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Status unknownNCT03529136Updated May 18, 2018

Clinical Trial of Umbilical Cord Mesenchymal Stem Cell Transfusion in Decompensated Liver Cirrhosis

A Phase 2 interventional study of UC-MSC in Decompensated Liver Cirrhosis, sponsored by Shandong Qilu Stem Cells Engineering Co., Ltd.. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-18.

Sponsored by Shandong Qilu Stem Cells Engineering Co., Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
252
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Decompensated liver cirrhosis is one of the life-threatening complication of chronic liver disease. Liver transplantation currently is the only effective method that can improve the survival of these patients. However, the severe shortage of donor livers, high cost, and potential serious complications have restricted the availability of liver transplantation.Umbilical cord mesenchymal stem cells (UC-MSC) has been generally shown to be safe and effective for liver diseases in some pre-clinical and clinical studies. This study aim to evaluate the safety and efficiency of human umbilical cord mesenchymal stem cell transfusion in patients with decompensated liver cirrhosis, and explore the best protocol of MSC transfusion.

Read the detailed description

This study is a multicenter non randomized control study. Patients with decompensated liver cirrhosis are going to be assigned to receive standard medical care plus UC-MSC treatment with two different protocol (group 1 and group 2) or standard medical care (control). Four times of MSC infusion (1.5x10E6 cells/kg body weight) via peripheral vein will be given to the group 1(once every 4 days), and two times of MSC infusion once every 7 days to the group 2. The primary outcome is survival rates in one year. Secondary outcomes are liver function, liver ascites and MELD score.

02

Conditions studied

  • Decompensated Liver Cirrhosis

Keywords

  • Mesenchymal Stem Cell
  • MSC
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 252 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Shandong Qilu Stem Cells Engineering Co., Ltd. is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Clinically diagnosed as decompensated liver cirrhosis.
  2. Hepatitis B/C Liver Cirrhosis After Viral Treatment, HBV/HCV Viral Loads Below Detection Level over six mouths, and the liver function remained below Child-pugh A grade or MELD score >10.
  3. Other causes of cirrhosis, liver function compensatory incomplete.
  4. In the past year, despite active medical treatment taken, the condition has continued to increase, at least because of cirrhosis complications such as ascites, spontaneous peritonitis, gastrointestinal bleeding, and hepatic encephalopathy in hospital over one time.
  5. Need to intermittently supplement albumin and apply diuretic therapy.
  6. Albumin \<35 g/L, total bilirubin \<170 umol/L, prothrombin activity> 30%; (Prothrombin time \<20 s, moderate or lower mass ascites, spontaneous peritonitis and hepatic encephalopathy (grade II or lower), Child-pugh score> 5 points).
  7. There was no history of gastrointestinal hemorrhage within the last month and population with no high-risk portal hypertension and gastrointestinal bleeding was evaluated recently.
  8. Unconditional acceptance of orthotopic liver transplantation.
  9. Aged from 18 to 65 years.
  10. Voluntarily signed informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. A malignant tumor with liver or other organs or a history of previous cancer.
  2. Complications include gastrointestinal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and Acute infection episodes.
  3. Patients with severe heart, lung, kidney or blood system diseases and failure status.
  4. Pregnant or lactating women.
  5. Allergic constitution.
  6. There is a history of alcohol abuse, drug abuse, and failure to effectively quit. 7. Patients did not participate in other clinical trials within 4 weeks.
  1. Any condition, investigator believe that patients should not participate in this study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
252 participants (estimated)

Study arms

  • Experimental
    MSC group 1

    Procedure:UC-MSC infusion via peripheral vein. Four times of MSC infusion (1.5x10E6 cells/kg body weight) via peripheral vein will be given to the group 1(once every 4 days).

    Biological: UC-MSC

  • Experimental
    MSC group 2

    Procedure:UC-MSC infusion via peripheral vein. Two times of MSC infusion (1.5x10E6 cells/kg body weight) via peripheral vein will be given to the group 2(once every 7 days).

    Biological: UC-MSC

  • Experimental
    Control group

    Control group with standard medical care. UC-MSC infusion could be considering in this group after 24 weeks' followed-up.

    Biological: UC-MSC

Interventions

  • BiologicalUC-MSC

    Human umbilical cord mesenchymal stem cells have driven from Wharton's jelly and cultured with serum-free medium in Shandong Cell and tissue bank. All of the cells in this study within three passages. Before transfusion, the mesenchymal stem cells were subjected to quality control. The UC-MSC were stained with anti-CD90-FITC, Anti-CD44-FITC, Anti-CD34-FITC and anti-45-FITC.

    Also known as: Human umbilical cord mesenchymal stem cells

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What researchers measure

Primary outcomes

  1. overall survival

    The overall survival ratio of three groups will be detection after infusion in one year.

    Time frame: one year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03529136
Lead sponsor
Shandong Qilu Stem Cells Engineering Co., Ltd.
Collaborators
Shanghai Public Health Clinical Center, First Affiliated Hospital of Fujian Medical University, Yantai Hospital for Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Jinan Hospital for Infectious Diseases
Responsible party
Sponsor
First posted
May 18, 2018
Start date
Jun 1, 2018 (estimated)
Primary completion
Dec 31, 2019 (estimated)
Completion
Apr 30, 2020 (estimated)
Last update
May 18, 2018

Study contacts

Xie
Contact
mm-xie@hotmail.com
+86 13256735916
Jingbo Wang
principal investigator · Jinan Hospital for Infectious Diseases

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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