Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-23

Study Completion Date

2020-08-04

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Diabetic Kidney Disease Diabetic Nephropathies Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Chronic Kidney Disease Diabetic Nephropathy Type 2 Kidney Failure Kidney Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lower Dose MSC

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

Group Type EXPERIMENTAL

Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose

Intervention Type BIOLOGICAL

Two MSC infusions of 2.5x10\^5 cells/kg at time zero and three months; single kidney, intra-arterial delivery

Higher Dose MSC

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

Group Type EXPERIMENTAL

Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose

Intervention Type BIOLOGICAL

Two MSC infusions of 5.0x10\^5 cells/kg at time zero and three months; single kidney, intra-arterial delivery

Interventions

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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

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No