Chronic Kidney Diseases, Kidney Transplant
Conditions
Keywords
stem cells, regenerative medicine, mesenchymal stromal cells, kidney disease, kidney failure, diabetic kidney disease
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.
Interventions
DRUGAllogeneic, 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.
Sponsors
Mayo Clinic
Ossium Health, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events and/or serious adverse events | 6 months after each MSC infusion | Number of adverse events and/or serious adverse events associated with mesenchymal stem cell (MSC) intervention |
Countries
United States
Contacts
CONTACTDonna K Lawson
CONTACTMayo Clinic Regenerative Nephrology Program
PRINCIPAL_INVESTIGATORLaTonya J Hickson, MD
Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida
Outcome results
None listed