Clinical trial NCT04869761: Stem Cell Therapy for Chronic Kidney Disease
Official title: Allogeneic Mesenchymal Stem Cell Therapy in Patients With Chronic Kidney Disease: A Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetes Mellitus
Diabetic Nephropathies
Keywords: Stem cell
mesenchymal stem cell
mesenchymal stromal cell
diabetes mellitus
diabetic nephropathy
diabetic kidney disease
kidney
GFR
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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)
* 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

Primary outcomes:
measure: Adverse events and/or serious adverse events
timeFrame: 22 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: LaTonya Hickson, MD
role: PRINCIPAL_INVESTIGATOR
References: