Status:
COMPLETED
Treatment of Steroid Resistant GVHD by Infusion MSC
Lead Sponsor:
N.M. Wulffraat
Conditions:
Graft-versus-host-disease
Eligibility:
All Genders
1-68 years
Phase:
PHASE1
PHASE2
Brief 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-dise...
Detailed Description
For numerous malignant and non-malignant hematological diseases allogeneic hemato¬poietic stem cell transplantation (HSCT) is the only curative therapy. One of the major complications is the occurrenc...
Eligibility Criteria
Inclusion
- Newly diagnosed acute grade II-IV GVHD or chronic GVHD with an acute pattern matching grade II-IV after allogeneic stem cell transplantation
- Patients must have received 2 mg/kg/day of prednisolon for at least 3 consecutive days and experience progression of GVHD or no response to at least 7 days of steroid treatment.
- In addition to steroids the patient has received either cyclosporin
- Written informed consent
- MSC donor must be HIV, HTLV, hepatitis BS antigen, HCV and HBC, Treponema Pallidum antibody negative. MSC donors can be mismatched related donor, third party matched or mismatched donor.
Exclusion
- Patients with poor performance, not expected to survive 3 weeks.
- Donor Chimerism below 90%
- Active uncontrolled CMV, EBV or fungal infection
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00827398
Start Date
January 1 2009
End Date
July 1 2013
Last Update
November 6 2014
Active Locations (2)
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1
UMC Utrecht, department of pediatrics
Utrecht, Netherlands, 3508AB
2
UMCU department of Haematology
Utrecht, Netherlands, 3584AB