NCT06752577 · Mayo Clinic
Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)
What this study is about
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) given through a vein (IV) or 2) given through a vein (IV) plus intra-arterial to both kidneys.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Jacksonville, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 28, 2026 · Source of record for eligibility and locations