Regenerative medicine therapy (RMT) is a process of replacing and regenerating human cell tissues and organs to restore or establish normal function. This field holds the promise of regenerating tissues and organs in the body by replacing damaged tissues or by stimulating growth mechanisms for tissue and organ healing (Mao and Mooney 2015). In RMT, tissues and organs are grown in the laboratory before they are safely implanted when the body is unable to heal (Bioengineering NIOBIA 2020). The tissues are retrieved in two ways: through cell culture and from cells that have been extracted from humans or animals (Fuchs 2012). To grow stem cells, scientists first extract samples from adult tissue or an embryo (Bioengineering NIOBIA 2020). The cells are then placed in a controlled culture where they will divide and proliferate but not specialized further. A stem-cell line is a collection of stem cells that are dividing and replicating in a controlled environment (Bioengineering NIOBIA 2020). Regenerative medicine strives to make it easier to repair or regenerate damaged tissues or organs (Bioengineering NIOBIA 2020).

A healthy human tissue, such as the liver, could naturally regenerate if destroyed either by disease or injury (Krafts 2010). Such tissue can return to its original size and function but not its original shape (Krafts 2010), however, the tissues do not regenerate in some cases (Krafts 2010). This is where regenerative medicine comes into play as it aims to promote tissue regeneration in the body or use tissue engineering for tissue replacements. As shown in Figure 1, RMT involves cell therapy, tissue engineering, and biomaterials. Biomaterials, also known as scaffolds, consist of natural and synthetic polymers. Meanwhile, common growth factors are critical molecules for tissue repair and regeneration, such as platelet, fibroblast, and vascular endothelial cells. Adult stem cells (induced pluripotent stem cells) are living cells that originate from adult somatic cells, and their potential use in personalized regenerative medicine has been demonstrated (Stoddard-Bennett and Pera 2018). These components are important because of the potential of regenerative medicine in organ and tissue repairs, such as brain, liver, skin, bone, cartilage, and nerve cell, and their applications in clinical settings.

Among the RMTs, stem cells transplantation, cellular therapy, and platelet-rich plasma (PRP) are the most prominent medical therapies being offered to patients. Others such as fibroblast cells, stem cell, and their cellular matrix, including PRP are used in anti-aging therapies. These diverse benefits depict that the potential of RMT can be further explored and implemented. Hence, this review is important to highlight and compare the progress and update of current RMT treatments or services including clinical trials in Malaysia with other developed Asian countries.

Malaysia has grown and become a strong competitor in the global health and medical tourism sector, which is now identified as a center of medicine in the region. There are two categories of health tourism offered in Malaysia: medical tourism and wellness programs. Patients may choose medical treatments and stay on the recuperating period, or they may come for a holiday and explore the various wellness programs in over 14 different states in Malaysia. With more than 35 well-established private hospitals, Malaysia offers a wide choice of state-of-the-art in-patient facilities and comfortable accommodation ranging from private rooms to luxury suites, a fine variety of meals, and highly qualified and trained nurses at a reasonable cost. Additionally, these hospitals are certified and internationally recognized quality standards, such as MS ISO 9002, and accredited by the Malaysian Society for Quality of Health.

Malaysia has become a preferred health tourism destination for many abroad patients. It offers competitive and affordable pricing and favorable exchange rate, highly qualified, experienced, and skilled consultants. Malaysia is ranked first in medical tourism compared to other countries as it attracted approximately 1.3 million medical tourists in 2019. Although the diverse culture and religion could be barriers in the implementation and practice of RMT, however, the unique entity and tolerant multi-racial and multi-cultural environment in Malaysia has successfully accommodated patients of different cultures and religions.

One of the benefits of RMT is increased functionality. When the tendons and tissues on and around the joints are strengthened, the range of motion in the joints is increased, allowing them to move freely and perform daily duties again (Benjamin et al., 2008). Next is faster recovery, where growth factors utilized in regenerative medicine aid in the regenerative process of tissues and tendons (Dzobo et al., 2018). Furthermore, RMT is beneficial in the treatment of cardiovascular diseases. Cardiovascular diseases can deplete oxygen supply to the heart tissue, causing scar tissue to develop while altering blood pressure and blood flow (Mozos 2015). Due to the production of various growth factors, stem cells from adult bone marrow can develop into cell types that are required to repair blood arteries and the heart (Zakrzewski et al., 2019). There are a few benefits of stem cells (HSCs and MSCs), where HSCs can make up all types of blood cells while MSCs can generate bone, bone marrow, and adipocytes (Charbord 2010). Adult stem cells that can be found in the brain can differentiate into neuron cells and non-neuron cells (Maldonado-Soto et al., 2014). Several studies have shown that hematopoietic stem cells are widely used in clinical trials (Bryder et al., 2006; Zakrzewski et al., 2019; Kabat et al., 2020; Khaddour et al., 2021).

