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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Diseases
• Kidney Transplant

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-22
• Primary completion: 2030-12-31
• Completion: 2031-12-31
• First posted: 2024-12-30
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study