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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01522716

Enrollment

Registered

2012-02-01

Start date

2011-08-31

Completion date

2017-03-31

Last updated

2020-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft-Versus-Host Disease

Brief 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.

Interventions

BIOLOGICALMesenchymal 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in disease activity according to National Institute of Health criteria	Baseline to 9 months	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.

Secondary

Measure	Time frame	Description
Change in disease activity as measured by histological examination	Baseline to 9 months	—
Change in self-assessed disease activity and quality of life	Baseline to 9 months	—
Safety (Adverse events, infections and relapse)	21 months	Frequency of complications, infections and relapse
Freedom from steroids at 1 year after MSC treatment	1 year after finishing treatment	Proportion of patients free from corticosteroids at 1 year after finishing MSC treatment.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026