Clinical Trials

Inclusion Criteria:

• Age >18 years
• Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2
• 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 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 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/04/2024. Questions regarding updates should be directed to the study team contact.