Cell therapy is one of the regenerative medicine therapy technologies that have been used worldwide. There are two types of cell therapy, which are stem cell therapy and somatic cell therapy. These cell therapies can either be autologous or allogeneic. In allogeneic therapies, a donor is a different person, who is usually a close family member or relative. It could also potentially come from a genetically matched donor. On the other hand, autologous treatments involve cells isolated from the donor. For acute myeloid leukemia (AML) patients, treatment is usually with allogeneic hematopoietic stem cell transplantation (HSCT). The treatment aims to identify prognostic factors associated with poor outcomes. The survival outcomes for Malaysian AML patients treated with allogeneic HSCT were good, where the overall 10-years overall survival (OS) and disease-free survival (DFS) for the patients after allogeneic HSCT were 63 and 67%, respectively (Ganceviciene et al., 2012). This treatment should be considered the standard therapeutic approach. In addition, stem cells have also been used in dentistry to treat periodontal disease. Gene therapy is the tissue engineering method that has been performed in periodontology (Chatterjee et al., 2013). Another RMT that has been used globally is graphene. Graphene has been employed as a scaffold to mediate stem cell growth and differentiation, whereas other researchers utilized the RMT to successfully transplant MSCs and guide their development into specific cells (Bryder et al., 2006; Kabat et al., 2020; Khaddour et al., 2021).

Numerous cell therapy trials are ongoing in Europe, the United States, and other parts of the world (Blasimme and Rial-Sebbag 2013). The regulatory framework for development and compliance procedures for the production and commercialization has progressed alongside the establishment of industries. These measures were taken to provide guidance and legislation on the assessment of safety, quality, purity, potency, and efficacy of cell therapy trials based on the experience gained from conventional pharmaceuticals and blood banks. Nevertheless, since the cell is an active therapeutic agent, the regulatory framework for such products is significantly more complex compared to typical molecular medicines, where the final product differs from cell culture bioprocessing.

The European Medicines Agency (EMA) has recommended Holoclar for approval in the European Union as the first advanced therapy medicinal product (ATMP) using stem cells (EU) (Yu et al., 2018). In adults, Holoclar is a treatment for limbal stem cell deficit (LSCD) caused by physical or chemical burns to the eye (s). It is the initial treatment option for LSCD, a rare eye disease that can lead to blindness. Stem cells have the potential to serve as the repair system of the body. Limbal stem cells are found on the edge of the cornea (the clear front section of the eye) and the sclera (the white region of the eye). LSCD can be caused by the loss of these stem cells as a result of physical or chemical damage. The repair system of the body could be aided by stem cells. Specifically, the limbal stem cells are necessary for the corneal epithelium to regenerate and repair after damage.

Compared to Western countries, Asia is less advanced in terms of RMT developments and applications. However, it is worth noting that some Asian countries, such as Japan and Singapore are among the high-ranked countries in terms of RMT.

Table 1 shows the RMT in Asian countries with a detailed explanation of the treatment cost, success rate, and first documented dates.

In Malaysia, regenerative medicine has gained more interest over the years. More researchers have been exploring the possibility of utilizing RMT in Malaysian clinical settings as an alternative to conventional treatment or to possibly become the superior choice of treatment in the future. In comparison to other developed nations, Malaysia is still far behind in keeping up with the current advances in medical therapies. Nonetheless, numerous developments have been recorded in Malaysia’s research sector in investigating RMTs and their clinical implications.

Table 2 presents detailed information on RMTs in Malaysia, which includes the related diseases, treatment cost, and the first documented dates.

