Stem Cell Therapy for Chronic Kidney Disease

NCT04869761 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 20-008380
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

Keywords

Stem cell; mesenchymal stem cell; mesenchymal stromal cell; diabetes mellitus; diabetic nephropathy; diabetic kidney disease; kidney; GFR

Outcome Measures

Primary Outcomes (1)

• Adverse events and/or serious adverse events

  Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention

  22 months

Study Arms (2)

Dose Arm 1

EXPERIMENTAL

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

Dose Arm 2

EXPERIMENTAL

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

Interventions

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

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

Dose Arm 2

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

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

Dose Arm 1

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LaTonya J. Hickson: lead

Study Sites (2)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 40333016 DERIVED

• 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.

  PMID: 40009460 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Diabetes Mellitus; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Diabetes Complications

Study Officials

• LaTonya Hickson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: October 7, 2021
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)