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U.S. vCJD Donor Screening: Human U.S. vCJD Donor Screening: Human Cells, Tissues, and Cellular and Tissue-Cells, Tissues, and Cellular and Tissue-
Based Products (HCT/Ps)Based Products (HCT/Ps)
Melissa A Greenwald, MDMelissa A Greenwald, MDCAPT, U.S. Public Health ServiceCAPT, U.S. Public Health Service
Chief, Human Tissues and Reproduction BranchChief, Human Tissues and Reproduction BranchDivision of Human TissuesDivision of Human Tissues
OCTGT/ CBER/ FDAOCTGT/ CBER/ FDA
TSE Advisory CommitteeTSE Advisory Committee1 August 20111 August 2011
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ScopeScope
Regulatory BackgroundRegulatory Background
Donor screening for vCJD in the USDonor screening for vCJD in the US
ComparisonsComparisons
ConclusionConclusion
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What is an HCT/P?What is an HCT/P?
Human cells, tissues and cellular and Human cells, tissues and cellular and tissue-based productstissue-based productsRegulatory definition: Articles containing or Regulatory definition: Articles containing or consisting of human cells or tissues that consisting of human cells or tissues that are intended for implantation, are intended for implantation, transplantation, infusion, or transfer into a transplantation, infusion, or transfer into a human recipient human recipient Encompass a wide variety of productsEncompass a wide variety of productsRegulated by OCTGTRegulated by OCTGT
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Examples of HCT/PsExamples of HCT/Ps
From deceased From deceased (cadaveric) donors:(cadaveric) donors:Musculoskeletal tissuesMusculoskeletal tissuesSkin Skin Dura mater Dura mater Cardiovascular tissues Cardiovascular tissues Ocular tissuesOcular tissuesTissue/device and other Tissue/device and other combined productscombined products
From living donors:From living donors:Hematopoietic Hematopoietic stem/progenitor cells from stem/progenitor cells from peripheral and cord blood peripheral and cord blood Other cell therapy products Other cell therapy products – pancreatic isletspancreatic islets– mesenchymal stem/ stromal mesenchymal stem/ stromal
cellscells– fibroblastsfibroblasts
Cells transduced with gene Cells transduced with gene therapy vectorstherapy vectorsReproductive cells and Reproductive cells and tissuestissues
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Not HCT/PsNot HCT/Ps
Vascularized human organs for Vascularized human organs for transplantation (HRSA transplantation (HRSA oversight)oversight)
Whole blood or blood Whole blood or blood components; blood derivative components; blood derivative productsproducts
Secreted or extracted human Secreted or extracted human products, e.g.products, e.g.o MilkMilko CollagenCollageno Cell FactorsCell Factors
In vitro diagnostic productsIn vitro diagnostic products
Minimally manipulated bone Minimally manipulated bone marrow for homologous use marrow for homologous use and not combined with another and not combined with another article article
Ancillary products used in the Ancillary products used in the manufacture of HCT/Psmanufacture of HCT/Ps
Cells, tissues, and organs Cells, tissues, and organs derived from animals other derived from animals other than humansthan humans
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21 CFR Part 127121 CFR Part 1271
RegulationRegulation Issues AddressedIssues Addressed
Establishment Registration Establishment Registration and Listingand Listing
Applicability: types and uses of products Applicability: types and uses of products that will be regulated by these rules, that will be regulated by these rules, requirements for registering and listing requirements for registering and listing productsproducts
Donor EligibilityDonor Eligibility Requirements for donor screening and Requirements for donor screening and testing for “relevant communicable testing for “relevant communicable disease agents and diseases”disease agents and diseases”
Current Good Tissue Current Good Tissue Practice (CGTP)Practice (CGTP)
Manufacturing to ensure that HCT/Ps do Manufacturing to ensure that HCT/Ps do not contain communicable disease not contain communicable disease agents, are not contaminated, and do not agents, are not contaminated, and do not become contaminatedbecome contaminated
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Goal of 21 CFR 1271 RegulationsGoal of 21 CFR 1271 Regulations
HCT/Ps carry a potential risk of communicable HCT/Ps carry a potential risk of communicable disease transmission from the donor to the disease transmission from the donor to the recipientrecipient1271 regulations are designed to minimize the 1271 regulations are designed to minimize the risk of communicable disease transmissionrisk of communicable disease transmission– Donor screeningDonor screening– Donor testingDonor testing– Ensure cells or tissues are not contaminated during Ensure cells or tissues are not contaminated during
recovery, processing, storage or distributionrecovery, processing, storage or distribution
Donor screening and testing only for Donor screening and testing only for relevant relevant communicable disease agents or diseasescommunicable disease agents or diseases (RCDADs)(RCDADs)
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Current RCDADsCurrent RCDADsAgentAgent Required Required
forforScreeninScreenin
ggTestingTesting
HIV-1 and -2HIV-1 and -2 AllAll XX XX
Hepatitis BHepatitis B AllAll XX XX
Hepatitis CHepatitis C AllAll XX XX
SyphilisSyphilis AllAll XX XX
TSETSE AllAll XX
WNVWNV AllAll XX
SepsisSepsis AllAll XX
Vaccinia (recent Vaccinia (recent smallpox smallpox vaccination)vaccination)
AllAll XX
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Current RCDADsCurrent RCDADs
AgentAgent Required Required forfor
ScreeningScreening TestingTesting
HTLV-I and IIHTLV-I and II Viable, Viable, Leukocyte- richLeukocyte- rich
XX XX
CMV*CMV* Viable, Viable, Leukocyte- richLeukocyte- rich
XX
Chlamydia Chlamydia tracomatistracomatis
ReproductiveReproductive XX XX
Neisseria Neisseria gonorrhoeaegonorrhoeae
ReproductiveReproductive XX XX
*CMV is not a RCDAD; donors of viable leukocyte-rich HCT/Ps must be tested for CMV and positive test results must be communicated to the responsible physician
