Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-01-10 @ 5:23 PM
Study NCT ID:
NCT04869761
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2021-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stem Cell Therapy for Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events and/or serious adverse events', 'timeFrame': '22 months', 'description': 'Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stem cell', 'mesenchymal stem cell', 'mesenchymal stromal cell', 'diabetes mellitus', 'diabetic nephropathy', 'diabetic kidney disease', 'kidney', 'GFR'], 'conditions': ['Chronic Kidney Diseases', 'Diabetes Mellitus, Type 2', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus', 'Diabetic Nephropathies']}, 'referencesModule': {'references': [{'pmid': '40333016', 'type': 'DERIVED', 'citation': 'Patel HA, Wang J, Zinn CJ, Learmonth M, Lerman LO, Wolfram J, Hickson LJ. Fortifying the Diabetic Kidney Disease Treatment Armamentarium: Multitarget Senotherapeutic and Regenerative Strategies. J Am Soc Nephrol. 2025 May 7;36(8):1655-1658. doi: 10.1681/ASN.0000000754. No abstract available.'}, {'pmid': '40009460', 'type': 'DERIVED', 'citation': 'Andrews TD, Day GS, Irani SR, Kanekiyo T, Hickson LJ. Uremic Toxins, CKD, and Cognitive Dysfunction. J Am Soc Nephrol. 2025 Jun 1;36(6):1208-1226. doi: 10.1681/ASN.0000000675. Epub 2025 Feb 26.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of allogeneic mesenchymal stem / stromal cell therapy in individuals with chronic kidney disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30-80 years.\n* Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m\\^2\n* Spot urine albumin:creatinine ≥30 mg/g unless on Renin-angiotensin-aldosterone system (RAAS) inhibition.\n* Ability to give informed consent.\n\nExclusion Criteria:\n\n* Hemoglobin A1c greater than or equal to 11%.(in individuals with diabetes mellitus)\n* Anemia (hemoglobin less than 9g/dL)\n* Body weight greater than 150 kg or BMI greater than 50\n* Uncontrolled hypertension: sustained systolic blood pressure (SBP) greater than 155 mmHg at screening exam (a maximum of 3 screening visits will be allowed for demonstration of blood pressure control)\n* Chronic hypotension: sustained SBP less than 85 mmHg at screening exam.\n* Glomerulonephritis not in partial or complete remission for 6 months (or estimated/measured proteinuria greater than 10 grams/day)\n* Active glomerulonephritis (glomerular disease) include: ANCA associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance.\n* Nephrotic syndrome defined as proteinuria greater than 3.5g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5g/L) and edema\n* Autosomal dominant or recessive polycystic kidney disease\n* Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation)\n* Active immunosuppression therapy (including prednisone greater than or equal to 10mg daily)\n* Kidney transplantation history\n* Solid organ transplantation history\n* Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure) within 6 months or uncontrolled cardiac arrhythmias\n* Liver cirrhosis\n* Chronic obstructive pulmonary disease, asthma\n* History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis)\n* Pregnancy\n* Active malignancy\n* Active infection\n* Active hepatitis B or C, or HIV infection\n* History of allergic reaction to cellular products (ie. blood transfusions, platelets)\n* Active tobacco use\n* Illicit drug use and excessive alcohol use presence of psychosocial issues (e.g., uncontrolled mental illness, unpredictable childcare or eldercare responsibilities, irregular/inflexible work schedule) that may interfere with the ability to complete all study procedures\n* Subjects anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits\n* Inability or unwilling to have magnetic resonance imaging (MRI) or computed tomography (CT) studies\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT04869761', 'briefTitle': 'Stem Cell Therapy for Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Allogeneic Mesenchymal Stem Cell Therapy in Patients With Chronic Kidney Disease: A Phase I Study', 'orgStudyIdInfo': {'id': '20-008380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Arm 1', 'description': 'Subjects with chronic kidney disease will receive allogeneic adipose tissue-derived mesenchymal stem cells (MSC) in two intravenous infusions of 75x10\\^6 cells at day 0 and month 3.', 'interventionNames': ['Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Arm 2', 'description': 'Subjects with chronic kidney disease will receive a single intravenous infusion of allogeneic adipose tissue-derived mesenchymal stem cells (MSC) of 150x10\\^6 cells at day 0.', 'interventionNames': ['Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion']}], 'interventions': [{'name': 'Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion', 'type': 'DRUG', 'description': 'Single MSC infusion of 150x10\\^6 cells at time zero; intravenous delivery', 'armGroupLabels': ['Dose Arm 2']}, {'name': 'Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions', 'type': 'DRUG', 'description': 'Two MSC infusions of 75x10\\^6 cells at time zero and three months; intravenous delivery', 'armGroupLabels': ['Dose Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'LaTonya Hickson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LaTonya J. Hickson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'LaTonya J. Hickson', 'investigatorAffiliation': 'Mayo Clinic'}}}}