Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Chronic Kidney Disease

NCT05362786 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 21-011822
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the safety and tolerability of intravenously delivered mesenchymal steml cells (MSC) in one of two fixed dosing regimens at two time points in patients with chronic kidney disease.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• Adverse events and/or serious adverse events

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

  15 months

• Change in eGFR Value

  Blood serum estimated glomerular filtration rate (eGFR) reported in milliliters per minute (mL/min)

  6 months

Study Arms (2)

Dose Arm 1

EXPERIMENTAL

Subjects with chronic kidney disease will receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) in two intravenous infusions of 100x10\^6 cells at time zero and three months

Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)

Dose Arm 2

EXPERIMENTAL

Subjects with chronic kidney disease will receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) single intravenous infusion of 200x10\^6 cells

Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)

Interventions

Allogeneic adipose-derived mesenchymal stem cells (MSC) DRUG

Two intravenous infusions delivered systemically through a peripheral IV(over 30 minutes to 2 hours) of 100x10\^6 cells at day 0 and day 84

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/1.73m2
• If eGFR 45-55 ml/min/1.73m2, then albumin:creatinine ratio ≥300 mg/g or proteinuria ≥300 mg/day despite maximally tolerated dose of RAAS drugs (e.g. ACE Inhibitors, Angiotensin Receptor Blockers)
• If eGFR 25-44 ml/min/1.73m2, must have urine albumin:creatinine ratio ≥30mg/g despite maximally tolerated dose of RAAS drugs (e.g. ACE Inhibitors, Angiotensin Receptor Blockers)
• Hemoglobin A1c of ≤ 8% despite maximally tolerated anti-diabetes therapy
• Ability to give informed consent

You may not qualify if:

• Anemia (hemoglobin \<9 g/dL)
• Body weight \>150 kg or BMI \>50
• Uncontrolled hypertension: sustained systolic blood pressure (SBP) \>150 mmHg or diastolic blood pressure (DBP) ≥100 mmHg despite maximal doses of at least 2 different classes of anti-hypertensive medications
• Chronic hypotension history: sustained SBP \<85 mmHg
• Glomerulonephritis not in partial or complete remission for 6 months (or estimated/ measured proteinuria greater than 10 grams/day),
• Active glomerulonephritis (glomerular diseases with evidence of active urinary sediment, serology or biopsy findings) including ANCA-associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance
• Autosomal dominant or recessive polycystic kidney disease
• Nephrotic syndrome defined as proteinuria \>3.5 g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5 g/L) and edema.
• Proteinuria \>5 g/day (with or without nephrotic syndrome).
• Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation)
• Active immunosuppression therapy (including prednisone greater than or equal to 10 mg daily)
• Kidney transplantation history
• Solid organ transplantation history
• Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure (NYHA class ≥III or ejection fraction ≤30%) within 6 months or uncontrolled cardiac arrhythmias (e.g. ventricular arrhythmia, supraventricular tachycardia and bradyarrhythmia)
• History of liver cirrhosis

Sponsors & Collaborators

• LaTonya J. Hickson: lead

Study Sites (2)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic 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

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

Study Officials

• LaTonya Hickson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: July 1, 2022
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

US (2)