- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03840343
Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease
April 3, 2023 updated by: LaTonya J. Hickson, Mayo Clinic
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).
Study Overview
Status
Terminated
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Donna Lawson
- Phone Number: 507-255-7975
- Email: Lawson.Donna3@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lower Dose MSC
This arm will receive 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
|
Two MSC infusions of 5.0x10^5 cells/kg at time zero and three months; single kidney, intra-arterial delivery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: Baseline through Month 15
|
The number of Adverse Events associated with MSC intervention per treatment arm
|
Baseline through Month 15
|
Adverse Events
Time Frame: Baseline through Month 15
|
The percentage of Adverse Events associated with MSC intervention per treatment arm
|
Baseline through Month 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kidney Function
Time Frame: baseline, month 6
|
Change in measured glomerular filtration rate (mGFR).
Measured as mL/min/BSA
|
baseline, month 6
|
Kidney Function
Time Frame: pretreatment, month 12
|
Change in estimated glomerular filtration rate (eGFR) slope.
Measured as mL/min/1.73m^2/month
|
pretreatment, month 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: LaTonya J Hickson, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 23, 2019
Primary Completion (Actual)
August 4, 2020
Study Completion (Actual)
August 4, 2020
Study Registration Dates
First Submitted
February 11, 2019
First Submitted That Met QC Criteria
February 11, 2019
First Posted (Actual)
February 15, 2019
Study Record Updates
Last Update Posted (Actual)
April 5, 2023
Last Update Submitted That Met QC Criteria
April 3, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Urologic Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Kidney Diseases
- Renal Insufficiency, Chronic
- Diabetes Mellitus, Type 1
- Diabetic Nephropathies
- Renal Insufficiency
Other Study ID Numbers
- 18-002423
- RMM 091718 CT 001 (Other Grant/Funding Number: Regenerative Medicine Minnesota)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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