AzTrials
AzTrials

Diabetic Kidney DiseasePhase 1NCT03840343

Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease

A Phase 1 study testing Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose and Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose in people with Diabetic Kidney Disease and Diabetic Nephropathies, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 45 to 75 years
What is being tested?
Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose and Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
23 Oct 2019to 4 Aug 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Hemoglobin A1c≥11%
  • Pregnancy
  • Active malignancy
  • Active Immunosuppression therapy
  • Kidney transplantation history
  • Concomitant glomerulonephritis
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Intra-arterially Delivered Autologous Mesenchymal Stem/Stromal Cell Therapy in Patients With Diabetic Kidney Disease: A Phase I Study

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).

Read the 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.

Being tested
Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose, Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose
Keywords
Mesenchymal Stem Cell, Mesencymal Stromal Cell, Stem Cell, Regenerative Medicine, Cell therapy, Rejuvenation
Medical subject headings
Diabetic Nephropathies, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Renal Insufficiency, Chronic, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

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

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

Study groups in NCT03840343
Study groupRoleWhat they receive
Lower Dose MSCExperimentalThis arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Lower Dose.
Receives: Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose
Higher Dose MSCExperimentalThis arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Higher Dose
Receives: Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

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

    Measured: Baseline through Month 15

  2. Adverse Events

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

    Measured: Baseline through Month 15

Secondary outcomes (2)

  1. Kidney Function

    Change in measured glomerular filtration rate (mGFR). Measured as mL/min/BSA

    Measured: baseline, month 6

  2. Kidney Function

    Change in estimated glomerular filtration rate (eGFR) slope. Measured as mL/min/1.73m^2/month

    Measured: pretreatment, month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start23 Oct 2019
  3. Primary completion4 Aug 2020
  4. Study completion4 Aug 2020

Why it stopped: Principal Investigator relocation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03840343
Sponsor's protocol ID
18-002423
Other IDs
RMM 091718 CT 001
Status last verified
Apr 2023
First submitted
11 Feb 2019
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40333016

  • 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.

    PubMed 41141513

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose and Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose in people with Diabetic Kidney Disease and Diabetic Nephropathies, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Principal Investigator relocation). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Baseline through Month 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03840343, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in