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A new structure is being put into place for subcommittees F04

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A new structure is being put into place for subcommittees F04

    UPDATED: MAY 3, 2012

    STRUCTURE FOR F04.40 DIVISION IV ON TEMPS

     Co-Chair Anthony Ratcliffe

     Co-Chair Warren Haggard

     Exec. Sec David Kaplan

    Strategic Planning Meeting held in conjunction with Nov. 2006 ASTM F04, Division IV. The outcome of the Session is summarized below:

1. Paul Tomlins presented information on VAMAS.

    2. Division IV members voted to keep the current structure of TEMPs (i.e., 6

    subcommittees).

    3. Each Subcommittee should prioritize the standards being developed within

    their committees. Keep in mind ―What we Should do‖, instead of ―What we

    Could do‖.

    4. Ask other countries for their input. Use Market research reports, other tissue

    engineering meetings, meet at other sites (such as in EU). 5. Additional possible work items which would require coordination with other

    subcommittee or organizations:

    a. Human clinical guidelines for evaluating these products (assessment).

    Solicit Orthopedic Device Forum input.

    b. Dissolution testing of particulate calcium substances (F04.15?). Joint

    TEMPs and Ceramics (Floyd Larson/Liisa Kuhn).

Proposed Division IV Workshops

    1. Workshop on Imaging TEMPs (Nov.07).

    a. Contacts Paul Tomlins and Marc Cicerone.

    1) F04.41 Classification and Terminology for TEMPs

    Scope: To develop classification of areas for standards for tissue engineered medical products and standard definitions of the terminology for use with standards for tissue engineered medical products.

    a. Leadership

    Chair Fred Cahn

    Vice-Chair Open

    Secretary Open

    b. Published Standards (No Action Required)

    i. F2312-04 Standard Terminology Relating to Tissue Engineered

    Medical Products

    a. Contact: Fred Cahn, Byron Hayes, Russ Alberts, Dave

    Williams

    ii. F2211-04 Standard Specification for General Classification for

    Tissue Engineered Medical Products

    a. Contact: Fred Cahn or David Kaplan.

    c. Published Standards which require re-ballot or other action

    i. F2311-06 Standard Guide for the Classification of Skin Substitutes.

    TG04.

    a. Contact: Fred Cahn

    d. Work Items

    i. WK8372 (TG04). Fred Cahn held teleconference to discuss revised

    draft F2311-06. Additional revisions were suggested. Document to

    be revised and ballot prior to May 07.

    a. Contact: Fred Cahn

    ii. ISO TC-150 N593 - Risk-Based Classification Of TEMPS

    Document not recommended for next ballot level at Korea

    meeting 05. Document will be re-written, new title: Cell-Based stImplants: Risk Assessment, with 1 draft expected Feb 06.

    a. Contact: David Kaplan

    b. Contact: Dr. Hwal Suh (ISO).

    iii. WK???? TG03 Combination Products involving TEMPs.. (New

    Work Item, Washington, D.C. 04). This series of documents will

    include 4 parts: Goal: Terminology and classification for regulatory

    standpoint.

    a. Definition of combination products (Starting with the

    Federal Register definition). Contact: Victor

    Zaporojan (victor.zaporojan@zimmer.com).

    b. Decision tree. Barbara Blum (bblum@wmt.com) Reto

    Luginbuehl, Jack Parr, Elliott Sanders. Action Item for

    ―a‖ and ―b‖: Barb. Blum to contact Mark Kramer at

    Office of Combination Products (FDA). Team will

    define types of products for TE.

    c. Carrier to release agent (Develop in F04.44). Contact:

    Jack Parr & Warren Haggard (Temporary Chairs).

    d. Carrier containing cells (Develop in F04.44). Include

    references in document for measuring cell adhesion

    (F04.43) & cell viability (F04.43). Contact: Jack Parr

    & Warren Haggard (Temporary Chairs). Cross with

    Cell Signaling SC. Anne Plant/Manny Horowitz to help

    find permanent chairs.

    2) F04.42 Biomaterials and Biomolecules

    Scope: To develop standards for both natural and recombinant biomolecules,

    biomaterials, and other non-cellular components of tissue engineered

    medical products.

a. Leadership

     Chair Liisa Kuhn

     Vice-Chair Monika Geiger

    Secretary Byron Hayes

b. Published Standards (No Action Required)

    i. F2064-00(2006) Standard Guide for Characterization and Testing

    of Alginates as Starting Materials Intended for Use in

    Biomedical and Tissue-Engineered Medical Products

    Application

    a. Contact: Are Kristiansen and David Kaplan

    b.

    ii. F2259-03 Test Method for Determination of Monomer Sequence

    and Composition of Alginate by NMR.

    a. Contact: Are Kristiansen

    iii. F2260-03 Test Method for the Determination of the Degree of

    Deacetylation of Chitosan Salts by Proton Nuclear 1Magnetic Resonance (H NMR) Spectroscopy.

    a. Contact: Are Kristiansen

    b.

    iv. F2347-03 Guide for the Characterization and Testing of

    Hyaluronan as Starting Materials Intended for Use in Biomedical and

    Tissue Engineered Medical Product Applications.

    a. Contacts: Are Kristiansen and David Kaplan v. F2450-04 Standard Guide for Assessing the Porosity of Polymeric

    Tissue Scaffolds for use in Tissue Engineered Medical Products.

    a. Contact: Paul Tomlins and Byron Hayes.

    c. Published Standards which require re-ballot or other action

    i. F2027-00e1 (TG13 WK9442) --Standard Guide for Characterization

    and Testing of Substrate Materials for Tissue-Engineered

    Medical Products (Kuhn to forward revised doc. To Hayes, F.

    Wang, Jamiolkowski for comment. SC Ballot Dec. 15th).

    a. Contact: Byron Hayes (bhayes@wlgore.com) /Liisa

    Kuhn (lkuhn@uchc.edu)

    b. Additional distribution: Haggard

    (whaggrd1@memphis.edu), Tomlins

    (paul.tomlins@npl.co.uk), Kuhn (lkuhn@uchc.edu),

    Zaporojan (victor.zaporojan@zimmer.com), Jizong Gao

    (Jizong.gao@zimmer.com), Wright

    (3mma.wright@smith-nephew.com), Hollenbeck

    (mhollenbeck@orthovita.com), Sawyer

    (asawyer@bd.com).

    ii. F2103-01 (TG15, WK13391) - Standard Guide for Characterization

    and Testing of Chitosan Salts as Starting Materials Intended

    for Use in Biomedical and Tissue-Engineered Medical

    Product Applications (Reballot as-is).

    a. Contact: Are Kristiansen and David Kaplan iii. F2131-02 (TG16, WK13392) - Test Method for In Vitro Biological

    Activity of Recombinant Human Bone Morphogenetic Protein-2

    (RHBMP-2) Using the W-20 Mouse Stromal Cell Line. (Reballot as-

    is).

    a. Contact: Monika Geiger (mgeiger@wyeth.com).

    iv. F2150-02 (TG14, WK11409). Standard Guide for Characterization

    and Testing of Biomaterial Scaffolds Used in Tissue-

    Engineered Medical Products. Revise new draft. SC ballot ththeither Dec. 15 or Feb. 12.

    a. Contact: Byron Hayes (bhayes@wlgore.com).

    v. F2212-02 (TG17, WK13393) Guide for Characterization of Type I

    Collagen as a Starting Material for surgical Implants and

    Substrates for Tissue Engineered Medical Products.

    (Reballot as-is).

    a. Contact: David Kaplan

    d. Withdrawn or Inactive Standards or Work Items

    i. WK2326 (Withdraw Work Item) Standard Guide on Protein

    Concentration Determination.

    a. Contact: Tom Porter

    ii. WK3502 TG12 (Withdraw Work Item). Standard Test Method for

    the Determination of Protein Concentration by Ultraviolet

    Spectrophotometry. Currently 2 docs that provide needed

    information: EP 2053 and USP 1047.

    a. Contact: Monika Geiger (mgeiger@wyeth.com).

    b. Additional distribution: Matthew Hollenbeck

    (mhollenbeck@orthovita.com).

    iii. WK???? TG10 (Withdraw Work Item) Standard Guide for

    Biocompatibility of Alginates.

    a. Contact: Michael Dornish and David Kaplan

    b. Additional Distribution: Victor Zaporojan

    (victor.zaporojan@zimmer.com), Martin Fritts, SAIC-

    Frederick, Inc., (frittsm@ncifcrf.gov).

    e. Work Items Jointly Worked on by 2 or more Subcommittees

    i. WK???? TG09 Development of Standard Test Method for

    Characterizing Biostability of Bioabsorbable Scaffolds for Tissue stEngineering. (New Work Item, Nov. 06). 1 draft of document

    presented. (Focus on polycaprolactone, PCL). F. Wang will revise

    draft and circulate for comment.

    a. Contact: Francis Wang Potentially joint with F04.15.

    b. Additional Contact: Tim Topoleski.

    f. Active Work Items

    i. WK964 TG03 -- Standard Test Method for the Determination of the

    Molecular Weight of Sodium Alginate by Size Exclusion

    Chromatography with Multi-angle Light Scattering Detection (SEC-

    MALS). (Are Kristiansen & F. Wang to discuss Neg. ballot & resolve

    ―Apparent Molar Mass Distribution‖. Reballot prior to May 07).

    a. Contact: Are Kristiansen

    b. Additional distribution: Victor Zaporojan

    (victor.zaporojan@zimmer.com), Martin Fritts, SAIC-Frederick, Inc.

    (frittsm@ncifcrf.gov).

    ii. WK 965 TG04-- Standard Test Method for the Determination of the

    Molecular Weight of Chitosan and Chitosan Salts by Size Exclusion

    Chromatography with Multi-angle Light Scattering Detection (SEC-

    MALS). (Are Kristiansen & F. Wang to discuss Neg. ballot & resolve

    ―Apparent Molar Mass Distribution‖. Reballot prior to May 07).

    a. Contact: Are Kristiansen

    b. Additional distribution: Martin Fritts, SAIC-Frederick,

    Inc., (frittsm@ncifcrf.gov).

    iii. WK6507 TG06 Development of reference scaffolds for Tissue

    Engineering. 1) Reference scaffold development from several sources.

    Company to prepare 50 of each of 3 scaffolds. To be delivered in

    approximately 1 month (Jan 07). Will be available for sale thru NIST. 2) SOP for interlab study. Add Steve Goldstein lab.

    a. Contact: John Tesk and Michael Yaszemski

    iv. WK7980 TG08, APPROVED FOR PUBLICATION Std. Guide for

    Interpreting Images of Polymeric Tissue Scaffolds Editorial

    comments inserted.

    a. Contact: Paul Tomlins and Marc Cicerone.

    b. Additional distribution: Byron Hayes.

    v. WK11381 TG11 Standard Guide for Assessment of the Surface Texture of Biomaterial Surfaces. Minor changes required. Current thversion broadened title of document. SC Ballot Feb. 12.

    a. Contact: Paul Tomlins.

    b. Additional distribution: Hayes

    vi. WK???? TG07 Standard Guide for Characterization of ceramic and mineral based scaffolds used for TEMPs and as medical devices for surgical implant applications. (Draft document

    presented May 06. Revised draft document to be presented at May 07 meeting).

    a. Contact: Reto Lubinbuehl. reto.luginbuehl@rms-

    foundation.ch

    b. Possible Co-chair: Gary Fischman, John Goode or

    Floyd Larson, Sandy Williams, Toshie Tsuchiya,

    Barbara Blum, Francis Wang.

    3) F04.43 Cells and Tissue Engineered Constructs

    Scope: To develop standards for cells in tissue engineered medical products that may contain a local- and/or systemically-acting cellular or tissue component of autologous, allogeneic, or xenogeneic origin or genetically modified cells of any species which may be formulated with a synthetic or natural material and/or biomolecule. Also to develop standards for structural and mechanical characterization, for delivery systems and the construct.

a. Leadership

     Chair Open

     Vice-Chair Anita Sawyer

    Secretary David Kaplan

b. Published Standards (No Action Required)

    i. F2315-03 Standard Guide for the Immobilization or Encapsulation

    of Living Cells or Tissue in alginate Gels

    a. Contact: Are Kristiansen.

    ii. F2386-04 Guide for Preservation of Tissue Engineered Medical

    Products

    a. Contact: Alison Hubel

    c. Published Standards which require re-ballot or other action

    i. F2149-01(Discuss re-ballot May 07) - Standard Test Method for

    Automated Analyses of Cellsthe Electrical Sensing Zone

    Method of Enumerating and Sizing Single Cell Suspensions

    a. Contact: Steve Szabo

    ii. F2210-02 (Discuss re-ballot May 07) Guide for the Processing of

    Cells, Tissues and Organs for Use in Tissue Engineered

    Medical Products

    a. Contact: Paul Price

    d. Withdrawn or Inactive Standards or Work Items

    i. Z9170Z (Withdraw Work Item due to inactivity). Test Method for

    Use of Fibrin Sealant in the Delivery of Cell and Bioactive

    Agents for Tissue Engineering Applications(Document on

    HOLD. If document not revised by May 05, subcommittee

    recommended TABLE document.)

    a. Contact: Bill Tawil

    ii. (Withdraw Work item due to inactivity) Biomarkers for Safety.

    a. Contact: Henry Rodriguez

    e. Work Items Jointly Worked on by 2 or more Subcommittees

    i. WK8031 TG06-- Standard Guide for Immunogenicity of TEMPs.

    Nov 05 held joint meeting with Ken St John (F04.16,

    biocompatibility). Ken recommended that a new document not

    necessary, but could modify F748 to include TEMPs. Ken and Liisa

    will meet to discuss changes. (Document Inactive)

    a. Contact: Liisa Kuhn/Olsen.

    f. Active Work Items

    i. WK3936 TG05 Standard Guide for assessing the attachment of cells

    to biomaterial surfaces by Physical Methods. Modify draft to

    respond to Negative ballots. Two Non-persuasive Negative votes

    approved by Main Committee (11/16/06). Concurrent Ballot Feb

    15th

    a. Contact: David Kaplan and Paul Tomlins.

    ii. WK11648 TG08Standardization of in situ

    visualization/quantification of mineralized matrix formed by

    mesenchymal cell culture. (New Work Item May 06). No new action,

    Nov. 06.

    a. Contact: Hirose.

    iii. WK???? TG04 Standard Guide for Assessment of Cell Viability

    within biomaterial scaffolds. New draft by Liisa Kuhn discussed.

    Liisa will make suggested modifications and ballot Dec. 15th.

    a. Contact: Liisa Kuhn.

    4) F04.44 - Assessment

    Scope: To develop standards for the pre-clinical evaluation of tissue

    engineered medical products, including

    a. Leadership

     Chair Barbara Boyan

     Co-chair Jack Parr

     Vice-Chair Floyd G. Larson

     Secretary (open)

    b. Published Standards (No Action Required)

    i. F2451-05 Standard Guide for the Assessment of Implantable

    Devices Intended to Repair or Regenerate Articular Cartilage.

    a. Contact: Russ Alberts

    c. Published Standards which require re-ballot or other action

    i.

    d. Withdrawn or Inactive Standards or Work Items

    i. Z9120Z (Guide Inactive) Guide for the Normal Biological Function

    of Aortic Heart Valves. (Boyan will request Ajit

    Yoganathan to develop document.)

    a. Contact:

    ii. WK???? (Withdraw Work Item). Standard Guide for Vascular

    Grafts. (Proposed new work item, Washington D.C. 04).

    a. Contact: Barbara Boyan and Robert Nerem.

    iii. WK8034 TG07 (Withdraw Work Item). Std. Guide For

    Performance Of Articular Cartilage TEMPS In Animal Models.

    May 05: Draft discussed, working group formed, new work item

    requested. Jack Parr will get status report from Russ.

    a. Contact: Russ Alberts.

    iv. WK???? TG05 (WK Item Inactive by TG chair request). Std. Guide

    For In Vivo Assessment of Dermal Regeneration Performance.

    No progress on draft. Fred wants a second document on

    Clinical Focus.

    a. Contact: Fred Cahn.

e. Work Items Jointly Worked on by 2 or more Subcommittees

    f. Active Work Items

    i. WK3551 TG02Standard Guide for the Assessment of Bone

    Inductive Materials. Persuasive negative votes (May 06) upheld and

    document will be revised as required.

    a. Contact: Lloyd Wolfinbarger.

    ii. WK6472-(Work Item Renamed & Redefined, formerly Z9744Z).

    Testing of Cartilage ex vivo Before Implantation.

    a. Contact: Boyan

    iii. WK8032 TG08 Std. Guide For Pre-Clinical in vivo Evaluation

    of Critical Size Segmental Bone Defects. Action: 1) Boyan

    provided F2451 which was modified to fit bone defects, 2)

    Summarize animal models, terminology, etc, 3) ID models from

    literature & look at test methods (i.e., mechanical, micro CT,

    subjective scales rating, etc)Boyan students assist), 3) Start

    with Boyan’s students thesis proposal & mechanical testing. thPlan to circulate to TG by Jan 07. SC Ballot Mar. 27.

    a. Contact: Monica Geiger and Byron Hayes.

    b. Task group: Bogdansky, Luginbuehl, Brown, Gao,

    Blum, Haggard, Yaszemski, Zian, Boyan, Parr, Lyle.

    c. Possible additional (Nov. 06): Hany, Aric Kaiser.

    iv. WK8033 TG06 Std. Guide For Characterization of Tendons and

    Ligaments TEMPS. New draft written (will have one document

    for both tendons & ligaments). Tony will distribute to TG by

    late Dec. 06 and to SC by late Jan. 07.

    a. Contact: Tony Ratcliffe.

    b. Task Group: Emma Wright, Barbara Blum, Jizonj Gao

    v. WK8035 TG03-- Std. Guide For In Vivo Assessment Of Meniscal

    Implants Intended To Repair Or Regenerate. Nov. 06 will

    start with Cartilage document & Ligament & Tendon documents

    and modify as needed. Draft document May 07.

    a. Contact: Greg Brown.

    b. Co-Chair: Victor Zaporojan.

    vi. WK???? TG04 (Revised Title) Std. Guide For Tissue Engineered

    Vascular Grafts. Draft by May 07.

    a. Contact: Brad Martin. Barbara Boyan recruited Bob

    Guldberg to lead.

    b.

    Strategic Planning (May 06): Possible Future Work Items.

    1. Defects in long bone (Central Defect).

    2. Spine: Posterior lateral fusion & intervertebral body fusion.

    3. TMJ:

    4. myocardial infarct.

    5) F04.45 Adventitious Agents Safety

a. Leadership

    Chairs Gail Sofer and Russell Mills (Tentative, Nov. 06)

    Vice-Chair Hwal Suh

    Secretary (open)

b. Published Standards (No Action Required)

    i. F2383-05 Standard Guide for Assessment of Adventitious Agents

    in Tissue Engineered Medical Products (TEMPs).

    a. Contact: Gail Sofer.

    c. Published Standards which require re-ballot or other action

    i.

    d. Withdrawn or Inactive Standards or Work Items

    i. WK7472 (Placed on Hold due to Inactivity). Standard Guide for

    TEMPs exposed or derived from non-human biological sources or

    components. (New work item proposed Washington D.C. 04). Scope

    needs to be defined.

    a. Contact: Gail Sofer

    e. Work Items Jointly Worked on by 2 or more Subcommittees

    f. Active Work Items

    i. WK9480 TG02 Standard Clinical Safety Guide for the Tissue

    Engineered Medical Products. Document will be revised to address

    the Negative Ballots.

    a. Contact: Hwal Suh

    6) F04.46 Cell Signaling

    a. Scope: The subcommittee will identify, develop and promulgate standards

    and accurate methods of measurement for cell signaling. Topics of interest

    will include, but are not limited to, cells and cell-containing therapeutic

    products, host-cell implant interactions, biosensors, biomarkers/phenotype,

    cytotoxicity, and cell signaling pathways and processes. The subcommittee

    will establish appropriate liaison relationships with relevant organization

    both internal and external to ATM international. (Scope will be re-

    evaluated and revised, as necessary, following Nov. 06 meeting.) b. Leadership

    Chair Anne Plant (Temporary)

    Co-Chair Manny Horowitz (Temporary)

    c. Published Standards (No Action Required)

    d. Published Standards which require re-ballot or other action

    e. Withdrawn or Inactive Standards or Work Items

    f. Work Items Jointly Worked on by 2 or more Subcommittees

    i. Z????Z TG07 Biocompatibility of TEMPs Gap Junction Testing for

    TEMPs. (Joint document with Biocompatibility group, Ken St. Johns,

    and Cell Signaling F04.46).

    ii. Contact: Toshie Tsuchiya

    g. Active Work Items: Task Groups and Structure will be re-evaluated and

    revised, as necessary, following Nov. 06 meeting.

    i. WK???? Standard Guide for Classification of Signaling Pathways

    that define outcome of cell material interaction. (i.e., G-protein

    coupled mechanical response, kinases, integrin dependent).

    a. Contact: Open

    ii. WK???? Cell Signaling Mechanism based assay for cytotoxicity.

    (i.e., Greater predictive value compared to ―Live/Dead‖)

    a. Contacts: Elliott/Plant

    iii. WK???? Terminology. Draft document presented. Manny will

    modify draft and circulate to Task Group.

    a. Contact: Horowitz.

    iv. WK???? Standard Protocol for extra cellular matrix materials

    preparation and presentation. (Expected response from cells under

    controlled conditions). Anne Plant and John Elliott to prepare doc.

    On collagen based on their work, focusing on matrices and

    reproducibility.

    a. Contact: Soung G. Lee, MD.

    v. WK???? Stable storage of cells. (Integrity wrt genetics, response

    to environment, ―health‖ of cells).

    a. Contact: Open.

    vi. Possible Task Group formation based on the following:

    1. Cell identification markers, transformation.

    2. Standard conditions of cell. (Feasibility of developing a

    Reference Cell Line).

    3. Defined media.

    4. Quantitative methods for comparison of cells.

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