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

Xuzhou Medical University

Status: Unknown

Conditions: Chronic Kidney Diseases; Renal Interstitial Fibrosis; Mesenchymal Stem Cells

Treatments: Drug: Control group; Drug: Treatment group

Study type: Interventional

Funder types: Other

Identifiers

NCT03321942

XYFY2016-KL031-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Treatment group

Active Comparator group

Description:

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

Treatment:

Drug: Treatment group

Control group

Placebo Comparator group

Description:

Treatment of chronic renal failure patients with conventional methods.

Treatment:

Drug: Control group