Clinical trial NCT05362786: Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Chronic Kidney Disease
Official title: Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse events and/or serious adverse events
timeFrame: 15 months
measure: Change in eGFR Value
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: LaTonya Hickson, MD
role: PRINCIPAL_INVESTIGATOR
References: