Ethical Issues And Challenges In Cellular-Based Therapies

Cellular-based therapy is defined as any treatment for a disease or a medical condition that fundamentally involves the use of any type of viable human stem cells including embryonic stem cells (ESCs), iPSCs and adult stem cells for autologous and allogeneic therapies.

Types of Cellular-Based Therapy

These are mainly embryonic stem cells, which are only capable of differentiating into (ectoderm, mesoderm and endoderm). Types include Adult, Embryonic, iPSc. Adult cells are multipotent, unipotent. Embryonic stem cells have ethical issues. There are ethical issues and challenges in clinical use, tumerogenic.

Challenges facing Cellular-based therapies

Cellular-based therapies face many obstacles that need to be urgently addressed. The most persistent concern is the ethical conflict regarding the use of ESCs. ESCs are far superior regarding their potency; however, their derivation requires embryonic stem cells is an ethical issue, hence are also have clinical practice challenges, as these cells are unstable source, tumerogenic. True, the iPSCs themselves currently don’t face ethical issue as they are induced from adult source and autologous cell. Research in stem cell science is completely different from other research, here the research molecule is a living cell which breathes like us. Research also is a complex and resource-intensive field, requiring specialized equipment and highly trained personnel. In addition, there is a significant cost associated with the development and clinical testing of stem cell therapies, which can make it difficult for smaller companies to compete in this field.

The science of stem cells has to be robust to have Stem cells to use as a drug molecule which adds principles of stability, quality, consistency, reproducibility and logistically transportable and mass production should be possible.

The use of stem cells in therapy today comes under the investigational treatment having many challenges from the regulatory pathway, investigational pathway, trained manpower etc. Such a challenge is currently addressed through developing optimized protocols. The most challenging ethical issues faced in the field of Cellular-based therapies at the moment, is the increasing number of unauthorized clinics offering unproven Cellular-based treatments. Researchers and regulators are thus morally obligated to ensure that ethical considerations are not undermined in pursuit of progress in clinical translation.

Current regulatory guidelines

With the increased number of clinical trials employing stem cells as therapeutic approaches, the need for developing regulatory guidelines and standards to ensure patients safety is becoming more and more essential. However, the fact that Cellular therapy is rather a new domain makes it subject to scientific, ethical and legal and social controversies that are yet to be regulated.

Leading countries in the field have developed guidelines for research and clinical use that differs from country to country, regulatory authorities are now demanding application of standardization and safety regulations protocols for cellular products, which include the use of Xeno-free culture media, recombinant growth factors in addition to “Good Manufacturing Practice” (GMP) culture supplies and clinical trials are must from Phase 1 to Phase 3.

Various different guidelines can make it difficult. Cross country standardization, regulation is supposed to be the same all over before the Stem cells become a drug molecule.


The article is written by Dr Pradeep Mahajan, Regenerative Medicine Researcher & Founder.


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