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

Phase 1

Completed

• Conditions: Trophic Ulcer; Non-healing Wound; Non-Healing Ulcer of Skin
• Interventions: Biological: Dermal fibroblasts; Device: LED phototherapy

• Registration Number: NCT04483934
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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.

Study Timeline

• Study Start: 2014-10-28
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Trophic Ulcers
• Chronic non-healing wounds

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients treated with dermal fibroblasts	LED phototherapy	Cultured dermal fibroblasts and LED phototherepy
Patients treated with dermal fibroblasts	Dermal fibroblasts	Cultured dermal fibroblasts and LED phototherepy

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus