Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT05682560
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2023-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Baseline to Week 26', 'description': 'Incidence of treatment-emergent adverse events (TEAEs)'}], 'secondaryOutcomes': [{'measure': 'Change of fatigue score as measured by CFQ-11', 'timeFrame': 'Baseline, Week 6, 12, 18 and 26'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Long COVID', 'Post-COVID Syndrome', 'Post-COVID condition', 'Umbilical cord blood', 'RegeneCyte'], 'conditions': ['Long COVID', 'Post-COVID Syndrome', 'Post COVID-19 Condition']}, 'descriptionModule': {'briefSummary': 'REGENECYTE (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID.', 'detailedDescription': 'This is a two-arm, single-center, single-blind, randomized, placebo-controlled phase IIa study. A total of 30 subjects with post-COVID will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Male or female aged ≥ 18\n* 2\\. With post-COVID syndrome\n* 3\\. Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test)\n* 4\\. Able to provide signed informed consent (by the subject or his/her legally authorized representative)\n* 5\\. Is willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing a written informed consent\n\nExclusion Criteria:\n\n* 1\\. Neurological disorders prior to COVID-19 diagnosis\n* 2\\. With pre-existing terminal illness\n* 3\\. With known immune disease\n* 4\\. Is pregnant or breastfeeding\n* 5\\. Is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening\n* 6\\. Has received any vaccination within 3 weeks prior to the first IP infusion\n* 7\\. Judged by the investigator to be not suitable for study participation\n* 8\\. Under the conditions that may increase risk of complications based on the medical judgment of the investigator and the parameters'}, 'identificationModule': {'nctId': 'NCT05682560', 'briefTitle': 'Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'StemCyte International, Ltd.'}, 'officialTitle': 'A Randomized Controlled Phase IIa, Two-arm Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome', 'orgStudyIdInfo': {'id': 'SCUS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REGENECYTE', 'description': 'HPC, Cord Blood', 'interventionNames': ['Biological: REGENECYTE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal Saline', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'REGENECYTE', 'type': 'BIOLOGICAL', 'description': 'HPC, Cord Blood', 'armGroupLabels': ['REGENECYTE']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Normal Saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Myrak Research Center', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "All information supplied by StemCyte, Inc in connection with this study and not previously published, is considered confidential information. This information includes, but is not limited to, the Investigator's Brochure, clinical protocol, case report forms and other scientific data. All data collected during the study are confidential. This confidential information shall remain the sole property of StemCyte, Inc, shall not be disclosed to others without the written consent of StemCyte, Inc, and shall not be used except in the performance of this study."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'StemCyte, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'StemCyte Taiwan Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}