(MITREG) Checklist
Must	Should	May
			(1) Cells at the start of procedure
			(a) Essential information about the donor
			(i) Species and strain
			Species
			Strain (if applicable)
			(ii) Characteristics of the organism
			Health
			Age
			Treatment/Environment
			Individual identifier number
			Source of purchase (if applicable)
			(b) Source of cell material
			Organ, tissue, fluid, or blood product
			Source (if applicable)
			Quantity (volume, size, or weight)
			Anti-coagulant (if applicable)
			If using cryopreserved sample
			Method and duration of storage
			Initial cell counts
			Ethical committee approval/written informed consent
			(c) Cell separation process
			(i) Cell handling and labeling
			Cell extraction method
			Tissue conditions between tissue retrieval and cell separation
			Duration
			Temperature
			Container
			Fluid
			Cell labeling
			Buffers and reagents (incl. source)
			Cell suspension volume and concentration
			Incubation temperature and duration
			Washing steps
			(ii) Cell separation equipment and process
			Methodology
			Equipment
			Presence of target cells in starting material described
			(d) Phenotype
			For any of the below, indicate the percentage of cells displaying the characteristic (if known)
			(i) Cell surface and intracellular markers
			Molecules measured [using cluster of differentiation (CD) names]
			Details of reagents used and source (incl. mAb clone, fluorochrome)
			Methodology
			Stimulus and time of stimulation (if applicable)
			Gating strategy to determine positive cells
			(ii) Secreted molecules
			Molecules measured
			Details of reagents used (incl. mAb clone, conjugate) and source
			Methodology
			Cell density/ml of medium and type of tissue culture plate
			Time point of supernatant collection
			Stimulus and time of stimulation (if applicable)
			(iii) Epigenetic modifications
			Epigenetic modification relevant to the characteristics
			(iv) Specificity
			Specificity of the cells (polyclonal or antigen-specific)
			Methodology used to obtain specificity
			Methodology used to confirm specificity
			(e) Cell numbers
			(i) Absolute cell number
			Total number of cells at the end of the isolation process
			Methodology
			(ii) Viability
			Percentage of viable cells
			Methodology
			(2) Expansion/differentiation
			(a) Pre-culture conditions
			Storage conditions
			Fluid
			Type of container
			Temperature
			Fresh or thawed
			Storage time
			(b) Culture conditions
			(i) Cell number
			The total number of cells put into culture
			(ii) Cell concentration
			The number of cells per ml of medium at start of culture
			(iii) Culture medium
			Type(s) of medium
			Source(s)
			Additives (excluding agents to maintain/induce T regulatory cells)
			Refreshment of the medium
			(iv) Culture container
			Type of container
			Size
			Manufacturer
			Cell culture volume per container or well
			Total number of containers or wells
			(v) Culture environment
			Temperature and CO2 concentration
			Use of pre-warmed medium
			Equipment
			(c) Differentiation/tolerization protocol
			Name of cytokine(s) or other agent(s) used
			Concentrations
			Time point(s) added to cell culture
			Total length of the culture period
			Rounds of stimulation
			Number of cell splitting
			(d) Stimulus
			Polyclonal/antigen-specific/alloantigen
			Stimulus (agent and/or accessory cell)
			Source
			Concentration
			Time point(s) added to culture
			Restimulation conditions (if applicable)
			(e) Storage
			Storage time
			Storage conditions
			If fresh
			Fluid
			Container
			Temperature
			If cryopreserved
			Freezing/thawing process
			Freezing medium
			Cell recovery and viability after thawing
			Time point at which cells are stored if different to the end of the culture process
			(3) Cells after expansion/differentiation
			(a) Phenotype
			For any of the below, indicate the percentage of cells displaying the characteristic (if known)
			Stability of the phenotype (if tested)
			Phenotype tested on fresh or thawed cells
			(i) Cell surface and intracellular markers
			Molecules measured (using CD names)
			Details of reagents used and source
			Methodology
			Stimulus and time of stimulation (if applicable)
			Gating strategy to determine positive cells
			(ii) Secreted molecules
			Molecules measured
			Details of reagents used and source
			Methodology
			Cell density/milliliter of medium and type of tissue culture plate
			Time point of supernatant collection
			Stimulus and time of stimulation (if applicable)
			(iii) Epigenetic modifications
			Epigenetic modification relevant to the characteristics
			(b) Functional assay
			Response of the cells to a defined stimulus
			Behaviour of other biological entities after exposure to the cells
			If using accessory cells, describe phenotype and source
			(c) Cell numbers
			(i) Absolute cell number
			Total number of cells at the end of the expansion process
			Methodology
			(ii) Viability
			Percentage of viable cells
			Methodology
			(d) Dosing
			Dose of cells transferred into organism (if applicable)
			Vehicle (solvent/medium) and intermediate components (for clinical trials only)
			(e) Quality control (for clinical trial only)
			Specificity
			Purity
			Sterility
			Potency
			(4) About the protocol
			(a) Regulatory authority
			External authority that approved the protocol
			Does protocol follow Good Manufacturing Practice?
			(b) Purpose
			The disorder for which the cell treatment has been manufactured
			(c) Relationship between the source organism for the cells and the target organism
			Allogeneic/autologous/xenogeneic/syngeneic
			(d) Contact details
			Name and contact information of the corresponding author(s)
			(e) Citation
			Acknowledge the MITREG reporting guidelines