Status:
COMPLETED
Stem Cell Therapy for Chronic Kidney Disease
Lead Sponsor:
LaTonya J. Hickson
Conditions:
Chronic Kidney Diseases
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-80 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Age 30-80 years.
- Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m\^2
- Spot urine albumin:creatinine ≥30 mg/g unless on Renin-angiotensin-aldosterone system (RAAS) inhibition.
- Ability to give informed consent.
Exclusion
- Hemoglobin A1c greater than or equal to 11%.(in individuals with diabetes mellitus)
- Anemia (hemoglobin less than 9g/dL)
- Body weight greater than 150 kg or BMI greater than 50
- 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)
- Chronic hypotension: sustained SBP less than 85 mmHg at screening exam.
- Glomerulonephritis not in partial or complete remission for 6 months (or estimated/measured proteinuria greater than 10 grams/day)
- Active glomerulonephritis (glomerular disease) include: ANCA associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance.
- 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
- Autosomal dominant or recessive polycystic kidney disease
- Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation)
- Active immunosuppression therapy (including prednisone greater than or equal to 10mg daily)
- Kidney transplantation history
- Solid organ transplantation history
- Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure) within 6 months or uncontrolled cardiac arrhythmias
- Liver cirrhosis
- Chronic obstructive pulmonary disease, asthma
- History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis)
- Pregnancy
- Active malignancy
- Active infection
- Active hepatitis B or C, or HIV infection
- History of allergic reaction to cellular products (ie. blood transfusions, platelets)
- Active tobacco use
- 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
- Subjects anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits
- Inability or unwilling to have magnetic resonance imaging (MRI) or computed tomography (CT) studies
- Inability to give informed consent
Key Trial Info
Start Date :
October 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04869761
Start Date
October 7 2021
End Date
April 26 2023
Last Update
June 6 2025
Active Locations (2)
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1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905