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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