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OpenTrials
Completed

NCT Number: NCT04869761

Stem Cell Therapy for Chronic Kidney Disease

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

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

Primary outcomes

  1. Adverse events and/or serious adverse events

    Time frame: 22 months

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

Sponsors and collaborators

Lead sponsor

LaTonya J. Hickson

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 3, 2021
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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