In private medical centers, the average cost for using hematopoietic stem cells (HSC - Hematopoietic Stem Cells) as an RMT for blood cancer (leukemia and lymphoma) is in the range of MYR 200,000 to 250,000. Through the Medical Assistance Fund of the Malaysian Ministry of Health Malaysia (MOH), the cost of treatment can be reduced to around MYR 40,000 to 60,000 at all University Hospitals. In addition to its use for the treatment of blood cancer, stem cells are still considered experimental and are only allowed for medical research purposes. However, many private centers provide stem cell treatments for other uses, such as for the treatment of knee joints, diabetes, and anti-aging. Since the use of RMT is still experimental as regulated by the MOH, the experimental type of stem cell treatment is not paid for or covered by the insurance company. Apart from bone marrow transplantation, stem cell treatment for other causes is already being investigated in clinical trials and has shown promising outcomes for treating disorders, such as diabetes, heart disease, knee osteoarthritis, autism, and anti-aging (Loo and Wong 2021). Approximately, 100 million MSCs treatment in Malaysia might cost between MYR 50,000 and MYR 80,000. Malaysia is among the countries in Southeast Asia in which PRP is extensively used for face, neck, and scalp treatments.

A few clinical trials are currently being conducted in Malaysia and have not been used yet in medical applications. Table 3 shows a few clinical trials of RMT that are currently ongoing in Malaysia.

Several RMTs are currently in clinical trials in Malaysia with precision medicine being one of them. Precision medicine can be used to treat cancer through a tumor profiling approach that can identify various anti-cancer-therapies (Krzyszczyk et al., 2018). Precision medicine is a “developing approach to illness treatment and prevention that considers an individual’s genetic diversity, environment, and lifestyle.” Doctors and researchers will be able to accurately predict whether treatment and prevention methods for a specific disease will be successful in the groups of people subjected to this approach. It differs from a one-size-fits-all strategy in which disease treatment and prevention techniques are designed for a specific person with little regard for individual differences. Precision medicine in cancer uses unique information about an individual’s tumor to help in the diagnosis, treatment planning, monitoring treatment effectiveness, and prognosis (Malone et al., 2020; Lightner and Chan 2021). Examples of precision medicine are targeted therapies for specific types of cancer cells, such as HER2-positive breast cancer cells. This approach plays the role of tumor marker testing to aid in cancer diagnosis.

Generally, cancer can be treated using chemotherapy, radiation, and surgery. These methods involve the application of medical tools by doctors while treating cancer. Meanwhile, in precision medicine, the doctors employ a patient’s genes to uncover clues for cancer treatment.

Unmatched donor umbilical cord-derived MSCs are also believed to treat knee articular cartilage defects (Arshi et al., 2020), and are currently viewed as an extensive research area for stem cells. However, their clinical applications are not common in Malaysia given the limitations of evidence-based clinical trials, particularly in hospitals with limited resources and competence. These RMTs are not yet recruiting and could not be used for medical purposes. Another example of a clinical trial conducted in the joint research in gene therapy for β-thalassemia. β-thalassemia is a blood disorder in which hemoglobin production is deficient in adults. Clinical trials have shown that by splitting certain genes, patients undergoing treatment can produce sufficient hemoglobin to reduce the effects of their disorders.

Another study focused on the treatment for Spinal Muscular Atrophy (SMA), a genetic disease that affects the part of the nervous system that controls voluntary muscle movement (Khaddour et al., 2021). The study found that patients suffering from SMA either lost or had a mutated gene known as the Survival Motor Neuron 1 (SMN1) gene. Missing or mutated genes can be replaced using viral transport mechanisms to insert corrected genes. Based on the observational studies conducted using mice models, the infusion of healthy bone marrow components into a myelosuppressive bone marrow could stimulate recovery of function in the recipient (Khaddour et al., 2021). A pediatric patient with severe combined immunodeficiency syndrome received the first successful allogeneic bone marrow transplant in Minnesota in 1968 (Khaddour et al., 2021). Allogeneic and autologous stem cell transplantation has become more popular in the United States and worldwide since then. The process of transplanting cells to an injured location to heal or replace damaged tissues or cells is known as cellular therapy. Several studies have demonstrated the introduction of stem cells using cellular treatment techniques. However, these studies only provide preclinical proof while clinical evidence in this area is sparse. Although little research has been performed on the cells of the ankle ligaments, researchers believed that they have distinct cellular features and components than the other ligaments, which makes it challenging for cellular therapy to restore the wounded ligaments to their pre-injury form. Another research that is still in the phase of a clinical trial is autologous peripheral blood stem cells (Saw et al., 2013). This autologous peripheral blood stem cell is used for articular cartilage regeneration and the update of these stem cells has been completed (Saw et al., 2013). Presently, the clinical trial is at the second phase and it has to pass through the third phase before completion. Approval from the governments of the countries is required before the stem cell can be used.

Another clinical trial uses MSCs as an anti-aging. The sources of MSCs are either autologous (adipose tissue) or allogeneic (adipose tissue or umbilical cord) (Zarei and Abbaszadeh 2019). This research is to evaluate the safety and efficacy of human MSCs infusion therapy in preserving general wellness (Saw et al., 2013) and reversing the effects of aging in the study population. The research is still in phase 1 clinical trial and is not yet recruiting. Furthermore, the Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS) is used to treat single coronary vessel disease (Zheng et al., 2019). This study was mainly designed to evaluate the feasibility, preliminary safety, and efficacy (IBS) and this research are currently still recruiting (Zheng et al., 2019).

Some RMTs such as stem cells and PRP have been used in clinical settings in Malaysia. These RMTs have been used widely and most are offered in government and private hospitals in Malaysia. The cost of the treatments is quite expensive, especially in private hospitals. Table 4 highlights the most prominent RMTs in Malaysia, the hospitals offering RMT, and the costs involved.

MSCs and HSCs are the most commonly used stem cells in RMT in Malaysia. One of the best hospitals that offer stem cell therapy is Hospital Ampang Clinical Stem Cell Services, which focuses more on blood cancer treatment. According to the MOH, the treatment cost is about MYR 50,000 to MYR 70,000 for 100 million cells. The cost in government hospitals is quite cheap compared to private hospitals. These stem cells are mostly used in treating blood cancer, such as leukemia. MSCs have been widely used in regenerative medicine for bone regeneration and are mostly still investigated in clinical studies. MSCs appear to be promising targets for cell treatment in a range of malignancies (Lee et al., 2019).

In Malaysia, PRP treatment is rare but the treatment is practiced, especially in Hospital Universiti Sains Malaysia (HUSM). The cost of PRP treatment in Malaysia ranges from MYR 800 to MYR 1500 per treatment. Nevertheless, the cost varies depending on the location and popularity of the hospital, and the PRP preparation kit used. The PRP treatments in Malaysia are mostly utilized to treat osteoarthritis. Osteoarthritis is the most common cause of joint discomfort and a condition that primarily affects the elderly. Osteoarthritis can affect every joint, but the knees, hips, shoulders, thumbs, and spine are the most commonly affected. The shock absorbers in these joints are called cartilage, and they are located within the joint. These cartilages are vulnerable to wear and strain as one gets older, and the process is accelerated by injury or misuse of the joints. PRP is useful in the treatment of osteoarthritis-related joint discomfort. It is thought that injecting PRP into the afflicted joints will induce cartilage formation. The pain caused by bone friction will be substantially decreased with the regeneration of these natural cushions. PRP has several advantages over surgical replacement, including being a non-invasive therapy with far lower risks. Surgical interventions expose a patient to infection, blood loss, anesthetic chemical allergies, and surgery failure that necessitates revision. The plasma-rich platelet obtained from the patient’s blood is another benefit of PRP, indicating that the material will not be rejected by the body as foreign and no reaction will occur. The platelets are extracted from the patient’s blood via centrifugation.

The application of PRP for cell therapy is seen in autoimmune diseases, urinary problems, and infectious diseases. In Malaysia, cell therapy may cost MYR 50,000 to MYR 80,000. The Cell Therapy Center is a Center of Excellence at UKM Medical Centre (UKMMC) that provides cell-based therapy to patients with blood disorders, cancers, bone marrow diseases, and degenerative diseases, including HSCs, lymphocytes, dendritic cells, MSCs, and mononuclear cells. The Cell Therapy Centre founded in November 2006, aspires to be a world leader in cancer immunotherapy and regenerative medicine research and development (R&D). In July 2008, a brand-new transplant unit with 10 transplant rooms, 6 post-transplant rooms, and 2 suites was opened. The Stem Cell Transplant unit was previously located in Hospital Kuala Lumpur, but it was relocated to Hospital Ampang in 2006, and designated as the National Referral Centre for Hematological Expertise. Since 2010, Hospital Ampang has been able to perform 180 transplants each year compared to only 40 to 45 transplants conducted earlier. The waiting period is now less than 2 months (compared to 6 months when the program first began), owing to the time required for donor and patient evaluations. Once a donor is found, emergency cases such as bone marrow failure can be treated within 2 weeks. From 1999 through 25 October 2012, this unit performed 834 adult transplants, including 443 autologous transplants, 359 allogeneic-fully matched sibling transplants, 18 allogeneic-matched unrelated transplants, and 7 cord blood transplants (Ministry of Health 2012).

The Malaysian Stem Cell Therapy Working Group (SCM) is a network of multi-disciplined medical professionals and specialists who provide sophisticated, research-driven regenerative medicine, integrative medicine, and lifestyle medicine in the country. In the case of stem cell therapy, there is no one-size-fits-all option. Mid Valley City, Pantai Hospital Kuala Lumpur, Subang Jaya Medical Centre, Life Care Medical Centre, Assunta Hospital, Publika KL, Petaling Jaya, Shah Alam, and Kajang are among the Malaysian Stem Cell nine partner clinics in the Klang Valley (Ministry of Health 2012). However, no available data to depict the number of treatments performed in these partner clinics. HUSM has specialists who have studied PRP abroad and have been practicing this treatment since 2018. They also ensure that all the equipment needed to provide PRP is ready to be used in surgery. This hospital has developed a new technique for extracting platelet-rich plasma from autologous white blood cells with a PRP enrichment of 6–10 times, which is about 3–5 times higher than for conventional ones. The treatment has been proven to be more effective at rejuvenating the skin, removing wrinkles, and reducing abnormalities caused by acne marks. Likewise, there is no data to reflect the number of treatments (PRP) administered in the center.

Regulatory oversight on the use of these biotechnology-derived cells and tissues as therapeutic products for the treatment of diseases is important to prevent any potential serious attendant risks to public health. Drug regulatory agencies across the globe including the United States, Canada, the European Union, Singapore, Japan, and Korea recognize cell therapy products as drugs or medicinal products. Regulatory agencies also recognize the current drug regulatory framework, which might not be the best framework to regulate these products. Hence, drug regulatory agencies have either established or are developing a separate framework to better regulate cell therapy products in the last few years (Kellathur and Lou 2012). As shown in Table 5, different countries worldwide have various regulations and laws that specify the clinical applications and research of RMT as of 2010.

In Malaysia, there is no law with regards to RMT, either in clinical application or research. Meanwhile, only a general regulation and guidelines for the use of stem cells in research and therapy exist, which was documented in 2009 (CRC 2009). Only hematopoietic stem cell and umbilical cord stem cell transplantations are allowed in Malaysia, and they have become the most established form of stem cell therapy in the country. The use of other stem cells such as hESCs and somatic stem cells is considered experimental. Xenotransplantation or therapies involving the use of animal stem cells or animal cells are currently prohibited. Private healthcare facilities and services intending to perform or perform stem cell or cell-based therapies need to be licensed under the Private Healthcare Facility and Services Act 1998 (CRC 2009). The guidelines provided were mainly based on those used by the United States Food and Drugs Administration (US FDA). Hence, it is time for Malaysia to have specific legislation for the application of RMT, either for aesthetic use or for disease treatments. Such legislation will help to regulate and monitor proper applications of RMT in the country, as well as prohibit any misuse or mis-advertising of RMT that is harmful to the public.

Another guideline in Malaysia regarding cell and gene therapy products (CGTPs) was documented in 2021 by the National Pharmaceutical Regulatory Agency (NPRA). However, this guideline is too brief as it only specifies that facilities producing CGTPs will only need to comply with the good manufacturing practice (GMP) that has been established. A more detailed and focused guideline is necessary to ensure a higher standard for producing CGTPs as it involves handling live cells, which will be used for various severe and chronic illnesses. Figure 2 illustrates the development of RMT, including but not limited to stem cells therapy worldwide and in Malaysia.

Lack of information and awareness regarding RMT are expected among the public as it is a newly developed technology. Hence, there are different views on cultural and religious aspects towards RMT. There may also be some cultural and religious barriers against RMT application, specifically in Malaysia.

Malaysia is a multicultural and multi-religious country that is proud of the diversity among its people. Malaysia’s population is currently 32.37 million people with 61.3% of the population practicing Islam, which amounts to approximately 19.5 million people (Ahmad 2007), followed by 19.8% Buddhism, 6.3% Hinduism and 9.2% Christianity (Ahmad 2007). Such diversity in beliefs may pose some challenges in implementing RMT for clinical applications, especially if the religion opposes it.

