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 : March 15, 2022
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Condition or disease | Intervention/treatment | Phase |
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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 | Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose | Phase 1 |
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 |

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

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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 |
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

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
Contact: Donna Lawson | 507-255-7975 | Lawson.Donna3@mayo.edu |
United States, Minnesota | |
Mayo Clinic in Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Donna Lawson 507-255-7975 Lawson.Donna3@mayo.edu | |
Principal Investigator: LaTonya J Hickson, MD |
Principal Investigator: | LaTonya J Hickson, MD | Mayo Clinic |
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: | March 15, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Mesenchymal Stem Cell Mesencymal Stromal Cell Stem Cell |
Regenerative Medicine Cell therapy Rejuvenation |
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 |