Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-25 @ 2:30 PM
Study NCT ID:
NCT07192666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2025-09-09', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (AEs)', 'timeFrame': 'from subjects receiving administration to Day 29 post-administration', 'description': 'Incidence and severity of adverse events (AEs) from subjects receiving administration to Day 29 post-administration.'}], 'secondaryOutcomes': [{'measure': 'CFS', 'timeFrame': 'from baseline to Day 8, Day 15 and Day 29 post-administration', 'description': 'Changes in corneal fluorescein staining (CFS) scores from baseline to Day 8, Day 15 and Day 29 post-administration.'}, {'measure': 'TBUT', 'timeFrame': 'from baseline on Day 8, Day 15 and Day 29 post-administration', 'description': 'Changes in Tear film break-up time (TBUT) from baseline on Day 8, Day 15 and Day 29 post-administration.'}, {'measure': 'OSDI', 'timeFrame': 'from baseline on Day 8, Day 15 and Day 29 post-administration', 'description': 'Changes in ocular surface disease index (OSDI) scores from baseline on Day 8, Day 15 and Day 29 post-administration'}, {'measure': "Schirmer's test", 'timeFrame': 'from baseline on Day 8, Day 15 and Day 29 post-administration', 'description': "Changes in Schirmer's test from baseline on Day 8, Day 15 and Day 29 post-administration."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Sjögren's Syndrome"]}, 'descriptionModule': {'briefSummary': 'This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.', 'detailedDescription': "This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial. To evaluate the clinical safety and efficacy of exosomes in patients with ocular involvement of Sjögren's syndrome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18-65 years old, including the boundary value, no gender restriction;\n* Subjects meeting the 2016 ACR/EULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement.\n* The ocular involvement symptoms and signs of these patients cannot be relieved after at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids.\n* Extra-ocular manifestations of Sjögren's syndrome clinically stable.\n* Subjects and their partners agree to use effective non-pharmacological contraception from screening through 6 months after the last dose and have no plans for conception during this period.\n* Willing to participate in the study, understand and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Known allergy to any component of the investigational drug.\n* Active ocular infection.\n* Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns.\n* History of any ocular surgery within the preceding 6 months, including cataract surgery.\n* Participation in another interventional clinical study.\n* Use of any ophthalmic medication that may interfere with the study outcomes, such as other stem-cell-derived products.\n* Having serious underlying diseases of the heart, brain vessels, liver, kidneys, and hematopoietic system.\n* Pregnant or lactating women; women of childbearing potential must employ an effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study and for at least 3 months after the final dose of study drug.\n* Subjects deemed unsuitable for participation in this trial by the investigator."}, 'identificationModule': {'nctId': 'NCT07192666', 'briefTitle': "Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome", 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong ProCapZoom Biosciences Co., Ltd.'}, 'officialTitle': "Exploratory Clinical Trial of Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome", 'orgStudyIdInfo': {'id': 'PLKR-MSC-Exos-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exosome Preparation Group', 'description': 'Each subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days.', 'interventionNames': ['Drug: Exosome Preparation']}], 'interventions': [{'name': 'Exosome Preparation', 'type': 'DRUG', 'otherNames': ['Exosome'], 'description': 'Each subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days.', 'armGroupLabels': ['Exosome Preparation Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jiexing Chen', 'role': 'CONTACT', 'email': 'jxchen@procapzoom.com', 'phone': '18302002029'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong ProCapZoom Biosciences Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}