Back to search results

Observational Study of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) for Chronic Kidney Disease

This study is looking at the safety of using vertebral bone marrow-derived mesenchymal stem cells (BM-MSC) in people with chronic kidney disease (CKD), including those who have had a kidney transplant. You might be able to join if you are over 18, have an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73m2 (a measure of kidney function), and meet other health criteria. The BM-MSC will be given either through a vein (intravenous) or through a vein and directly into the kidney (intra-arterial). Researchers will track any side effects for 6 months after each treatment. The study aims to enroll 75 participants, but its current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch how participants respond to treatment. It plans to enroll 75 participants.
What's involved
You would receive infusions of BM-MSC, which can be repeated every 6 months. You will have follow-up appointments to check for safety.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for safety evaluations for 6 months after each BM-MSC infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06752577

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

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~75 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse events and/or serious adverse events
Measured over 6 months after each MSC infusion

Conditions

Chronic Kidney Diseases
Kidney Transplant

Explore related trials

Chronic Kidney DiseaseDiabetic NephropathyKidney Transplantation

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • LaTonya J Hickson, MD · PRINCIPAL_INVESTIGATOR · Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida

Who to contact

Donna K Lawson
[email protected]
507-255-7975
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Adverse events and/or serious adverse events6 months after each MSC infusion

    Number of adverse events and/or serious adverse events associated with mesenchymal stem cell (MSC) intervention