臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 27, 2020
Last modified on	Dec. 26, 2023
Trial ID	jRCTa031190228

Scientific Title	Regenerative medicine for spinal cord injury at subacute stage using human induced pluripotent stem cell-derived neural stem/progenitor cells
Public Title	Regenerative medicine for spinal cord injury at subacute stage using human induced pluripotent stem cell-derived neural stem/progenitor cells
Manager (representative manager when conducting as a multicenter joint research)	Matsumoto Morio

Contact for Scientific Queries	Name	Okano Hideyuki
	Affiliation	Keio University School of Medicine
	Address	35 Shinanomachi, Shinjuku-ku Tokyo
	Telephone	+81-3-5363-3747
	E-mail	okanolab2020sci@gmail.com
Contact for Public Queries	Name	Kozuki Tsuneo
	Affiliation	Keio University School of Medicine
	Address	35 Shinanomachi, Shinjuku-ku Tokyo
	Telephone	+81-3-5363-3747
	E-mail	okanolab2020sci@gmail.com

Target sample size		4
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Complete spinal cord injury (ASIA impairment scale A) at C3/4-Th10 level, within predetermined days after spinal cord injury at acquiring consent. 2) Possible to transplant cells between predetermined days after the injury. 3) Possible to be hospitalized first to Keio University Hospital after the transplantation, then to the Murayama Medical Center up to predetermined months after cell transplantation.Also able to visit Keio University Hospital up to predetermined weeks after cell transplant surgery. 4) 18 years old, or older. 5) Sufficient informed consent.
	Exclusion Criteria	1)Multiple or transection injury of spinal cord, or combined damage of dural membrane by preoperative MRI imaging 2)Past diseases Primary neurodegenerative diseases Unable to take MRI Intoxication Other diseases which make it difficult to comply with protocol treatment 3)Comorbidity Major respiratory complications. Trauma, or organ injuries to make the assessments difficult Other severe medical complications including heart failure, diabetes mellitus, hypertension, interstitial pneumonia, renal failure, autoimmune disease, and cancer. Active infectious diseases that contraindicate surgery. 4)Significant abnormality in clinical laboratory values 5)Allergy to immunosuppressant 6)Combination therapy Participation in another clinical trial Medication with predetermined drugs 7)Pregnancy
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		spinal cord injury at subacute stage
Intervention(s) Code
Intervention(s) Keyword
Intervention(s)		Transplantation of iPSC derived neural stem/progenitor cells between predetermined day after spinal cord injury
Health Condition(s) Code
Health Condition(s) Keyword
Primary Outcome(s)		Safety
Secondary Outcome(s)		Effectiveness

Anticipated date of first enrollment	Dec. 01, 2020
Actual date of first enrollment	Dec. 07, 2021
Recruitment status	Not Recruiting

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

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

Name of Certified Review Board	Keio University Certified Committee for Regenerative Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Telephone	+81-3-5363-3503
E-Mail	med-saisei-jimu@adst.keio.ac.jp
Approval Status	Approval
Date of approval	Nov. 27, 2018

Secondary ID(s)	R000039960
Issuing Authority	UMIN-CTR

History of Changes

No	Publication date
15	Dec. 26, 2023	(this page)	Changes
14	Nov. 02, 2023	Detail	Changes
13	July. 03, 2023	Detail	Changes
12	Feb. 28, 2023	Detail	Changes
11	Oct. 21, 2022	Detail	Changes
10	Aug. 22, 2022	Detail	Changes
9	Feb. 21, 2022	Detail	Changes
8	Oct. 22, 2021	Detail	Changes
7	Aug. 02, 2021	Detail	Changes
6	May. 31, 2021	Detail	Changes
5	April. 27, 2021	Detail	Changes
4	Mar. 30, 2021	Detail	Changes
3	Dec. 16, 2020	Detail	Changes
2	Aug. 07, 2020	Detail	Changes
1	Feb. 27, 2020	Detail

List of change history