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

NCT ID: NCT03321942

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Mesenchymal Stem Cells Chronic Kidney Diseases Renal Interstitial Fibrosis

Keywords

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Adipose Tissue-derived Mesenchymal Stem Cells Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure.

Group Type ACTIVE_COMPARATOR

Treatment group

Intervention Type DRUG

Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure on the basis of conventional treatment.

Control group

Treatment of chronic renal failure patients with conventional methods.

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type DRUG

Conventional treatment were used to treat patients with chronic renal failure.

Interventions

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Treatment group

Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure on the basis of conventional treatment.

Intervention Type DRUG

Control group

Conventional treatment were used to treat patients with chronic renal failure.

Intervention Type DRUG

Other Intervention Names

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Stem cells treatment group Conventional treatment group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dong Sun, MD

Role: STUDY_DIRECTOR

The Affiliated Hospital of Xuzhou Medical University

Locations

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The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Sun, MD

Role: CONTACT

Phone: 15862158578

Email: [email protected]

Facility Contacts

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Dong Sun, MD

Role: primary

References

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Other Identifiers

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XYFY2016-KL031-01

Identifier Type: -

Identifier Source: org_study_id