臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 05, 2020
Last modified on	Sept. 29, 2021
Trial ID	jRCTa050190117

Scientific Title	Clinical study of autologous transfusion of iPS cell-derived platelets for thrombocytopenia (iPLAT1)
Public Title	iPSC-derived platelet transfusion trial1 (iPLAT1)
Manager (representative manager when conducting as a multicenter joint research)	Miyamoto Susumu

Completion date	Jan. 20, 2021
Result actual enrolment	1
Baseline Characteristics	50's-year-old female
Participant flow	The first cohort was enrolled in May 2019.
Adverse events	There was an increase in fibrin D-dimer in the second and third cohorts, but no death or any serious adverse events
Outcome measures	There was an increase in fibrin D-dimer in the second and third cohorts. No significant increase in corrected count increment was observed.
Brief summary	No problems were found regarding the safety of autologous transfusion of iPS cell-derived platelets in a thrombocytopenia patient. No significant increase in corrected count increment was observed.
Date of posting of results summaries	Sept. 30, 2021
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s) with version and date	https://jrct.niph.go.jp/latest-detail/jRCTa050190117

Contact for Scientific Queries	Name	Takaori-Kondo Akifumi
	Affiliation	Kyoto University Hospital
	Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Kyoto
	Telephone	+81-75-751-3150
	E-mail	atakaori@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Name	Kanda Junya
	Affiliation	Kyoto University Hospital
	Address	54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Kyoto
	Telephone	+81-75-751-3150
	E-mail	jkanda16@kuhp.kyoto-u.ac.jp

Target sample size		1
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Diagnosis of aplastic anemia with platelet transfusion refractoriness due to platelet-reactive antibody 2) Age 20 years and older at the time of consent 3) A document consent from the patient
	Exclusion Criteria	1) Positive test for Human immunodeficiency virus or Human T-lymphotropic virus infection 2) Positive test for Hepatitis B virus surface (HBs) antigen, HBs antibody, core (HBc) antibody or Hepatitis C virus antibody. In case of HBs antigen negative and HBs or HBc antibody positive, eligible if quantitative HBV-DNA is below detection limit 3) Severe liver or kidney dysfunction 4) Severe respiratory disease or poor control heart failure and arrhythmia 5) Significant bleeding tendency, or complication of hemophilia or other coagulation factor abnormality 6) Thrombotic thrombocytopenic purpura and other diseases in which platelet transfusions are contraindicated 7) Active infectious diseases requiring treatment 8) Malignant tumors in non-remission 9) Pregnancy or nursing, a possibility of pregnancy and pregnancy wish 10) Other conditions determined inappropriate by the responsible/sub doctor
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Aplastic anemia with platelet transfusion refractoriness due to anti-platelet alloantibo
Intervention(s) Code
Intervention(s) Keyword
Intervention(s)		transfusion
Health Condition(s) Code
Health Condition(s) Keyword
Primary Outcome(s)		Safety (frequency and extent of adverse events)
Secondary Outcome(s)		Efficacy (corrected count increment)

Anticipated date of first enrollment	Mar. 05, 2020
Actual date of first enrollment	May. 14, 2019
Recruitment status	Complete

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Kyoto University Specially Certified Committee for Regenerative Medicine
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Kyoto
Telephone	+81-75-753-4680
E-Mail	ethcom@kuhp.kyoto-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 11, 2019

Secondary ID(s)
Issuing Authority

History of Changes

No	Publication date
4	Sept. 29, 2021	(this page)	Changes
3	May. 28, 2021	Detail	Changes
2	July. 13, 2020	Detail	Changes
1	Mar. 05, 2020	Detail

List of change history