Newly developed nanoparticles for cell tracking using magnetic resonance imaging .PDF 1.42MB

The utilisation of magnetic resonance imaging (MRI) to noninvasively monitor cells using superparamagnetic iron oxide nanoparticles (SPIONs) as MRI contrast agents has been one of the major research focuses over the past several years. The ability to use MRI to image longitudinally offers an invaluable opportunity to track the migration, persistence and distribution of cell based therapeutics in vivo in humans.

Current approaches for cell labelling have focused on using commercial SPIONs with varying success. Therefore, there is a clinical need to develop SPIONs that are non-toxic, with appropriate size and high MRI contrast. We have utilised SPIONs with a silica coating to investigate the labelling ability and contrast enhancement of CD45+ and CD34+ expressing cells.

--------------------------------------------------------------------------------

Commercializing Cell Based Therapies within or alongside an Academic Institution .PDF 840Kb

Cell Therapies P/L is an independent CMO specialising in translational medicine where cGMP skills are required. We would appear to have achieved a novel position in that we are a successful commercial venture running inside/alongside an academic institution.

We are a multidisciplinary resource with a track record of translating research protocols into successful clinical trials. Our clients are organisations that need to manage their risk profile and have embraced an outsourcing policy.

--------------------------------------------------------------------------------

Obtaining Manufacturing Approval for the First Culture Expanded Adult Stem Cell Therapy under an Evolving Regulatory Framework: Challenges and Opportunities .PDF 50Kb

In 2002, the Australian Government committed to a new framework to allow biological products to be regulated as a distinct class of goods. The new legislation was passed by the Senate in 2010 and will be implemented by 31 May 2011. Administered by the Therapeutics Goods Administration (TGA), and known as the “Biologicals Framework” it will radically reshape the regulatory environment applying to cellular therapies for both existing licence holders and potential applicants. Products will be divided into four categories based on degree of manipulation, intended use and risk.

Preparing a licensure submission is demanding at any time: doing so in the context of an evolving regulatory framework, and with a novel therapy, compounds the challenges involved. We present our experiences in navigating this pathway and discuss the challenges and opportunities that we have encountered in the process.

--------------------------------------------------------------------------------

Effective collaboration between laboratory and clinical researchers is vital for improving the outcomes of patients with cancer .PDF 445Kb

Using basic research, clinical trials and collaboration with industry to maximise the future impact of research findings for cancer patients. Our translational research aims to foster dialogue and collaboration between Cancer Research and the clinical divisions of Peter Mac, with the ultimate goal of accelerating the application of research findings into clinical practice.

The fusion of an integrated research environment within a dedicated specialist cancer hospital provides unique opportunities to support our translational focus. Close collaborations between laboratory and clinical researchers facilitates important developments in clinical practice, and ensures our continued leadership role in translating research findings into clinical practice to provide patients with new and better treatment options.

--------------------------------------------------------------------------------

Autologous Cellular Therapies .PDF 67Kb

Numerous autologous cell-based therapies currently are being developed in public and private biotech companies across the United States and, to a lesser degree, around the world.

Cell-based therapies may hold the promise of providing new opportunities for managing immune-mediated chronic diseases and some forms of cancer and for repairing or replacing degenerated tissues with regenerated healthy tissues.

--------------------------------------------------------------------------------

Analysis and Characterization of Antitumor T-cell Response 459KB

The primary goal of cancer vaccines is to induce CD8+ T cells specific for tumor-associated antigens (TAA) but the characterization of these cells has been difficult because of the low sensitivity of ex vivo assays. Here, we focused on TAAspecific CD8+ T-cell responses in melanoma patients after vaccination with autologous dendritic cells loaded with lysates derived from allogeneic tumor-cell lines (Lysate-DC).

Out of 40 patients treated, 16 patients developed immune response to tumor-cell lysate and/or CD8+ T cells specific for differentiation and cancer-testis antigens. TAA-specific CD8+ T-cell responses were detected by interferon (IFN)-g enzyme-linked immunospot after in vitro sensitization and were, either transient during the treatment period or delayed, that is, observed after completion of all vaccinations.

--------------------------------------------------------------------------------

Prediction of CD34+ PBSC Collection .pdf 300 Kb

Despite its acceptance as an effective treatment option in a range of haematological & other settings, peripheral blood stem cell (PBSC) collection & cryopreservation for later re-infusion post- myeloablative therapy remains a highly resourceDespite it’s acceptance as an effective treatment option in a range of haematological & other settings, peripheral blood stem cell (PBSC) collection & cryopreservation for later re-infusion post- myeloablative therapy remains a highly resource consumptive procedure. consumptive procedure1

Our primary aim was to investigate the affect that mobilisation regimen had on the ability of the PB CD34 count (x106/L) to predict the collection CD34 (x106/kg).

--------------------------------------------------------------------------------

Tracking Dendritic Cells PDF 211Kb

The objective of this study was to determine the in-vivo distribution of dendritic cells (DC) when given to patients (pts) with Multiple Myeloma (MM).

--------------------------------------------------------------------------------

Technological Trajectories and Stem Cell "Dominant Design" .PDF 805Kb

Collaborating with Ray Wood, the Managing Director of Cell Therapies Pty Ltd, we expand on the premise of the primary article and further discuss the likelihood and attributes for the emergence of a dominant design in the stem cell industry. First of all, we need draw a distinction between a dominant cell type and a dominant commercial design. By utilizing the concept of technology "factors" or "trajectories," we will provide an outline of how the coincidence of multiple technological solutions and commercial dynamics (each with their own development path or "trajectory") will influence the makeup and timing of a dominant design.

--------------------------------------------------------------------------------

View Poster .PDF 647 kb

High-dose myeloablative therapy in conjunction with Autologous Peripheral Blood Stem Cell (APBSC) transplantation is being used with increased frequency to treat a range of haematological malignancies including Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) and Acute Myeloid Leukemia (AML).

--------------------------------------------------------------------------------

Cancer Vaccines/Adjuvants/Delivery - Lisbon .PDF 77Kb

The investigational drug Uvidem® is a cryopreserved autologous dendritic cell vaccine for the treatment of patients with advanced/high risk malignant melanoma. We have standardized a clinically compatible process to generate large quantities of monocyte-derived dendritic cells (DCs), in serum-free medium containing GM-CSF and IL-13. The vaccine includes DC loaded with lysates produced from 3 allogeneic melanoma tumor cell lines: M44, COLO 829 and SK-MEL-28.

--------------------------------------------------------------------------------

A phase I/II study of a multivalent dendritic cell vaccine in patients with metastatic melanoma .PDF 203Kb

CONCLUSIONS According to protocol objectives: ��Treatment is feasible ��Treatment is well tolerated: most AEs were mild and not related to treatment ��Treatment induced an immune response in some patients, not significantly associated with matured or non matured dendritic cells ��No Complete or Partial Response according to RECIST criteria but disease stabilization in 10 patients

--------------------------------------------------------------------------------

IDM Press Release ASCO .PDF 54Kb

--------------------------------------------------------------------------------

Cell Tracking Powerpoint Presentation .PPT 858Kb

--------------------------------------------------------------------------------

Cell processing for clinical trials and commercial manufacture .PDF 472Kb

"We elected to design and construct a facility that would remain as “generic“ as possible, to enable adaptation to potential future demands of CT. This design meets the technical and regulatory demands required to sustain cells in short- and long-term culture (process cleanroom) as well as meeting the sometimes conflicting requirements for gene transduction protocols (process cleanroom, containment). Because of our own long-term research objectives, we also incorporated more specialized equipment, such as a high-speed cell sorter for rare target cell isolation, within the cleanroom environment."

--------------------------------------------------------------------------------

I.S.C.T. Poster of Sequential tomographic tracking and localisation .PDF 2.2MB

Sequential tomographic tracking and localisation in vivo of dendritic and macrophage cells by various routes of administration into humans by in vitro labelling of cells with ¹¹¹Indium oxine and ¹⁸F fluoro-deoxyglucose.

--------------------------------------------------------------------------------

Regulation of Cellular Therapies: the Australian Perspective .PDF 82Kb

"The first step in the process of regulating cell-based products was taken in 1991, when the code of good manufacturing practice (cGMP) for 'Blood and Blood Components' was instituted." "The TGA will become the formal regulator of all cell-based therapies and laboratories will be required to apply for cGMP auditing and licensing. It is likely that the Foundation for the Accreditation of Cellular Therapy (FACT) guidelines or others of a similar nature, will form the basis of one of the regulatory standards for HSC processing. Of particular note is the the inclusion of apheresis as an integral component of cGMP licensing.

--------------------------------------------------------------------------------