Figure 1. Although there have not yet been any clinical trials to prove that stem cell treatments are effective – and to demonstrate that they are safe – there are many companies offering treatments for a wide array of diseases and conditions. Unlike clinical trials, which typically do not cost the patient money beyond their…
The biology of human gene therapy is very complex, and there are many techniques that still need to be developed and diseases that need to be understood more fully before gene therapy can be used appropriately. In addition, because gene therapy involves making changes to the body’s genetic setup, it raises many unique ethical concerns. Scientific and…
ABOUT CONFERENCE In continuation to 1st successful past scientific meetings, 2nd World Congress on Genetics & Genetic Disorders will be held on May 13-14, 2019 on Stockholm, Sweden. EuroSciCon suggests every single person to attend “Genetics 2019” in the midst of May 13-14, 2019 at Stockholm, Sweden which merges brief keynote introductions, speaker talks, Poster Presentations , Exhibitions, Symposia, Workshops. Genetics 2019 will gather world-class educators, researchers,…
It is our pleasure to welcome you to the 1st Edition International Conference On Stemcell & Molecular Biology the Stemcell & Molecular Biology 2019 Special Conference builds on the hugely successful preceding conferences, hosted by the SciTech Conferences (STC). The program includes multiple opportunities for networking and interaction. As well as the lively Poster Discussion sessions, there will be Panel Discussions at…
D7 CODING AND LABELING OF CELLULAR THERAPY PRODUCTS D7.1 ISBT 128 CODING AND LABELING D7.1.1 Cellular therapy products shall be identified according to the proper name of the product, including appropriate modifiers and attributes, as defined in ISBT 128 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions. D7.1.2 If the Processing Facility has…
C9 CELLULAR THERAPY PRODUCT STORAGE C9.1 Apheresis Collection Facilities shall control storage areas to prevent mix-ups, deterioration, contamination, cross-contamination, and improper release or distribution of products. C9.2 Apheresis Collection Facilities shall establish policies for the duration and conditions of storage prior to distribution to a Processing Facility or Clinical Program. C10 CELLULAR THERAPY PRODUCT TRANSPORTATION…
CM9 CELLULAR THERAPY PRODUCT STORAGE CM9.1 Marrow Collection Facilities shall establish policies for the duration and conditions of storage prior to distribution to a Processing Facility or Clinical Program. CM10 CELLULAR THERAPY PRODUCT TRANSPORTATION AND SHIPPING CM10.1 Procedures for transportation and shipping of the cellular therapy product shall be designed to protect the integrity of…
B6.4 ADDITIONAL REQUIREMENTS FOR ALLOGENEIC DONORS B6.4.1 Allogeneic donors and allogeneic recipients shall be tested for ABO group and Rh type using two independently collected samples. Discrepancies shall be resolved and documented prior to issue of the cellular therapy product. B6.4.2 A red cell antibody screen shall be performed on allogeneic recipients. B6.4.3 Allogeneic donors…
CLINICAL PROGRAM STANDARDS: B1 GENERAL B1.1 The Clinical Program consists of an integrated medical team housed in geographically contiguous or proximate space with a Clinical Program Director(s) and common staff training, programs, protocols, and quality management systems. B1.1.1 Clinical Programs that include non-contiguous institutions shall demonstrate common protocols, procedures, quality management systems, and review of…