Overview
The purpose of this treatment protocol is to treat an intermediate-sized population with chronic kidney disease (CKD). Protocol includes a single treatment with intravenously-delivered allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) infusion. Individuals will have subsequent follow up for safety evaluations.
Eligibility
Inclusion Criteria
- Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m^2
- Hemoglobin A1c of ≤9%, if diabetes mellitus present
- 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 (hemodialysis, peritoneal dialysis, or kidney transplantation)
- Active immunosuppression therapy (including prednisone ≥10 mg daily)
- Kidney transplantation history
- Solid organ transplantation history
- 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)
- 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
- Patients anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits.
- Inability to give informed consent