Q.1
The driving force behind the conceptualization of in vivo culturing of tissues was the limited number of donors available and graft-rejection by the immune system.
  • a) True
  • b) False
Q.2
Prosthetic devices are capable of restoring normal function, and the number of organ donors is always way less than required.
  • a) True
  • b) False
Q.3
Which is the Competent Authority for tissues and cells in the United Kingdom?
  • a) Human Tissue Authority
  • b) Health and Youth Care Inspectorate
  • c) Medical Products Agency
  • d) Slovenija-transplant
Q.4
What is the Goal of Tissue Engineering?
  • a) Providing biological substitutes to maintain and improve the function of damaged tissues
  • b) Cure or slow down a genetic disease by repairing the damaged gene responsible for the disease
  • c) Restore structure and function of damaged tissues and organs
  • d) Identifying basic genetic and molecular defects causing a disease, and developing molecular interventions to treat the same
Q.5
Title ______________ constitutes of a comprehensive regulatory Framework for the producers of human cells, tissues, and cellular and tissue-based products (HCT/Ps).
  • a) 21 CFR Part 1271
  • b) 21 CFR Part 1308
  • c) 21 CFR Part 110
  • d) 21 CFR Part 111
Q.6
Which Act governs the manufacture of HCT/Ps?
  • a) Public Health Service Act
  • b) Food, Drug, and Cosmetic Act
  • c) Food Adulteration Act
  • d) Meat Food Products Order
Q.7
Umbilical cord blood stem cells are an example ofHCT/Ps that meet the criteria in Titleof CFR part 1271.
  • a) True
  • b) False
Q.8
_____________ need to register with FDA under Titleof Code of Federal Regulations (CFR).
  • a) Laboratories doing speciation of microorganisms detected in HCT/P cultures
  • b) Companies collecting Blood samples from donors
  • c) School laboratories
  • d) Hospitals storing HTC/Ps
Q.9
Name oneHCT/P which cannot be imported.
  • a) Cartilage
  • b) Bone
  • c) Infected Peripheral Blood Stem Cells
  • d) Cornea
Q.10
Which of the following Tissue Engineering products has been approved by the European Medicines Agency (EMA) as an Advanced Therapy medicinal product (Drug)?
  • a) ChondroCelect®
  • b) CarticelTM
  • c) Provenge®
  • d) Laviv®
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