email

shigeruk@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Morio
Middle name
Last name Ueno

Organization

Kyoto Prefectural University of Medicine

Division name

Ophthalmology

Zip code

6028566

Address

465 Kajii-cho, kamigyo-ku, Kyoto-shi,Kyoto

TEL

075-251-5578

Homepage URL


Email

mueno@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

MHLW

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

KPUM IRB

Address

465 Kajii-cho kamigyo-ku

Tel

+81752515337

Email

rinri@koto.kpu-m.ac.jp


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

2013 Year 12 Month 09 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications

https://www.nejm.org/doi/10.1056/NEJMoa1712770?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_d

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

Open public recruiting

Date of protocol fixation

2012 Year 12 Month 19 Day

Date of IRB

2012 Year 11 Month 01 Day

Anticipated trial start date

2013 Year 12 Month 09 Day

Last follow-up date

2025 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 12 Month 09 Day

Last modified on

2024 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014592