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Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03840343
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 26, 2021
Sponsor:
Collaborator:
Regenerative Medicine Minnesota
Information provided by (Responsible Party):
LaTonya J. Hickson, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE February 11, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 26, 2021
Actual Study Start Date  ICMJE October 23, 2019
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2019)
  • Adverse Events [ Time Frame: Baseline through Month 15 ]
    The number of Adverse Events associated with MSC intervention per treatment arm
  • Adverse Events [ Time Frame: Baseline through Month 15 ]
    The percentage of Adverse Events associated with MSC intervention per treatment arm
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • Kidney Function [ Time Frame: baseline, month 6 ]
    Change in measured glomerular filtration rate (mGFR). Measured as mL/min/BSA
  • Kidney Function [ Time Frame: pretreatment, month 12 ]
    Change in estimated glomerular filtration rate (eGFR) slope. Measured as mL/min/1.73m^2/month
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease
Official Title  ICMJE Intra-arterially Delivered Autologous Mesenchymal Stem/Stromal Cell Therapy in Patients With Diabetic Kidney Disease: A Phase I Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Kidney Disease
  • Diabetic Nephropathies
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1
  • Chronic Kidney Disease
  • Diabetic Nephropathy Type 2
  • Kidney Failure
  • Kidney Insufficiency
Intervention  ICMJE
  • Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose
    Two MSC infusions of 2.5x10^5 cells/kg at time zero and three months; single kidney, intra-arterial delivery
  • Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose
    Two MSC infusions of 5.0x10^5 cells/kg at time zero and three months; single kidney, intra-arterial delivery
Study Arms  ICMJE
  • Experimental: Lower Dose MSC
    This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Lower Dose.
    Intervention: Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose
  • Experimental: Higher Dose MSC
    This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Higher Dose
    Intervention: Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: B Tietje 507-255-0401 tietje.beverly@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03840343
Other Study ID Numbers  ICMJE 18-002423
RMM 091718 CT 001 ( Other Grant/Funding Number: Regenerative Medicine Minnesota )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LaTonya J. Hickson, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Regenerative Medicine Minnesota
Investigators  ICMJE
Principal Investigator: LaTonya J Hickson, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP