Veterinary medicine has evolved from the initial conservative practices to the advanced therapeutic options like regenerative medicine utilizing stem cells. While stem cells may not yet offer solutions for all the clinical challenges, their utilization into veterinary care can provide understanding and can be a relief for many ailments. India, a home to the largest population of farm animals since antiquity, witnesses a boom in pet ownership as well, with over 30 million pets. This trend is also evident in the Kashmir valley, where cats are preferred as pets. Animal owners especially pet owners are willing to go to any extent to save their animals and an increasing number of pet parents seek advanced treatments. In line, stem cell therapy is rapidly becoming a must-have option.
A growing diverse literature on stem cell based regenerative medicine makes it inconvenient for the interested audience to understand the current status. The information in this regard, true or false, is also circulated across the borders attracting stem cell tourism. Talking about stem cell research and therapy in humans, India along with the China and Japan are one of the main countries in Asia Pacific that undertake this field seriously. Stem cell and/ or stem cell-based products (SCPs) unlike small-molecule drugs are currently least understood with lack of standard safety test methods. European Medicines Agency (EMAs), a regulatory body of European Union puts stem cells under advanced therapy medicinal products (ATMPs). The clinical use of ATMPs may pose risks to patients and third parties. The risks are determined by factors related to the quality, biological activity, and application of the ATMPs. This calls for the urgent need for clear guidelines and regulations to ensure safe and ethical practices within the field.
Why Stem Cell Research and Therapeutics in Veterinary Medicine in India:
High Incidence of non-treatable animal diseases
The prevalence of musculoskeletal disorders in animals like dogs is estimated at around 20%, with significant impacts on quality of life and healthcare costs. In equines, musculoskeletal disorders like osteoarthritis (OA), tendon and ligament injuries and bone injuries account for around 40-50%, 30% and 15%, respectively in competitive and/ or race horses. Similarly, there are spinal cord injuries or other nervous affections like Wobblers syndrome, distemper and cardiac diseases in animals that make them morbid or endanger their life. In cattle, reproductive disorders pose a significant challenge for veterinarians. Currently, effective standard treatment for these conditions is lacking. There are diseases in animals that share pathophysiology with that of the humans and can therefore successful therapeutics in animals can provide basis of therapy in humans, one-health approach.
Livestock Health
Livestock diseases lead to substantial economic losses. Notable diseases like mastitis or mammary gland fibrosis and reproductive disorders in cattle and musculoskeletal injuries in equines make them economically non-viable. The Department of Animal Husbandry, Dairying and Fisheries, Ministry of Animal Husbandry, Govt of India (GoI) estimates losses due to diseases can reach up to RS 15,000 crore annually.
Advancements in Veterinary Medicine
The compound annual growth rate (CAGR) for global animal stem cell therapy market is projected to be between 5.2% to 5.6%. It is projected to grow from $256.0 million in 2023 to $440.0 million in 2033. India can benefit from this trend by investing in stem cell research.
Demand for Alternative Therapies
Growing animal ethical considerations, human-companion animal bond, growing investment from pet insurance companies, animal-dependant companion support for aged and childless owners, growing pharmacy for animals and utilization of pets as experimental model animals for studies on animal drug testing make it important to provide advanced therapeutics in veterinary practice. Furthermore, the one-health concept has increased the importance of the veterinary sector to provide health-for-all. Stem cell therapies can enhance the recovery process for injured animals and improve their overall well-being, aligning with the growing emphasis on animal welfare. Stem cell therapy utilizes the body’s natural healing mechanisms by deploying cells that can differentiate into various cell types, facilitating the repair of damaged tissues. In animals, mesenchymal stem cells (MSCs) derived from sources like bone marrow, adipose tissue, and umbilical cords have shown significant potential in treating a range of afflictions. From osteoarthritis to tendinopathies, from liver affections to neurological disorders, and from immune affections to infections, the potential applications of MSCs are vast and varied. Research reveals that stem cell therapy can improve an animal’s quality of life, reduce pain, and even restore lost function in some cases.
