|Comments V1 - Cecile Gouttefangeas, PhD (University of Tuebingen, Germany); posted on July 1, 2010|
Thanks for the summary and version 1.0 of MIATA.
Here my few comments to the new document:
Module 1D: quality of cell material
"mean recovery and viability”: what is meant here is probably after isolation and before freezing of the cells. I would make it clear to avoid confusion with Module 2A.
Module 2A: cell counting
To make it perfectly clear: add “after thawing”. If assay is done on fresh cells, then 2A is equivalent to 1D?
“Cell recovery”: this parameter may be difficult to give with high precision when manual freezing and counting are used, cell viability is the most important parameter.
Module 2C: the assay
Info on how many replicates were performed should be included.
“Details about treatment procedures of cells”: I would add cytokines including manufacturers, dose and frequency.
Module 2D: controls
Details about "which details" are required should be given: i.e. addition of a control sample (PBMC, T-cell clone); control stimulation for checking cell viability.
Module 4: The results
I have no further comment except one regarding the response determination: in trials involving many patients and time points, it may well be that publications do not include each single data (possibly given in the supplmentary info), but a summary of them: in this case, I think that the info on how many time points should be "positive" to declare a patient responder should be given (i.e. 1, 2, more??)