Treatment of Patients With Trophic Ulcers Using Mesenchym... | NCT04457037

Studies
Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells

NCT04457037

Sponsor

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

Status

Completed

Last Update Posted

Jul 7, 2020Actual

Enrollment

18Actual

Phase

Phase 1Phase 2

Conditions

Trophic Ulcer

Interventions

Autologous adipose-derived mesenchymal stem cells

Countries

Belarus

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2009Actual

Primary Completion Date

Dec 31, 2013Actual

Completion Date

Dec 31, 2013Actual

First Submitted Date

Jun 30, 2020

First Submission Date that Met QC Criteria

Jun 30, 2020

First Posted Date

Jul 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2020

Last Update Posted Date

Jul 7, 2020Actual

Name	Class
Belarusian State Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MSC	Experimental	Patients with trophic ulcers received standard treatment and MSC	Biological: Autologous adipose-derived mesenchymal stem cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous adipose-derived mesenchymal stem cells	Biological	Autologous adipose-derived mesenchymal stem cells	MSC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with tropic ulcers cured	Number of patients cured	1 month
Number of patients with treatment-related adverse events	MSC injection related adverse events assessed by blood count and function tests	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Trophic Ulcers

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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 Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus		Minsk		220072	Belarus

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided