NCT02705742

Brief Summary

In this study, investigators aimed to transplant autologous, adipose tissue derived mesenchymal stem cells to the patients with liver cirrhosis due to HCV. We also aimed to assess liver tissue regeneration, downgrade of clinical findings and antiviral efficacy. Finally investigators aimed to establish an alternative treatment modality to liver transplantation.

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
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 7, 2016

Status Verified

June 1, 2016

Enrollment Period

1.5 years

First QC Date

March 7, 2016

Last Update Submit

June 6, 2016

Conditions

Liver Cirrhosis

Keywords

Mesenchymal stem cellsLiver cirrhosisHepatitis C

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    one year

Study Arms (1)

stem cells group

OTHER

mesenchymal stem cells only

Biological: Mesenchymal Stem Cells

Interventions

Mesenchymal Stem CellsBIOLOGICAL

1.000.000 (one million) cells/kg, IV of dose in the Peripheral vein and 3.000.000 (three million) cells/kg of dose into the right hepatic artery)

stem cells group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical, radiologic and pathologically proven Liver Cirrhosis Due to HCV Hepatitis
  • Patients with no hepatic malignancies
  • No co-existing serious respiratory and/or cardiovascular morbidities
  • Patients who approved to join the study group with informed and written consent
  • Patients with platelet count more than 30.000/mm3

You may not qualify if:

  • Current alcohol consumption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Military Medical Academy

Ankara, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Kantarcioglu M, Demirci H, Avcu F, Karslioglu Y, Babayigit MA, Karaman B, Ozturk K, Gurel H, Akdogan Kayhan M, Kacar S, Kubar A, Oksuzoglu G, Ural AU, Bagci S. Efficacy of autologous mesenchymal stem cell transplantation in patients with liver cirrhosis. Turk J Gastroenterol. 2015 May;26(3):244-50. doi: 10.5152/tjg.2015.0074.

    PMID: 26006200RESULT

  • Kantarcioglu M, Caliskan B, Demirci H, Karacalioglu O, Kekilli M, Polat Z, Gunal A, Akinci M, Uysal C, Eksert S, Gurel H, Celebi G, Avcu F, Ural AU, Bagci S. The efficacy of mesenchymal stem cell transplantation in caustic esophagus injury: an experimental study. Stem Cells Int. 2014;2014:939674. doi: 10.1155/2014/939674. Epub 2014 May 4.

    PMID: 24876849RESULT

MeSH Terms

Conditions

Liver CirrhosisHepatitis C

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis

Study Officials

  • Murat Kantarcioglu, M.D.

    Gulhane Military Medical Academy, Department of Gastroenterology

    STUDY CHAIR

Central Study Contacts

Hakan Demirci, M.D.

CONTACT

00905325140028hakandemircigata@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 10, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

June 7, 2016

Record last verified: 2016-06

Locations

TU(1)