Human Umbilical Cord Mesenchymal Stem Cell(UC-MSC)Delayed Renal Chronic Kidney Disease(CKD3、4 )

NCT05512988 | Unknown Phase 1

• 1 other identifier: TongjiHospitalxugangtjh
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The chronic kidney disease is caused by renal structural and functional impairment for more than 3 months due to various causes, including normal and abnormal glomerular filtration rate (GFR), abnormal blood, urine, and imaging findings, or an unexplained decline in GFR (\<60 ml/min). Recent years, the incidence of chronic kidney disease has increased year by year worldwide, the incidence of CKD is 8% to 16% in the world's total population. chronic kidney disease has become an important public health problem in China and even the world. Summarizing the basic and clinical studies at home and abroad, inflammatory factors such as inflammatory chemokines, cytokines, and reactive oxygen species interact with fibrosis factors such as mesangial cells, fibroblasts, and fibroblast activation, which are the root causes of the progression of CKD and the formation of tubular interstitial fibrosis and glomerular sclerosis and developing into end-stage renal disease. Current treatments for chronic kidney disease are very limited, and to be precise, there is currently no cure for chronic kidney disease, nor is there a proven way to improve the kidneys survive after acute kidney injury (AKI). The progression of the disease itself can only be delayed as much as possible by changing the diet, controlling related complications with oral medications (such as hypertension, hyperlipidemia, nephropathy, etc.), and actively controlling blood glucose and glycosylated hemoglobin levels in patients with diabetes. For patients with stage CKD5 and more severe, renal replacement therapy is recommended, including hemodialysis and peritoneal dialysis, but there are many complications in both dialysis methods, such as narrowing of the internal fistula, occlusion, catheter infection, peritonitis, etc. Kidney transplantation may be considered when economic conditions permit and there is a matching kidney source, but kidney transplant surgery is riskier. The above treatment methods have brought a heavy burden to patients and social medicine. In order to seek innovative and effective strategies to cultivate the limited regenerative capacity of the kidneys and reverse renal fibrosis, the mesenchymal stem cells (MSCs) with tissue regenerative potential and immunomodulatory functions have brought new ideas and hopes for the prevention and treatment of chronic kidney disease.

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Diseases; human umbilical cord Mesenchymal stem cell; CKD3/CKD4

Outcome Measures

Primary Outcomes (3)

• Change of GFR

  GFR decrease at 2.5ml/min/year or more from baseline

  baseline, 6-month after 2nd treatment, 12-month after 2nd treatment

• Incidence of Treatment-Serious Adverse Events as assessed by SPSS 23.0 and Graphpad prism 6

  To observe the incidence of serious adverse events，such as fatal cardiovascular and cerebrovascular disease, tumor, organ failure, severe infection.

  Through study completion, an average of 13 months

• Number of participants with treatment-related adverse events as assessed by SPSS 23.0 and Graphpad prism 6

  Collecting and comparing the number and severity of participants with skin reactions, fever, infection, allergic reactions, etc. in the two groups.

  Through study completion, an average of 13 months

Secondary Outcomes (19)

• IgA

  2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment

• IgG

  2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment

• IgM

  2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment

• C3

  2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment

• C4

  2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment

Study Arms (2)

Experimental

EXPERIMENTAL

MSCs Participants will receive HUC-MSCs

Biological: UC-MSC

Comparator

PLACEBO COMPARATOR

Comparator participants will receive saline solution

Biological: Saline solution

Interventions

UC-MSC BIOLOGICAL

Usage: The stem cell preparation in this study is used intravenously in the elbow. Dose: The dose of stem cell injection in this clinical study is set at 1×10\^6/Kg/time per injection, and the injection frequency is 2 weeks/time. Duration: 2 injections per trial group for the entire duration of the course, with a total dose of 2×10\^6/Kg/person.

Experimental

Saline solution BIOLOGICAL

Usage: The saline solution in this study is used intravenously in the elbow. Dose: The dose of saline solution in this clinical study is set at 250ml/time per injection, and the injection frequency is 2 weeks/time. Duration: 2 injections per person for the entire duration of the course

Comparator

Eligibility Criteria

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

You may qualify if:

• Patients with clinical diagnosis of chronic kidney disease (CKD) and stage 3 and stage 4 (GFR 15-60 ml/min) of CKD (American Kidney Disease Foundation stage)
• Agree to sign the informed consent form at the same time by means of participation of the pilot group
• Age between 18-65 years old

You may not qualify if:

• Patients who are taking immunosuppressants or have been taking them within a month
• Patients with a 30% increase in creatinine in the past 3 months and who are about to undergo dialysis
• Suffering from severe heart, respiratory insufficiency, viral hepatitis, and sexually transmitted diseases
• Hypersensitivity to stem cells themselves or stem cell-related media
• Patients with recent bacterial, viral, or fungal infections
• Have a history of tumors or are currently suffering from tumor conditions
• Pregnant or breastfeeding
• Have participated in drug-related clinical trials in the past two months
• Any form of substance abuse, mental illness, and other conditions that researchers believe may affect the effectiveness of the test or the patient's physical health

Sponsors & Collaborators

• Tongji Hospital: lead
• Zhongyuan Xiehe Biological Cell Storage Service (Tianjin) Co., Ltd.: collaborator

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Saline Solution

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)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• GANG XU

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RUI ZENG

CONTACT

+86 15002726366; zengrui@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 23, 2022
• Study Start: April 13, 2021
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)