Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease

This study is currently recruiting participants.
Verified November 2013 by Karolinska Institutet
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Lena von Bahr, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01522716
First received: January 24, 2012
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as treatment for steroid-refractory chronic graft-versus-host disease.


Condition Intervention Phase
Graft-Versus-Host Disease
Biological: Mesenchymal stromal cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Change in disease activity according to National Institute of Health criteria [ Time Frame: Baseline to 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in disease activity as measured by histological examination [ Time Frame: Baseline to 9 months ] [ Designated as safety issue: No ]
  • Change in self-assessed disease activity and quality of life [ Time Frame: Baseline to 9 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
    Frequency of complications, infections and relapse


Estimated Enrollment: 10
Study Start Date: August 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal stromal cell treatment Biological: Mesenchymal stromal cells
Allogenous mesenchymal stromal cells, to be injected intravenously at a dose of 1-2 million/kg at a frequency of once a month (frequency may be changed during the study if deemed appropriate by investigators) for 6-9 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic graft-versus-host disease, grade moderate or severe despite at least 3 months treatment with calcineurin inhibitors and steroids OR
  • Chronic graft-versus-host disease, grade moderate or severe, where full treatment with calcineurin inhibitors and steroids is impossible due to intolerable side-effects

Exclusion Criteria:

  • Active malignancy
  • Fulfilling criteria for previously initiated study for treatment of chronic graft-versus-host disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522716

Contacts
Contact: Lena von Bahr, MD +46-704451810 lena.von.bahr@ki.se
Contact: Katarina Le Blanc, professor katarina.leblanc@ki.se

Locations
Sweden
Hematology Center, Karolinska University Hospital Huddinge Recruiting
Stockholm, Sweden
Contact: Lena von Bahr         
Principal Investigator: Lena von Bahr, MD         
Principal Investigator: Katarina Le Blanc, professor         
Sub-Investigator: Hans Hägglund, Assistant professor         
Sub-Investigator: Gabriel Afram, MD         
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
  More Information

No publications provided

Responsible Party: Lena von Bahr, Leg läkare, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01522716     History of Changes
Other Study ID Numbers: MSC-cGVH
Study First Received: January 24, 2012
Last Updated: November 27, 2013
Health Authority: Sweden: The National Board of Health and Welfare
Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on April 22, 2014