Expanding the manufacturing capacity for cell and gene therapies: an interview with Julie G Allickson.

Julie G Allickson, PhD, is the Michael S and Mary Sue Shannon Family Director of Mayo Clinic's Center for Regenerative Biotherapeutics at Mayo Clinic (Minnesota, Florida and Arizona) and the Otto Bremer Trust Director, Biomanufacturing and Product Development, Center for Regenerative Biotherapeutics. With over 25 years of experience in regenerative medicine, cellular therapies and regulatory affairs, Dr Allickson leads the center as it pivots toward biomanufacturing, ensuring that discoveries are successful for clinical translation and eventually commercialization. The center is in the process of building their industry experienced team on all pillars of biomanufacturing to support clinical and principal investigators at the Mayo Clinic.

Dynamic Changes in Erectile Function and Histological Architecture After Intracorporal Injection of Human Placental Stem Cells in a Pelvic Neurovascular Injury Rat Model.

Introduction: The human placenta provides a bountiful and noncontroversial source of stem cells which have the potential for regeneration of injured tissue. These cells may restore erectile function after neurovascular tissue injury such as that seen in radical pelvic surgeries and pelvic trauma.

Aim: To determine the effect of human placenta-derived stem cells on erectile function recovery and histological changes at various time points in a cavernous nerve injury rat model and to study the fate of injected stem cells throughout the regenerative process.

A consensus introduction to serum replacements and serum-free media for cellular therapies.

The cell therapy industry is a fast-growing industry targeted toward a myriad of clinical indications. As the cell therapy industry matures and clinical trials hit their pivotal Phase 3 studies, there will be a significant need for scale-up, process validation, and critical raw material quality assurance. Part of the well discussed challenges of upscaling manufacturing processes there is a less discussed issue relating to the availability of raw materials in the needed quality and quantities.

The battle of the sexes for stroke therapy: female- versus male-derived stem cells.

Cell therapy is a major discipline of regenerative medicine that has been continually growing over the last two decades. The aging of the population necessitates discovery of therapeutic innovations to combat debilitating disorders, such as stroke. Menstrual blood and Sertoli cells are two gender-specific sources of viable transplantable cells for stroke therapy.

Menstrual blood transplantation for ischemic stroke: Therapeutic mechanisms and practical issues.

Cerebrovascular diseases are a major cause of death and long-term disability in developed countries. Tissue plasmin activator (tPA) is the only approved therapy for ischemic stroke, strongly limited by the short therapeutic window and hemorrhagic complications, therefore excluding most patients from its benefits. The rescue of the penumbra area of the ischemic infarct is decisive for functional recovery after stroke.

Toward personalized cell therapies: autologous menstrual blood cells for stroke.

Cell therapy has been established as an important field of research with considerable progress in the last years. At the same time, the progressive aging of the population has highlighted the importance of discovering therapeutic alternatives for diseases of high incidence and disability, such as stroke. Menstrual blood is a recently discovered source of stem cells with potential relevance for the treatment of stroke.

Recent Studies Assessing the Proliferative Capability of a Novel Adult Stem Cell Identified in Menstrual Blood.

We are in the beginning of the era of regenerative medicine and many researchers are testing adult stem cells to be used for tissue repair and regeneration in the human body. Many adult stem cells have been discovered since the late 1990's with more recently a novel adult stem cell described in menstrual blood. The menstrual blood is derived from shedding of the endometrial lining, specifically the functionalis layer, which contains highly proliferative cells used to prepare the female body for implementation of a fertilized egg.

Recent progress in cell therapy for basal ganglia disorders with emphasis on menstrual blood transplantation in stroke.

Cerebrovascular diseases are the third leading cause of death and the primary cause of long-term disability in the United States. The only approved therapy for stroke is tPA, strongly limited by the short therapeutic window and hemorrhagic complications, therefore excluding most patients from its benefits. Parkinson's and Huntington's disease are the other two most studied basal ganglia diseases and, as stroke, have very limited treatment options.

The treatment of neurodegenerative disorders using umbilical cord blood and menstrual blood-derived stem cells.

Stem cell transplantation is a potentially important means of treatment for a number of disorders. Two different stem cell populations of interest are mononuclear umbilical cord blood cells and menstrual blood-derived stem cells. These cells are relatively easy to obtain, appear to be pluripotent, and are immunologically immature.

Menstrual blood cells display stem cell-like phenotypic markers and exert neuroprotection following transplantation in experimental stroke.

Cell therapy remains an experimental treatment for neurological disorders. A major obstacle in pursuing the clinical application of this therapy is finding the optimal cell type that will allow benefit to a large patient population with minimal complications. A cell type that is a complete match of the transplant recipient appears as an optimal scenario.

Multipotent menstrual blood stromal stem cells: isolation, characterization, and differentiation.

The stromal stem cell fraction of many tissues and organs has demonstrated to exhibit stem cell properties such as the capability of self-renewal and multipotency, allowing for multilineage differentiation. In this study, we characterize a population of stromal stem cells derived from menstrual blood (MenSCs). We demonstrate that MenSCs are easily expandable to clinical relevance and express multipotent markers such as Oct-4, SSEA-4, and c-kit at the molecular and cellular level.