Chronic Kidney Diseases
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of intravenously delivered mesenchymal steml cells (MSC) in one of two fixed dosing regimens at two time points in patients with chronic kidney disease.
Interventions
DRUGAllogeneic adipose-derived mesenchymal stem cells (MSC)
Two intravenous infusions delivered systemically through a peripheral IV(over 30 minutes to 2 hours) of 100x10\^6 cells at day 0 and day 84
Sponsors
LaTonya J. Hickson
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 30-80 years 2. Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m2 1. If eGFR 45-55 ml/min/1.73m2, then albumin:creatinine ratio ≥300 mg/g or proteinuria ≥300 mg/day despite maximally tolerated dose of RAAS drugs (e.g. ACE Inhibitors, Angiotensin Receptor Blockers) 2. If eGFR 25-44 ml/min/1.73m2, must have urine albumin:creatinine ratio ≥30mg/g despite maximally tolerated dose of RAAS drugs (e.g. ACE Inhibitors, Angiotensin Receptor Blockers) 3. Hemoglobin A1c of ≤ 8% despite maximally tolerated anti-diabetes therapy 4. Ability to give informed consent
Exclusion criteria
1. Anemia (hemoglobin \<9 g/dL) 2. Body weight \>150 kg or BMI \>50 3. Uncontrolled hypertension: sustained systolic blood pressure (SBP) \>150 mmHg or diastolic blood pressure (DBP) ≥100 mmHg despite maximal doses of at least 2 different classes of anti-hypertensive medications 4. Chronic hypotension history: sustained SBP \<85 mmHg 5. Glomerulonephritis not in partial or complete remission for 6 months (or estimated/ measured proteinuria greater than 10 grams/day), 6. Active glomerulonephritis (glomerular diseases with evidence of active urinary sediment, serology or biopsy findings) including ANCA-associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance 7. Autosomal dominant or recessive polycystic kidney disease 8. Nephrotic syndrome defined as proteinuria \>3.5 g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5 g/L) and edema. 9. Proteinuria \>5 g/day (with or without nephrotic syndrome). 10. Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation) 11. Active immunosuppression therapy (including prednisone greater than or equal to 10 mg daily) 12. Kidney transplantation history 13. Solid organ transplantation history 14. Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure (NYHA class ≥III or ejection fraction ≤30%) within 6 months or uncontrolled cardiac arrhythmias (e.g. ventricular arrhythmia, supraventricular tachycardia and bradyarrhythmia) 15. History of liver cirrhosis 16. Chronic obstructive pulmonary disease or asthma requiring daily medication 17. History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis) 18. Pregnancy 19. Unwilling to use contraception for at least 2 months after MSC infusion if sexually active and able to become pregnant or father a child. 20. Active malignancy 21. Active infection (e.g. systemic or specific organ involvement such as pneumonia or osteomyelitis) 22. Recent COVID-19 infection within the last 3 months 23. History of hepatitis B or C (without cure), or HIV infection 24. History of allergic reaction to cellular products (ie. blood transfusions, platelets) 25. Active tobacco use 26. Illicit drug use and excessive alcohol use 27. 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 28. Subjects anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits. 29. Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events and/or serious adverse events | 15 months | Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention |
| Change in eGFR Value | 6 months | Blood serum estimated glomerular filtration rate (eGFR) reported in milliliters per minute (mL/min) |
Countries
United States
Outcome results
None listed