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

Recruitingn/aAges 18 Years - anyAllMayo Clinic
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria * Age \>18 years * Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2 * Hemoglobin A1c โ‰ค9%, if diabetes mellitus present * If kidney transplant recipient, must have eGFR\<60 mL/min/1.73m2 and evidence of progressive kidney function loss over โ‰ฅ6 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) โ‰ฅ100 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 โ‰ฅ20 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 โ‰ฅIII or ejection fraction โ‰ค30%) 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
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What it tests

  • Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC)
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Where

1 site
Mayo Clinic
Jacksonville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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