Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients with Chronic Kidney Disease (CKD)

Recruiting

• Conditions: Chronic Kidney Diseases
• Interventions: Drug: Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC)

• Registration Number: NCT06752577
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this treatment protocol is to treat an intermediate-sized population with chronic kidney disease (CKD). Protocol includes a single treatment with intravenously-delivered allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) infusion. Individuals will have subsequent follow up for safety evaluations.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-22
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study First Posted: 2024-12-30
• Last Update Posted: 2024-12-30
• Primary Completion: 2030-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single dose	Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC)	Individuals with chronic kidney disease will receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) in a single intravenous infusion.

Primary Outcome Measures

Name	Time	Method
Adverse events and/or serious adverse events	6 months	Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States