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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035074
Receipt No. R000039960
Scientific Title Regenerative medicine for spinal cord injury at subacute stage using human induced pluripotent stem cell-derived neural stem/progenitor cells
Date of disclosure of the study information 2020/12/01
Last modified on 2021/10/11

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Basic information
Public title Regenerative medicine for spinal cord injury at subacute stage using human induced pluripotent stem cell-derived neural stem/progenitor cells
Acronym Transplantation of iPSC-NS/PCs for subacute-stage spinal cord injury
Scientific Title Regenerative medicine for spinal cord injury at subacute stage using human induced pluripotent stem cell-derived neural stem/progenitor cells
Scientific Title:Acronym Transplantation of iPSC-NS/PCs for subacute-stage spinal cord injury
Region
Japan

Condition
Condition complete spinal cord injury at subacute stage
Classification by specialty
Orthopedics Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The first objective is to confirm the safety of the transplantation therapy of iPSC derived neural stem/progenitor cells for the patients with subacute stage spinal cord injury. The secondary objective is to study its effectiveness.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Safety: Check adverse events occurred from the time of cell transplantation to the end of 1-year observation period
Key secondary outcomes Effectiveness

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Transplantation of iPSC derived neural stem/progenitor cells between 14th to 28th day after spinal cord injury
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) 24 days within spinal cord injury with the injury level of between 3rd/4th cervical vertebrae to 10th thoracic vertebrae, with the paralysis of AIS grade A at the time of consent.
2) Able to get transplant of hiPSC-NS/PCs between 14 to 28 days after SCI.
3) Able to be hospitalized to Keio University Hospital in acute period after cell transplant surgery, afterwards to Murayama Medical Hospital at least till the 6th month after the transplantation. Also able to visit Keio University Hospital up to 52 weeks after cell transplantation.
4) 18 years or older at the time of consent.
5) Written informed consent with the patient's own voluntary will. When unable to sign by himself, written proof of the patient's agreement by witness of adult relative. When the patient is under 20 years, written proof of the agreement of substitute of adult relative, in addition to the patient's consent.
Key exclusion criteria 1)Condition of spinal cord injury
Multiple or transection injury of spinal cord, or combined damage of dural membrane by preoperative MRI imaging.
2)Past history, comorbidity
History of spinal cord injury, or history or coexistence of abnormalities in the spinal cord or intrathecal space (tumors, inflammation, hemorrhage, etc.).
Difficult or unable to capture MRI image (such as patients with the pacemaker in the heart).
History or coexistence of intoxication of alcohol or other drugs.
3)Comorbidity
Major respiratory complications which require tracheal intubation, tracheostomy, or ventilation.
Trauma, or organ injuries that interfere with safety / efficacy evaluation.
Other severe or uncontrolled medical complications including heart failure, diabetes mellitus, hypertension, interstitial pneumonia, renal failure, autoimmune disease, cancer, and mental illness.
Active infection that becomes a contraindication for surgery.
Dementia or high risk of dementia.
4)Laboratory data
WBC<3.5x10^3/mm3, Neutrophil (%)>90, Platelets<1.5x10^5/mm3, Hb<10.0g/dL, PT-INR>1.2 (without the patients with anticoagulant), APTT>41sec(without the patients with anticoagulant), creatinine>male1.1mg/dL, female 0.8mg/dL, Hepatic transferase (AST or ALT)>70 IU/L, total bililbin>1.0mg/dL.
*The border data can be included (insufficient display of inequality sign due to the system problem)
5)History of Allergy
Allergy to FK506.
Allergy to ARTCEREB irrigation and perfusion solution for cerebrospinal surgery.
6)Combination therapy
Cyclosporine, Bosentan, Pottasium-sparing diuretics at the time of consent.
Use of other investigational new drug within 1 months from the time of consent.
Use of steroid after spinal cord injury.
7)Pregnancy
Women who are pregnant, lactating, or may be pregnant or are planning pregnancy during clinical study participation period.
Men who want partner's pregnancy during clinical study participation period.
8)Other patients who are deemed inappropriate by researcher.
Target sample size 4

Research contact person
Name of lead principal investigator
1st name Hideyuki
Middle name
Last name Okano
Organization Keio University School of Medicine
Division name Department of Physiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL +81-3-3353-1211
Email okanolab2020sci@gmail.com

Public contact
Name of contact person
1st name Tsuneo
Middle name
Last name Kozuki
Organization Keio University School of Medicine
Division name Department of Physiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL +81-3-5363-3747
Homepage URL
Email okanolab2020sci@gmail.com

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Certified Committee for Regenerative Medicine at Keio University
Address 35 Shinanomachi, Shinjuku, Tokkyo, Japan
Tel 03-5363-3503
Email med-saisei-jimu@adst.keio.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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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
2018 Year 11 Month 27 Day
Date of IRB
2018 Year 11 Month 27 Day
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2023 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2024 Year 02 Month 29 Day

Other
Other related information

Management information
Registered date
2018 Year 11 Month 30 Day
Last modified on
2021 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039960

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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