Status:
COMPLETED
Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Chronic Kidney Disease
Lead Sponsor:
LaTonya J. Hickson
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
30-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and tolerability of intravenously delivered mesenchymal steml cells (MSC) in one of two fixed dosing regimens at two time points in patients with chro...
Eligibility Criteria
Inclusion
- Age 30-80 years
- Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m2
- If eGFR 45-55 ml/min/1.73m2, then albumin:creatinine ratio ≥300 mg/g or proteinuria ≥300 mg/day despite maximally tolerated dose of RAAS drugs (e.g. ACE Inhibitors, Angiotensin Receptor Blockers)
- If eGFR 25-44 ml/min/1.73m2, must have urine albumin:creatinine ratio ≥30mg/g despite maximally tolerated dose of RAAS drugs (e.g. ACE Inhibitors, Angiotensin Receptor Blockers)
- Hemoglobin A1c of ≤ 8% despite maximally tolerated anti-diabetes therapy
- Ability to give informed consent
Exclusion
- Anemia (hemoglobin \<9 g/dL)
- Body weight \>150 kg or BMI \>50
- Uncontrolled hypertension: sustained systolic blood pressure (SBP) \>150 mmHg or diastolic blood pressure (DBP) ≥100 mmHg despite maximal doses of at least 2 different classes of anti-hypertensive medications
- Chronic hypotension history: sustained SBP \<85 mmHg
- Glomerulonephritis not in partial or complete remission for 6 months (or estimated/ measured proteinuria greater than 10 grams/day),
- Active glomerulonephritis (glomerular diseases with evidence of active urinary sediment, serology or biopsy findings) including ANCA-associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance
- Autosomal dominant or recessive polycystic kidney disease
- Nephrotic syndrome defined as proteinuria \>3.5 g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5 g/L) and edema.
- Proteinuria \>5 g/day (with or without nephrotic syndrome).
- Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation)
- Active immunosuppression therapy (including prednisone greater than or equal to 10 mg daily)
- Kidney transplantation history
- Solid organ transplantation history
- Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure (NYHA class ≥III or ejection fraction ≤30%) within 6 months or uncontrolled cardiac arrhythmias (e.g. ventricular arrhythmia, supraventricular tachycardia and bradyarrhythmia)
- History of liver cirrhosis
- Chronic obstructive pulmonary disease or asthma requiring daily medication
- History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis)
- Pregnancy
- Unwilling to use contraception for at least 2 months after MSC infusion if sexually active and able to become pregnant or father a child.
- Active malignancy
- Active infection (e.g. systemic or specific organ involvement such as pneumonia or osteomyelitis)
- Recent COVID-19 infection within the last 3 months
- History of hepatitis B or C (without cure), 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 to give informed consent
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05362786
Start Date
July 1 2022
End Date
July 24 2024
Last Update
August 19 2024
Active Locations (2)
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1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
2
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905