NCT04457037

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
Last Updated

July 7, 2020

Status Verified

June 1, 2020

Enrollment Period

4.3 years

First QC Date

June 30, 2020

Last Update Submit

June 30, 2020

Conditions

Trophic Ulcer

Keywords

Trophic UlcerMesenchymal stem cells

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

MSC

EXPERIMENTAL

Patients with trophic ulcers received standard treatment and MSC

Biological: Autologous adipose-derived mesenchymal stem cells

Interventions

Autologous adipose-derived mesenchymal stem cellsBIOLOGICAL

Autologous adipose-derived mesenchymal stem cells

MSC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Trophic Ulcers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Minsk, 220072, Belarus

Location

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients with trophic ulcers received standard treatment and mesenchymal stem cells
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 7, 2020

Study Start

October 1, 2009

Primary Completion

December 31, 2013

Study Completion

December 31, 2013

Last Updated

July 7, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)