Stem Cell Therapy for Chronic Kidney Disease

Phase 1

Active, not recruiting

• Conditions: Chronic Kidney Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetic Nephropathies
• Interventions: Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion; Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions

• Registration Number: NCT04869761
• Lead Sponsor: LaTonya J. Hickson

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-03
• Study Start: 2021-10-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-22
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Arm 2	Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion	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.
Dose Arm 1	Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions	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.

Primary Outcome Measures

Name	Time	Method
Adverse events and/or serious adverse events	22 months	Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention

Trial Locations

Locations (2)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States