This set of Tissue Engineering Interview Questions and Answers focuses on “Need for Tissue Engineering”.
1. 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
View Answer
Explanation: The goal of Tissue Engineering is to provide biological substitutes to maintain and improve the function of damaged tissues. The goal of gene therapy is to cure or slow down a genetic disease by repairing the damaged gene responsible for the disease. Regenerative medicine aims to correct the damaged tissue’s structure and function. Molecular medicine aims to identify the basic genetic and molecular defects causing a disease, and developing molecular interventions to treat the same.
2. 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
View Answer
Explanation: The possibility of replacing an entire organ with an organ from a donor, known today as organ transplantation. Although this is widely practiced today and is known to be the ultimate solution for organ failure, the need for organs always surpasses the number of available donated organs. The driving force behind the conceptualization of in vitro culturing of tissues was the limited number of donors available and graft-rejection by the immune system. The success in tissue engineering of skin grafts boosted the interest in applying similar concepts to other tissues and organs.
3. Prosthetic devices are capable of restoring normal function, and the number of organ donors is always way less than required.
a) True
b) False
View Answer
Explanation: Tissue Engineering is a better alternative to prosthetic devices as they cannot restore the normal and natural function of a tissue. Less number of donors is also a major problem faced with the usage of prosthetics. Tissue Engineering is the go-to solution for treating diseases which cannot be cured by regular means and ways such as pharmaceuticals, organ transplant, etc.
4. 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
View Answer
Explanation: The Human Tissue Authority is one of the Competent Authorities for Tissue and Cells in The United Kingdom, Health and Youth Care Inspectorate is in the Netherlands, Medical Products Agency in Sweden and Slovenija-transplant in Slovenia.
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
View Answer
Explanation: Title 21 of Code of Federal Regulations, part 1271 constitutes a comprehensive regulatory Framework for the producers of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Part 1308 of the same title constitutes Schedules of controlled substances like narcotic substances and chemical formulations. Part 110 under Title 21 is relevant to “Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food” and Part 111 is relevant to “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements”.
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
View Answer
Explanation: The HCT/Ps that meet the criteria mentioned in Title 21 CFR 1271.10(a) are subject only to the regulation under section 361, Public Health Service Act and the regulations mentioned in 21 CFR Part 1271.
7. Umbilical cord blood stem cells are an example of 361 HCT/Ps that meet the criteria in Title 21 of CFR part 1271.
a) True
b) False
View Answer
Explanation: Umbilical cord blood stem cells are an example of 361 HCT/Ps that meet the criteria in Title 21 of CFR part 1271. Other examples include Ligament, Cornea, Cartilage, bone, Dura matter, Heart valves, etc.
8. _____________ need to register with FDA under Title 21 of 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
View Answer
Explanation: Laboratories doing speciation of microorganisms detected in HCT/P cultures need to register with FDA under Title 21 of Code of Federal Regulations (CFR), by definition manufacture includes processing and processing includes testing of microorganisms according to 21 CFR 1271.3(e) and 21 CFR 1271.3(ff). Whereas Companies collecting Blood samples from donors and Hospitals storing HTC/Ps need not register with the FDA.
9. Name one 361 HCT/P which cannot be imported.
a) Cartilage
b) Bone
c) Infected Peripheral Blood Stem Cells
d) Cornea
View Answer
Explanation: Infected Peripheral Blood stem cells are an exception of 361 HCT/P offered for import, whereas Cartilage, Bone, and Cornea do not have any such restrictions. The reason being, they can be a source for communicable diseases.
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®
View Answer
Explanation: ChondroCelect® is has been approved by the EMA as an Advanced Therapy medicinal product, whereas are CarticelTM, Provenge®;, and Laviv® have been approved by the Food and Drug Administration (FDA) as Biologics.
Sanfoundry Global Education & Learning Series – Tissue Engineering.
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