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Treatment of severe acute GVHD after allogeneic hematopoietic stem cell transplantation with steroids versus MSC and steroids.
A prospective double-blind placebo-controlled randomized phase III trial

To improve the response rate to treatment of severe acute GVHD (grade II-IV with gut involvement ) by adding infusion of Mesenchymal Stroma Cells to standard high dose prednisolone.

Unrelated cord blood transplantation after reduced toxicity conditioning with mesenchymal stromal cell co-infusion in patients with severe epidermolysis bullosa

We propose a phase II study (intervention) in patients with severe generalized recessive dystrophic EB receiving reduced toxicity conditioning chemotherapy followe by cord blood transplantation with co-infusion of mesenchymal stromal cell units.…

Treatment of severe steroid-refractory acute GvHD with mesenchymal stromal cells.
A phase III randomized double-blind multi-center HOVON study.

Primary objective* To improve the response rate to treatment of severe steroid-refractory acute GvHD grade II-IV (with gut and/or liver involvement) by early addition of MSC to standardized second line treatmentSecondary objectives* To study the…

Infusion of IL-15 activated NK cells after allogeneic stem cell transplantation in children transplanted for relapsed/refractory leukemia: a feasibility study

Primary: The main objective of the study is to evaluate the feasibility, safety and tolerability of allogeneic IL15-activated NK cell infusions in children transplanted for refractory or relapsed leukemia.Secondary: To document immune reconstitution…

A phase I/II *minor histocompatibility antigen UTA2-1 loaded, PD-L silenced Dendritic cell vaccination trial after allogeneic Stem Cell Transplantation to improve the safety and efficacy of Donor Lymphocyte Infusions.

Primary objectives:- To evaluate the toxicity and feasibility of a DLI-combined minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination in B cell hematological malignancies- To evaluate the effect of a DLI-combined minor H ag UTA2-1…

A phase I/II trial to boost the graft-versus-tumor effect of Allogeneic Stem Cell Transplantation by vaccination with PD-L silenced, minor histocompatibility antigen UTA2-1 peptide-loaded Dendritic Cells

Primary objectives: - To evaluate the toxicity and feasibility of a preemptive minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination.- To evaluate the effect of a minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination on…

A phase I/II post-cord blood HCT dendritic cell vaccination trial directed against WT1 for pediatric acute myeloid leukemia: the U-DANCE-anti-AML trial

Although DC vaccinations have been used in allo-HCT settings, no previous studies have been performed using a CBDC vaccine after CBT. This study will therefore be subdivided into 2 parts:- Part A: to determine a safe dose of the vaccination, and -…

Umbilical cord blood transplantation in high-risk hematological patients using stemregenin-1 expanded hematopoietic stem cells.
A feasibility study focussing on engraftment and hematopoietic recovery.

To study the feasibility of single UCBT with one ex-vivo SR-1 expanded unitTo assess side effects and TRM after single UCBT with one expanded unitTo assess engraftment and engraftment kinetics; to evaluate immune reconstitution, acute and chronic…

Infusion of ex vivo-cultured allogeneic NK cells in acute myeloid leukemia patients not eligible for stem cell transplantation (a phase I dose escalation study)

The primary aim of our study is to evaluate safety and toxicity of ex vivo-expanded NK cell infusions following a non-myeloablative conditioning regimen in elderly AML patients who are no candidates for allogeneic SCT. Moreover there is also a…

ADMINISTRATION OF HA-1 TCR TRANSDUCED VIRUS-SPECIFIC T-CELLS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION IN PATIENTS WITH HIGH-RISK LEUKEMIA (LUMC 2010-02)

Primary Objective• To investigate the feasibility and safety of administration of donor HA-1 TCR transduced virus-specific T-cells after allo-SCT.Secondary Objectives• To evaluate the persistence of donor HA-1 TCR transduced virus-specific T-cells…

Double umbilical cord blood transplantation in high-risk haematological patients.
A phase II study focussing on the mechanism of graft predominance

Objective of the study is to evaluate whether parameters can be identified that predict which graft ultimately prevails following cord blood transplantation after a reduced intensity conditioning regimen in adult patients .In addition engraftment,…

Vaccination with minor histocompatibility antigen-loaded donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem cell transplantation (a phase I study)

The primary objectives of our study are to evaluate safety, toxicity and capability of inducing T cell responses of vaccination with, monocyte-derived donor DC electroporated with mRNA encoding hematopoietic-restricted MiHA in patients who had…

Mesenchymal stromal cells for treatment of drug resistant pediatric Juvenile idiopathic arthritis

To find out if intravenous MSC is a safe treatment for children with therapy-resistant JIA

A Randomized Phase III study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.

To evaluate LFS after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy

Safety of allogeneic bone marrow derived mesenchymal stromal cell therapy in renal transplant recipients

To study whether selected allogeneic bone marrow derived MSCs are safe by assessing the composite end point Biopsy Proven Acute Rejection (BPAR)/ graft loss at 12 months

PSCT19 Vaccination with PD-L1/L2-silenced minor histocompatibility antigen-loaded donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem cell transplantation (a phase I/II study)

The primary objectives of our study are to evaluate safety, toxicity and capability of inducing T cell responses of vaccination with, monocyte-derived donor DC transfected with PD-L1/L2 siRNA and electroporated with mRNA encoding hematopoietic-…

Phase I, randomized, parallel group, placebo control, unicentric, interventional study to assess the effect of expanded human allogeneic adipose-derived mesenchymal adult stem cells on the human response to lipopolysaccharide in human volunteers

To investigate the effect of expanded adipose-derived allogeneic adult stem cells (eASCs) on the inflammatory response to intravenous LPS in humans.

Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulas in Patients with Refractory Perianal Crohn*s Disease

In a dose escalation study we will determine the safety and preliminary efficacy of allogeneic bmMSCs in the induction of response for active fistulizing CD.

TREATMENT WITH CMV PP65 SPECIFIC T CELLS GENERATED BY USE OF A CMV PP65 PROTEIN-SPANNING PEPTIDE POOL IN PATIENTS WITH CMV REACTIVATION OR CMV DISEASE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION

• To assess the feasibility, tolerability and safety of administration of donor or patient derived CMV pp65-specific T cells in patients with CMV reactivation or CMV disease after alloSCT.• To determine the presence of CMV specific T cells at…

A randomized phase II study for the evaluation of T cell depleted non-myeloablative
allogeneic stem cell transplantation followed by early consolidation with lenalidomide
or lenalidomide combined with bortezomib and subsequent DLI for patients with
multiple myeloma in progression or relapse following first line therapy

Primary objective:Assesment of feasibility and toxicity of T cell depleted NMA Allo-SCT followed by lenalidomide or lenalidomide combined with bortezomib,and subsequent DLI; as treatment of relapsed multiple myeloma.Secondary objectives:To…