Human Gene and Cell Therapy Center of Akdeniz University

Human Gene and Cell Therapy Center of Akdeniz University

Human Gene Therapy Unit was first established in 2003 by Dr. Salih Sanlioglu at the Akdeniz University, Faculty of Medicine in order to initiate gene therapy research in Turkey. Soon, the infrastructure of the gene therapy research laboratory was completed and research results were published in the leading gene therapy journals such as Human Gene Therapy, Gene Therapy, Cancer Gene Therapy, Current Gene Therapy etc. In order to substantiate our leading position in the country, gene therapy unit was restructured as the Center for Gene and Cell Therapy of Akdeniz University bylaw published on official gazette 27701-dated September 16, 2010.

The use of adenoviral vectors for the treatment of prostate cancer was the first gene therapy related research activity performed in the center. The fact that not all prostate cancer cells were sensitive to the adenoviral delivery of apoptosis inducing gene TRAIL encouraged the scientists in the center to develop a novel siRNA strategy as a complementary gene delivery modality. This led to down-regulation of a specific decoy receptor expression on cell surface then the prostate cancer cells became sensitive to apoptosis inducing effects of death ligand known as TRAIL.

These studies were conducted in close collaboration with our colleagues from the University of Iowa Gene Therapy Center in which the first gene therapy clinical trial against the prostate cancer patients was conducted by our collaborator Dr. Thomas S. Griffith.

Dr.SanlioglurIn order to conduct clinical trials in a center, it is necessary to have some years of research experience (preferably 5-10 years or more) in the field of gene and cell therapy. During this time scientists and clinicians have to work in a collaborative fashion. Research results are expected to be published in well-known gene and cell therapy journals if possible, supported by international societies such as American Society of Gene and Cell Therapy or European Society of Gene and Cell Therapy.

Furthermore, there has been a great interest in the production of clinical grade gene therapy vectors in the Center. However, vectors used in clinical research have to be produced in compliance with cGMP regulations. Both the Institutional Review Board and Food and Drug Administration have to approve proposed clinical trial prior to start of the project.

In order to compensate that, a huge effort is currently being spend in getting financial support to set up cGMP level vector manufacturing laboratory from different resources though the effort has not yet landed in success. Without a doubt, in a couple of years down the line, clinical grade vector production will become a reality in our center.

Bioreactors, biofermantors, liquid chromatography systems, cGMP certified instruments are all planned to be acquired for this purpose. Additionally, primate studies will be conducted to test the the safety and the efficacy of the state of the art gene therapy vectors produced in the Center. Consequently, the Center for Gene and Cell Therapy is dedicated to the development of novel gene and cell therapy methods for the treatment of human genetic diseases. It is a pioneering gene therapy research center in the country.

vision

Develop novel molecular genetic profiling scheme to determine susceptibility of an individual to genetic diseases.

Treat and cure both acquired and inherited human genetic diseases utilizing the most advanced gene and cell delivery technology.

Deploy personalized medicine in the context of gene and cell therapy.

mission

Administer the state of the art molecular genetic profiling methods for personalized medicine.

Establish experimental novel gene and cell therapy methods effective in treating human genetic diseases.

Diabetes and Cancer have a priority due to their prevalence.

Special emphasis is given to the generation and production of lentiviral, retroviral and adenoviral vectors.

Testing of the therapeutic efficacy of novel vectors in gene therapy clinical trials.

Organize meetings, scientific symposium and panels for the purpose of disseminating gene therapy information.

Establish a communication bridge among scientists working on gene therapy around the world.

Sponsor, support and finance gene therapy initiative in the country.

Establish the foundation of the Turkish Society of Gene and Cell Therapy.

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Set up a clinical vector production laboratory conforming to cGMP regulations.

Generate the most effective and advanced vectors for clinical use.

Design and conduct gene therapy clinical trials.

Provide consultation services to patients seeking gene therapy.

ByLaws of the Center for Gene and Cell Therapy of Akdeniz University

The Center for Gene and Cell Therapy of Akdeniz University was established on the grounds to foster gene therapy research in Turkey, to facilitate transition of gene therapy research from benchtop to clinical trials.

Goals and Purposes

The Main Goal of the Center

The main goal of the Center is to develop and deploy gene and cell therapy strategies against inherited or acquired human genetic diseases.

Center Activities in regard to Research and Demonstration:

Design genomic, proteomic and pharmaco-genomic molecular profiling methods to determine a person's susceptibility to diseases or drugs,

Figure out new gene delivery methods involving viral or non viral (DNA, plasmid or liposome) delivery systems,

Facilitate novel recombinant vector and cell production for clinical use,

Assess the therapeutic efficacy of gene and cell therapy methods in animal models prior to testing in humans,

Generate and produce gene and cell therapy agents in accordance with cGMP regulations imposed by health authorities.

Develop gene therapy methods against cancers of lung, breast and prostate,

Generate new therapeutic options involving gene therapy against metabolic and autoimmune diseases such as diabetes and rhomatoid arthritis,

Employ gene and cell therapy approaches for diseases affecting cardiovascular system or central nervous system like Parkinson's and Alzheimer's,

Explore gene and cell therapy for the purpose of somatic or embryonic stem cell research

Center Activities for Consulting and Project Planning:

Support scientific projects, research and thesis studies involving gene and cell therapy research in close collaboration with national and international bodies,

Design protocols and conduct clinical phase trials of gene and cell therapy conforming to ethical standards,

Provide consulting services for patients and relatives in the field of gene and cell therapy.

Center Activities in Education and Scientific Meetings

Organize seminars, panels, conferences and congresses in Gene and Cell Therapy,

Schedule national and international training programs and courses on vector technology,

Distribute certificate, acceptance letters or similar forms as a result of attendance to such activities concerning gene and cell therapy,

Conclusion

Researchers of the Center for Gene and Cell Therapy are expected to make some groundbreaking discoveries especially in diabetes and cancer related gene therapy research in the near future.