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

Sponsor
The Affiliated Hospital of Xuzhou Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03321942
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(AMSCs) and its treatment effects on chronic renal failure.

Condition or Disease Intervention/Treatment Phase
  • Drug: Treatment group
  • Drug: Control group
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
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
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2018
Anticipated Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Conventional treatment group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. serum creatinine [after 3 months of adipose tissue-derived mesenchymal stem cells treatment]

      intravenous blood sampling

    Secondary Outcome Measures

    1. glomerular filtration rate [after 3 months of adipose tissue-derived mesenchymal stem cells treatment]

      emission computed tomography

    2. apparent relaxation rate [after 3 months of adipose tissue-derived mesenchymal stem cells treatment]

      blood oxygen level dependent magnetic resonance imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu China 221000

    Sponsors and Collaborators

    • The Affiliated Hospital of Xuzhou Medical University

    Investigators

    • Study Director: Dong Sun, MD, The Affiliated Hospital of Xuzhou Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The Affiliated Hospital of Xuzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT03321942
    Other Study ID Numbers:
    • XYFY2016-KL031-01
    First Posted:
    Oct 26, 2017
    Last Update Posted:
    Oct 26, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    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

    Study Results

    No Results Posted as of Oct 26, 2017