UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035074 |
|---|---|
| Receipt number | 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 | 2024/12/06 05:15:47 |
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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
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
okanolab2020sci@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
4
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
No longer 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
| 2024 | 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
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039960
