Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)
NCT ID: NCT06752577
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
75 participants
OBSERVATIONAL
2024-12-22
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MSC
Individuals with chronic kidney disease (including a kidney transplant that is losing function) will receive allogeneic, bone marrow-derived mesenchymal stem cells (MSC). Two administration routes will be used. Repeat dosing is allowed.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ossium Health, Inc.
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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LaTonya J. Hickson
Division Chair of Nephrology and Hypertension
Principal Investigators
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LaTonya J Hickson, MD
Role: PRINCIPAL_INVESTIGATOR
Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida
Locations
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Mayo Clinic
Jacksonville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Related Links
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Other Identifiers
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24-011356
Identifier Type: -
Identifier Source: org_study_id
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