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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04483934

Enrollment

Registered

2020-07-23

Start date

2014-10-28

Completion date

2016-09-30

Last updated

2020-07-23

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

Conditions

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

Keywords

Trophic Ulcer, Non-healing Wound, Dermal fibroblasts

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.

Interventions

BIOLOGICALDermal 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.

DEVICELED phototherapy

LED phototherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Trophic Ulcers * Chronic non-healing wounds

Exclusion criteria

* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis * mental disorders * pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with tropic ulcers cured	1 month	Number of patients cured
Number of patients with treatment-related adverse events	4 weeks	Fibroblasts injection related adverse events assessed by blood count and function tests

Countries

Belarus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026