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Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells

Primary Purpose

Trophic Ulcer

Status
Completed
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
Autologous adipose-derived mesenchymal stem cells
Sponsored by
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trophic Ulcer focused on measuring Trophic Ulcer, Mesenchymal stem cells

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Trophic Ulcers

Exclusion Criteria:

  • diagnosed cancer
  • acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
  • mental disorders
  • pregnancy

Sites / Locations

  • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MSC

Arm Description

Patients with trophic ulcers received standard treatment and MSC

Outcomes

Primary Outcome Measures

Number of patients with tropic ulcers cured
Number of patients cured
Number of patients with treatment-related adverse events
MSC injection related adverse events assessed by blood count and function tests

Secondary Outcome Measures

Full Information

First Posted
June 30, 2020
Last Updated
June 30, 2020
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04457037
Brief Title
Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells
Official Title
Treatment of Patients With Trophic Ulcers Using Autologous Adipose-derived Mesenchymal Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2009 (Actual)
Primary Completion Date
December 31, 2013 (Actual)
Study Completion Date
December 31, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trophic Ulcer
Keywords
Trophic Ulcer, Mesenchymal stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients with trophic ulcers received standard treatment and mesenchymal stem cells
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MSC
Arm Type
Experimental
Arm Description
Patients with trophic ulcers received standard treatment and MSC
Intervention Type
Biological
Intervention Name(s)
Autologous adipose-derived mesenchymal stem cells
Intervention Description
Autologous adipose-derived mesenchymal stem cells
Primary Outcome Measure Information:
Title
Number of patients with tropic ulcers cured
Description
Number of patients cured
Time Frame
1 month
Title
Number of patients with treatment-related adverse events
Description
MSC injection related adverse events assessed by blood count and function tests
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Trophic Ulcers Exclusion Criteria: diagnosed cancer acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis mental disorders pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor Volotovski, Dr
Organizational Affiliation
Head of the Lab of Institute of Biophysics and Cell Engineering
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stanislav Tretyak, Prof
Organizational Affiliation
Head of 2 Department of Surgical Diseases of BSMU
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
City
Minsk
ZIP/Postal Code
220072
Country
Belarus

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells

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