Using stem cells to treat chronic kidney disease
Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)
This study is testing whether a single infusion of stem cells can be safely given to people with chronic kidney disease to see how well they tolerate it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06752577 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and tolerability of allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) in patients with chronic kidney disease (CKD). Participants will receive a single intravenous infusion of BM-MSCs and will be monitored for safety outcomes over time. The study focuses on a real-world population with CKD, specifically targeting those with an estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73m². Follow-up assessments will help determine the treatment's safety profile in this patient group.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with chronic kidney disease and an eGFR of less than 60 ml/min/1.73m².
Not a fit: Patients requiring ongoing kidney replacement therapy or those with a history of solid organ transplantation are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with chronic kidney disease, potentially improving kidney function and overall health.
How similar studies have performed: While the use of stem cells in kidney disease is an emerging field, this specific approach has not been extensively tested in prior studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: LaTonya J Hickson, MD — Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida
- Study coordinator: Donna K Lawson
- Email: lawson.donna3@mayo.edu
- Phone: 507-255-7975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.