Safety And Tolerability Of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) In Real World Scenarios Of Patients With Chronic Kidney Disease (CKD)

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m^2

  • Hemoglobin A1c of ≤9%, if diabetes mellitus present

  • 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 (hemodialysis, peritoneal dialysis, or kidney transplantation)

  • Active immunosuppression therapy (including prednisone ≥10 mg daily)

  • Kidney transplantation history

  • Solid organ transplantation history

  • 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)

  • 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

  • Patients anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits.

  • Inability to give informed consent


Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 01/12/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Latonya Hickson, M.D.

Open for enrollment

Contact information:

Donna Lawson CCRP

(507) 255-7975

Lawson.Donna3@mayo.edu

More information

Publications

  • Drawing from basic knowledge of stem-cell biology, embryonic development, wound healing, and aging, regenerative medicine seeks to develop therapeutic strategies that complement or replace conventional treatments by actively repairing diseased tissue or generating new organs and tissues. Among the various clinical-translational strategies within the field of regenerative medicine, several can be broadly described as promoting disease resolution indirectly through local or systemic interactions with a patient's cells, without permanently integrating or directly forming new primary tissue. In this review, we focus on such therapies, which we term disease-modulating regenerative therapies (DMRT), and on the extent to which they have been translated into the clinical arena in four distinct areas of nephrology: renovascular disease (RVD), sepsis-associated AKI (SA-AKI), diabetic kidney disease (DKD), and kidney transplantation (KTx). As we describe, the DMRT that has most consistently progressed to human clinical trials for these indications is mesenchymal stem/stromal cells (MSCs), which potently modulate ischemic, inflammatory, profibrotic, and immune-mediated tissue injury through diverse paracrine mechanisms. In KTx, several early-phase clinical trials have also tested the potential for -expanded regulatory immune cell therapies to promote donor-specific tolerance and prevent or resolve allograft injury. Other promising DMRT, including adult stem/progenitor cells, stem cell-derived extracellular vesicles, and implantable hydrogels/biomaterials remain at varying preclinical stages of translation for these renal conditions. To date (2021), no DMRT has gained market approval for use in patients with RVD, SA-AKI, DKD, or KTx, and clinical trials demonstrating definitive, cost-effective patient benefits are needed. Nonetheless, exciting progress in understanding the disease-specific mechanisms of action of MSCs and other DMRT, coupled with increasing knowledge of the pathophysiologic basis for renal-tissue injury and the experience gained from pioneering early-phase clinical trials provide optimism that influential, regenerative treatments for diverse kidney diseases will emerge in the years ahead. Read More on PubMed
  • Chronic kidney disease (CKD) is a global health care burden affecting billions of individuals worldwide. The kidney has limited regenerative capacity from chronic insults, and for the most common causes of CKD, no effective treatment exists to prevent progression to end-stage kidney failure. Therefore, novel interventions, such as regenerative cell-based therapies, need to be developed for CKD. Given the risk of allosensitization, autologous transplantation of cells to boost regenerative potential is preferred. Therefore, verification of cell function and vitality in CKD patients is imperative. Two cell types have been most commonly applied in regenerative medicine. Endothelial progenitor cells contribute to neovasculogenesis primarily through paracrine angiogenic activity and partly by differentiation into mature endothelial cells in situ. Mesenchymal stem cells also exert paracrine effects, including proangiogenic, anti-inflammatory, and antifibrotic activity. However, in CKD, multiple factors may contribute to reduced cell function, including older age, coexisting cardiovascular disease, diabetes, chronic inflammatory states, and uremia, which may limit the effectiveness of an autologous cell-based therapy approach. This Review highlights current knowledge on stem and progenitor cell function and vitality, aspects of the uremic milieu that may serve as a barrier to therapy, and novel methods to improve stem cell function for potential transplantation. Read More on PubMed