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Recruiting NCT06752577

Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)

— Observational Chronic Kidney Diseases Kidney Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC).
Who it may be relevant to
Registry conditions: Chronic Kidney Diseases, Kidney Transplant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this protocol is to treat an intermediate-sized population with chronic kidney disease (CKD) including kidney transplant recipients. The protocol uses allogeneic bone marrow-derived mesenchymal stem cells (MSCs). MSC infusion may be delivered 1) intravenous or 2) intravenous plus intra-arterial to both kidneys. Individuals will have subsequent follow up for safety evaluations. Repeat dosing is allowed.

Interventions

  • Drug Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC)
    1\) intravenous infusion or 2) combined intravenous plus intra-arterial (to kidney) infusion of cells. Total dose: 200x10\^6 MSC (administered over 15 minutes to 2 hours). Repeat dosing allowed at 6 month intervals.

Primary outcome measures

  • Adverse events and/or serious adverse events [Time frame: 6 months after each MSC infusion]

Eligibility criteria

Inclusion criteria

  • Age >18 years
  • Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2
  • Hemoglobin A1c ≤9%, if diabetes mellitus present
  • If kidney transplant recipient, must have eGFR<60 mL/min/1.73m2 and evidence of progressive kidney function loss over ≥6 months
  • Ability to give informed consent

Exclusion criteria

  • Anemia (hemoglobin <8.5 g/dL)
  • Body weight >150 kg or BMI >50
  • Uncontrolled hypertension: sustained systolic blood pressure (SBP) >160 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
  • Kidney failure requiring ongoing kidney replacement therapy including hemodialysis or peritoneal dialysis
  • Active, high-dose immunosuppression therapy (e.g. chronic prednisone ≥20 mg daily)
  • Solid organ transplantation history; excluding kidney transplant
  • Active treatment for acute cellular rejection, in kidney transplant recipients
  • Recent cardiovascular event (hospitalization for myocardial infarction, stroke, congestive heart failure (NYHA class ≥III or ejection fraction ≤30%) within 3 months or uncontrolled cardiac arrhythmias (e.g. ventricular arrhythmia, supraventricular tachycardia and bradyarrhythmia)
  • History of liver cirrhosis
  • Chronic obstructive pulmonary disease or asthma requiring daily medication
  • History of recurring blood clotting disorder (thromboembolism: pulmonary embolism, deep venous thrombosis) requiring chronic anticoagulation therapy
  • Pregnancy
  • Unwilling to use contraception for at least 2 months after MSC infusion if sexually active and able to become pregnant or father a child.
  • Active malignancy
  • Active infection (e.g. systemic or specific organ involvement such as pneumonia or osteomyelitis; in kidney transplant recipients, active BK nephropathy)
  • Recent COVID-19 infection, within the last 1 month
  • History of hepatitis B or C (without cure), or HIV infection
  • History of allergic reaction to cellular products (i.e. 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
  • Anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits.
  • Inability to give informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic — Jacksonville

Publications

  • Hickson LJ, Eirin A, Lerman LO. Challenges and opportunities for stem cell therapy in patients with chronic kidney disease. Kidney Int. 2016 Apr;89(4):767-78. doi: 10.1016/j.kint.2015.11.023. Epub 2016 Jan 26. PMID 26924058
  • Hickson LJ, Herrmann SM, McNicholas BA, Griffin MD. Progress toward the Clinical Application of Mesenchymal Stromal Cells and Other Disease-Modulating Regenerative Therapies: Examples from the Field of Nephrology. Kidney360. 2021 Mar;2(3):542-557. doi: 10.34067/KID.0005692020. PMID 34316720
  • 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
  • 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

Identifiers

NCT: NCT06752577 · 24-011356

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