Stem Cell Therapy for Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Official Title
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Allogeneic Mesenchymal Stem Cell Therapy in Patients With Chronic Kidney Disease: A Phase I Study

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

Intervention / Treatment
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* Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion
* Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Arm 1<br>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. | Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions<br>* Two MSC infusions of 75x10^6 cells at time zero and three months; intravenous delivery<br>|
| Experimental: Dose Arm 2<br>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. | Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion<br>* Single MSC infusion of 150x10^6 cells at time zero; intravenous delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and/or serious adverse events | Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention | 22 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GFR, Stem cell, mesenchymal stem cell, mesenchymal stromal cell, diabetes mellitus, diabetic nephropathy, diabetic kidney disease, kidney