NCT04483934

Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Autologous Dermal Fibroblasts

Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Local LED Phototherapy and Autologous Dermal Fibroblasts

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trophic Ulcer
• Non-healing Wound
• Non-Healing Ulcer of Skin

Interventions

Type	Name	Description
BIOLOGICAL	Dermal fibroblasts	Cultured autologous dermal fibroblasts. For PR: The name "dermal fibroblasts" is exactly the name of the cell product registered by our ministry of health. There is no trade or international name.
DEVICE	LED phototherapy	LED phototherapy

Timeline

• Start date: 2014-10-28
• Primary completion: 2016-09-30
• Completion: 2016-09-30
• First posted: 2020-07-23
• Last updated: 2020-07-23

Locations

1 site across 1 country: Belarus