Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells

Trophic Ulcer Clinical Trial

Official title:

Treatment of Patients With Trophic Ulcers Using Autologous Adipose-derived Mesenchymal Stem Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04457037
• Other study ID #: IBCE_MSC(TrophicUlcer)
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 1, 2009
• Est. completion date: December 31, 2013

Study information

• Verified date: June 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 trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells around and inside the wound

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2013
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Trophic Ulcers

Exclusion Criteria:

• diagnosed cancer

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

• mental disorders

• pregnancy

Related Conditions & MeSH terms

• Trophic Ulcer
• Ulcer

Intervention

Biological:
• Autologous adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells

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	Belarusian State Medical University

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	MSC injection related adverse events assessed by blood count and function tests	4 weeks