NCT02943707

Brief Summary

This study evaluates the effect of autologous bone marrow stem cells infusion (ABMSCi) therapy for liver diseases.Treatment group will receive ABMSCi and drugs therapy ,while control group will only receive drugs therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 17, 2016

Last Update Submit

October 21, 2016

Conditions

Liver Diseases

Keywords

liver diseasesBone Marrow Cell Transplantation

Outcome Measures

Primary Outcomes (10)

  • Change from baseline alanine aminotransferase at 6 months

    alanine aminotransferase (ALT)

    baseline and 6 months after treatment

  • Change from baseline aspartate aminotransferase at 6 months

    aspartate aminotransferase (AST)

    baseline and 6 months after treatment

  • Change from baseline total bilirubin at 6 months

    total bilirubin (TBil)

    baseline and 6 months after treatment

  • Change from baseline direct bilirubin at 6 months

    direct bilirubin (DBil)

    baseline and 6 months after treatment

  • Change from baseline total bile acid at 6 months

    total bile acid (TBA)

    baseline and 6 months after treatment

  • Change from baseline albumin at 6 months

    albumin (ALB)

    baseline and 6 months after treatment

  • Change from baseline prothrombin time at 6 months

    prothrombin time (PT),

    baseline and 6 months after treatment

  • Change from baseline international normalized ratio at 6 months

    international normalized ratio (INR)

    baseline and 6 months after treatment

  • Change from baseline white blood cell at 6 months

    white blood cell (WBC)

    baseline and 6 months after treatment

  • Change from baseline platelet at 6 months

    platelet (PLT)

    baseline and 6 months after treatment

Secondary Outcomes (7)

  • Change from baseline liver density at 6 months

    baseline and 6 months after treatment

  • Change from baseline liver size at 6 months

    baseline and 6 months after treatment

  • Change from baseline spleen thickness at 6 months

    baseline and 6 months after treatment

  • Incidence of adverse events that are related to treatment

    baseline and 6 months after treatment

  • Number of participants that survive without developing disease

    12 months after treatment

  • +2 more secondary outcomes

Study Arms (2)

treatment group: ABMSCi & drugs

EXPERIMENTAL

ABMSCi: Autologous bone marrow stem cells infusion drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally

Procedure: Autologous bone marrow stem cells infusionDrug: drugs such as Ursodeoxycholic Acid tablets

control group: drugs

ACTIVE COMPARATOR

drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally

Drug: drugs such as Ursodeoxycholic Acid tablets

Interventions

Autologous bone marrow stem cells infusionPROCEDURE

Autologous bone marrow stem cells are infused into proper hepatic artery

Also known as: ABMSCi
treatment group: ABMSCi & drugs
drugs such as Ursodeoxycholic Acid tabletsDRUG

Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally

Also known as: UDCA
control group: drugstreatment group: ABMSCi & drugs

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Definite liver diseases (such as viral hepatitis, autoimmune liver diseases, fatty liver diseases, ect);
  • Active bone marrow hyperplasia showed by bone marrow biopsy before ABMSCi;
  • Age between 18 and 60 years;
  • Abnormal liver function.

You may not qualify if:

  • Enlisted for liver transplantation
  • Diagnosis of hepatocellular carcinoma or other cancers
  • Other severe medical disease, and acute infection
  • pregnant or nursing females,co-infections with HIV ,serious bacterial infection
  • other vital organ or system dysfunction
  • with severe complications of liver cirrhosis
  • hematological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (6)

  • Ma XR, Tang YL, Xuan M, Chang Z, Wang XY, Liang XH. Transplantation of autologous mesenchymal stem cells for end-stage liver cirrhosis: a meta-analysis based on seven controlled trials. Gastroenterol Res Pract. 2015;2015:908275. doi: 10.1155/2015/908275. Epub 2015 Mar 15.

    PMID: 25861263BACKGROUND

  • Xu L, Gong Y, Wang B, Shi K, Hou Y, Wang L, Lin Z, Han Y, Lu L, Chen D, Lin X, Zeng Q, Feng W, Chen Y. Randomized trial of autologous bone marrow mesenchymal stem cells transplantation for hepatitis B virus cirrhosis: regulation of Treg/Th17 cells. J Gastroenterol Hepatol. 2014 Aug;29(8):1620-8. doi: 10.1111/jgh.12653.

    PMID: 24942592RESULT

  • Peng L, Xie DY, Lin BL, Liu J, Zhu HP, Xie C, Zheng YB, Gao ZL. Autologous bone marrow mesenchymal stem cell transplantation in liver failure patients caused by hepatitis B: short-term and long-term outcomes. Hepatology. 2011 Sep 2;54(3):820-8. doi: 10.1002/hep.24434. Epub 2011 Jul 14.

    PMID: 21608000RESULT

  • Deng Q, Cai T, Zhang S, Hu A, Zhang X, Wang Y, Huang J. Autologous Peripheral Blood Stem Cell Transplantation Improves Portal Hemodynamics in Patients with Hepatitis B Virus-related Decompensated Cirrhosis. Hepat Mon. 2015 Dec 20;15(12):e32498. doi: 10.5812/hepatmon.32498. eCollection 2015 Dec.

    PMID: 26977164RESULT

  • Mohamadnejad M, Vosough M, Moossavi S, Nikfam S, Mardpour S, Akhlaghpoor S, Ashrafi M, Azimian V, Jarughi N, Hosseini SE, Moeininia F, Bagheri M, Sharafkhah M, Aghdami N, Malekzadeh R, Baharvand H. Intraportal Infusion of Bone Marrow Mononuclear or CD133+ Cells in Patients With Decompensated Cirrhosis: A Double-Blind Randomized Controlled Trial. Stem Cells Transl Med. 2016 Jan;5(1):87-94. doi: 10.5966/sctm.2015-0004. Epub 2015 Dec 10.

    PMID: 26659833RESULT

  • Chen Y, Chen S, Liu LY, Zou ZL, Cai YJ, Wang JG, Chen B, Xu LM, Lin Z, Wang XD, Chen YP. Mesenchymal stem cells ameliorate experimental autoimmune hepatitis by activation of the programmed death 1 pathway. Immunol Lett. 2014 Dec;162(2 Pt B):222-8. doi: 10.1016/j.imlet.2014.10.021. Epub 2014 Oct 28.

    PMID: 25445618RESULT

MeSH Terms

Conditions

Liver Diseases

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Officials

  • yongping chen

    First Affiliated Hospital of Wenzhou Medical University

    STUDY CHAIR

Central Study Contacts

yongping chen

CONTACT

861350577728113505777281@163.com

lanman xu

CONTACT

861358764631513587646315@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director,Clinical Research

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 25, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2020

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

CN(1)