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

NCT06752577 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2026-01-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ossium Health, Inc.

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • LaTonya J Hickson, MD · Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-22
Primary Completion
2030-12-31
Completion
2031-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06752577 on ClinicalTrials.gov