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 Belarus

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-Healing Ulcer of Skin; Trophic Ulcer; Non-healing Wound

Treatments: Biological: Dermal fibroblasts; Device: LED phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04483934

IBCE_Fibr(TrophicUlcer)

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Trophic Ulcers
• Chronic non-healing wounds

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Patients treated with dermal fibroblasts

Experimental group

Description:

Cultured dermal fibroblasts and LED phototherepy

Treatment:

Device: LED phototherapy

Biological: Dermal fibroblasts