Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 11:49 PM
Study NCT ID:
NCT05152394
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2021-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosomes for Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (adverse events)', 'timeFrame': 'Four year follow-up', 'description': 'Clinical monitoring of possible adverse events or complications'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'stem cell treatment'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This trial will study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Parkinson's Disease", 'detailedDescription': "This patient funded trial aims to study the safety and efficacy of intranasal installation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSC) exosomes for the treatment of Parkinson's Disease. Patients will receive a dose of 4 CCs of AlloEx, approximately 800 billion exosomes, between both nasal cavities. A second equivalent dose will be administered on the subsequent day. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Parkinson's Disease\n* Understanding and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Active infection\n* Active cancer\n* Chronic multisystem organ failure\n* Pregnancy\n* Clinically significant Abnormalities on pre-treatment laboratory evaluation\n* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.\n* Continued drug abuse\n* Pre-menopausal women not using contraception\n* Previous organ transplant\n* Hypersensitivity to sulfur\n* Anticoagulation medicine use"}, 'identificationModule': {'nctId': 'NCT05152394', 'briefTitle': "Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosomes for Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'The Foundation for Orthopaedics and Regenerative Medicine'}, 'officialTitle': "Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillation for the Treatment of Parkinson's Disease", 'orgStudyIdInfo': {'id': 'ATG-1-MSC-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group (AlloEx)', 'description': 'Intranasal instillations of 4 CCs of AlloEx, approximately 800 billion exosomes. Treatments on back-to-back days, totaling 2 doses.', 'interventionNames': ['Biological: AlloEx']}], 'interventions': [{'name': 'AlloEx', 'type': 'BIOLOGICAL', 'description': 'cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes', 'armGroupLabels': ['Treatment Group (AlloEx)']}]}, 'contactsLocationsModule': {'locations': [{'city': "St John's", 'status': 'RECRUITING', 'country': 'Antigua and Barbuda', 'contacts': [{'name': 'Chadwick Prodromos, M.D.', 'role': 'CONTACT', 'email': 'care@thepsci.com', 'phone': '8476996810'}], 'facility': 'Medical Surgical Associates Center', 'geoPoint': {'lat': 17.12096, 'lon': -61.84329}}], 'overallOfficials': [{'name': 'Chadwick Prodromos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Foundation for Orthopaedics and Regenerative Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Foundation for Orthopaedics and Regenerative Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}