Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells

Sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus (Other)

Overall Status

Completed

CT.gov ID

NCT04457037

Collaborator

Belarusian State Medical University (Other)

Enrollment

Location

Arm

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Trophic Ulcer	Biological: Autologous adipose-derived mesenchymal stem cells	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 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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Patients with trophic ulcers received standard treatment and mesenchymal stem cellsPatients with trophic ulcers received standard treatment and mesenchymal stem cells

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Dec 31, 2013

Actual Study Completion Date :

Dec 31, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MSC Patients with trophic ulcers received standard treatment and MSC	Biological: Autologous adipose-derived mesenchymal stem cells Autologous adipose-derived mesenchymal stem cells

Arm

Intervention/Treatment

Experimental: MSC

Patients with trophic ulcers received standard treatment and MSC

Biological: Autologous adipose-derived mesenchymal stem cells

Autologous adipose-derived mesenchymal stem cells

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Trophic Ulcers

Exclusion Criteria:

diagnosed cancer
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
Belarusian State Medical University

Investigators

Study Director: Igor Volotovski, Dr, Head of the Lab of Institute of Biophysics and Cell Engineering
Study Director: Stanislav Tretyak, Prof, Head of 2 Department of Surgical Diseases of BSMU

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:

NCT04457037

Other Study ID Numbers:

IBCE_MSC(TrophicUlcer)

First Posted:

Jul 7, 2020

Last Update Posted:

Jul 7, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Trophic Ulcer

Mesenchymal stem cells

Additional relevant MeSH terms:

Ulcer

Study Results

No Results Posted as of Jul 7, 2020