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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Diabetic Nephropathies Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Chronic Kidney Disease Diabetic Nephropathy Type 2 Kidney Failure Kidney Insufficiency Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-arterially Delivered Autologous Mesenchymal Stem/Stromal Cell Therapy in Patients With Diabetic Kidney Disease: A Phase I Study
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Lower Dose MSC
This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Lower Dose.
 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
Experimental: Higher Dose MSC
This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Higher Dose
 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


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Baseline through Month 15 ]
    The number of Adverse Events associated with MSC intervention per treatment arm

  2. Adverse Events [ Time Frame: Baseline through Month 15 ]
    The percentage of Adverse Events associated with MSC intervention per treatment arm


Secondary Outcome Measures :
  1. Kidney Function [ Time Frame: baseline, month 6 ]
    Change in measured glomerular filtration rate (mGFR). Measured as mL/min/BSA

  2. Kidney Function [ Time Frame: pretreatment, month 12 ]
    Change in estimated glomerular filtration rate (eGFR) slope. Measured as mL/min/1.73m^2/month


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840343


Contacts
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Contact: B Tietje 507-255-0401 tietje.beverly@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: B Tietje    507-255-0401    tietje.beverly@mayo.edu   
Principal Investigator: LaTonya J Hickson, MD         
Sponsors and Collaborators
Mayo Clinic
Regenerative Medicine Minnesota
Investigators
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Principal Investigator: LaTonya J Hickson, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: LaTonya J. Hickson, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03840343    
Other Study ID Numbers: 18-002423
RMM 091718 CT 001 ( Other Grant/Funding Number: Regenerative Medicine Minnesota )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LaTonya J. Hickson, Mayo Clinic:
Mesenchymal Stem Cell
Mesencymal Stromal Cell
Stem Cell
 Regenerative Medicine
Cell therapy
Rejuvenation
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Diabetes Complications