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Treatment of Chronic Renal Failure With Adipose Tissue-derived Mesenchymal Stem Cells

This study is currently recruiting participants.
Verified October 2017 by The Affiliated Hospital of Xuzhou Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03321942
First Posted: October 26, 2017
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The Affiliated Hospital of Xuzhou Medical University
  Purpose
To investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(AMSCs) and its treatment effects on chronic renal failure.

Condition Intervention
Mesenchymal Stem Cells Chronic Kidney Diseases Renal Interstitial Fibrosis Drug: Treatment group Drug: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Biological Characteristics of Adipose Tissue-derived Mesenchymal Stem Cells and Its Role in the Treatment of Chronic Renal Failure

Resource links provided by NLM:


Further study details as provided by The Affiliated Hospital of Xuzhou Medical University:

Primary Outcome Measures:
  • serum creatinine [ Time Frame: after 3 months of adipose tissue-derived mesenchymal stem cells treatment ]
    intravenous blood sampling


Secondary Outcome Measures:
  • glomerular filtration rate [ Time Frame: after 3 months of adipose tissue-derived mesenchymal stem cells treatment ]
    emission computed tomography

  • apparent relaxation rate [ Time Frame: after 3 months of adipose tissue-derived mesenchymal stem cells treatment ]
    blood oxygen level dependent magnetic resonance imaging


Estimated Enrollment: 100
Actual Study Start Date: January 1, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment group
Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure.
Drug: Treatment group
Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure on the basis of conventional treatment.
Other Name: Stem cells treatment group
Placebo Comparator: Control group
Treatment of chronic renal failure patients with conventional methods.
Drug: Control group
Conventional treatment were used to treat patients with chronic renal failure.
Other Name: Conventional treatment group

Detailed Description:
This study aims to investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(AMSCs) and its effect on oxidative stress, inflammation and mitochondrial damage.We intend to use blood oxygen level-dependent magnetic resonance imaging(BOLD-MRI), emission computed tomography(ECT) and enhanced magnetic resonance imaging to monitor renal oxygenation, tissue perfusion and renal function.Ultimately, we evaluate the treatment effects of AMSCs on chronic renal failure through these observations mentioned above.We hope to delay the progression of renal function in patients with chronic renal failure, and save huge social cost for dialysis by these research.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enroll the chronic renal failure patients without dialysis in the department of nephrology of Affiliated Hospital of Xuzhou Medical University from January 2017 to December 2018.
  • The patients enrolled were not treated with drugs that affect the renal blood flow and oxygen consumption, such as ACEI, ARB, calcium channel blockers, diuretics, vasodilators and other related factors within 2 weeks.

Exclusion Criteria:

  • Exclude those patients with diabetes, cardiovascular disease, severe infection, shock, dehydration, abnormal liver function, received glucocorticoid therapy, surgery and emergency dialysis.
  • Eliminate those patients with respiratory disease(such as chronic obstructive pulmonary disease, bronchiectasis, asthma), cardiovascular diseases(such as acute and chronic cardiac insufficiency), blood system diseases (such as aplastic anemia, nutritional anemia and polycythemia vera).
  Contacts and Locations
Information from the National Library of Medicine

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): NCT03321942


Contacts
Contact: Dong Sun, MD 15862158578 sundong126@yahoo.com

Locations
China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Dong Sun, MD    15862158578    sundong126@yahoo.com   
Sponsors and Collaborators
The Affiliated Hospital of Xuzhou Medical University
Investigators
Study Director: Dong Sun, MD Affiliated Hospital of Xuzhou Medical University
  More Information

Publications:

Responsible Party: The Affiliated Hospital of Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03321942     History of Changes
Other Study ID Numbers: XYFY2016-KL031-01
First Submitted: October 19, 2017
First Posted: October 26, 2017
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by The Affiliated Hospital of Xuzhou Medical University:
Adipose Tissue-derived Mesenchymal Stem Cells
Chronic Kidney Diseases

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases