Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Chronic Kidney Disease

Prior treatment

• Active immunosuppression therapy (including prednisone greater than or equal to 10 mg daily)
• Kidney transplantation history
• Solid organ transplantation history
• Illicit drug use and excessive alcohol use

Other illness

• 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
• 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
• Proteinuria \>5 g/day (with or without nephrotic syndrome).
• Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation)
• History of liver cirrhosis
• Chronic obstructive pulmonary disease or asthma requiring daily medication
• History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis)
• 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
• 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

Lab values

• Anemia (hemoglobin \<9 g/dL)
• 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.
• 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 allergic reaction to cellular products (ie. blood transfusions, platelets)

Other

• Body weight \>150 kg or BMI \>50
• 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),
• 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 tobacco use
• Subjects anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits.
• Inability to give informed consent

• 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