Stem Cell Therapy for Spinal Cord Injuries

Stem cell-based therapies are an emerging branch of medicine with the purpose of restoring tissue function for patients with serious injuries, such as a spinal cord injury. As a result, scientists and engineers are increasing research efforts in the field of regenerative medicine. Due to the delicate nature of stem cells, producing the large quantity required for a successful therapy has proved challenging. In recent years, research has shown the potential of stem cell-based therapies, and thus there is a need for the commercialization of these treatments. The proposed facility targets the demand for spinal cord injury treatments and can support production for both clinical trials and a commercial release. Bioreactors designed specifically for the culture and growth of stem cells have flexibility in their ability to support different stem cell lines for various therapies. Small reactors in parallel can easily adapt to changes in production size. This process also takes advantage of the best options currently available for purification and preservation to maximize the product yield. Due to the strict regulations set in place by the FDA and lack of adequate funding, there is an untapped market for stem cell therapies for spinal cord injuries. Approximately 250,000 people in the United States suffer from spinal cord injuries, varying in severity, and this patient base increases at a rate of 12,000 new injuries every year (“Spinal Cord Injury Facts and Figures”, 2009). Future markets include expansion into Europe and Asia. There are two steps to this proposal: the upstream process and the downstream process. The upstream process includes the scale-up, differentiation, and purification of human embryonic stem cells; the downstream process consists of the scale-up of neurons for injection. The upstream process will be built initially and yield enough cells for clinical trials, without incurring the capital costs of building the entire plant. Upon success of the clinical trials, the downstream process will be built for maximum production. The profitability of this proposal is based on running 26 batches a year at 1.02x1010 cells per batch or 2.66x1011 cells per year. By targeting 5,000 patients, two percent of the current market, and charging $45,000 per dose, a profitable profile can be created. Assuming 50$961,892,600, and 242.81% respectively. Using a 50% production capacity allows for higher profit margins upon expansion. The proposed plan will meet the need of this growing market

Development and testing of the insulin treatment experience questionnaire (ITEQ)

OBJECTIVES: To develop and psychometrically evaluate a domain-specific questionnaire to assess subtle but clinically relevant differences in treatment experiences and satisfaction over a wide range of currently available insulin therapy regimens. The study focussed on patients with type 2 diabetes mellitus and placed particular attention on the impact of different forms of insulin therapy on diabetes self-management. METHODS: The development of the Insulin Treatment Experience Questionnaire (ITEQ) was conducted in three steps: (i) a qualitative phase to generate relevant items and identify relevant domains; (ii) a pilot study to reduce the number of generated items; and (iii) a validation study to assess major psychometric properties of the final ITEQ version. RESULTS: The final version of the questionnaire comprised 28 items with the subscales 'leisure activities' (four items), 'psychological barriers' (two items), 'handling' (five items), 'diabetes control' (six items), 'dependence' (five items), 'weight control' (three items), 'sleep' (two items), and one further item assessing general treatment satisfaction. The subscales' internal consistencies (Cronbach's alpha) ranged from 0.52 to 0.83. Motivated by the homogenous structure of inter-scale-correlations (range 0.10-0.46), a summary composite score was calculated (alpha = 0.86). Construct validity showed statistically significant correlations with other scales (ITEQ vs the Problem Areas in Diabetes [PAID] questionnaire total score -0.60, ITEQ vs the Diabetes Treatment Satisfaction Questionnaire [DTSQ] total score 0.52). CONCLUSION: The newly developed ITEQ displayed satisfactory to good psychometric properties, thereby allowing the assessment of everyday life experience and treatment satisfaction in patients with insulin-treated type 2 diabetes. Additional research is needed to assess test-retest reliability and sensitivity to change

Development and Testing of the Insulin Treatment Experience Questionnaire (ITEQ)

Objectives: To develop and psychometrically evaluate a domain-specific questionnaire to assess subtle but clinically relevant differences in treatment experiences and satisfaction over a wide range of currently available insulin therapy regimens. The study focussed on patients with type 2 diabetes mellitus and placed particular attention on the impact of different forms of insulin therapy on diabetes self-management. Methods: The development of the Insulin Treatment Experience Questionnaire (ITEQ) was conducted in three steps: (i) a qualitative phase to generate relevant items and identify relevant domains; (ii) a pilot study to reduce the number of generated items; and (iii) a validation study to assess major psychometric properties of the final ITEQ version. Results: The final version of the questionnaire comprised 28 items with the subscales 'leisure activities' (four items), 'psychological barriers' (two items), 'handling' (five items), 'diabetes control' (six items), 'dependence' (five items), 'weight control' (three items), 'sleep' (two items), and one further item assessing general treatment satisfaction. The subscales' internal consistencies (Cronbach's alpha) ranged from 0.52 to 0.83. Motivated by the homogenous structure of inter-scale-correlations (range 0.10-0.46), a summary composite score was calculated (alpha - 0.86). Construct validity showed statistically significant correlations with other scales (ITEQ vs the Problem Areas in Diabetes [PAID] questionnaire total score -0.60, ITEQ vs the Diabetes Treatment Satisfaction Questionnaire [DTSQ] total score 0.52). Conclusion: The newly developed ITEQ displayed satisfactory to good psychometric properties, thereby allowing the assessment of everyday life experience and treatment satisfaction in patients with insulin-treated type 2 diabetes. Additional research is needed to assess test-retest reliability and sensitivity to change.Diabetes-mellitus, treatment, Insulin, therapeutic se, Outcome-assessment-(health-care)