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Treatment of Steroid Resistant GVHD by Infusion MSC

NCT00827398 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-11-06

No results posted yet for this study

Summary

For numerous malignant diseases allogeneic hematopoietic stem cell transplantation (HSCT) is the only curative therapy. One of the major complications is the occurrence of acute graft-versus-host-disease (aGVHD). Thirty to eighty percent of patients after HSCT develop aGVHD despite the prophylactic application of different immunosuppressive drugs.

The response rates to the conventional first line treatment are only 15-35%4. In case of a steroid refractory aGVHD different therapeutic strategies have been evaluated, but with no satisfactory results so far. The mortality of patients suffering from steroid refractory aGVHD remains at 75-80%. Therefore, it remains important to search for new therapeutical strategies for the treatment of aGVHD.

Conditions

  • Graft-versus-host-disease

Interventions

BIOLOGICAL

MSC (hPPL)

Treatment with MSCs (hPPL) is indicated as soon as steroid refractory acute GVHD is diagnosed

Sponsors & Collaborators

  • N.M. Wulffraat

    lead OTHER

Principal Investigators

  • Nico M Wulffraat · UMC Utrecht

  • Jurgen H Kuball, MD · UMC Utrecht

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00827398 on ClinicalTrials.gov