Current Efficacy Statistics
Global studies indicate that approximately 80% of dogs with arthritis show significant improvements after stem cell therapy. In equines, around 80-90% of horses treated with stem cell therapy for tendon or ligament injuries return to full function, with a reduced likelihood of reinjury compared to those treated with traditional methods. In cases of joint disease or cartilage degradation, stem cell therapy has shown significant improvement in about 70% of treated horses. Stem cell therapy has been found to reduce recovery time by approximately 30-40% for soft tissue injuries, allowing horses to return to training and competition sooner. The reduced recovery period is a major advantage for trainers and owners aiming to maintain performance schedules.
In cattle, stem cell therapy in endometritis, ovarian dysfunction and cysts, infertility, and reduction in postpartum complications has given success rate of around 70-80%, 60-70%, 15-20%, and 50%. It also improves embryo transfer success rate of 10-15%. Despite these statistics, stem cell therapy remains to be established as standard therapeutics due to incomplete understanding of their properties and mechanisms of actions. However, all these results drive a 20% annual growth rate in veterinary regenerative medicine globally, and India is no exception.
Why Regulations for the Stem Cell Research and Therapy in India
For medical/ veterinary sciences, it is imperative to establish a strict regulatory system to prevent malpractice. The incredible potential of stem cells allows it to grow rapidly, necessitating the development of specific guidelines and regulations. There are various types of stem cells and their properties and social values also vary. Pluripotent stem cells like embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs), have involved ethical issues and tumor formation risks, are least opted for therapeutics. Adult stem cells like mesenchymal stem cells (MSCs), commonly opted for therapeutic tend end to waive off such factors, but nevertheless are susceptible to phenotypic changes in the ex vivo environment and are little understood.
Developed countries like the United States and those in the European Union regulate veterinary stem cell research and treatments by strict frameworks while India lacks such a formal oversight. Regulations help to prevent emergence of risks that hinder the progress of the field as is discussed under:
- Quality Control: For any therapeutic agent, ensuring standardized practices are must. A risk of subpar stem cell products to enter the market is quite imminent considering the tall therapeutic claims being made and marketing strategies opted. Uncertain quality or improperly processed stem cells can lead to ineffectiveness or adverse reactions. These therapeutic trials cannot provide desired outcome and can lead to misinterpretation of the results. As such regulatory guidelines need to be set-up to establish strict quality standards.
- Ethical Sourcing: There are number of incidents in India that show utilization of xenogeneic (other species) sources of stem cells being used in humans which goes against the permissible and ethical sourcing of the cells. Such practices can be quite rampant or can arise, considering the rise of the stem cell therapy in the veterinary field. Regulatory system would allow strict guidelines and standardizing practices to be implemented, avoiding any practices that could compromise animal and veterinary medicine ethics.
- Training for vet clinicians: For successful stem cell therapy, understanding of the pros and cons of the field requires specialized training. This includes the ways and means of administering the cells as well. Lack of regulations may allow these procedures to be conducted without sufficient expertise, increasing the risks of complications. Therefore, certification training programs for vet clinicians in regenerative medicine would suffice the need. These certification programs may be well regulated under the field.
- Cost and Accessibility: The cost factor of stem cell therapy is a big setback for undertaking this field in the veterinary regenerative medicine which limits its accessibility. These procedures may be govt funded and by roping the industries interested in initiating such a therapy. Currently, stem cell therapy, barring for some haematological conditions, does not offer standard therapeutic option for any clinical condition. However, there are reports that show good outcome with the therapy. Regulation in practices and final support form govt could help in undertaking this field. Regulations in practices could help in standardizing costs. All these steps would increase availability of this technology to a broader section of the animal population.
The Need for Encouraging the Scientific Research
In India, stem cell research in animals is still in infancy, though there is encouraging progress. Institutes like Indian Veterinary Research Institute (IVRI), Madras Veterinary College, Chennai and Faculty of Veterinary Sciences and Animal Husbandry, SKUAST-K, are routinely conducting research and therapeutic studies that could shape the future of veterinary regenerative medicine in India. Establishing a regulatory framework with an option of funding for the field could foster additional research, promote data collection, and enable nationwide tracking of treatment outcomes, facilitating advancements in therapy protocols and applications. The animal studies are double-edged as the data can also be extrapolated for humans.
