臨床研究等提出・公開システム

Date of registration	July. 03, 2019
Last modified on	Feb. 10, 2025
Trial ID	jRCT1080224764

Scientific Title	A clinical study of CL2020 in patients with spinal cord injury
Public Title	A clinical study of CL2020 in patients with spinal cord injury

Completion Date or Terminated date	Sept. 28, 2021
Actual Enrolled Number	10
Baseline Characteristics	Subjects aged 16 to < 75 years of age with Modified Frankel score of B1 or B2 at the end of screening.
Participant flow	CL2020 was administered to 10 subjects, and 9 subjects completed the observation period and the study.
Adverse events	There was 1 death (pneumonia aspiration) during the observation period, with no causal relationship with the study product. A serious adverse event was 1 event of neurogenic bladder in 1 patient, with no causality.
Primary Outcome Measures	The change from baseline in ISNCSCI motor score at Week 28 tended to improve.
Secondary Outcome Measures	The change from baseline in ISNCSCI motor score at Week 12, an important secondary endpoint, showed a trend toward improvement. The change from baseline in sensory scores (superficial touch and pinprick) in ISNCSCI showed a trend toward improvement at Week 28. Improvements in ISNCSCI scores were associated with at least a 1 grade improvement in Modified Frankel Classification in more than half of subjects at Week 28. In addition, SCIM and EQ-5D-5L changes in health status today showed a trend toward improvement at Week 28.
Brief summary	The efficacy and safety of CL2020 were evaluated in spinal cord injury patients with Modified Frankel Classification of B1 or B2 after the standard acute treatment period. As a result, it was effective in improving functional impairment and QOL in patients with subacute spinal cord injury. On the other hand, there were no safety concerns with administration of CL2020, showing tolerability.
Posting of journal publication	Feb. 14, 2025
Date of the first journal publication of results	Aug. 13, 2024
URL hyperlink(s) related to results and publications	https://stemcellres.biomedcentral.com/articles/10.1186/s13287-024-03842-w

Plan to share IPD	No
Plan description	-
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name	Fukushima Tatsunobu
	Contact Name for Scientific Queries	Life Science Institute Inc.
	Address	1-1 Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-8251
	Phone Number	+81-3-6748-7200
	E-mail Address	lsii.chiken-inq@eppharmaline.co.jp

Contact for Public Queries	Name	Call center
	Contact Name for Public Queries	Life Science Institute Inc.
	Address	1-1 Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-8251
	Phone Number	+81-3-6748-7200
	E-mail Address	lsii.chiken-inq@eppharmaline.co.jp

Recruitment Status	completed

Date of First Enrolment		July. 09, 2019
Target Sample Size		10
Study Type		Interventional
Study Design	Study Design	open label, non-randomized
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with cervical spinal cord injury within 2weeks of injury Severity of modified Frankel classification grade B1 or B2 Patients with Neurological level of injury between C4 and C7
	Exclusion Criteria	Patients with any existing or previous malignant tumor Female patients who are or may be pregnant or who are breastfeeding
	Minimum Age	16age old over
	Maximum Age	74age old under
	Gender	Both
Health Condition or Problem Studied		spinal cord injury
Intervention(s)		investigational material(s) Generic name etc : CL2020 INN of investigational material : - Therapeutic category code : 49- Other agents affecting cellular function Dosage and Administration for Investigational material : intravenous infusion control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy efficacy after infusion of CL2020
Secondary Outcome		safety safety after infusion of CL2020

Primary Sponsor	Life Science Institute Inc.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Chiba University Hospital Institutional Review Board
Address of IRB	1-8-1 Inohana Chuo-ku Chiba 260-8677, JAPAN
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	June. 17, 2019

Secondary ID No.	JapicCTI-194841
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
5	Feb. 14, 2025	(this page)	Changes
4	Sept. 04, 2023	Detail	Changes
3	Aug. 04, 2023	Detail	Changes
2	June. 11, 2021	Detail	Changes
1	July. 09, 2019	Detail

List of change history