Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Chronic Kidney Disease
Overview
- Phase
- Phase 1
- Intervention
- Allogeneic adipose-derived mesenchymal stem cells (MSC)
- Conditions
- Chronic Kidney Diseases
- Sponsor
- LaTonya J. Hickson
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Adverse events and/or serious adverse events
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
LaTonya J. Hickson
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Age 30-80 years
- •Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m2
- •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)
- •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)
- •Hemoglobin A1c of ≤ 8% despite maximally tolerated anti-diabetes therapy
- •Ability to give informed consent
Exclusion Criteria
- •Anemia (hemoglobin \<9 g/dL)
- •Body weight \>150 kg or BMI \>50
- •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
- •Chronic hypotension history: sustained SBP \<85 mmHg
- •Glomerulonephritis not in partial or complete remission for 6 months (or estimated/ measured proteinuria greater than 10 grams/day),
- •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
- •Autosomal dominant or recessive polycystic kidney disease
- •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.
- •Proteinuria \>5 g/day (with or without nephrotic syndrome).
- •Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation)
Arms & Interventions
Dose Arm 1
Subjects with chronic kidney disease will receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) in two intravenous infusions of 100x10\^6 cells at time zero and three months
Intervention: Allogeneic adipose-derived mesenchymal stem cells (MSC)
Dose Arm 2
Subjects with chronic kidney disease will receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) single intravenous infusion of 200x10\^6 cells
Intervention: Allogeneic adipose-derived mesenchymal stem cells (MSC)
Outcomes
Primary Outcomes
Adverse events and/or serious adverse events
Time Frame: 15 months
Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention
Change in eGFR Value
Time Frame: 6 months
Blood serum estimated glomerular filtration rate (eGFR) reported in milliliters per minute (mL/min)