Stem Cell Therapy for Chronic Kidney Disease

November 29, 2023 updated by: LaTonya J. Hickson

Allogeneic Mesenchymal Stem Cell Therapy in Patients With Chronic Kidney Disease: A Phase I Study

The purpose of this study is to assess the safety and tolerability of allogeneic mesenchymal stem / stromal cell therapy in individuals with chronic kidney disease.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

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

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Renin-angiotensin-aldosterone system (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 9g/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 disease) include: ANCA associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance.
  • Nephrotic syndrome defined as proteinuria greater than 3.5g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5g/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 10mg daily)
  • Kidney transplantation history
  • Solid organ transplantation history
  • Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure) within 6 months or uncontrolled cardiac arrhythmias
  • Liver cirrhosis
  • Chronic obstructive pulmonary disease, asthma
  • History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis)
  • Pregnancy
  • Active malignancy
  • Active infection
  • Active hepatitis B or C, or HIV infection
  • History of allergic reaction to cellular products (ie. 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

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Arm 1
Subjects with chronic kidney disease will receive allogeneic adipose tissue-derived mesenchymal stem cells (MSC) in two intravenous infusions of 75x10^6 cells at day 0 and month 3.
Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions
Two MSC infusions of 75x10^6 cells at time zero and three months; intravenous delivery
Experimental: Dose Arm 2
Subjects with chronic kidney disease will receive a single intravenous infusion of allogeneic adipose tissue-derived mesenchymal stem cells (MSC) of 150x10^6 cells at day 0.
Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion
Single MSC infusion of 150x10^6 cells at time zero; intravenous delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events and/or serious adverse events
Time Frame: 22 months
Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention
22 months

Collaborators and Investigators

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

Sponsor

LaTonya J. Hickson

Investigators

  • Principal Investigator: LaTonya Hickson, MD, Mayo Clinic

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.

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)

October 7, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-008380

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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