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vCJD Donor Screening vCJD Donor Screening RecommendationsRecommendations
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HCT/P Donor Screening (vCJD)HCT/P Donor Screening (vCJD)
Donor Screening Criteria (donor ineligible if Donor Screening Criteria (donor ineligible if they meet any of the following criteria)they meet any of the following criteria)– Persons diagnosed with any form of CJD, Persons diagnosed with any form of CJD,
including vCJDincluding vCJD– Persons who have spent more than 3 months Persons who have spent more than 3 months
cumulatively in the United Kingdom from the cumulatively in the United Kingdom from the beginning of 1980 to the end of 1996beginning of 1980 to the end of 1996
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HCT/P Donor Screening (vCJD)HCT/P Donor Screening (vCJD)
Persons who are current or former U.S. Persons who are current or former U.S. military members, civilian military employees, military members, civilian military employees, or dependants of a military member or civilian or dependants of a military member or civilian employee who resided at U.S. military bases in employee who resided at U.S. military bases in Northern Europe (Germany, Belgium, and the Northern Europe (Germany, Belgium, and the Netherlands) for 6 months or more Netherlands) for 6 months or more cumulatively from 1980 through 1990, or cumulatively from 1980 through 1990, or elsewhere in Europe (Greece, Turkey, Spain, elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) for 6 months or more Portugal, and Italy) for 6 months or more cumulatively from 1980 through 1996 cumulatively from 1980 through 1996
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HCT/P Donor Screening (vCJD)HCT/P Donor Screening (vCJD)
Persons who have spent 5 years or more cumulatively in Persons who have spent 5 years or more cumulatively in Europe from 1980 until the presentEurope from 1980 until the presentThis criterion includes time spent in the U.K. from 1980- This criterion includes time spent in the U.K. from 1980- 19961996
– Albania, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Albania, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Liechtenstein, Luxembourg, Greece, Hungary, Ireland, Italy, Liechtenstein, Luxembourg, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, United Slovak Republic, Slovenia, Spain, Sweden, Switzerland, United Kingdom, and Yugoslavia.Kingdom, and Yugoslavia.
– The United Kingdom should include all of the following: England, The United Kingdom should include all of the following: England, Northern Ireland, Scotland, Wales, the Isle of Man, the Channel Northern Ireland, Scotland, Wales, the Isle of Man, the Channel Islands, Gibraltar, and the Falkland Islands.Islands, Gibraltar, and the Falkland Islands.
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HCT/P Donor Screening (vCJD)HCT/P Donor Screening (vCJD)– Persons who received any transfusion of blood or Persons who received any transfusion of blood or
blood components in the U.K. or France between blood components in the U.K. or France between 1980 and the present1980 and the present
No current donor screening recommendations No current donor screening recommendations regarding Saudi Arabiaregarding Saudi Arabia
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Major difference between HCT/P Major difference between HCT/P and blood donor screening criteriaand blood donor screening criteria
HCT/P donor screening recommendationsHCT/P donor screening recommendations– Do not exclude donors for exposure to injected Do not exclude donors for exposure to injected
bovine insulinbovine insulin– Do not distinguish between France and the rest of Do not distinguish between France and the rest of
EuropeEurope
Donor medical history interview for deceased Donor medical history interview for deceased donors is performed by questioning someone donors is performed by questioning someone other than the donor, and this information other than the donor, and this information would be difficult to obtain reliablywould be difficult to obtain reliably
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Health Canada Cell and Tissue Health Canada Cell and Tissue Donor ScreeningDonor Screening
Health Canada requires that travel Health Canada requires that travel information be collected, and requires information be collected, and requires some donor screening for vCJD risk some donor screening for vCJD risk factorsfactors
However, for cell and tissue donors, there However, for cell and tissue donors, there are no exclusion criteria based upon risk are no exclusion criteria based upon risk factors associated with residence or travel factors associated with residence or travel history to specific geographic areashistory to specific geographic areas
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SummarySummary
Geography-based screening for vCJD risk is Geography-based screening for vCJD risk is based on evaluating the donor’s risk of based on evaluating the donor’s risk of exposure to the BSE agentexposure to the BSE agent
Screening criteria are consistent for all Screening criteria are consistent for all HCT/Ps; they are not product-specific HCT/Ps; they are not product-specific
Today’s discussion regarding risk of Today’s discussion regarding risk of exposure to the BSE agent in Saudi Arabia exposure to the BSE agent in Saudi Arabia applies to HCT/P donor screeningapplies to HCT/P donor screening
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Additional InformationAdditional Information
21 CFR 127121 CFR 1271
www.accessdata.fda.gov/scripts/cdrh/cfdocswww.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart/cfcfr/CFRSearch.cfm?CFRPart=1271=1271
Donor Eligibility GuidanceDonor Eligibility Guidance
www.fda.gov/BiologicsBloodVaccines/Guidawww.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm073964.htmnces/Tissue/ucm073964.htm
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Questions?Questions?
2020
Contact Information:Contact Information:
[email protected]@fda.hhs.gov
General inquiries: 301-827-1800General inquiries: 301-827-1800
Consumer inquiries: Consumer inquiries: [email protected]@fda.hhs.gov
Manufacturer inquiries: Manufacturer inquiries: [email protected]@fda.hhs.gov
www.fda.gov/BiologicsBloodVaccines/default/htmwww.fda.gov/BiologicsBloodVaccines/default/htm
