Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)
Recruiting now
Conditions studied: Chronic Kidney Diseases, Kidney Transplant
In brief
The purpose of this protocol is to treat an intermediate-sized population with chronic kidney disease (CKD) including kidney transplant recipients. The protocol uses allogeneic bone marrow-derived mesenchymal stem cells (MSCs). MSC infusion may be delivered 1) intravenous or 2) intravenous plus intra-arterial to both kidneys. Individuals will have subsequent follow up for safety evaluations. Repeat dosing is allowed.
Key facts
- Study ID
- NCT06752577
- Run by
- Mayo Clinic
- People needed
- 75
- Starts
- 2024-12-22
- Expected to finish
- 2031-12-31
- Last updated by the study team
- 2026-01-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Jacksonville, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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