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

Graft-Versus-Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01522716
• Other study ID #: MSC-cGVH
• Status: Terminated
• Phase: Phase 1
• Start date: August 2011
• Est. completion date: March 2017

Study information

• Verified date: November 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-Versus-Host Disease

Intervention

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.

Locations

Country	Name	City	State
Sweden	Hematology Center, Karolinska University Hospital Huddinge	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease activity according to National Institute of Health criteria	Patients are evaluated according to NIH criteria at 3, 6 and (if applicable) 9 months after initialising MSC treatment, and the score compared to baseline score.	Baseline to 9 months
Secondary	Change in disease activity as measured by histological examination		Baseline to 9 months
Secondary	Change in self-assessed disease activity and quality of life		Baseline to 9 months
Secondary	Safety (Adverse events, infections and relapse)	Frequency of complications, infections and relapse	21 months
Secondary	Freedom from steroids at 1 year after MSC treatment	Proportion of patients free from corticosteroids at 1 year after finishing MSC treatment.	1 year after finishing treatment