we are going to test a type of stem cells in a specific disease and expecting the results after six months. Is just not observing any abnormal signs and -of course- deaths in the models enough to say that the drug was safe to start clinical trials on humans ( I know it must be effective also)?
yeah, as kamil mentioned, it's a bit too simple to only use the observed "no bad" effect is enough. you need lots of test, if it's a drug, but you mentioned stem cell treatment, maybe you can clarify that, it will be very different if it's a small molecule drug or stem cell.
for drug, you need to do preclinical pharmcodynamic, pharmacokenetic study to test the drug metabolism unless it's been tested. meanwhile, you have to do cytogenetic toxicity test...etc before you can really file an IND. maybe you should consult a pharmacologist in your school first.
First in human studies are all about short-term safety. Usually you must find DL10 for a candidate drug in animal models, and set initially this as maximal first dose in humans. DL10 is the dose associated with 10% rate of unwanted effect in animal (adverse event or death), that will be converted to human dosing by conventional formulas (e.g., mg/kg in animals to mg/m2 in human). Then, an empirical schedule for dose escalation is proposed based on preliminary PK data or investigator opinion, and you can run a phase I trial. More on this: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684552
Many thanks to all of you
It is about stem cells. I asked this way as I didn't expect a difference.
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