Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT04484402
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2020-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003320', 'term': 'Corneal Ulcer'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}], 'ancestors': [{'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2020-07-20', 'studyFirstSubmitQcDate': '2020-07-20', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cured patients', 'timeFrame': '2 month', 'description': 'Number of patients cured'}, {'measure': 'Number of patients with treatment-related adverse events', 'timeFrame': '4 weeks', 'description': 'MSC/LSC application related adverse events assessed by blood count, liver and function tests'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Corneal Disease'], 'conditions': ['Corneal Ulcer', 'Corneal Disease', 'Corneal Dystrophy']}, 'descriptionModule': {'briefSummary': 'Treatment of patients with inflammatory-dystrophic diseases of the cornea using autologous limbal stem cells (corneal epithelial stem cells) or adipose-derived mesenchymal stem cells', 'detailedDescription': 'In order to treat inflammatory and dystrophic diseases of the cornea perilimbal injections of cultured autologous stem cells are performed. Corneal (limbal) epithelial stem cells (LSC) or mesenchymal stem cells derived from adipose tissue (ADSC) are mixed with sodium hyaluronate 1%'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* inflammatory-dystrophic diseases of the cornea:\n\n 1. Epithelial defects of the cornea, ulcerative keratitis of various etiology, resistant to standard methods of treatment\n 2. Dystrophic diseases of the cornea, accompanied by edema\n 3. Burns of the cornea\n 4. Neurotrophic forms of keratitis\n 5. Persistent post-traumatic, postoperative, contusion keratitis and keratopathy\n\nExclusion Criteria:\n\n1. Pregnancy.\n2. Viral hepatitis B and C, HIV, tubeculosis and other chronic viral and bacterial infections.\n3. Cancer or leukemia\n4. Any diseases in the stage of decompensation.\n5. Mental disorders.\n6. Anomalies of eye refraction'}, 'identificationModule': {'nctId': 'NCT04484402', 'briefTitle': 'Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus'}, 'officialTitle': 'Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Limbal Stem Cells (Corneal Epithelial Stem Cells) or Adipose-derived Mesenchymal Stem Cells', 'orgStudyIdInfo': {'id': 'IBCE_LSC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mesenchymal stem cells', 'description': 'Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells', 'interventionNames': ['Biological: mesenchymal stem cells', 'Other: standard treatment']}, {'type': 'EXPERIMENTAL', 'label': 'limbal stem cells', 'description': 'Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells', 'interventionNames': ['Biological: limbal stem cells', 'Other: standard treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment', 'interventionNames': ['Other: standard treatment']}], 'interventions': [{'name': 'mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution', 'armGroupLabels': ['mesenchymal stem cells']}, {'name': 'limbal stem cells', 'type': 'BIOLOGICAL', 'description': 'Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution', 'armGroupLabels': ['limbal stem cells']}, {'name': 'standard treatment', 'type': 'OTHER', 'description': 'Standard treatment according to the Clinical protocols', 'armGroupLabels': ['control', 'limbal stem cells', '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 Volotovski, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the Lab of Institute of Biophysics and Cell Engineering'}, {'name': 'Liudmila Marchenko, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the Department of eyes diseases of Belarusian State Medical University'}, {'name': 'Zinaida Kvacheva', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leading researcher, 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 State Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}