Treatment of Steroid Resistant GVHD by Infusion MSC
MSCforGVHD
1 other identifier
interventional
50
1 country
2
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-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2009
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
January 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedNovember 6, 2014
November 1, 2014
4.5 years
January 20, 2009
November 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
number of adverse events after infusion of MSC (hPPL)
6 months
Number of severe infections after MSC infusion
6 months
Secondary Outcomes (3)
Response of acute GVHD
6 months
Determination of incidence of chronic GVHD
6 months
Survival
6 months
Interventions
Treatment with MSCs (hPPL) is indicated as soon as steroid refractory acute GVHD is diagnosed
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with poor performance, not expected to survive 3 weeks.
- Donor Chimerism below 90%
- Active uncontrolled CMV, EBV or fungal infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- N.M. Wulffraatlead
Study Sites (2)
UMC Utrecht, department of pediatrics
Utrecht, 3508AB, Netherlands
UMCU department of Haematology
Utrecht, 3584AB, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nico M Wulffraat
UMC Utrecht
- PRINCIPAL INVESTIGATOR
Jurgen H Kuball, MD
UMC Utrecht
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 20, 2009
First Posted
January 22, 2009
Study Start
January 1, 2009
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
November 6, 2014
Record last verified: 2014-11