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Formulating Haematopoietic Stem Cell Transplantation for Practitioners

A technology-based health service

S Dravida, Founder CEO, Transcell Biologics

Lakshman Varanasi, Scientist, Instructor

Transplantation is a medical procedure in which cells, or an organ, are extracted from one body and ‘fitted’ elsewhere, either in the same body or in an altogether different one. Transplanted entities could also be stem cells. Haematopoietic stem cell transplantation is a technological procedure intended for various ailments, genetic disorders or malignancies, and applied by Hemato-Oncologists at the point-of-care; the technology involves the handling of clinical-grade bioreagents/bio-components in closed systems. The clinical presentation/aspect of the treatment could be designed as a comprehensive healthcare service model. Benefits of such a model would be wide-ranging and would include cost, ease-of-use, ease of access to high-end technology as translated to a medical procedure, and measurable treatment outcomes for the targeted medical condition, such as debilitating cancers, obtained from next-generation readouts.

Transplantation is a compelling need in India, and one that has few and very pricey providers mismatching the necessity. The frequency of occurrence of congenital or acquired blood disorders which can be treated by Haematopoietic Stem Cell Transplantations (HSCT, and sometimes termed Bone Marrow Transplant, or BMT) is sufficiently large for a viable corporate opportunity. Market research for these blood-related disorders in India indicates a rewarding market for HSCT treatment. The Asia-Pacific (APAC) and Latin-American markets hold the most promise for the bleeding/blood disorders disease indication. Their anticipated growth is due to steady increase in investments of local governments in improving access to healthcare, and the increasing tilt by Big Pharma towards emerging economies. The blood cancer therapies market comprises leukaemia, multiple myeloma, and lymphoma; the first is further subdivided into Chronic Myeloid Leukaemia (CML), Acute Lymphocytic Leukaemia (ALL), Chronic Lymphocytic Leukaemia (CLL), and Acute Myeloid Leukaemia (AML). This market is anticipated to grow at a compound annual growth rate of 11 per cent year on year while the estimates from the footfall at different hospitals paint a similar picture.

The Indian Society for Blood and Marrow Transplantation maintains a registry of the stem cell transplantations done in India through its affiliate centres. The number of centres in India offering Bone Marrow Transplants (BMTs), also known as HSCTs, grew from 52 to 65 in 2016, and continue to increase at the rate of 10 per cent per year. 1878 transplants were made in 2016, as reported to the Indian Stem Cell Transplant Registry (ISCTR). Among patients with aplastic anaemia, only 20- 30 per cent receive standard-ofcare treatment; which points to a larger need of HSCT procedure to be imparted. There is therefore a large need for improving access to HSCTs in India (Kulkarni and George, 2019, Journal of Postgraduate Medicine). Data on disease prevalence is widely available, as is other census data in this regard. The leap from advancing clinical research, adoptions from the western medical technologies and practices to treatment centres in India, HSCT as a clinical procedure has been standardised and validated, has the sanction/approval of the national medical agency, the ICMR Governmental guidelines. In the same pace, it is also believed that the new disease management strategies will evolve with home-grown scientific technological breakthroughs, R&D.

The World Health Organization (WHO) in collaboration with the Worldwide Network for Blood and Marrow Transplantation (WBMT) monitors, coordinates, and recommends guidelines, standards for HSCT practice, all essential to harmonisation. Guidelines from the WHO state that regulation of transplantation at the national level is a government’s responsibility. The collection of accurate data on HSCTs and on relevant innovation and experience from responsible agencies worldwide, followed by its analysis and timely dissemination, encourages establishment of uniform standards, best practices in this field. This will in turn automatically improve the packaging and clinical delivery of this critical treatment, enabling a vendor or technology provider to offer services to more than one market.

Post HSCT, survival in haematological disorders is linked to national macroeconomic indicators, one reason why the procedure must be optimised and delivered at cost. Organised support with financing the transplantation procedure would go a long way towards improving lifesaving access for a variety of haematological disorders. The disparity between GDP per capita and the cost of the HSCT is substantial while the government mediated financing in the form of a public-private partnership at national level such as the Aarogyasree scheme in India would go a long way towards improving life-saving access to a variety of haematological disorders. This would also incentivise the continued development of the technology and drive down its cost to be borne by the patient, and consequently make it affordable to the patient. Reimbursements will help the patient and the technology that will cause a proliferation of providers. A financing system for this technology, which is tailored to the Indian context, will benefit every stakeholder in its practice. While equitable and affordable healthcare is not easy to deliver, it need not remain a pipe dream in India forever. The larger concept of equitable and affordable healthcare as envisioned by the WHO in the Sustainable Developmental Goals 3.0 (SDG3.0) is applicable here too.

Myeloblasts with Auer rods seen in Acute Myeloid Leukemia (AML), advanced stage. Bone Marrow/May-Grunwald Giemsa (MGG) stain. Author: Paulo Henrique Orlandi Mourao. The figure has been reproduced in the original format without any modifications. Use of this figure is governed by the Creative Commons Attribution-share Alike 3.0 Unported license.

