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High Costs of Clinical Trials Poses A Major Challenge for The Stem Cells Industry
Human embryonic/Adult stem cells have been known to have the remarkable potency to mature into different body cell types like skin, bone, nerve, blood, heart etc. This property of stem cells creates great promise for treating many diseases/disorders like Alzheimer’s, Parkinson’s, cancer, osteoarthritis, diabetes etc.
According to many research articles, Regenerative medicine research has two main goals. One is to make use of stem cells safely and efficiently in therapies to treat injured cells, tissues or organs. And second is to develop strategies that will improve the quality and functioning of stem cells.
To achieve these goals, extensive research is necessary. The cost of research and clinical trials is very high, thus restricting the research goals. Apart from cost/huge investments, the other challenges are regulatory challenges with varied guidelines across different countries, because of differences in the opinions and cultural viewpoints. Setting up a single/common policies or guidelines across the globe to govern stem cell research will be helpful. Human embryos for research, somatic cell nuclear transfer (“therapeutic cloning”), IPSCs have created problems and never took to life and allogenic cells have high incubation period. In most of the countries use of autologous adult stem cells is however permitted.
A number of stem cell therapies using different cellular models are still in the experimental stages, and are controversial (Francis et al., 2013). There are many challenges to overcome to create new possibilities and strategies to treat various diseases that can promote health and extend the human life span.
Growing Interests in Stem Cell Banking and Stem Cell Therapy Markets
According to the article published in GLOBE NEWSWIRE Dublin, Feb. 06, 2018 The “Global Stem Cells Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2017 to 2025”, The global stem cells market was valued at US$ 5,231.7 Million in 2016, and is expected to reach US$ 13,731.5 Million by 2025 expanding at a CAGR of 10.50% from 2017 to 2025.
America is believed to have biggest market with great revenue share followed by Europe and Asia Pacific. The technological advances and supportive regulatory environment for stem cell-based products Asia Pacific will be one of the fastest growing market in future.
According to the report adult stem cells from bone marrow, adipose, placenta etc is growing due to the immunomodulatory properties which can avoid immunological rejection and easy to administer during the clinical trials and will be the market will be upfront in the period 2017-2025. There is huge market for stem cells across the globe as more than 300 ongoing clinical trials are reported which can create a new avenue for stem cell research.
Since last two decades stem cell banking and related therapy have seen a constant growth, due to the increasing awareness among people, raise in number of clinical trials, and growing interests in R&D initiatives to develop more advanced therapeutic procedures.
The growing interests from many government and private sectors in terms of investments, developing new strategies and partnerships will further create a new path for growing market. However, there is a need to bridge the gap between government bodies and stem cell industries. For instance, US-FDA – Office of Tissues and Advanced Therapies (OTAT) have only approved one product (HPC Cord blood) to be used in Humans1, there is a need to review their current guidelines and approve more products.
Creating A Common Guideline Might Be The Key To Attract Higher Investments
Creating the regulatory guidelines was one of the important tasks for the government organizations of different countries, in the last decade, several countries have emerged as leading centers for the research in stem cells and their possible therapeutic applications.
Many countries have greatly expanded the scope of stem cell research, creating an array of scientific advances and medical applications. However due to difference of opinions and cultural viewpoints, each country has developed its own policies or set of guidelines. It is important that the regulatory bodies accept the value of research and come up with the common or single set of guidelines around the world, which shall help to materialize the growing progress and creating a path for more investments and improved research.
It will be helpful to many stem cell organizations if, the government bodies keep open the use of autologous stem cells and plan to impose less stringent regulations for adult stem cells. However, the strict policies for use of IPSCs and Embryonic stem cells can be retained as the fate of these cells is still unclear. There is a need to adopt the Japanese model to fast track trials from sources which are relatively safe to use.
Author:
Rohit Kulkarni
Vice President/Director
Stem Cell Society of India/ Reelabs, India
www.linkedin.com/in/rohit-kulkarni-36565728/