Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 11:36 PM
Study NCT ID:
NCT04483934
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2020-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Autologous Dermal Fibroblasts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with tropic ulcers cured', 'timeFrame': '1 month', 'description': 'Number of patients cured'}, {'measure': 'Number of patients with treatment-related adverse events', 'timeFrame': '4 weeks', 'description': 'Fibroblasts injection related adverse events assessed by blood count and function tests'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trophic Ulcer', 'Non-healing Wound', 'Dermal fibroblasts'], 'conditions': ['Trophic Ulcer', 'Non-healing Wound', 'Non-Healing Ulcer of Skin']}, 'descriptionModule': {'briefSummary': 'Treatment of patients with non-healing wounds and trophic ulcers using local LED phototherapy with local transplantation of autologous dermal fibroblasts', 'detailedDescription': 'During the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous dermal fibroblasts in the wound.\n\nThe positive outlook for the effectiveness of photodiode therapy with dermal fibroblasts is due to the following:\n\n* the ability of fibroblasts to stimulate tissue regeneration\n* positive results of preclinical studies of the method of treatment of long-term non-healing wounds in animals (rats).\n\nTwelve patients were included in the study. Dermal fibroblasts were isolated from the skin patients, cultured and then transplanted back to the wound.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trophic Ulcers\n* Chronic non-healing wounds\n\nExclusion Criteria:\n\n* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis\n* mental disorders\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04483934', 'briefTitle': 'Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Autologous Dermal Fibroblasts', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus'}, 'officialTitle': 'Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Local LED Phototherapy and Autologous Dermal Fibroblasts', 'orgStudyIdInfo': {'id': 'IBCE_Fibr(TrophicUlcer)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients treated with dermal fibroblasts', 'description': 'Cultured dermal fibroblasts and LED phototherepy', 'interventionNames': ['Biological: Dermal fibroblasts', 'Device: LED phototherapy']}], 'interventions': [{'name': 'Dermal fibroblasts', 'type': 'BIOLOGICAL', 'description': 'Cultured autologous dermal fibroblasts.\n\nFor 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.', 'armGroupLabels': ['Patients treated with dermal fibroblasts']}, {'name': 'LED phototherapy', 'type': 'DEVICE', 'description': 'LED phototherapy', 'armGroupLabels': ['Patients treated with dermal fibroblasts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220072', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}], 'overallOfficials': [{'name': 'Igor Volotovski, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the Lab of Institute of Biophysics and Cell Engineering'}, {'name': 'Stanislav Tretyak, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of 2nd Department of Surgical Diseases of BSMU'}, {'name': 'Evgeny Baranov, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ass prof of 2nd Department of Surgical Diseases of BSMU'}, {'name': 'Zinaida Kvacheva, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lead Researcher of Institute of Biophysics and Cell Engineering'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}