Author Correction: At the end of the beginning: immunotherapies as living drugs.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Proceedings: cell therapies for Parkinson's disease from discovery to clinic.

In March 2013, the California Institute for Regenerative Medicine, in collaboration with the NIH Center for Regenerative Medicine, held a 2-day workshop on cell therapies for Parkinson's disease (PD), with the goals of reviewing the state of stem cell research for the treatment of PD and discussing and refining the approach and the appropriate patient populations in which to plan and conduct new clinical trials using stem cell-based therapies for PD. Workshop participants identified priorities for research, development, and funding; discussed existing resources and initiatives; and outlined a path to the clinic for a stem cell-based therapy for PD. A consensus emerged among participants that the development of cell replacement therapies for PD using stem cell-derived products could potentially offer substantial benefits to patients.

Proceedings: international regulatory considerations on development pathways for cell therapies.

Regenerative medicine is a rapidly evolving field that faces novel scientific and regulatory challenges. In September 2013, the International Workshop on Regulatory Pathways for Cell Therapies was convened to discuss the nature of these challenges and potential solutions and to highlight opportunities for potential convergence between different regulatory bodies that might assist the field's development. The workshop discussions generated potentially actionable steps in five main areas that could mitigate cell therapy development pathway risk and accelerate moving promising therapies to patients.

How California Institute for Regenerative Medicine research programs support science and regulatory policy.

The authors discuss the California Institute for Regenerative Medicine’s focus on state, national, and international regulatory policy issues impacting basic research and translational medicine.

The proceedings of the California Stem Cell Agency.

The California Institute for Regenerative Medicine (CIRM) is a state agency charged with accelerating stem cell research through the dispersal of $3 billion in funds for stem cell research. CIRM is partnering with Stem Cells Translational Medicine to launch the Proceedings of the California Stem Cell Agency, a monthly series of commentaries, articles, interviews, webinars, forums, and concise reviews on a wide range of topics in regenerative medicine.

The potential for immunogenicity of autologous induced pluripotent stem cell-derived therapies.

Induced pluripotent stem cell (iPSC) technology offers the promise of immune-matched cell therapies for a wide range of diseases and injuries. It is generally assumed that cells derived from autologous iPSCs will be immune-privileged. However, there are reasons to question this assumption, including recent studies that have tested iPSC immunogenicity in various ways with conflicting results.

Translation of stem cell research: points to consider in designing preclinical animal studies.

Stem cell-based therapies hold tremendous promise for the treatment of serious diseases and injuries. Although hematopoietic stem cell transplantation is routinely used as part of the treatment regime for some malignancies and genetic diseases, most stem cell-based therapeutic products are investigational and still require preclinical and clinical studies to support their many novel therapeutic uses. Because of the multiple sources of stem cells, the plethora of potential applications, and the novel mechanism of action of stem cell-based therapies, there is no single set of universal guidance documents that can be used to inform the preclinical development path for these therapeutics.

Perspective: communications with the Food and Drug Administration on the development pathway for a cell-based therapy: why, what, when, and how?

Effective interaction between key stakeholders and the U.S. Food and Drug Administration (FDA) is central to successfully navigating the regulatory process and advancing new therapies into clinical trials.

The Alpha Stem Cell Clinic: a model for evaluating and delivering stem cell-based therapies.

Cellular therapies require the careful preparation, expansion, characterization, and delivery of cells in a clinical environment. There are major challenges associated with the delivery of cell therapies and high costs that will limit the companies available to fully evaluate their merit in clinical trials, and will handicap their application at the present financial environment. Cells will be manufactured in good manufacturing practice or near-equivalent facilities with prerequisite safety practices in place, and cell delivery systems will be specialized and require well-trained medical and nursing staff, technicians or nurses trained to handle cells once delivered, patient counselors, as well as statisticians and database managers who will oversee the monitoring of patients in relatively long-term follow-up studies.

Oncogenomics 2005 meeting report: dissecting cancer through genome research.

The Oncogenomics Conference was held on February 2 to 5, 2005 at the Omni San Diego Hotel, San Diego, CA. The meeting chairpersons were Dr. Jeffrey Trent (Translational Genomics Research Institute, Phoenix, AZ) and Dr.

Capacity building for the clinical investigation of AIDS malignancy in East Africa.

Purpose: To build capacity in the resource-poor setting to support the clinical investigation and treatment of AIDS-related malignancies in a region of the world hardest hit by the AIDS pandemic.

Methods: An initial MEDLINE database search for international collaborative partnerships dedicated to AIDS malignancies in developing countries failed to identify any leads. This search prompted us to report progress on our collaboration in this aspect of the epidemic.

Annual report to the nation on the status of cancer, 1973-1999, featuring implications of age and aging on U.S. cancer burden.

Background: The American Cancer Society, the National Cancer Institute, the North American Association of Central Cancer Registries (NAACCR), the National Institute on Aging (NIA), and the Centers for Disease Control and Prevention, including the National Center for Health Statistics (NCHS) and the National Center for Chronic Disease Prevention and Health Promotion, collaborated to provide an annual update on cancer occurrence and trends in the United States. This year's report contained a special feature focusing on implications of age and aging on the U.S.