Recruiting

BM-MSCs

Sponsor:

Mayo Clinic

Code:

NCT06752577

Conditions

Chronic Kidney Diseases

Kidney Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC)

Study Details

Brief 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.

Conditions

Chronic Kidney Diseases

Kidney Transplant

Study ID

NCT06752577

Start date

Dec 22, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

MSC

Individuals with chronic kidney disease (including a kidney transplant that is losing function) will receive allogeneic, bone marrow-derived mesenchymal stem cells (MSC). Two administration routes will be used. Repeat dosing is allowed.

Interventions

Allogeneic, 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.

Primary outcome measure

  • Adverse events and/or serious adverse events [ Time Frame: 6 months after each MSC infusion ]

Central Contacts and Locations

Central contacts

Donna K Lawson

507-255-7975lawson.donna3@mayo.edu

Mayo Clinic Regenerative Nephrology Program

regenerativenephrology@mayo.edu

Locations

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Donna K Lawson

507-255-7975lawson.donna3@mayo.edu

Regenerative Nephrology Program

regenerativenephrology@mayo.edu

Principal Investigator:

LaTonya J Hickson, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • stem cells
  • regenerative medicine
  • mesenchymal stromal cells
  • kidney disease
  • kidney failure
  • diabetic kidney disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-28.