Stem Cell Therapy for Chronic Kidney Disease

• Status: Recruiting
• Trial end date: 2027-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LaTonya J. Hickson

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)

• Active immunosuppression therapy (including prednisone greater than or equal to 10mg daily)

• Kidney transplantation history

• Solid organ transplantation history

• Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure) within 6 months or uncontrolled cardiac arrhythmias

• Liver cirrhosis

• Chronic obstructive pulmonary disease, asthma

• History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis)

• Pregnancy

• Active malignancy

• Active infection

• Active hepatitis B or C, or HIV infection

• History of allergic reaction to cellular products (ie. 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

• Subjects anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits

• Inability or unwilling to have magnetic resonance imaging (MRI) or computed tomography (CT) studies

• Inability to give informed consent