Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)

Launched by MAYO CLINIC · Dec 22, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the safety and tolerability of a treatment using special cells called bone marrow-derived mesenchymal stem cells (BM-MSCs) for people with chronic kidney disease (CKD). The goal is to see how well this treatment works in real-life situations for patients who have CKD and to ensure it is safe. Participants will receive a single infusion of these stem cells through an intravenous (IV) line, and then they will be monitored for any side effects or issues afterward.

To be eligible for this trial, participants must be adults aged between 65 and 74 years and have a specific level of kidney function, measured by something called estimated glomerular filtration rate (eGFR) of less than 60. Additionally, if they have diabetes, their blood sugar levels must be controlled. However, there are certain conditions that would disqualify someone from participating, such as severe anemia, recent heart problems, or ongoing kidney treatment like dialysis. For those who qualify, joining this study may provide an opportunity to access a new treatment option while contributing to important research that could help others with CKD in the future.

Gender

ALL

Eligibility criteria

• • 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