Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease

Phase 1

Terminated

• Conditions: Kidney Failure; Chronic Kidney Disease; Diabetic Nephropathy Type 2; Diabetic Kidney Disease; Diabetes Mellitus, Type 1; Diabetic Nephropathies; Diabetes Mellitus, Type 2; Kidney Insufficiency
• Interventions: Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose; Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose

• Registration Number: NCT03840343
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-15
• Study Start: 2019-10-23
• Primary Completion: 2020-08-04
• Study Completion: 2020-08-04
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower Dose MSC	Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose	This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Lower Dose.
Higher Dose MSC	Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose	This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Higher Dose

Primary Outcome Measures

Name	Time	Method
Adverse Events	Baseline through Month 15	The percentage of Adverse Events associated with MSC intervention per treatment arm

Secondary Outcome Measures

Name	Time	Method
Kidney Function	pretreatment, month 12	Change in estimated glomerular filtration rate (eGFR) slope. Measured as mL/min/1.73m\^2/month

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States