Actively Recruiting
Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)
Led by Mayo Clinic · Updated on 2026-01-28
75
Participants Needed
1
Research Sites
366 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
O
Ossium Health, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
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
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
D
Donna K Lawson
CONTACT
M
Mayo Clinic Regenerative Nephrology Program
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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