Stem Cell Therapy for Chronic Kidney Disease

NCT ID: NCT04869761

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-07
• Study Completion Date: 2023-04-26

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dose Arm 1

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Two MSC infusions of 75x10\^6 cells at time zero and three months; intravenous delivery

Dose Arm 2

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Single MSC infusion of 150x10\^6 cells at time zero; intravenous delivery

Interventions

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

Single MSC infusion of 150x10\^6 cells at time zero; intravenous delivery

Intervention Type: DRUG

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

Two MSC infusions of 75x10\^6 cells at time zero and three months; intravenous delivery

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LaTonya J. Hickson

OTHER

Sponsor Role: lead

Responsible Party

LaTonya J. Hickson

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

LaTonya Hickson, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

Patel HA, Wang J, Zinn CJ, Learmonth M, Lerman LO, Wolfram J, Hickson LJ. Fortifying the Diabetic Kidney Disease Treatment Armamentarium: Multitarget Senotherapeutic and Regenerative Strategies. J Am Soc Nephrol. 2025 May 7;36(8):1655-1658. doi: 10.1681/ASN.0000000754. No abstract available.

Reference Type: DERIVED

PMID: 40333016 (View on PubMed)

Andrews TD, Day GS, Irani SR, Kanekiyo T, Hickson LJ. Uremic Toxins, CKD, and Cognitive Dysfunction. J Am Soc Nephrol. 2025 Jun 1;36(6):1208-1226. doi: 10.1681/ASN.0000000675. Epub 2025 Feb 26.

Reference Type: DERIVED

PMID: 40009460 (View on PubMed)

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

20-008380

Identifier Type: -

Identifier Source: org_study_id