CHALLENGES ASSOCIATED WITH STEM CELL THERAPY 

Despite successful efforts to refine existing methodologies and to develop better ones, several challenges have to be overcome before stem cell therapy can become a viable clinical approach.

 

Manufacturing issues - 

Careful consideration of the manufacturing processes and safety assessment of the stem cells is absolutely necessary before introducing them into an organism. Establishing communication with health authorities and preclinical testing specialists is the best way to streamline safety evaluation. Broadly speaking, early interaction between regulatory agencies, therapy developers and drug safety scientists is the most useful in this regard.

 

Genetic instability - 

Certain evidence shows the genetic instability of hESCs, iPSCs and adult stem cells in culture. Also, the recipient of a transplant of undifferentiated or incorrectly differentiated cells faces a substantial immunogenic and/or tumorigenic risk. Therefore, it is necessary to perform a detailed genetic analysis. This should include evaluation of transcription factors’ expression, proliferation capacity, differentiation propensity, heterogeneity of culture and karyotyping of the genome.

 

Pharmacological issues

Sometimes, stem cell treatment results in transplant rejection, decreased immunity at the time of transplant, teratomas, and other issues. Stem cells are also highly sensitive to drugs. Therefore, pharmacokinetic behaviour of stem cells must be considered by preclinical studies using large animal models.

 

Stem cell distribution after transplant

A major problem is improper distribution and localization of the stem cells after transplant, which can cause ectopic tissue formation or tumorigenicity. Hence, the ability to monitor cell distribution in the host after administration is required. Since the stem cells may be essentially indistinguishable from host cells, a suitable methodology (such as GFP-labelled cells) is required to monitor the behaviour of transplanted cells.

 

Ethical concerns

Stem cells of high quality are found in embryos. The idea of harvesting such cells from embryos is abhorrent to many, who consider it to be a crime against humanity. However, when scientists take such stem cells, they are usually from extra embryos that result from in vitro fertilization. The use of adult stem cells avoids any concerns altogether, but these are comparatively more specialized than embryonic stem cells.

 

Challenges in developing countries

There are many challenges that are suppressing the advent of stem cell therapy in developing countries.

• People still believe in primitive therapy, due to lack of upgraded knowledge of modern medicine.

• Lack of skilled human resources.

• Poor socioeconomic status and financial limitations – i.e., they cannot access or afford such therapy.

• Poor government support and policies. There should be funds and policies to strengthen existing facilities and encourage the development of more centres for research, both private and government-run.