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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030985

Enrollment

Registered

2018-02-01

Start date

2018-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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)

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
- Recipient site wound closure	—

Secondary

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

Countries

Japan

Contacts

Public ContactHiromi Yamada

Tokyo Medical University Hospital Clinical Trial Management Section

hiyamada@tokyo-med.ac.jp03-3342-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026