Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)
Mayo Clinic
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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-hypert…
Interventions
- DrugAllogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC)
1\) intravenous infusion or 2) combined intravenous plus intra-arterial (to kidney) infusion of cells. Total dose: 200x10\^6 MSC (administered over 15 minutes to 2 hours). Repeat dosing allowed at 6 month intervals.
Location
- Mayo ClinicJacksonville, Florida