UMIN-CTR Clinical Trial

Public title

Prospective, single-arm, observational study of IMJ-01 for Japanese patients with burns

Acronym

Prospective, single-arm, observational study of IMJ-01 for Japanese patients with burns

Scientific Title

Prospective, single-arm, observational study of IMJ-01 for Japanese patients with burns

Scientific Title:Acronym

Prospective, single-arm, observational study of IMJ-01 for Japanese patients with burns

Region

Japan

Condition

The subject who was diagnosed as second-degree burns(SDB:Superficial Dermal Burns, DDB:Deep Dermal Burns), third-degree burns (DB:Deep Burns), or mixed-thickness burns(second and third degree burns)

Classification by specialty

Plastic surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This clinical trial will be conducted to confirm safety and efficacy of IMJ-01 for Japanese patients with burns based on the following objectives:
- Confirmation of IMJ-01 therapy technique in accordance with IFU for the purpose of rapid spreading in Japan after approval.
- Confirmation of alternative dressing technique using dressing products available in Japan.
- Investigation of some combination therapies with currently available therapy/agents for burns in Japan, such as STSG, bFGF (Fiblast spray) or artificial dermis.
- Confirmation of usefulness of IMJ-01 application in larger donor sites for STSG.
- Establishment of a useful and proper training program of IMJ-01 technique for Japanese clinicians.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Others

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

- Recipient site wound closure

Key secondary outcomes

- Donor site healing
- Recipient and donor site evaluation using the Vancouver Scar Scale (VSS)
- Subject Satisfaction
- Safety (Delayed Healing, Infection, devices malfunctioning etc.)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Mono-therapy of IMJ-01 or combination therapy using IMJ-01 and bFGF will be performed for Superficial Dermal Burns (SDB) to evaluate recipient site wound closure and donor site healing at 4 weeks and 2 weeks, respectively (Follow-up period: 24weeks).
Mono-therapy of IMJ-01 or combination therapy using IMJ-01 and STSG or bFGF will be performed for Deep Dermal Burns (DDB) to evaluate recipient site wound closure and donor site healing at 4 weeks and 2 weeks, respectively (Follow-up period: 24weeks).
Combination therapy using IMJ-01 and STSG or IMJ-01 and STSG and artificial dermis or IMJ-01 and artificial dermis (for small wound) will be performed for Deep Burns (DB) to evaluate recipient site wound closure and donor site healing at 8 weeks and 2 weeks, respectively (Follow-up period: 24weeks).

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

1

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) The subject who was diagnosed as second-degree burns (SDB: Superficial Dermal Burns, DDB: Deep Dermal Burns), third-degree burns(DB: Deep Burns), or mixed-thickness burns (second and third degree burns)
(2) The area of total burn injury is less than 15% TBSA for DDB and less than 5% TBSA for DB
(3) The subject who is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.

Key exclusion criteria

(1) The subject's burn injuries are caused by chemicals, electricity, and/or radioactive substances.
(2) The subject has concurrently more than medium leveled respiratory burn
(3) The subject who is already infected.
(4) The subject who has a known hypersensitivity to compound sodium lactate for irrigation solution, anesthetic, adrenaline, povidone iodine, or chlorhexidine.
(5) The subject who has experience of commit suicide or depression indicating high possibilities of commit suicide.
(6) The subject who has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.

Target sample size

12

Name of lead principal investigator

1st name	Hajime
Middle name
Last name	Matsumura

Organization

Tokyo Medical University Hospital

Division name

Plastic surgery

Zip code

160-0023

Address

6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 160-0023, Japan

TEL

03-3342-6111

Email

hmatsu-tki@umin.ac.jp

Name of contact person

1st name	Hiromi
Middle name
Last name	Yamada

Organization

Tokyo Medical University Hospital

Division name

Clinical Trial Management Section

Zip code

160-0023

Address

6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 160-0023, Japan

TEL

03-3342-6111

Homepage URL

Email

hiyamada@tokyo-med.ac.jp

Institute

Clinical Trial Coordinator Office,
Tokyo Medical University Hospital

Institute

Department

Personal name

Organization

Indee-Medical Co., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

IRB, Tokyo Medical University Hospital

Address

6-7-1, Nishishinjyuku Shinjyuku-ku, Tokyo 160-0023

Tel

03-3342-6111

Email

chiken@tokyo-med.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

東京医科大学病院（東京都）
日本大学板橋病院（東京都）

Date of disclosure of the study information

2018

Year

02

Month

01

Day

URL releasing protocol

None

Publication of results

Unpublished

URL related to results and publications

None

Number of participants that the trial has enrolled

8

Results

At treatment area, the efficacy of IMJ-01 was confirmed as "effective" in 4 of 5 patients with deep dermal burn and in all 3 patients with deep burns.

Results date posted

2022

Year

01

Month

31

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

2 of 8 patients were male and an average age of 31.4 years.

Participant flow

Study was started after confirmation of the eligibility criteria and informed consent. The treatment depended on the depth of the burn and its was either NCRES only or combination of NCRES and existing therapy; STSG, bFGF, artificial skin. Follow-up was conducted at Weeks 1, 2, 4, 6, 8, 12, 24.

Adverse events

Eight patient had nine AEs during the study: one was serious adverse event, this was viral gastroenteritis, remaining eight were all mild(NOT serious AE). All nine AE were recovered and not related to this study.

Outcome measures

Healing of treatment areas, Healing of donor area, Scar assessment(Vancouver Scar Scale :VSS), Patient Satisfaction

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

10

Month

26

Day

Date of IRB

2017

Year

11

Month

14

Day

Anticipated trial start date

2018

Year

06

Month

01

Day

Last follow-up date

2019

Year

06

Month

01

Day

Date of closure to data entry

2019

Year

06

Month

07

Day

Date trial data considered complete

2019

Year

07

Month

05

Day

Date analysis concluded

2019

Year

10

Month

31

Day

Other related information

Registered date

2018

Year

01

Month

25

Day

Last modified on

2022

Year

01

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035359