Allogeneic Mesenchymal Stem Cell Therapy in Patients With Chronic Kidney Disease: A Phase I Study
Overview
- Phase
- Phase 1
- Intervention
- Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions
- Conditions
- Chronic Kidney Diseases
- Sponsor
- LaTonya J. Hickson
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Adverse events and/or serious adverse events
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
The purpose of this study is to assess the safety and tolerability of allogeneic mesenchymal stem / stromal cell therapy in individuals 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/1.73m\^2
- •Spot urine albumin:creatinine ≥30 mg/g unless on Renin-angiotensin-aldosterone system (RAAS) inhibition.
- •Ability to give informed consent.
Exclusion Criteria
- •Hemoglobin A1c greater than or equal to 11%.(in individuals with diabetes mellitus)
- •Anemia (hemoglobin less than 9g/dL)
- •Body weight greater than 150 kg or BMI greater than 50
- •Uncontrolled hypertension: sustained systolic blood pressure (SBP) greater than 155 mmHg at screening exam (a maximum of 3 screening visits will be allowed for demonstration of blood pressure control)
- •Chronic hypotension: sustained SBP less than 85 mmHg at screening exam.
- •Glomerulonephritis not in partial or complete remission for 6 months (or estimated/measured proteinuria greater than 10 grams/day)
- •Active glomerulonephritis (glomerular disease) include: ANCA associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance.
- •Nephrotic syndrome defined as proteinuria greater than 3.5g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5g/L) and edema
- •Autosomal dominant or recessive polycystic kidney disease
- •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 adipose tissue-derived mesenchymal stem cells (MSC) in two intravenous infusions of 75x10\^6 cells at day 0 and month 3.
Intervention: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions
Dose Arm 2
Subjects with chronic kidney disease will receive a single intravenous infusion of allogeneic adipose tissue-derived mesenchymal stem cells (MSC) of 150x10\^6 cells at day 0.
Intervention: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion
Outcomes
Primary Outcomes
Adverse events and/or serious adverse events
Time Frame: 22 months
Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention