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Cellular Therapy Coding & Labeling Advisory Group

TerminologyGroup

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Task Group MembersAlan LankesterPat DistlerDerwood PamphilonLeigh PostonKathy LoperIneke Slaper-CortenbachPhyllis Warkentin


Assignment

• Review existing definitions in ISBT 128 data base for cellular therapy products

• Recommend:• Standard definitions for cellular products • Rules for future assignment of cellular product

codes • Retirement of existing terminology that does

not fit


Information Hierarchy

Definition Product Code


Product Definitions

Product


Methodology• Work within existing product code structure• Review existing terminology (FACT, AABB, NMDP, COI)• Start at the top with existing terms and definitions plus

suggested list from Alan LankesterClass → Modifiers → Attributes:

Core Conditions → Groups and variables• For each existing term, determine to retain, modify or

retire; then define. • Concentrate on most common products

• Suggest new terms needed within each area• Draft recommendations for comment


Product Code Hierarchy• CLASS – broad description of product

» Each product has only one class

• MODIFIER – describes physical state of product» Each product may have up to one modifier

• ATTRIBUTE » Each product may have many• CORE CONDITIONS:

• Anticoagulant / Collection Media » Only one• Collection volume » XX• Storage temperature » Only one

• GROUPS and VARIABLES:


Product Code Hierarchy• GROUPS and VARIABLES

» Each product can have many groups but only one variable from each group; variables are mutually exclusive.

Intended Use (Patient Use, Not for Patient Use)System Integrity (Closed, Open)CryoprotectantManipulationFurther ProcessingAdditivesAdditives – additional donor exposure


Example• CLASS HPC, APHERESIS• MODIFIER Cryopreserved• ATTRIBUTES: Core Conditions

• Anticoagulant Citrate• Collection Volume NS• Storage Temperature ≤ -150C

• ATTRIBUTES: Variables• Intended Use For Patient Use• System Integrity Open• Cryoprotectant 10% DMSO• Manipulation Plasma reduction• Additional additives none


Recommendations• CLASS – the product as collectedRetain the classes:

HPC, APHERESISHPC, CORD BLOODHPC, MARROWHPC, WHOLE BLOODCONCURRENT PLASMA, APHERESIS

Retire:POOLED HPC, APHERESIS

[“Pooled” will become modifier]


Recommendations

Retain the classes:TC, APHERESISTC, WHOLE BLOOD

Add:TC, MARROWTC, CORD BLOODTHERAPEUTIC CELLS

Modify the classes:TC-T CELLS TC-CYTOTOXIC LYMPHOCYTESTC-T REGULATORY CELLSTC-DENDRITIC CELLSTC-NATURAL KILLER CELLSTC-TUMOR DERIVED CELLSTC-MESENCHYMAL CELLS

• CLASS – the product as collected


Recommendations

Retain the modifiers:CryopreservedWashed (non-frozen)

Retire the modifiers:ThawedFrozenHeparinized

Add the Modifiers:Thawed WashedCulturedMobilized (TC, Apheresis)Pooled (same donor)

•MODIFIER – describes physical state of product


Recommendations

Simplify anticoagulants:NoneCitrateHeparinCitrate and HeparinNS (not specified)

Volume: (no change)XX

Storage Temperature:Retain: ?Retire:

Refg ≤ -120 RT≤ -18 C≤ -80 C≤ -150 CLN2 liquid

•ATTRIBUTE: CORE CONDITIONS


Recommendations

Intended Use (Patient use; Not for Patient use)System Integrity (Closed; Open [no default])Preparation - change to cryoprotectant only

No cryoprotectant6% HES + 5% DMSO (± 1%)10% DMSO (± 2%)5% DMSO (± 1%)DMSO content reduced by washing

•ATTRIBUTE: Groups and Variables


Recommendations

Additional Information (retire)[Was a mix of additives, cryoprotectants, split units, etc]

Manipulation GroupNoneDilutedPlasma reducedRBC reducedBuffy coat enrichedMNC enriched



Recommendations

Manipulation Group (cont)

T Cell depletedT Cell reducedB Cell reducedT/B Cell reducedCD 8 reduced

CD 34 enrichedCD 133 enrichedTumor cells reducedHPC expandedPUV treated



Recommendations

Preparation: AdditivesN/SHeparinHESAntibioticsCulture MediaOthers

Problem – variables must be mutually exclusive

Alternative:Preparation: Additives

Not specifiedNoYes – details in accompanying paperwork

•ATTRIBUTE: Groups and VariablesPossible New Groups


Recommendations

Preparation: Additional Donor Exposure

AlbuminRed cellsPlasmaAB serum

Problem – variables must be mutually exclusive

Alternative:Preparation: Additional Donor Exposure

Not specifiedNoYes – details in accompanying paperwork

•ATTRIBUTE: Groups and VariablesPossible New Groups


Next Steps

Feedback on Terminology proposalCell Therapy IndividualsProfessional SocietiesRegulatory Agencies

Comments to: [email protected] use

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Cellular Therapy Coding and Labeling Advisory Group Terminology Group

May 2006

Proposed Cell Therapy Product Terms and Definitions 3. Cellular Therapy Products 3.1 Class HPC, APHERESIS Hematopoietic Progenitor Cells obtained by an automated

apheresis procedure. HPC, CORD BLOOD Hematopoietic Progenitor Cells obtained from umbilical

cord and/or placenta at the time of delivery. HPC, MARROW Hematopoietic Progenitor Cells aspirated from the iliac

crests, sternum or other bones of an autologous or allogeneic donor.

HPC, WHOLE BLOOD Whole Blood collected for HPC contained within it CONCURRENT PLASMA, APHERESIS

Plasma collected from the donor as part of an apheresis cell collection procedure for use by the laboratory in further processing of that donor’s product.

THERAPEUTIC CELLS Nucleated cells collected for therapeutic purposes other

than hematopoietic progenitor cells TC, APHERESIS Nucleated Cells for therapeutic purposes collected by

apheresis TC, MARROW Nucleated Cells for therapeutic purposes collected from

bone marrow TC, WHOLE BLOOD Nucleated Cells for therapeutic purposes collected from

whole blood TC, CORD BLOOD Nucleated Cells for therapeutic purposes collected from

umbilical cord and/or placental blood TC-T CELLS Enriched preparation of T lymphocytes for therapeutic

use. TC- CYTOTOXIC LYMPHOCYTES

Enriched preparation of Cytotoxic lymphocytes for therapeutic use.

TC- T REGULATORY CELLS

Enriched population of regulatory T lymphocytes

TC- DENDRITIC CELLS Dendritic Cells prepared for therapeutic use. TC- NATURAL KILLER CELLS

Enriched preparation of Natural Killer Cells for therapeutic use.

TC- TUMOR DERIVED CELLS

Cells derived from a tumor that can be used in the preparation of a therapeutic product.

TC- MESENCHYMAL CELLS

Mesenchymal stromal cells isolated by suitable technologies, expanded and processed for therapeutic use.

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3.2 Modifier 3.2.1 Bounded List and Definitions Mobilized [only can be used for TC, APHERESIS] Cryopreserved describes a product to which a cryopreservative solution

has been added and maintained in the frozen state after preparation.

Pooled Multiple combined collections from the same donor. Thawed Washed A cryopreserved product that has been thawed and

subsequently washed to remove cryoprotectant or other solution.

Cultured ??still needs input

Describes a product that has been incubated in a system including added growth factors and/or nutrients to promote development or expansion of particular cell populations

Washed Deliberate reduction of plasma, anticoagulant, or other solution from a non-cryopreserved product.

3.3 Attribute 3.3.1 Core Conditions 3.3.1.1 Bounded list (anticoagulant, volume, and storage temperature) Anticoagulant type Anticoagulant description Citrate Any anticoagulant medium containing citrate Heparin Heparin used at any concentration as the sole method of

anticoagulation Citrate and Heparin Combined use of citrate and heparin at any concentration in

the anticoagulant medium NS - ?? Not coded – details in accompanying paperwork Volume XX Storage Temperature Definition Refg Refrigerated (between 1 - 10°C; narrower

range may be nationally specified) Rt Ambient room temperature ≤ -18 C Below -18C but warmer than -80C ≤ -80C Less than or equal to -80°C ≤ -150 C Less than or equal to -150°C LN2 liquid Completely immersed in the liquid phase

of liquid nitrogen

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3.3.2 Groups and Variables 3.3.2.1 Groups – bounded list and definitions Intended Use describes the expected use of the product System Integrity describes the microbiological integrity of the collection/

storage system. Requires choice; no default allowed. Preparation — Cryoprotectant

Active cryoprotectant in the product

Manipulation Describes processing applied to the collection Possible New Groups Preparation – other additives

Preparation - Additional donor exposure

Describes blood products from other donors used during processing, such as albumin, FFP, AB serum, RBC

3.3.3 Variables – bounded lists and definitions For each group, the variable value shown in bold characters is the default value. 3.3.3.1 Intended Use Group

Default: For tx

For patient use: The product is intended for use in patient treatment

Not for tx Not for Patient Use: a product that is not intended for use in patient treatment of further manufacturing.

3.3.3.2 System Integrity Group [No Default]

Closed The product has been prepared in a closed system and the microbiological integrity of the system has not been compromised.

Open The product has been prepared in an open system or the system has been opened and the microbiological integrity may have been compromised.

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3.3.3 Variables – bounded lists and definitions (cont) 3.3.3.3 Preparation: Cryoprotectant Group Default: no cryoprotectant No cryoprotectant has been added. Cryoprotectant: 6% HES + 5% DMSO

the cells were frozen using 6% HES and 5% DMSO as cryoprotective agents (+/- 1%)

Cryoprotectant: 10% DMSO the cells were frozen using 10% DMSO (+/- 2%) as a cryoprotective agent

Cryoprotectant: 5% DMSO The cells were frozen using 5% DMSO (+/- 1%) as the

cryoprotective agent DMSO content reduced by washing

The cells were frozen using DMSO as a cryoprotective agent which has subsequently been partially removed using a wash procedure after thawing.

3.3.3.4 Manipulation Group Default: no manipulation No further processing has occurred following

collection. Diluted

A product to which an additional diluent (e.g. Concurrent Plasma) has been added after collection to reduce cell counts for transit, storage, processing or cryopreservation

Plasma Reduced

Cells remaining after a portion of the plasma has been depleted by sedimentation or centrifugation using devices, supplies, and techniques validated for the procedure(s).

RBC Reduced Cells remaining after reduction of mature erythrocytes using devices, supplies, and techniques validated for the procedure(s).

Buffy coat enriched

Cells remaining after reduction of mature erythrocytes and plasma by centrifugation.

Mononuclear cells enriched Cells remaining after reduction or depletion of mature erythrocytes, granulocytes and plasma using devices, supplies, and techniques validated for the procedure(s).

T-cell depleted Cells remaining after T cells have been depleted using devices, supplies, and techniques validated for the procedure(s).

T-cell reduced Cells remaining after T cells have been reduced using devices, supplies, and techniques validated for the procedure(s).

B-cell reduced Cells remaining after B-cells have been reduced using devices, supplies, and techniques validated for the procedure(s).

T/B-cell reduced Cells remaining after T&B cells have been reduced using devices, supplies, and techniques validated for the procedure(s).

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CD8 reduced Cells remaining after the CD8 cell population has been reduced using devices, supplies, and techniques validated for the procedure(s).

CD34-enriched

Product in which the CD34 cell population has been enriched using devices, supplies, and techniques validated for the procedure(s).

CD133-enriched

A product in which the CD133 cell population has been enriched using devices, supplies, and techniques validated for the procedure(s).

Tumor cells reduced An identified tumor cell population has been reduced using devices, supplies, and techniques validated for the procedure(s).

HPC expanded Target progenitor cell population(s) have been increased using devices, supplies, and techniques validated for the procedure(s).

PUV-treated Cells treated with psoralen/ultra violet light Possible new groups 3.3.3.5 Preparation - other additives deliberately added Additive N/S Default Heparin Heparin has been added to the product after collection HES Added for cell separation, not cryoprotectant Antibiotics-Penicillin Also see accompanying paperwork Culture solution Others? 3.3.3.6 Preparation – additional donor exposure Blood product Reason for exposure N/S Default Albumin Albumin solution added as component of incubation

buffers, processing machine priming solutions, or other processing steps

RBC X-matched 3rd party donor red cells have been added to enable completion of requested processes

Plasma Thawed or fresh plasma added during processing AB serum AB serum has been added during processing as a source of

complement, or other reason Etc.

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Problem with the proposed new groups: variables are not mutually exclusive. More than one of the additional additives in each group could be added. Alternative: 3.3.3.5 Preparation Definition N/S Default. Not specified NO No added additives YES Other additives. See accompanying paperwork 3.3.3.6 Preparation: Additional Donor Exposure N/S Default. Not Specified NO No blood components added. YES Additives present that represent exposure to a blood component

from a third party donor. See accompanying paperwork. Please submit your comments. Turn in today or e-mail to: [email protected]

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