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Sponsors and Collaborators: |
UMC Utrecht Dr. med. Ingo Müller. Universitätsklinikum Tübingen |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00827398 |
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.
Condition | Intervention | Phase |
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Graft-Versus-Host-Disease |
Biological: MSC (hPPL) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official 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 |
Estimated Enrollment: | 10 |
Study Start Date: | January 2009 |
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 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 depending on risk factors such as HLA-match, donor relation, age etc.1-3.
First line therapy of aGVHD > grade I consists of steroids at a dose of 2 mg/kg. The response rates to this 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%, although numerous studies with different treatment strategies have been conducted2-5.
Therefore, it remains important to search for new therapeutical strategies for the treatment of aGVHD.
The first patient to receive mismatched Mesenchymal Stem Cells was a twenty-year-old woman with acute myeloid leukemia treated with peripheral blood stem cells combined with MSC from her haploidentical father. Lazarus et al. reported on 46 patients who received HSCs and culture-expanded MSCs from HLA-identical siblings. Moderate to severe acute GvHD was observed in 28% of the patients, and chronic GvHD was seen in 61%. The two-year progression-free survival was observed in 53% of the patients. MSC infusion caused no acute or long-term MSC-associated adverse events.
Traditionally, for MSC isolation and expansion, fetal calf serum (FCS) supplemented media are used. The use of FCS has however several drawbacks and potential problems. We have therefore established a MSC culture protocol in animal serum free conditions using human platelet lysate and human plasma instead. The present phase I/II study is designed to gather further insight into the clinical benefit in 10 patients (adults and children) with GvHD exerted by MSC expanded with human platelet lysate and plasma
Ages Eligible for Study: | 1 Month to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nico M Wulffraat, MD, PhD | (31)88-7554003 | n.wulffraat@umcutrecht.nl |
Contact: Eefke J Petersen, MD,PhD | E.J.Petersen@umcutrecht.nl |
Netherlands | |
UMC Utrecht, department of pediatrics | Not yet recruiting |
Utrecht, Netherlands, 3508AB | |
Contact: Nico M Wulffraat n.wulffraat@umcutrecht.nl | |
Principal Investigator: Nico M Wulffraat, MD | |
UMCU department of Haematology | Recruiting |
Utrecht, Netherlands, 3584AB | |
Contact: Eefke J Petersen (31)88.7556299 E.J.Petersen@umcutrecht.nl |
Principal Investigator: | Nico M Wulffraat | University Medical Center Utrecht |
Principal Investigator: | Ingo Müller, MD | Universitatsklinikum Tübingen Germany |
Responsible Party: | Dept pediatrics, UMCU ( NM Wulffraat ) |
Study ID Numbers: | NL13729.000.07 |
Study First Received: | January 20, 2009 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00827398 History of Changes |
Health Authority: | Netherlands: Ministry of Health, Welfare and Sport |
MSC GVHD Adults Children steroid refractory acute GVHD occurring after allogeneic stem cell transplantation |
Graft Versus Host Disease Graft vs Host Disease Homologous Wasting Disease |
Immune System Diseases Graft vs Host Disease |