Stem Cell Therapy for Chronic Kidney Disease

Overview

About this study

The purpose of this study is to assess the safety, tolerability, optimal dosing, effectiveness signals reflecting kidney repair, and markers of mesenchymal stem cells (MSC) function that relate to response to allogenenic adipose tissue-derived MSC in patients with Chronic Kidney Disease (CKD).

 

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:

  • Age 30-80 years.
  • Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m^2.
  • Spot urine albumin:creatinine ≥ 30 mg/g unless on RAAS inhibition.
  • Ability to give informed consent.

Exclusion Criteria:

  • Hemoglobin A1c greater than or equal to 11% (in individuals with diabetes mellitus).
  • Anemia (hemoglobin less than 9 g/dL).
  • Body weight greater than 150 kg or BMI greater than 50.
  • Uncontrolled hypertension: sustained systolic blood pressure (SBP) greater than 155 mmHg at screening exam (a maximum of 3 screening visits will be allowed for demonstration of blood pressure control).
  • Chronic hypotension: sustained SBP less than 85 mmHg at screening exam.
  • Glomerulonephritis not in partial or complete remission for 6 months (or estimated/ measured proteinuria greater than 10 grams/day),
  • Active glomerulonephritis (glomerular diseases) include ANCA-associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance.
  • Nephrotic syndrome defined as proteinuria greater than 3.5 g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5 g/L) and edema. Autosomal dominant or recessive polycystic kidney disease.
  • Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation).
  • Active immunosuppression therapy (including prednisone greater than or equal to 10 mg daily).
  • Kidney transplantation history.
  • Solid organ transplantation history.
  • Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure) within 6 months or uncontrolled cardiac arrhythmias.
  • History of liver cirrhosis.
  • Chronic obstructive pulmonary disease or asthma requiring daily medication.
  • History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis).
  • Pregnancy.
  • Active malignancy.
  • Active infection.
  • 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.
  • Subjects anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits.
  • Inability or unwilling to have magnetic resonance imaging (MRI) or computed tomography (CT) studies.
  • Inability to give informed consent.

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.

Closed for enrollment

Contact information:

Latonya Hickson M.D.

(904) 956-8989

Hickson.Latonya@mayo.edu

More information

Publications

Publications are currently not available