This paper examines the safety and efficacy of non-viral gene transfer in cartilage tissue engineering (TE) from the worldview of Islam. The first clinical trial treating adenosine deaminase deficient patients conducted in 1990 has triggered the development of gene transfer technology. The potential of gene transfer is further explored in TE field with the hope that it could prosper the regenerative medicine application. However, ethical issues become important when it comes to application of new treatment modalities, primarily in gene transfer because of genetic modification influences the basis of life - the DNA. Besides ethical issue, the application of gene transfer in treating diseases also attract views from religious context. The questions on the techniques to administer the gene in human, social acceptance of genetically modified cell and adverse effects from it are still debatable and unresolved. Apart from that dilemma, both safety and efficacy issues are raised due to the scientific uncertainty and social perception of the technology. Despite countless number of encouraging findings and recommendations by the proponents of
the technology, gene transfer is currently available only in the research setting. The established guidelines are used to complement and provide the necessary foundations in discussing the aspects involved in the incorporation of gene transfer with cartilage TE. Relevant Islamic input are identified and aligned to those particular guidelines. It is hoped that the integration of Islamic inputs in the existing guidelines could suggest the safest approach in treating cartilage degenerative disease through gene transfer and TE.
Tissue engineering (TE) research serves to overcome the major obstacles in organ transplantation. This paper summarizes the progress of TE in Malaysia. The online database of Elsevier’s SCOPUS was accessed. Publications related to TE from 1960 till 2017 were scrutinized. The results show an increasing trend in tissue engineering research and development in Malaysia. The search result identified and examined 264 original article publications. It is hoped that the outcomes of this study could serve as a point of reference for researchers on the status of TE research and development in Malaysia. The findings of this study could assist TE researchers in Malaysia to identify the strengths, weaknesses, opportunities and obstacles towards further enhancement in their activities. Consolidating, realigning and re-strategizing those initiatives should also be seen within the context of nurturing potential and budding researchers in TE.
Presently, there is no specific federal legislation governing articular cartilage tissue engineering (ACTE) experimenta- tion practices in Malaysia. However, there are related regulations and guidelines provided by government agencies to oversee and guide such practices. The rules and regulations provided in the documents have the essential aim of safeguarding public health through ensuring that non-clinical studies reach a certain quality, efficient and safe for hu- man use. There are themes identified when scrutinising relevant documents which includes, the need for authorised personnel and the establishment of facilities in conducting such experiments, the aspect of cell-scaffold construct development, the use of human materials, the aspect of biosafety, animal care and use during the experiments, and considerations on the impact on the environment. The individual laboratory or facility shall adopt and adapt these standards as deemed appropriate by the ACTE researchers to ensure that non-clinical studies are conducted in a proper and ethical manner.