Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-02 @ 7:12 PM
Study NCT ID:
NCT04483934
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2020-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Autologous Dermal Fibroblasts
Sponsor:
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Organization:
Study Overview
Official Title:
Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Local LED Phototherapy and Autologous Dermal Fibroblasts
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Treatment of patients with non-healing wounds and trophic ulcers using local LED phototherapy with local transplantation of autologous dermal fibroblasts
Detailed Description:
During the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous dermal fibroblasts in the wound.
The positive outlook for the effectiveness of photodiode therapy with dermal fibroblasts is due to the following:
* the ability of fibroblasts to stimulate tissue regeneration
* positive results of preclinical studies of the method of treatment of long-term non-healing wounds in animals (rats).
Twelve patients were included in the study. Dermal fibroblasts were isolated from the skin patients, cultured and then transplanted back to the wound.
The therapeutic dose of cells was 50k per cm2 of the wound area. Follow up patients monitoring was performed at 1, 2 and more months after injection.
The positive outlook for the effectiveness of photodiode therapy with dermal fibroblasts is due to the following:
* the ability of fibroblasts to stimulate tissue regeneration
* positive results of preclinical studies of the method of treatment of long-term non-healing wounds in animals (rats).
Twelve patients were included in the study. Dermal fibroblasts were isolated from the skin patients, cultured and then transplanted back to the wound.
The therapeutic dose of cells was 50k per cm2 of the wound area. Follow up patients monitoring was performed at 1, 2 and more months after injection.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: