Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells
NCT ID: NCT04457037
Last Updated: 2020-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2009-10-01
2013-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MSC
Patients with trophic ulcers received standard treatment and MSC
Autologous adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells
Interventions
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Autologous adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders
* pregnancy
18 Years
80 Years
ALL
Yes
Sponsors
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Belarusian State Medical University
OTHER
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
OTHER_GOV
Responsible Party
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Principal Investigators
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Igor Volotovski, Dr
Role: STUDY_DIRECTOR
Head of the Lab of Institute of Biophysics and Cell Engineering
Stanislav Tretyak, Prof
Role: STUDY_DIRECTOR
Head of 2 Department of Surgical Diseases of BSMU
Locations
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Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, , Belarus
Countries
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Other Identifiers
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IBCE_MSC(TrophicUlcer)
Identifier Type: -
Identifier Source: org_study_id
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