Using stem cells to treat chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the safety and tolerability of allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) in patients with chronic kidney disease (CKD). Participants will receive a single intravenous infusion of BM-MSCs and will be monitored for safety outcomes over time. The study focuses on a real-world population with CKD, specifically targeting those with an estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73m². Follow-up assessments will help determine the treatment's safety profile in this patient group.

Why it matters

Who can join: the full rules

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
* 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

Where it's running

• Mayo Clinic
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: LaTonya J Hickson, MD — Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida
• Study coordinator: Donna K Lawson
• Email: lawson.donna3@mayo.edu
• Phone: 507-255-7975

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.