NCT01765660

Brief Summary

The purpose of this study is to evaluate the utility of treating patients experiencing refractory chronic graft-versus-host disease with ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors. The objective was to evaluate the effect and safety of such treatment on refractory chronic graft-versus-host disease.

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
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2013

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, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

2.9 years

First QC Date

January 5, 2013

Last Update Submit

January 8, 2013

Conditions

Chronic Graft-versus-host Disease

Keywords

Hematopoietic Stem Cell TransplantationMesenchymal Stem CellsChronic Graft-versus-host disease

Outcome Measures

Primary Outcomes (1)

  • The efficacy of treatment for refractory cGVHD

    The response criteria include complete response (CR), part response (PR), stable disease(SD) and progressive disease(PD). CR:cGVHD symptoms and signs disappear; PR:cGVHD symptoms and signs improve; SD:cGVHD symptoms and signs remain (without improvement or deterioration);PD: cGVHD symptoms and signs deteriorate.

    1 year

Secondary Outcomes (1)

  • acute and late toxic side effects of MSCs treatment

    1 year

Other Outcomes (1)

  • infections

    1 year

Study Arms (2)

Non-mesenchymal stem cells

EXPERIMENTAL

Non-mesenchymal stem cell group refers to treatment with other second line drugs

Biological: Non-mesenchymal stem cells

Mesenchymal stem cells

EXPERIMENTAL

Mesenchymal stem cell group refers to treatment with mesenchymal stem cells (1×10\^6 cells/kg, intravenously)every two weeks, four times for a cycle

Biological: Mesenchymal stem cells

Interventions

Mesenchymal stem cellsBIOLOGICAL

Mesenchymal stem cells will be intravenously infused via a central venous catheter(at a dose of 1×10\^6 cells/kg, over 15 mins) every two weeks, four times for a cycle.

Also known as: MSCs
Mesenchymal stem cells
Non-mesenchymal stem cellsBIOLOGICAL

Other second line drugs are taken.

Also known as: Non-MSCs
Non-mesenchymal stem cells

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A patient age of 12-65 years
  • Recipients of allogeneic hematopoietic stem cell transplantation
  • Patients with refractory cGVHD
  • On a voluntary basis, patients are divided into MSCs and Non-MSCs group
  • 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)

  • Perez-Simon JA, Lopez-Villar O, Andreu EJ, Rifon J, Muntion S, Diez Campelo M, Sanchez-Guijo FM, Martinez C, Valcarcel D, Canizo CD. Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial. Haematologica. 2011 Jul;96(7):1072-6. doi: 10.3324/haematol.2010.038356. Epub 2011 Mar 10.

    PMID: 21393326BACKGROUND

  • Ringden O, Uzunel M, Rasmusson I, Remberger M, Sundberg B, Lonnies H, Marschall HU, Dlugosz A, Szakos A, Hassan Z, Omazic B, Aschan J, Barkholt L, Le Blanc K. Mesenchymal stem cells for treatment of therapy-resistant graft-versus-host disease. Transplantation. 2006 May 27;81(10):1390-7. doi: 10.1097/01.tp.0000214462.63943.14.

    PMID: 16732175BACKGROUND

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Qifa Liu

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2013

First Posted

January 10, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

CN(1)