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)
| NCT ID | NCT06752577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Chronic Kidney Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-12-22 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75 participants in total. It began in 2024-12-22 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
LaTonya J Hickson, MD
PRINCIPAL INVESTIGATOR
Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida
Frequently Asked Questions
Who can join the NCT06752577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06752577 currently recruiting?
Yes, NCT06752577 is actively recruiting participants. Contact the research team at lawson.donna3@mayo.edu for enrollment information.
Where is the NCT06752577 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT06752577 clinical trial?
NCT06752577 is sponsored by Mayo Clinic. The principal investigator is LaTonya J Hickson, MD at Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida. The trial plans to enroll 75 participants.
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