Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT06752577
- Status
- Recruiting
- Sponsor
- Mayo Clinic