Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Autologous Dermal Fibroblasts
NCT ID: NCT04483934
Last Updated: 2020-07-23
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
12 participants
INTERVENTIONAL
2014-10-28
2016-09-30
Brief Summary
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Detailed Description
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The positive outlook for the effectiveness of photodiode therapy with dermal fibroblasts is due to the following:
* the ability of fibroblasts to stimulate tissue regeneration
* positive results of preclinical studies of the method of treatment of long-term non-healing wounds in animals (rats).
Twelve patients were included in the study. Dermal fibroblasts were isolated from the skin patients, cultured and then transplanted back to the wound.
The therapeutic dose of cells was 50k per cm2 of the wound area. Follow up patients monitoring was performed at 1, 2 and more 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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Patients treated with dermal fibroblasts
Cultured dermal fibroblasts and LED phototherepy
Dermal fibroblasts
Cultured autologous dermal fibroblasts.
For PR: The name "dermal fibroblasts" is exactly the name of the cell product registered by our ministry of health. There is no trade or international name.
LED phototherapy
LED phototherapy
Interventions
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Dermal fibroblasts
Cultured autologous dermal fibroblasts.
For PR: The name "dermal fibroblasts" is exactly the name of the cell product registered by our ministry of health. There is no trade or international name.
LED phototherapy
LED phototherapy
Eligibility Criteria
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Inclusion Criteria
* Chronic non-healing wounds
Exclusion Criteria
* mental disorders
* pregnancy
18 Years
ALL
No
Sponsors
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Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
OTHER_GOV
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, Prof
Role: STUDY_DIRECTOR
Head of the Lab of Institute of Biophysics and Cell Engineering
Stanislav Tretyak, Prof
Role: STUDY_DIRECTOR
Head of 2nd Department of Surgical Diseases of BSMU
Evgeny Baranov, Dr
Role: PRINCIPAL_INVESTIGATOR
Ass prof of 2nd Department of Surgical Diseases of BSMU
Zinaida Kvacheva, Dr
Role: PRINCIPAL_INVESTIGATOR
Lead Researcher of Institute of Biophysics and Cell Engineering
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_Fibr(TrophicUlcer)
Identifier Type: -
Identifier Source: org_study_id
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