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

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus12 enrolled

Overview

Treatment of patients with non-healing wounds and trophic ulcers using local LED phototherapy with local transplantation of autologous dermal fibroblasts

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Dermal fibroblastsBIOLOGICAL

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.

LED phototherapyDEVICE

LED phototherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Trophic Ulcers * Chronic non-healing wounds Exclusion Criteria: * acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis * mental disorders * pregnancy

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, Belarus

Outcomes

Primary Outcomes

Number of patients with tropic ulcers cured

Number of patients cured

Time frame: 1 month

Number of patients with treatment-related adverse events

Fibroblasts injection related adverse events assessed by blood count and function tests

Time frame: 4 weeks

Data from ClinicalTrials.gov

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