Stem Cell Therapy for Chronic Kidney Disease

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04869761
• Other study ID #: 20-008380
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 7, 2021
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion
Single MSC infusion of 150x10^6 cells at time zero; intravenous delivery
• Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions
Two MSC infusions of 75x10^6 cells at time zero and three months; intravenous delivery

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
LaTonya J. Hickson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events and/or serious adverse events	Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention	22 months

External Links

•   Mayo Clinic Clinical Trials