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

NCT03321942 | Unknown DMC

• 1 other identifier: XYFY2016-KL031-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mesenchymal Stem Cells; Chronic Kidney Diseases; Renal Interstitial Fibrosis

Keywords

Adipose Tissue-derived Mesenchymal Stem Cells; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• serum creatinine

  intravenous blood sampling

  after 3 months of adipose tissue-derived mesenchymal stem cells treatment

Secondary Outcomes (2)

• glomerular filtration rate

  after 3 months of adipose tissue-derived mesenchymal stem cells treatment

• apparent relaxation rate

  after 3 months of adipose tissue-derived mesenchymal stem cells treatment

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

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

Drug: Treatment group

Control group

PLACEBO COMPARATOR

Treatment of chronic renal failure patients with conventional methods.

Drug: Control group

Interventions

Treatment group DRUG

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

Also known as: Stem cells treatment group

Treatment group

Control group DRUG

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

Also known as: Conventional treatment group

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dong Sun, MD

  The Affiliated Hospital of Xuzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Dong Sun, MD

CONTACT

15862158578; sundong126@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 26, 2017
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)