Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT04432467
Status:
COMPLETED
Last Update Posted:
2021-12-10
First Post:
2020-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fertility Restoration Using Autologous Mesenchymal Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D006175', 'term': 'Gynatresia'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cured patients', 'timeFrame': '6 months', 'description': 'Number of patients cured'}, {'measure': 'Number of patients with treatment-related adverse events', 'timeFrame': '4 weeks', 'description': 'MSC application related adverse events assessed by blood count, liver and function tests'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fertility restoration', 'Mesenchymal stem cells'], 'conditions': ['Chronic Endometritis', 'Uterus; Scar', 'Uterine Synechiae', 'Fallopian Tube Obstruction']}, 'descriptionModule': {'briefSummary': 'Treatment of the patients with scarring and adhesions in the uterus resulting from caesarean section or chronic inflammation in the mucosa of the uterus and fallopian tubes and preventing the occurrence of these effects in the future', 'detailedDescription': 'The aim of the project is to develop a biomedical cell product based on autologous adipose tissue derived mesenchymal stem cells and a biodegradable carrier for highly effective treatment and prevention of scarring and adhesions in the uterus acquired as a result of cesarean section or chronic inflammatory processes in the uterine mucosa and fallopian tubes; to conduct the clinical trials of the biomedical cell product in the treatment of uterus scarring and infertility in women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic endometritis\n* postoperative uterus scars\n* uterine synechia\n* fallopian tube obstruction\n* absence of acute inflammation in the uterus\n\nExclusion Criteria:\n\n* Patients with genetic diseases of muscle and connective tissue;\n* Patients with malformations of the uterus;\n* Acute and chronic infectious diseases: HIV, mycoplasma infection, hepatitis B and C, syphilis; autoimmune diseases; oncological diseases; continuous hormonal therapy with cytostatics corticosteroids; acute noncommunicable diseases;\n* mental disorders;\n* Drug or alcohol addiction;\n* Benign tumors of uterus and appendages;\n* Hypersensitivity to any component of the studied biomedical cell product.'}, 'identificationModule': {'nctId': 'NCT04432467', 'briefTitle': 'Fertility Restoration Using Autologous Mesenchymal Stem Cells', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus'}, 'officialTitle': 'Fertility Restoration Using Autologous Adipose Tissue Derived Mesenchymal Stem Cells', 'orgStudyIdInfo': {'id': 'IBCE_MSC(Fertility)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mesenchymal stem cells', 'description': 'Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment and mesenchymal stem cells', 'interventionNames': ['Biological: Autologous mesenchymal stem cells', 'Other: standard treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment', 'interventionNames': ['Other: standard treatment']}], 'interventions': [{'name': 'Autologous mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'Autologous adipose tissue-derived mesenchymal stem cells', 'armGroupLabels': ['mesenchymal stem cells']}, {'name': 'standard treatment', 'type': 'OTHER', 'description': 'standard treatment according to clinical protocols', 'armGroupLabels': ['control', 'mesenchymal stem cells']}]}, '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 D Volotovski, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the Lab 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': 'Belarusian Medical Academy of Post-Graduate Education', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}