India's first successful allogeneic bone marrow transplantation, i.e HSCT procedure, was done on 20th March 1983 at Tata Memorial Hospital, 37 years ago. Although HSCT is a procedure based on a simple principle, the outcome is now known to be dependent on a number of non-clinical technological factors: the sourcing of the biosample, the harvest and enrichment of the stem cell fraction from the biosample, stem cell yield, purity of the cellular fraction, the biosample’s innate and process induced bioburden, product specifications and components, extraneous agents added to preserve the product until is transplantation, and product handling for clinical presentation, or HSCT; these factors can make or break the outcome. Also, these factors and their control constitute an integral part of the technology (and of any associated intellectual property). In order to best control these various variables and enable the best outcome, the technology provider should ideally (be a dedicated biotechnology company) provide services ranging from cell collection from donors to delivery at the point-of-care. Biobanking facilities for haematopoietic stem cells can constitute a service in itself, and one that is of fundamental value in offering HSCT for immediate and tandem applications. The integrated banking cum transplantation procedure can, on the other hand, be offered as a package to the practitioner. (Biosamples are collected from bone marrow, or peripheral blood (after mobilisation from the bone marrow), or umbilical cord blood. For the autologous version of the procedure, stem cells are obtained from the patient in question (during remission); umbilical cord blood is not used here. The allogeneic HSCT procedure requires stem cells obtained from a matched donor who may be related to the patient. The authors believe that the ideal clientele for HSCT as a technological package are Haemato-Oncologists. (Haemato-oncology pertains to the diagnoses and treatment of cancerous blood disorders.) HSCTs are provided in India at BMT units in several reputed hospitals such as the Tata Memorial Hospital, Mumbai, the Christian Medical College, Vellore, Adiyar Cancer Centre, Madras, Apollo Speciality Hospital, Chennai, R&R Army Hospital, New Delhi, Gujarat Cancer & Research Institute, Ahmedabad. These units are known to continuously refine their facilities, techniques involved, and most often, the refinement is applied to making their services safer, more effective, and less expensive in the interest of the patients while the practising Hemato-Oncologists play a key role in the process.

The authors opine that if the Haemato-Oncologist is made the decision maker for both the patient and the centre where HSCT is offered, access to the technology, economies of the technology application in imparting HSCT works well popularising the cure option available. Neither the patient nor the treating centre will be at loss with this new service model where the practitioner is the user and client driving the demand sanctifying the very application with accountability of the transplant outcome, in control – An out of the box service model to offer HSCT with next generation benefits.

The HSCT procedure should be considered a medical technology for treating blood disorders as it is intended to improve the quality of healthcare at the point-of-care. The point-of-care refers to the physical location where the treatment is dispensed. The parts of the procedure that occur even before the encounter with the HSCT recipient have been unified, integrated, and take place inside a clinical-grade closed system made possible by recent advancements in the field bagging FDA approvals. The said steps include only the fractionation of the collected sample, isolation of the cellular population of interest, but not its customised formulation and ‘packaging’ for administration to the patient that involves human intervention. The system is portable, can be situated and operated at the point-of-care, at a hospital or at the practitioner-designated technology provider’s facility opening up several working relationships between the stakeholders of HSCT technology practice.

“I have been actively monitoring the developments in the Healthcare industry around the world for nearly two decades and how it is facing the challenge of burgeoning cost of Healthcare. Healthcare budgets in advanced economies like the USA etc have reached unsustainable levels. The world needs very urgent reforms in the way pharma industry is providing solutions for major diseases like Cancers causing unsustainable burden on governments. The only way to drastically reduce healthcare costs is by introduction of advanced technologies like Stem Cell based treatments, Gene Editing, Personalized Medicine using Precision Medicine, Application of Artificial Intelligence and Machine Learning based Diagnostics and other such cutting edge technologies and innovation. India is uniquely positioned to adopt some of these advanced technologies and combined with its cost arbitrage deliver affordable healthcare to the world” says Mr Uday Chatterjee an angel investor in global med and biotech industry, representing a reputed global investment fund Indian Angel Network.

The benefits of advanced HSCTs in the form proposed, can be availed of not only by Indian nationals, but by patients worldwide. There are “those who travel across international borders with the intention of receiving some form of treatment”, and many come to India. Medical tourism in India has grown by leaps and bounds in the past decade into a US$ 9 billion industry in 2020, and is growing by 200 per cent. An increasingly large piece of this pie is for HSCT for blood -related disorders such as those mentioned above. The portion is likely to grow with an increase in the incidence of these diseases, and as hospitals in India continue to deliver. The foreign clientele comprises numerous nationalities, including Africa, and other Asian countries. A sizeable cohort of patients from Europe (Russia included), and the United States also visit every year. Cost, or the absence of analogous care in one’s native country, or both, is the primary driver of such tourism, for service that is on par, or nearly on par, with that in developed countries (Other determinants include to a lesser degree, culture, proximity, or perception of care). Here’s the point though that India has become a hub for medical tourists is not happenstance; it is the direct consequence of investment in training and technology, and supportive government policies. (It would be a shame if it were to squander this advantage.) All the more reason, then, for the design of a service model for HSCT, one that is appropriate to the Indian context and can benefit all. Technology is wealth- agnostic, and a lowering of the treatment cost of HSCTs will benefit people across the socio-economic continuum.

--Issue 41--

Author Bio

S Dravida

Subhadra Dravida is the Founder and CEO of Transcell Oncologics (www.transcellonco.science) that has developed a cell-based technology offered as point-of-care service to Hemato-Oncologists performing transplant (HSCT) procedures. She is a technocrat shaping new landscapes in the field of stem cell technology and it’s applications through Transcell. She can be contacted at suba.dravida@tran-scell.com

Lakshman Varanasi

Lakshman Varanasi is a Scientist, Instructor, Writer deeply interested in advancing research on catastrophic diseases. He has been involved in Oncology research for several years, and currently works as a Science Associate.

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