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  Section: General Biotechnology / Genes & Genetic Engineering
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Genetic Engineering for Human Welfare


Success of gene therapy
The success of gene therapy depends on gene delivery mechanism as well as on the choice of target tissue. Rangarajan and Padmanaban (1996) have discussed different conditions leading to success of gene therapy:


Cell types capable of dividing in vitro (e.g. myeloblasts, hepatocytes, keratinocytes, endothelial cells, etc.) are amenable for in vitro and in vivo gene therapy, both the in vivo methods are preferred for cell types such as neuronal cells.


The function of gene products also govern the selection of tissues, for example in case of haemophilia a gene can be delivered in any tissue provided the gene product is released into blood stream. In addition, in case of cystic fibrosis the gene should be delivered to specific cell types where introduction of correct gene is required.


Another attractive strategy for the treatment of several disorders is antisense gene transfer, for example in b-thalassemia, a-globin chains are accumulated in RBCs that result in their premature decay. Such types of destruction can be prevented by infection of K562 erythroleukemia cells with AAV expressing human a-globin gene in antisense orientation.


The potential of a gene delivery system is first found out in cultured cells or laboratory animals by using reporter genes (for luciferase, growth hormone, b-galactosidase, etc. For detailed discussion on reporter genes see Biotechnological Applications of Plant Cell, Tissues and Organ Cultures). On the basis of result of these studies again pretrials are conducted in laboratory animals to test the level and duration of expression of the introduced genes. Finally clinical efficacy is evaluated in human patients. But before conducting clinical trials in humans permission is necessary from the Regulatory Agencies such as recombinant DNA Advisory Committee (RAC) and the Food and Drug Administration (FDA) in the USA, the Gene Therapy Advisory Committee (GTAC) in the UK, etc. In India also guidelines have been formulated (see Biotechnology and Biosafety, Intellectual Property Right (IPR) and Protection (IPP)). Clinical trials on gene therapy are given in Table 5.3.




Cloned genes and production of chemicals


Human peptide hormone genes














Human interferon genes


Genes for vaccines



Vaccine for hepatitis-B virus



Vaccines for Rabies virus



Vaccines for poliovirus



Vaccine for foot and mouth disease virus



Vaccines for small pox virus



Malaria vaccines



DNA vaccines


Genes associated with genetic diseases














Enzyme engineering


Commercial chemicals

Prevention, diagnosis and cure of diseases


Prevention of diseases


Diagnosis of diseases



Parasitic diseases



Monoclonal antibodies



Antenatal diagnosis


Gene therapy



Types of gene therapy



Methods of gene therapy



Success of gene therapy



Potential of gene delivering system



Future needs of gene therapy in India

DNA profiling (fingerprinting)


Methods of DNA profiling


Application of DNA profiling



Genetic databank



Reuniting the lost children



Solving disputed problems of parentage, identity of criminals, rapists, etc



Immigrant dispute


Hurdles of DNA profiling

Animal and plant improvement


Transgenic Farm Animals


Crop Improvements



Transgenic plants



Nif gene transfer



Phaseolin gene transfer



Conversion of C3 plants to C4 plants



Herbicide resistant plants



Insect pest resistant plants



Plant improvement through genetic transformation


Crop Protection



Use of antagonists



Use of insecticides

Abatement of pollution

Table 5.3. Clinical trials on gene therapy.  


Gene inserted

Cell types


ADA defficient SCID


Peripheral T-lymphocytes and bone marrow cells

Repeated injections to be given

Duchenne's muscular dystrophy

Dystrophin gene


Trials in USA

Haemophilia B

Factor IX

Autologous skin fibroblast

Trials in China

Cystis fibrosis

CFTR gene


Gene delivery to lung cells via liposomes



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