Graft-versus-host-disease Clinical Trial
— MSCforGVHDOfficial title:
Treatment of Steroid Resistant Grade II to IV GVHD by Infusion MSCof Mesenchymal Stem Cells Expanded With Human Plasma and Platelet Lysate a Phase I/II Study
Verified date | November 2014 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Ministry of Health, Welfare and Sport |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 68 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - Patients with poor performance, not expected to survive 3 weeks. - Donor Chimerism below 90% - Active uncontrolled CMV, EBV or fungal infection |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | UMC Utrecht, department of pediatrics | Utrecht | |
Netherlands | UMCU department of Haematology | Utrecht |
Lead Sponsor | Collaborator |
---|---|
N.M. Wulffraat |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of adverse events after infusion of MSC (hPPL) | 6 months | Yes | |
Primary | Number of severe infections after MSC infusion | 6 months | No | |
Secondary | Response of acute GVHD | 6 months | No | |
Secondary | Determination of incidence of chronic GVHD | 6 months | No | |
Secondary | Survival | 6 months | No |
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