Empower to Impact
Evolution of veterinary regenerative medicine in India is at a crucial juncture. Veterinary regenerative medicine must be implemented on the principles that protect animal welfare, ensure treatment efficacy, and promote ethical practices. This calls for development and implementation of a national framework for stem cell therapy. There is need for veterinary associations, policymakers, and research institutions to work together to frame guidelines that cover ethical sourcing, practitioner certification, standardized protocols, and treatment monitoring and reviewing. These guidelines can safeguard the quality and safety of stem cell therapies and additionally can lead to further breakthroughs in the field.
The steps enlisted below may ensure workable system in India:
Establishment of a Central Regulatory Authority and its collaborations
An apex body, Regulatory Authority for Stem Cell Research and Therapeutics in Veterinary Sciences (RASCVS), may be created to oversee all aspects of animal stem cell research and therapeutics. The authority may be brought under the ambit of Indian Council for Agricultural Research (ICAR) that regulates research in veterinary sciences. This body may collaborate with the Indian Council of Medical Research (ICMR), Department of Biotechnology and the Central Drugs Standard Control Organization (CDSCO) to leverage existing national guidelines for human stem cell research and therapy.
Additionally, animal welfare considerations through Animal Welfare Board of India (AWBI), besides, Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) and other relevant bodies may be roped in to formulate in-depth regulatory guidelines. The guidelines for humans were initially formulated in 2007 and later revised in 2013& 2017. The regular updates to India’s national guidelines for human stem cell research and therapy underscore the need for their refinement and advancement, given the field’s rapid progress. However, it is worth mentioning that stem cell research and therapy are largely considered experimental and are not yet recognized as established definitive treatments, barring haematopoietic stem cells (HSCs) for specific clinical conditions.
The role of the apex body in consultation with the other relevant bodies shall be to:
- Formulate comprehensive guidelines for ethical research and therapeutic applications.
- Monitor compliance with regulations and conduct regular audits of research institutions and veterinary clinics.
Framing of the Guidelines
Ethical guidelines framed must tailor to veterinary medicine, in general and veterinary stem cell research, in particular. This must include well-informed consent, animal welfare standards, and pre-, intra- and post-treatment monitoring. Creation of standard operating procedures (SOPs) for stem cell sourcing, collection, processing, storage, and application. This shall ensure consistency and quality across practices.
Research Standards and Registering of Clinical Trials
A simple, clear process should be kept in place to approve clinical trials involving stem cell therapies in animals focusing on safety and efficacy. This shall also include the details of the stem cell donor and patient, although may be kept confidential for general public.
Data Collection, Reporting and Continuous Monitoring
The status of the registered clinical trials may be updated timely. A system may be established that can help collecting the continuous feedback from stakeholders to adapt and update regulations as the field evolves.
Education and awareness
There has to be a portal and body that launches initiatives to educate veterinarians, pet owners, and livestock producers about the benefits and risks of stem cell therapies. This shall also grant funds to the research institutes to organize training programs for veterinary practitioners on the latest advancements in the field along with regulations.
Compliant to Global Regulations
The guidelines framed should align with international standards set by organizations such as the International Society for Stem Cell Research (ISSCR), Australasian Society for Stem Cell Research (ASSCR), Japanese Society for Regenerative Medicine (JSRM), Korean Society for Stem Cell Research (KSSCR), U.S. Food and Drug Administration, European Medicines Agency and Circle of Stem Cell Institutes & Centers, besides, the World Organization for Animal Health (WOAH). These organizations provide frame work as per the national rulings and same may be the case with the Indian system.
Conclusion
Stem cell therapy has an immense potential to improve the quality of life (QoL) of animals, and can therefore transform the landscape of veterinary care. However, current lack of standard practices and in-depth knowledge and understanding about the therapeutic mechanisms of stem cells jeopardizes their definitive therapeutic use. There are, however, millions of animal owners especially pet owners in India that seek cutting-edge treatments like stem cell therapy. It is therefore time to regulate this promising therapy to ensure its safe, ethical, and effective application. Framing guidelines and implementing them would not only protect animal rights but shall enable competent veterinarians to utilize the stem cell therapy to its fullest potential. This can foster a new era of compassionate and advanced care for India’s beloved animal companions.
(The Author is Assistant Professor and Stem Cell Researcher at SKUAST-Kashmir. Feedback: [email protected])
