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

Non-healing Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483934
• Other study ID #: IBCE_Fibr(TrophicUlcer)
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 28, 2014
• Est. completion date: September 30, 2016

Study information

• Verified date: July 2020
• Source: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Trophic Ulcers

• Chronic non-healing wounds

Exclusion Criteria:

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

• mental disorders

• pregnancy

Related Conditions & MeSH terms

• Non-Healing Ulcer of Skin
• Non-healing Wound
• Trophic Ulcer
• Ulcer
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Belarus	Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Minsk

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Country where clinical trial is conducted

Belarus, 

Outcome

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