Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT04388761
Status:
WITHDRAWN
Last Update Posted:
2023-10-18
First Post:
2020-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Challenges in recruiting participants.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious Adverse Events (SAEs)', 'timeFrame': '1 year', 'description': 'Number of serious adverse events reported. SAEs will include delayed graft function (30 days post-transplant), difficult to control bleeding (intraoperative), sub-scapular kidney hematoma or arteriovenous fistula formation (24 hours postop), and development of stroke, myocardial infarction, or pulmonary embolism (1 year post-transplant).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemia Reperfusion Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to test an investigational drug called Adipose Mesenchymal Stem Cells (aMSCs) for the treatment of ischemia re-perfusion injury (IRI) in patients that have had a kidney transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female kidney transplant candidates age 18 and above.\n* Patient is receiving kidney allograft from deceased donor with KDPI\\>85%.\n* Ability of subject to give appropriate consent.\n* Females of childbearing potential with agreement to use birth control for six months post-transplant.\n* Approved by the Mayo Clinic Transplant Selection Committee.\n* Signed Authorization for Donation of Anatomical Gifts on file.\n\nExclusion Criteria:\n\n* Positive pregnancy test at the time of the kidney offer is called for the potential recipient.\n* Kidney transplant potential recipients with active malignancy (except none melanoma skin malignancies).\n* Patients with previous history of solid organ transplant (Heart, Lung, Intestine, Kidney and/or Pancreas).\n* Patients with previous history of bone marrow transplant.'}, 'identificationModule': {'nctId': 'NCT04388761', 'briefTitle': 'Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)', 'orgStudyIdInfo': {'id': '20-000264'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra parenchymal injection', 'description': '5 subjects will receive AMSCs via direct injection into the kidney parenchyma only', 'interventionNames': ['Drug: Allogeneic adipose derived mesenchymal stem cells']}, {'type': 'EXPERIMENTAL', 'label': 'Intra-arterial infusion', 'description': '5 subjects will receive AMSCs via intra-arterial infusion only', 'interventionNames': ['Drug: Allogeneic adipose derived mesenchymal stem cells']}, {'type': 'EXPERIMENTAL', 'label': 'Intra parenchymal injection & Intra-arterial infusion', 'description': '5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion', 'interventionNames': ['Drug: Allogeneic adipose derived mesenchymal stem cells']}], 'interventions': [{'name': 'Allogeneic adipose derived mesenchymal stem cells', 'type': 'DRUG', 'description': 'Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft', 'armGroupLabels': ['Intra parenchymal injection', 'Intra parenchymal injection & Intra-arterial infusion', 'Intra-arterial infusion']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tambi Jarmi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tambi Jarmi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tambi Jarmi', 'investigatorAffiliation': 'Mayo Clinic'}}}}