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Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease

NCT03840343 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-08-17

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Regenerative Medicine Minnesota

    collaborator UNKNOWN

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • LaTonya J Hickson, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2020-08-04
Completion
2020-08-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03840343 on ClinicalTrials.gov