Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease

NCT03840343 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: 18-002423RMM 091718 CT 001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Mesenchymal Stem Cell; Mesencymal Stromal Cell; Stem Cell; Regenerative Medicine; Cell therapy; Rejuvenation

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  The number of Adverse Events associated with MSC intervention per treatment arm

  Baseline through Month 15

• Adverse Events

  The percentage of Adverse Events associated with MSC intervention per treatment arm

  Baseline through Month 15

Secondary Outcomes (2)

• Kidney Function

  baseline, month 6

• Kidney Function

  pretreatment, month 12

Study Arms (2)

Lower Dose MSC

EXPERIMENTAL

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

Higher Dose MSC

EXPERIMENTAL

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

Interventions

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

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

Lower Dose MSC

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

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

Higher Dose MSC

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Regenerative Medicine Minnesota: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Alatta LS, Elhusseiny KM, Dietz AB, Herrmann SM, Lorenz EC, Lawson DK, Bendel EC, Reisenauer CJ, Misra S, Vaughan LE, Lerman LO, Hickson LJ. Intraarterial Autologous Mesenchymal Stem Cell Therapy for Diabetic Kidney Disease. Kidney Int Rep. 2025 Aug 6;10(10):3656-3660. doi: 10.1016/j.ekir.2025.07.042. eCollection 2025 Oct. No abstract available.

  PMID: 41141513 BACKGROUND

• Patel HA, Wang J, Zinn CJ, Learmonth M, Lerman LO, Wolfram J, Hickson LJ. Fortifying the Diabetic Kidney Disease Treatment Armamentarium: Multitarget Senotherapeutic and Regenerative Strategies. J Am Soc Nephrol. 2025 May 7;36(8):1655-1658. doi: 10.1681/ASN.0000000754. No abstract available.

  PMID: 40333016 BACKGROUND

Related Links

• Diabetic Kidney Disease Stem Cell Trial - Mayo Clinic
• Video of Stem Cell Trial in Diabetic Kidney Disease - Regenerative Medicine Minnesota

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Renal Insufficiency, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• LaTonya J Hickson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: October 23, 2019
• Primary Completion: August 4, 2020
• Study Completion: August 4, 2020
• Last Updated: August 17, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)