UMIN-CTR Clinical Trial

Public title

Phase 2 study of treatment for spinal cord injury(ASIA impairment scale A,B) with autologous mononuclear cells derived from bone marrow

Acronym

Phase 2 study of treatment for spinal cord injury with autologous mononuclear cells

Scientific Title

Phase 2 study of treatment for spinal cord injury(ASIA impairment scale A,B) with autologous mononuclear cells derived from bone marrow

Scientific Title:Acronym

Phase 2 study of treatment for spinal cord injury with autologous mononuclear cells

Region

Japan

Condition

Spinal cord injury

Classification by specialty

Neurology	Orthopedics	Neurosurgery
Plastic surgery	Emergency medicine	Intensive care medicine
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of mononuclear cells transplantaion therapy for spinal cord injury

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

To investigate the recovery of motor and sensory function after transplantaion of bone marrow-derived mononuclear cells into cerebrospinal fluid of patients with subacute spinal injury

Key secondary outcomes

Type and grade of adverse events
Frequency of adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Intrathecal single injection of autologous mononuclear cells

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

20

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Patients with spinal cord injuries classified as A or B on the ASIA impairment scale
2.Patients within 3 weeks after injury
3.Patients with partial spinal cord injury demonstrated by diagnostic imaging
4.Patients aged between 20 and 60 years at the acquisition of informed consent
5.Patients who submitted written informed consent by themselves

Key exclusion criteria

1.Patients with a completely transected spinal cord
2.Patient with spinal shock
3.Patients with central spinal cord injury
4.Patients with organ failure with a SOFA score of 3 points or higher
5.Patients in whom hepatitis B, hepatitis C, human immunodeficiency virus infection, adult T-cell leukemia, or parvovirus B19 infection could not be ruled out
6.Patients with malignant tumor or a history of malignant tumor within 5 years
7.Patients with one of the following diseases/disorders:
･Myeloproliferative disorder or
myelodysplastic syndrome
･Autoimmune disease
･Spinal stenosis
･Limb paralysis due to central nervous
system disorder not attributed to spinal
cord injury
･Poorly controlled psychiatric disorder
8.Patients who were participating in other clinical trials or who completed participation within 6 months
9.Patients who were pregnant or possibly pregnant
10.Other patients who were judged to be ineligible by the investigators

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Yoshihisa Suzuki

Organization

The Tazuke Kofukai Medical Research Institute, Kitano Hospital

Division name

Plastic surgery, 5 th laboratory

Zip code

Address

2-4-20 Ohgimachi, Kita-ku, Osaka, Japan

TEL

06-6312-1221

Email

yo-suzuki@kitano-hp.or.jp

Name of contact person

1st name
Middle name
Last name	Yoshihisa Suzuki

Organization

The Tazuke Kofukai Medical Research Institute, Kitano Hospital

Division name

Plastic surgery, 5 th laboratory

Zip code

Address

2-4-20 Ohgimachi, Kita-ku, Osaka, Japan

TEL

06-6312-1221

Homepage URL

http://www.kitano-hp.or.jp/etcproject/kenkyu_keisei/index.html

Email

yo-suzuki@kitano-hp.or.jp

Institute

Department of plastic surgery, Kitano hospital

Institute

Department

Personal name

Organization

The Tazuke Kofukai Medical Research Institute, Kitano Hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Shiga University of Medical Science

Name of secondary funder(s)

Shiga University of Medical Science

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

公益財団法人田附興風会医学研究所北野病院（大阪府）、滋賀医科大学（滋賀県）

Date of disclosure of the study information

2014

Year

11

Month

23

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

Preinitiation

Date of protocol fixation

2014

Year

08

Month

14

Day

Date of IRB

Anticipated trial start date

2014

Year

12

Month

01

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

11

Month

23

Day

Last modified on

2018

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018242