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

• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus (Other)
• Overall Status: Completed
• CT.gov ID: NCT04483934
• Collaborator: Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology (Other)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 23.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Trophic Ulcer; Non-healing Wound; Non-Healing Ulcer of Skin	Biological: Dermal fibroblasts; Device: LED phototherapy	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Local LED Phototherapy and Autologous Dermal Fibroblasts
• Actual Study Start Date: Oct 28, 2014
• Actual Primary Completion Date: Sep 30, 2016
• Actual Study Completion Date: Sep 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients treated with dermal fibroblasts Cultured dermal fibroblasts and LED phototherepy	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

Outcome Measures

Primary Outcome Measures

1. Number of patients with tropic ulcers cured [1 month]

   Number of patients cured

2. Number of patients with treatment-related adverse events [4 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Trophic Ulcers

• Chronic non-healing wounds

Exclusion Criteria:

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

• mental disorders

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Minsk		Belarus	220072

Sponsors and Collaborators

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

Investigators

• Study Director: Igor Volotovski, Prof, Head of the Lab of Institute of Biophysics and Cell Engineering
• Study Director: Stanislav Tretyak, Prof, Head of 2nd Department of Surgical Diseases of BSMU
• Principal Investigator: Evgeny Baranov, Dr, Ass prof of 2nd Department of Surgical Diseases of BSMU
• Principal Investigator: Zinaida Kvacheva, Dr, Lead Researcher of Institute of Biophysics and Cell Engineering

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• ClinicalTrials.gov Identifier: NCT04483934
• Other Study ID Numbers: IBCE_Fibr(TrophicUlcer)
• First Posted: Jul 23, 2020
• Last Update Posted: Jul 23, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus: Trophic Ulcer; Non-healing Wound; Dermal fibroblasts
• Additional relevant MeSH terms: Ulcer; Wounds and Injuries

Study Results

No Results Posted as of Jul 23, 2020