Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)

Inclusion Criteria

• Age >18 years

• Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2

• Hemoglobin A1c ≤9%, if diabetes mellitus present

• If kidney transplant recipient, must have eGFR<60 mL/min/1.73m2 and evidence of progressive kidney function loss over ≥6 months

• Ability to give informed consent

Exclusion Criteria

• Anemia (hemoglobin <8.5 g/dL)

• Body weight >150 kg or BMI >50

• Uncontrolled hypertension: sustained systolic blood pressure (SBP) >160 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

• Kidney failure requiring ongoing kidney replacement therapy including hemodialysis or peritoneal dialysis

• Active, high-dose immunosuppression therapy (e.g. chronic prednisone ≥20 mg daily)

• Solid organ transplantation history; excluding kidney transplant

• Active treatment for acute cellular rejection, in kidney transplant recipients

• Recent cardiovascular event (hospitalization for myocardial infarction, stroke, congestive heart failure (NYHA class ≥III or ejection fraction ≤30%) within 3 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 recurring blood clotting disorder (thromboembolism: pulmonary embolism, deep venous thrombosis) requiring chronic anticoagulation therapy

• 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; in kidney transplant recipients, active BK nephropathy)

• Recent COVID-19 infection, within the last 1 month

• History of hepatitis B or C (without cure), or HIV infection

• History of allergic reaction to cellular products (i.e. 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

• Anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits.

• Inability to give informed consent