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Safety assessment of dried allogeneic cultured epidermis in skin defects

Safety assessment of dried allogeneic cultured epidermis in skin defects - Safety assessment of dried allogeneic cultured epidermis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052190079
Enrollment
6
Registered
2019-12-05
Start date
2020-04-15
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

skin defects burn, injury, skin ulcer

Interventions

Number of transplants: Once in principle. However, taking into consideration of the condition for the wound site after transplantation, multiple transplantation is admitted. Transplant volume: Up to 2

Sponsors

Sakamoto Michiharu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with skin defect whose diameter is over 3 cm and whose body surface area is under 10%.

Exclusion criteria

Exclusion criteria: 1. Patients who are apparently infected with applied injuries. 2. Patients with hypersensitivity to antibiotics such as penicillin, kanamycin, streptomycin and amphotericin B. Patients who have a history of hypersensitivity to penicillin antibiotics and aminoglycoside antibiotics. 3. Patient with allergy to animals (bovine, mouse, pig). 4. Patients with malignant cutaneous tumors, patients with suspected malignant cutaneous tumors or patients with a history of malignant cutaneous tumors. 5. Pregnant women, lactating women and patients who may possibly be pregnant or who have preference for pregnancy during the study period 6. Patients participating in other clinical trials at the time of consent acquisition and patients planning to participate in other clinical trials during the study participation.

Design outcomes

Primary

MeasureTime frame
Safety (Adverse events and malfunction)

Secondary

MeasureTime frame
1. Closure rate of transplantation site on day 14 after grafting(%) 2. exudate level

Contacts

Public ContactMichiharu Sakamoto

Kyoto University Hospital

dojis@kuhp.kyoto-u.ac.jp+81-75-751-3613

Outcome results

None listed

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