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

January 26, 2026 updated by: LaTonya J. Hickson, Mayo Clinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients With Chronic Kidney Disease (CKD) or Kidney Transplant losing function

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MSC
Individuals with chronic kidney disease (including a kidney transplant that is losing function) will receive allogeneic, bone marrow-derived mesenchymal stem cells (MSC). Two administration routes will be used. Repeat dosing is allowed.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events and/or serious adverse events
Time Frame: 6 months after each MSC infusion
Number of adverse events and/or serious adverse events associated with mesenchymal stem cell (MSC) intervention
6 months after each MSC infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Ossium Health, Inc.

Investigators

  • Principal Investigator: LaTonya J Hickson, MD, Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

December 22, 2024

First Submitted That Met QC Criteria

December 22, 2024

First Posted (Actual)

December 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-011356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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