RecruitingNCT06752577

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


Sponsor

Mayo Clinic

Enrollment

75 participants

Start Date

Dec 22, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether injections of mesenchymal stem cells derived from vertebral bone marrow are safe and can help slow the progression of chronic kidney disease (CKD) in people whose kidneys are gradually losing function. **You may be eligible if...** - You are over 18 years old - You have chronic kidney disease (eGFR below 60 mL/min/1.73m²) - If you are a kidney transplant recipient, your kidney function has been declining for at least 6 months - If you have diabetes, your HbA1c is 9% or below **You may NOT be eligible if...** - You are severely anemic (hemoglobin below 8.5 g/dL) - You weigh more than 150 kg or have a BMI over 50 - Your blood pressure is severely uncontrolled despite multiple medications - You are currently on dialysis (hemodialysis or peritoneal) - You have had a recent heart attack, severe heart failure, or stroke within 3 months - You have liver cirrhosis, severe lung disease, or a history of recurring blood clots - You have had a solid organ transplant other than a kidney Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Mayo Clinic

Jacksonville, Florida, United States

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NCT06752577


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