Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
75 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for adults with chronic kidney disease or kidney transplant recipients who have worsening kidney function. Participants will receive infusions of stem cells and will have follow-up visits to monitor their safety and health.
Are You a Good Fit for This Trial?
Rules you outChronic obstructive pulmonary diseaseHepatitis B or CHIV infectionHistory of blood clotting disorders
You may be able to join if
I am over 18 years old
I have chronic kidney disease with poor kidney function
I can provide informed consent
I have diabetes with hemoglobin A1c at or below 9%
I have evidence of kidney function loss over the last 6 months
You may not be able to join if
I have anemia with hemoglobin below 8.5 g/dL
I weigh more than 150 kg or have a BMI over 50
I have uncontrolled high blood pressure
I need ongoing kidney replacement therapy like dialysis
I had a heart problem recently
I have an active cancer
I am pregnant or could become pregnant and do not agree to use contraception
I have an active infection
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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. Repea…
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.
Trial Locations
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Status
Eligibility Criteria
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 giv…
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
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