Stem Cell Therapy for Chronic Kidney Disease
Primary Purpose
Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion
Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions
Sponsored by
About this trial
This is an interventional other trial for Chronic Kidney Diseases focused on measuring Stem cell, mesenchymal stem cell, mesenchymal stromal cell, diabetes mellitus, diabetic nephropathy, diabetic kidney disease, kidney, GFR
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic FloridaRecruiting
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose Arm 1
Dose Arm 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Adverse events and/or serious adverse events
Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04869761
Brief Title
Stem Cell Therapy for Chronic Kidney Disease
Official Title
Allogeneic Mesenchymal Stem Cell Therapy in Patients With Chronic Kidney Disease: A Phase I Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
LaTonya J. Hickson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Mellitus, Diabetic Nephropathies
Keywords
Stem cell, mesenchymal stem cell, mesenchymal stromal cell, diabetes mellitus, diabetic nephropathy, diabetic kidney disease, kidney, GFR
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose Arm 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion
Intervention Description
Single MSC infusion of 150x10^6 cells at time zero; intravenous delivery
Intervention Type
Drug
Intervention Name(s)
Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions
Intervention Description
Two MSC infusions of 75x10^6 cells at time zero and three months; intravenous delivery
Primary Outcome Measure Information:
Title
Adverse events and/or serious adverse events
Description
Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention
Time Frame
22 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Federico Simon
Phone
(904) 953-4205
Email
Simon.FedericoRey@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas George
Phone
(904) 953-3880
Email
George.Andreas@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LaTonya Hickson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LaTonya Hickson
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Stem Cell Therapy for Chronic Kidney Disease
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