Recruitment Phase I trial with NK-cells for AML open
13-11-11
On November 1 st, 2011 our phase I study treatment of AML-patients with ex-vivo generated NK-cells has opened.
This trial is listed as HOVON-associated PLMA25 NK-cell study, see http://www.hovon.nl/studies/studies-per-ziektebeeld/aml.html?action=showstudie&studie_id=88&categorie_id=4
For an outline of the protocol see http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2818
For patient recruitment brochure see download section of our webiste.
This is the first study in which NK-cells derived from Umbilical Cord Blood using Glycostem Therapeutics’ proprietary GBGM® ex-vivo expansion / differentiation technology will be applied.
In this study we will together with the University Medical Center St Radboud in Nijmegen the Netherlands, test the safety and toxicity of allogeneic NK cell infusions with an escalating dose of ex vivo expanded NK cells following immunosuppressive conditioning therapy in elderly patients with AML.
AML-patients above 60 years, treated with intensive chemotherapy achieve complete remission (CR) rates of about 50%. However, over 75% of the patients relapse thereafter despite CR and only about 10% of those patients are still alive after 3 years.
Although allogeneic stem cell transplantation (SCT) can be curative, this option is unavailable for the majority of patients due to age and co-morbidity.
It has been demonstrated that Natural Killer (NK) cell alloreactivity can control relapse of AML without causing graft-versus-host disease (GVHD) in the setting of HLA-mismatched haploidentical allogeneic SCT. Furthermore, in non-transplant setting it has been demonstrated that allogeneic NK cell infusions can induce CR in poor-prognosis AML patients.
Unlike existing procedures we will generate allogeneic NK cell products ex vivo from CD34+ hematopoietic progenitor cells, previously enriched from umbilical cord blood (UCB).
ProGraft Study for Improving UCB transplantations
06-06-11
As per January 1st, 2011 Glycostem Therapeutics joined the Dutch ProGraft Study, together with Erasmus Medical Centre Rotterdam, Utrecht University and GE Healthcare.
The objective of the ProGraft study is to improve cord blood stem cell homing and engraftment.
Glycostem Therapeutics’ proprietary GBGM® expansion / differentiation technology for Hematopoietic Stem Cells (“HSC”) plays a central role in the ProGraft Study together with technology for down-regulating HSC differentiation.
A group of 15 patients will receive a transplant with HSC’s generated via this new method.
A second part of the study focuses on the visualization of the efficacy of the treatment. HSC’s will be labeled with metal spheres, so that they can be seen on an MRI scan.
Although the technique already exists, it will be applied in this manner for the first time during the ProGraft study.
For details of the ProGraft study, see http://www.tipharma.com/projects/drug-formulation-delivery-and-targeting...
