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

Mayo Clinic

Status: Enrolling

Conditions: Chronic Kidney Diseases; Kidney Transplant

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06752577

24-011356

Details and patient eligibility

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

75 participants in 1 patient group

MSC

Description:

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.

Treatment:

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