NCT02083731

Brief Summary

The purpose of this study is to evaluate the efficacy of mesenchymal stem cells (MSC) in the treatment of refractory cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation (allo-HSCT).

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
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 7, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

March 8, 2014

Last Update Submit

January 6, 2015

Conditions

Stem Cell Transplantation, HematopoieticCMV InfectionHematological Diseases

Keywords

CMV infectionMesenchymal Stem CellsAllogeneic hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants achieved complete remission of CMV infection

    1 year

Secondary Outcomes (1)

  • Number of Participants with Serious and Non-Serious Adverse Events

    up to 1 year

Study Arms (1)

MSCs

EXPERIMENTAL

MSCs will be used to treat refractory CMV infection or CMV-associated diseases. MSCs will be intravenously infused at a dose of 1×10\^6 cells/kg. If anticipates do not attain the complete remission standards within 14d, a second course of the same treatment will be given.

Biological: MSCs

Interventions

MSCsBIOLOGICAL
MSCs

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A patient age of 14-65 years
  • Refractory CMV infection or CMV-associated diseases
  • Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

You may not qualify if:

  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  • Patients with any conditions not suitable for the trial (investigators' decision)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (2)

  • Meisel R, Brockers S, Heseler K, Degistirici O, Bulle H, Woite C, Stuhlsatz S, Schwippert W, Jager M, Sorg R, Henschler R, Seissler J, Dilloo D, Daubener W. Human but not murine multipotent mesenchymal stromal cells exhibit broad-spectrum antimicrobial effector function mediated by indoleamine 2,3-dioxygenase. Leukemia. 2011 Apr;25(4):648-54. doi: 10.1038/leu.2010.310. Epub 2011 Jan 18.

    PMID: 21242993BACKGROUND

  • Ljungman P, de la Camara R, Cordonnier C, Einsele H, Engelhard D, Reusser P, Styczynski J, Ward K; European Conference on Infections in Leukemia. Management of CMV, HHV-6, HHV-7 and Kaposi-sarcoma herpesvirus (HHV-8) infections in patients with hematological malignancies and after SCT. Bone Marrow Transplant. 2008 Aug;42(4):227-40. doi: 10.1038/bmt.2008.162. Epub 2008 Jun 30.

    PMID: 18587440BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus InfectionsHematologic Diseases

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsHemic and Lymphatic Diseases

Study Officials

  • Qifa Liu, MD.

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ren Lin, MD.

CONTACT

+86-020-61641613lansinglinren@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2014

First Posted

March 11, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2017

Last Updated

January 7, 2015

Record last verified: 2015-01

Locations

CN(1)