臨床研究等提出・公開システム

Scientific Title	Evaluation of efficacy and safety of autologous bone marrow mesenchymal stem cells for traumatic spinal cord injury: Use-results comparative survey
Public Title	Evaluation of efficacy and safety of autologous bone marrow mesenchymal stem cells for traumatic spinal cord injury: Use-results comparative survey

Contact for Scientific Queries	Name	Room Stemirac Information
	Affiliation	NIPRO CORPORATION
	Address	3-3-13 TOYOSAKI, KITA-KU, OSAKA
	Telephone	+81-120-002-192
	E-mail	saisei-clinicalstudy-information@nipro.co.jp
Contact for Public Queries	Name	Room Stemirac Information
	Affiliation	NIPRO CORPORATION
	Address	3-3-13 TOYOSAKI, KITA-KU, OSAKA
	Telephone	+81-120-002-192
	E-mail	saisei-clinicalstudy-information@nipro.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 01, 2019
Actual date of first enrollment		May. 16, 2019
Target sample size		612
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients using autologous mesenchymal stem cells derived from bone marrow for the first time for traumatic spinal cord injury (2) Patients or their surrogates must provide informed consent before the start
	Exclusion Criteria	none
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Spinal Cord Injury
Intervention(s)		Intravenous infusion of autologous mesenchymal stem cells derived from bone marrow
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Cohort 1: Percentage of the case with 2 or more levels of AIS improvement from 6-8 weeks (49 +/- 7 days) to 180 days +/- 30 days after injury in AIS A patients aged 20 to 70 years with traumatic cervial spinal cord injury Cohort 2: Percentage of the case with 1 or more levels of AIS improvement from 6-8 weeks (49 +/- 7 days) to 180 days +/- 30 days after injury in AIS B or C patients aged 20 to 70 years with traumatic cervial spinal cord injury
Secondary Outcome(s)

Primary Sponsor	NIPRO CORPORATION

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Not Applicabale
Address	-, Shiga
Telephone
E-Mail
Approval Status
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none