Stem Cell Therapy for Chronic Kidney Disease

LaTonya J. Hickson

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Chronic Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2

Treatments: Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion; Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions

Study type: Interventional

Funder types: Other

Identifiers

NCT04869761

20-008380

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Dose Arm 1

Experimental group

Description:

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.

Treatment:

Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions

Dose Arm 2

Experimental group

Description:

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.

Treatment:

Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion