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Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease

Primary Purpose

Diabetic Kidney Disease, Diabetic Nephropathies, Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose
Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease focused on measuring Mesenchymal Stem Cell, Mesencymal Stromal Cell, Stem Cell, Regenerative Medicine, Cell therapy, Rejuvenation

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diabetes mellitus (on anti-diabetes drug therapy)
  • Age 45-75 years
  • eGFR 25-55 ml/min/1.73m2 at time of consent with: a) eGFR decline of 5 ml/min over 18 months or 10 ml/min over 3 years or b) an intermediate or high 5-year risk of progression to end-stage kidney failure (dialysis or transplant) based on the validated Tangri 4-variable (age, sex, eGFR, urinary albumin-creatinine ratio) kidney failure risk equation https://kidneyfailurerisk.com/
  • Primary cause of kidney disease is diabetes without suspicion of concomitant kidney disease beyond hypertension
  • Spot urine albumin:creatinine ≥30 mg/g unless on RAAS inhibition
  • Ability to give informed consent

Exclusion Criteria:

  • Hemoglobin A1c≥11%
  • Pregnancy
  • Active malignancy
  • Active Immunosuppression therapy
  • Kidney transplantation history
  • Concomitant glomerulonephritis
  • Nephrotic syndrome
  • Solid organ transplantation history
  • Autosomal dominant or recessive polycystic kidney disease
  • Known renovascular disease
  • Kidney failure (hemodialysis, peritoneal dialysis, or kidney transplantation)
  • Active tobacco use
  • Body weight >150 kg or BMI>50
  • Uncontrolled hypertension: Systolic blood pressure (SBP) >180 mmHg despite antihypertensive therapy
  • Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure within 6 months
  • Evidence of hepatitis B or C, or HIV infection, chronic
  • Anticoagulation therapy requiring heparin bridging for procedures.
  • History of methicillin-resistant staphylococcus aureus colonization
  • Recent plastic, chemical or surgical manipulation of adipose tissue for cosmetic purposes within 6 months
  • Inability to give informed consent
  • Potentially unreliable subjects and those judged by the investigator to be unsuitable for the study

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lower Dose MSC

Higher Dose MSC

Arm Description

This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Lower Dose.

This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Higher Dose

Outcomes

Primary Outcome Measures

Adverse Events
The number of Adverse Events associated with MSC intervention per treatment arm
Adverse Events
The percentage of Adverse Events associated with MSC intervention per treatment arm

Secondary Outcome Measures

Kidney Function
Change in measured glomerular filtration rate (mGFR). Measured as mL/min/BSA
Kidney Function
Change in estimated glomerular filtration rate (eGFR) slope. Measured as mL/min/1.73m^2/month

Full Information

First Posted
February 11, 2019
Last Updated
April 3, 2023
Sponsor
Mayo Clinic
Collaborators
Regenerative Medicine Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03840343
Brief Title
Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease
Official Title
Intra-arterially Delivered Autologous Mesenchymal Stem/Stromal Cell Therapy in Patients With Diabetic Kidney Disease: A Phase I Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator relocation
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
August 4, 2020 (Actual)
Study Completion Date
August 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Regenerative Medicine Minnesota

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 Researchers will assess the safety, tolerability, dosing effect, and early signals of efficacy of intra-arterially delivered autologous (from self) adipose (fat) tissue-derived mesenchymal stem/stromal cells (MSC) in patients with progressive diabetic kidney disease (DKD).
Detailed Description
This is a single center, open-label dose-escalating study assessing safety, tolerability, dosing effect, and early signals of efficacy of intra-arterially delivered autologous (from self) adipose tissue-derived mesenchymal stem/stromal cells (MSC) in 30 patients with progressive diabetic kidney disease (DKD). DKD will be defined as chronic kidney disease (CKD; estimated glomerular filtration rate; eGFR<60 mL/min/1.73m2) in the setting of diabetes mellitus (type 2; on anti-diabetes therapy) without overt etiologies of CKD beyond concomitant hypertension. Progressive DKD will be considered as eGFR 25-55 ml/min/1.73m2 with a) eGFR decline of 5 ml/min over 18 months or 10 ml/min over 3 years or b) an intermediate or high 5-year risk of progression to end-stage kidney failure (dialysis or transplant) based on the validated Tangri 4-variable (age, sex, eGFR, urinary albumin-creatinine ratio) kidney failure risk equation. Fifteen subjects will be placed in one of two cell dosage arms in a parallel design with single-kidney MSC administration at Day 0 and Month 3. Subjects will be followed a total of 15 months from time of initial cell administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease, Diabetic Nephropathies, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Chronic Kidney Disease, Diabetic Nephropathy Type 2, Kidney Failure, Kidney Insufficiency
Keywords
Mesenchymal Stem Cell, Mesencymal Stromal Cell, Stem Cell, Regenerative Medicine, Cell therapy, Rejuvenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lower Dose MSC
Arm Type
Experimental
Arm Description
This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Lower Dose.
Arm Title
Higher Dose MSC
Arm Type
Experimental
Arm Description
This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Higher Dose
Intervention Type
Biological
Intervention Name(s)
Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose
Intervention Description
Two MSC infusions of 2.5x10^5 cells/kg at time zero and three months; single kidney, intra-arterial delivery
Intervention Type
Biological
Intervention Name(s)
Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose
Intervention Description
Two MSC infusions of 5.0x10^5 cells/kg at time zero and three months; single kidney, intra-arterial delivery
Primary Outcome Measure Information:
Title
Adverse Events
Description
The number of Adverse Events associated with MSC intervention per treatment arm
Time Frame
Baseline through Month 15
Title
Adverse Events
Description
The percentage of Adverse Events associated with MSC intervention per treatment arm
Time Frame
Baseline through Month 15
Secondary Outcome Measure Information:
Title
Kidney Function
Description
Change in measured glomerular filtration rate (mGFR). Measured as mL/min/BSA
Time Frame
baseline, month 6
Title
Kidney Function
Description
Change in estimated glomerular filtration rate (eGFR) slope. Measured as mL/min/1.73m^2/month
Time Frame
pretreatment, month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes mellitus (on anti-diabetes drug therapy) Age 45-75 years eGFR 25-55 ml/min/1.73m2 at time of consent with: a) eGFR decline of 5 ml/min over 18 months or 10 ml/min over 3 years or b) an intermediate or high 5-year risk of progression to end-stage kidney failure (dialysis or transplant) based on the validated Tangri 4-variable (age, sex, eGFR, urinary albumin-creatinine ratio) kidney failure risk equation https://kidneyfailurerisk.com/ Primary cause of kidney disease is diabetes without suspicion of concomitant kidney disease beyond hypertension Spot urine albumin:creatinine ≥30 mg/g unless on RAAS inhibition Ability to give informed consent Exclusion Criteria: Hemoglobin A1c≥11% Pregnancy Active malignancy Active Immunosuppression therapy Kidney transplantation history Concomitant glomerulonephritis Nephrotic syndrome Solid organ transplantation history Autosomal dominant or recessive polycystic kidney disease Known renovascular disease Kidney failure (hemodialysis, peritoneal dialysis, or kidney transplantation) Active tobacco use Body weight >150 kg or BMI>50 Uncontrolled hypertension: Systolic blood pressure (SBP) >180 mmHg despite antihypertensive therapy Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure within 6 months Evidence of hepatitis B or C, or HIV infection, chronic Anticoagulation therapy requiring heparin bridging for procedures. History of methicillin-resistant staphylococcus aureus colonization Recent plastic, chemical or surgical manipulation of adipose tissue for cosmetic purposes within 6 months Inability to give informed consent Potentially unreliable subjects and those judged by the investigator to be unsuitable for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LaTonya J Hickson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials/cls-20438442
Description
Diabetic Kidney Disease Stem Cell Trial - Mayo Clinic
URL
https://regenerativemedicineblog.mayoclinic.org/2018/10/26/stem-cells-and-chronic-kidney-disease/
Description
Stem Cells and Kidney Disease - Mayo Clinic
URL
https://youtu.be/DQ7r3UFMDN8
Description
Video of Stem Cell Trial in Diabetic Kidney Disease - Regenerative Medicine Minnesota

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Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease

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