Cell processing and manufacture of any product must be conducted under scrupulous, expert, and independent review Demonstrate that the product is safe, pure and potent 6. Product Show that the product has been registered registration with the National Pharmaceutical Control Bureau before use in human trials License for clinical trial has been obtained 7. Cell History of the cells in the stem cell or cell- characterization ( based product pre-requisite to clinical trials) Biological characterisation of cell type Demonstration of purity Demonstration of potency (e.g. cells produce insulin in a physiological manner) Manufacturing standards and independent certification, where relevant Evidence that cells are free from contamination Evidence of viability and longevity of after transplantation (to determine the likely duration of the therapeutic effect) Evidence that cells will home into the area of damage or repair Evidence of genomic stability during culture 8. Investigators and Is the Principal Investigator trained in cell researchers transplantation? (Show evidence of credentialing) Are other investigators trained in cell transplantation? (Show evidence of credentialing) Qualifications of scientists and researchers Registration with National Medical Research Register, Ministry of Health (MOH) 9. Centres Registration with PHCFS Act, Ministry of performing Health therapy (Information for Informing subjects about the human patients) embryonic cell source, if applicable
Cell processing and manufacture of any product must be conducted under scrupulous, expert, and independent review Demonstrate that the product is safe, pure and potent 6. Product registration Show that the product has been registered with the National Pharmaceutical Control Bureau before use in human trials License for clinical trial has been obtained 7. Cell characterization ( pre-requisite to clinical trials) History of the cells in the stem cell or cell- based product Biological characterisation of cell type Demonstration of purity Demonstration of potency (e.g. cells produce insulin in a physiological manner) Manufacturing standards and independent certification, where relevant Evidence that cells are free from contamination Evidence of viability and longevity of after transplantation (to determine the likely duration of the therapeutic effect) Evidence that cells will home into the area of damage or repair Evidence of genomic stability during culture 8. Investigators and researchers Is the Principal Investigator trained in cell transplantation? (Show evidence of credentialing) Are other investigators trained in cell transplantation? (Show evidence of credentialing) Qualifications of scientists and researchers Registration with National Medical Research Register, Ministry of Health (MOH) 9. Centres performing therapy (Information for patients) Registration with PHCFS Act, Ministry of Health Informing subjects about the human embryonic cell source, if applicable