Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells

Phase 1

Completed

• Conditions: Trophic Ulcer
• Interventions: Biological: Autologous adipose-derived mesenchymal stem cells

• Registration Number: NCT04457037
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief Summary

Treatment of patients with trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells around and inside the wound

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 adipose-derived mesenchymal stem cells in the wound. The positive outlook for the effectiveness of MSCs is due to the following:

* the ability of MSCs to stimulate tissue regeneration

* positive results of preclinical studies of the method of treatment of trophic ulcers in animals (rats).

In study were included 18 patients (28 trophic ulcers treated). MSCs will be isolated from adipose tissue, cultured and then transplanted back to the wound. From 1 to 10 million MSCs in 4 ml were injected depending on the area of the wound. Follow up patients monitoring will occur at 1，2 and 3, 6, 12, 22 months after injection.

Study Timeline

• Study Start: 2009-10-01
• Primary Completion: 2013-12-31
• Study Completion: 2013-12-31
• Status Verified: 2020-06
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Last Update Submitted: 2020-06-30
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Trophic Ulcers

Exclusion Criteria

• diagnosed cancer
• 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
MSC	Autologous adipose-derived mesenchymal stem cells	Patients with trophic ulcers received standard treatment and MSC

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	MSC 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