Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-03 @ 1:18 PM
Study NCT ID:
NCT05147766
Status:
TERMINATED
Last Update Posted:
2025-04-06
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 Cells for Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Insufficient efficacy seen in treated patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}}, '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': ['Angina', 'Congestive Heart Failure', 'stem cell treatment'], 'conditions': ['Congestive Heart Failure', 'Angina']}, 'descriptionModule': {'briefSummary': 'This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of congestive heart failure and angina', 'detailedDescription': "This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of congestive heart failure and angina. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. 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.\n\nFor patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Congestive Heart Failure or Angina\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"}, 'identificationModule': {'nctId': 'NCT05147766', 'briefTitle': 'Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'The Foundation for Orthopaedics and Regenerative Medicine'}, 'officialTitle': 'Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Heart Disease', 'orgStudyIdInfo': {'id': 'ATG-1-MSC-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group (AlloRx)', 'description': 'Single intravenous infusion of 100 million cells', 'interventionNames': ['Biological: AlloRx']}], 'interventions': [{'name': 'AlloRx', 'type': 'BIOLOGICAL', 'description': 'cultured allogeneic adult umbilical cord derived mesenchymal stem cells', 'armGroupLabels': ['Treatment Group (AlloRx)']}]}, 'contactsLocationsModule': {'locations': [{'city': "St John's", 'country': 'Antigua and Barbuda', 'facility': 'Medical Surgical Associates Center', 'geoPoint': {'lat': 17.12096, 'lon': -61.84329}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Center for Investigation in Tissue Engineering and Cellular Therapy', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], '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'}}}}