Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 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 50 patients (adults and children) with GvHD exerted by MSC expanded with human platelet lysate and plasma ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00827398
Study type Interventional
Source UMC Utrecht
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 2009
Completion date July 2013

See also
  Status Clinical Trial Phase
Recruiting NCT04792580 - The Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease Early Phase 1
Not yet recruiting NCT05969743 - Letermovir Prophylaxis for Cytomegalovirus (CMV) in Patients With Graft-versus-host Disease Phase 2
Active, not recruiting NCT04669210 - PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT Phase 2
Completed NCT04014790 - RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation Phase 2
Recruiting NCT06008808 - Ruxolitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation Phase 1
Recruiting NCT03395860 - Low Dose ATG Plus Low Dose PTCy as GVHD Prophylaxis in Haplo-HSCT Phase 2
Completed NCT03207958 - Belimumab for Prevention of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation Phase 1
Completed NCT03414645 - Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease Phase 1/Phase 2
Completed NCT03846479 - Itacitinib for Low Risk GVHD Phase 2
Active, not recruiting NCT01927120 - In Vivo Treg Expansion and Graft-Versus-Host Disease Prophylaxis Phase 2
Recruiting NCT06321003 - SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography
Not yet recruiting NCT06279585 - Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD N/A
Suspended NCT05617625 - CD34+ Enriched Transplants to Treat Myelodysplastic Syndrome Phase 2
Not yet recruiting NCT06392711 - Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia Phase 1
Withdrawn NCT00723593 - Natural History and Pathophysiology of Gastrointestinal Graft-versus-Host Disease N/A
Recruiting NCT03148197 - Changes in the Gut Microbiota of Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT) N/A
Recruiting NCT03456817 - HIgh Dose Thymoglobulin Instead of Cyclosporine With a Low Dose of Thymoglobulin for GVHD Prophylaxis Phase 2
Recruiting NCT03842696 - Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation Phase 1/Phase 2
Completed NCT03605927 - CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease Phase 1
Recruiting NCT04688021 - A Single-arm Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT. Phase 2