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 | Recruiting DMC FDA Drug

• 1 other identifier: 24-011356
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

stem cells; regenerative medicine; mesenchymal stromal cells; kidney disease; kidney failure; diabetic kidney disease

Outcome Measures

Primary Outcomes (1)

• Adverse events and/or serious adverse events

  Number of adverse events and/or serious adverse events associated with mesenchymal stem cell (MSC) intervention

  6 months after each MSC infusion

Study Arms (1)

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)

Interventions

Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC) DRUG

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.

MSC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Ossium Health, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Related Publications (4)

• Hickson LJ, Eirin A, Lerman LO. Challenges and opportunities for stem cell therapy in patients with chronic kidney disease. Kidney Int. 2016 Apr;89(4):767-78. doi: 10.1016/j.kint.2015.11.023. Epub 2016 Jan 26.

  PMID: 26924058 BACKGROUND

• Hickson LJ, Herrmann SM, McNicholas BA, Griffin MD. Progress toward the Clinical Application of Mesenchymal Stromal Cells and Other Disease-Modulating Regenerative Therapies: Examples from the Field of Nephrology. Kidney360. 2021 Mar;2(3):542-557. doi: 10.34067/KID.0005692020.

  PMID: 34316720 BACKGROUND

• Patel HA, Wang J, Zinn CJ, Learmonth M, Lerman LO, Wolfram J, Hickson LJ. Fortifying the Diabetic Kidney Disease Treatment Armamentarium: Multitarget Senotherapeutic and Regenerative Strategies. J Am Soc Nephrol. 2025 May 7;36(8):1655-1658. doi: 10.1681/ASN.0000000754. No abstract available.

  PMID: 40333016 DERIVED

• Andrews TD, Day GS, Irani SR, Kanekiyo T, Hickson LJ. Uremic Toxins, CKD, and Cognitive Dysfunction. J Am Soc Nephrol. 2025 Jun 1;36(6):1208-1226. doi: 10.1681/ASN.0000000675. Epub 2025 Feb 26.

  PMID: 40009460 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases; Renal Insufficiency; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• LaTonya J Hickson, MD

  Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna K Lawson

CONTACT

507-255-7975; lawson.donna3@mayo.edu

Mayo Clinic Regenerative Nephrology Program

CONTACT

regenerativenephrology@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chair of Nephrology and Hypertension

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 30, 2024
• Study Start: December 22, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)