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Идёт набор 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)

— Наблюдательное Chronic Kidney Diseases Kidney Transplant

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC).
Кому может быть актуально
Состояния в реестре: Chronic Kidney Diseases, Kidney Transplant. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Препарат 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Mayo Clinic — Jacksonville

Публикации

  • 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

Идентификаторы

NCT: NCT06752577 · 24-011356

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