UMIN-CTR Clinical Trial

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

complete spinal cord injury at subacute stage

Classification by specialty

Orthopedics

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Keio University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院（東京都）

Date of disclosure of the study information

2020

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

11

Month

30

Day

Last modified on

2023

Year

12

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039960