Intra-arterially Delivered Autologous Mesenchymal Stem/Stromal Cell Therapy in Patients With Diabetic Kidney Disease: A Phase I Study
Overview
- Phase
- Phase 1
- Intervention
- Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose
- Conditions
- Diabetic Kidney Disease
- Sponsor
- Mayo Clinic
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Adverse Events
- Status
- Terminated
- Last Updated
- 8 months ago
Overview
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.
Investigators
LaTonya J. Hickson
Principal Investigator
Mayo Clinic
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
Arms & Interventions
Lower Dose MSC
This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Lower Dose.
Intervention: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose
Higher Dose MSC
This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Higher Dose
Intervention: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose
Outcomes
Primary Outcomes
Adverse Events
Time Frame: Baseline through Month 15
The percentage of Adverse Events associated with MSC intervention per treatment arm
Secondary Outcomes
- Kidney Function(pretreatment, month 12)