With the majority of believers in Malaysia, Islam states that the sources of stem cells must be from adult stem cells, the procedure does not cause harm, and the fetus is aborted spontaneously or miscarried. The National Fatwa Deliberation Committee for the 51st time on 11 March 2002 (Mazri and E-fatwa 2012) has decided as follows in determining the use of stem cells: 1) human cloning for any purpose whatsoever is illegal because it is contrary to the nature of the event of man who has been ordained by God, 2) the use of stem cells for medical purposes in a study which does not involve the cloning process is required as long as it does not conflict with the Sharia law. On 25 May 2006, the Mufti Department of Selangor also stated that stem cells from specified sources are to be used for treatment purposes, medicine, and survey through fatwa legislation no. 13. The sources of stem cells are specified as follows: 1) from an adult (adult stem cell) with permission and the procedure did not cause harm, 2) from a child with the parent’s consent and the procedure did no harm, 3) from the placenta and umbilical cord blood of the baby with consent from parents, 4) from a spontaneous abortion or miscarriage as a result of medical treatment permitted by Sharia provided that the parent’s consent is obtained, not a fetus that is intentionally aborted or aborted without medical reasons permitted by Sharia, 5) from excess embryos stored frozen from IVF fertility assistance technology with the condition of obtaining the parent’s consent.

On the other hand, according to Christianity, the cloning process demands the use of human embryos in which cells can be produced to make new organs to obtain the necessary DNA where some embryos must be killed (Ghazali et al., 2014). Meanwhile, Buddhism stated that embryogenesis at 4–5 days post-fertilization is not categorized as a living thing. According to Hinduism, there are three types of living things: plants, animals, and humans (Sivaraman and Noor 2017). The human body, including all its elements, also has a nature of its own. The same applies to nails on the feet, hair on the head, and so on. All of that goes according to the law of nature or the law of omnipotence (Sivaraman and Noor 2017). Table 6 summarizes the religious views towards RMT in Malaysia.

In addition to religious beliefs, Malaysia also has various cultures that go back to their ancestral practices, especially among the indigenous people, such as Iban, Kadazan, Kayan, and many more. Each ethnic group will have its own cultures that are still practiced today. The views towards RMT according to local cultures have received extensive attention in terms of ethical issues in regenerative medicine. These topics have consumed significant debate about the use of human embryonic stem cells in research, specifically, the destruction of embryos in order to create cell lines. Others include the disputes over the role of federal funding for research with human embryonic stem cells, and concerns about the safety, scientific purity, and adequacy of consent for the use of human embryonic stem cell lines in research. Like other novel biotechnologies, regenerative medicine raises several additional critical research ethics issues that are not new but have not yet been adequately addressed. Instead, as is common in new science, familiar and longstanding questions appear in the fresh context of regenerative medicine research and renew old debates (McCormick and Huso 2010). More studies are needed to fully understand the perspective of the local cultures and religious beliefs towards RMT applications in Malaysia.

Further basic studies are required to completely comprehend the process of deep cell specialization in humans. Scientists are currently striving to develop a reproducible procedure for transforming stem cells into the cells and tissues needed for transplantation. Furthermore, scientists must overcome the problem of immunological rejection before mature cells produced from embryonic stem cells or hematopoietic stem cells may be employed in transplantation. Incompatibility between these cells must be kept to a minimum as they are genetically distinct from that of the receiver. Adult stem cell research has also faced numerous challenges, including identifying, isolating, and detecting specific cells, developing adult stem cells in the lab, and demonstrating adaptability (McCormick and Huso 2010). Several studies are currently ongoing in this sector all over the world, and several trials are being performed in the clinic (Hall et al., 2010). For instance, one of such research is the successful implantation of artificial bladders into young children (Atala et al., 2006), and a trachea made from a patient’s split trachea and seeded with autologous MSCs, which has been successfully transplanted back into the same patient (Macchiarini et al., 2008). Most RMTs in Malaysia are yet to be approved by the government as they are currently undergoing clinical trials.

Stem cells and cosmetic medicine are other areas of technology that are also affected by medical tourism. Given their unique regenerative quality, stem cells are regarded as an emerging technology for their medicinal potential. The ability of stem cells to self-renew, duplicate, and differentiate into any cell or tissue has paved the way for a slew of exciting new medicines and research that would otherwise be unavailable in many parts of the world (Bianco et al., 2013; Gopalan et al., 2020). It persuades people to fly abroad in search of these procedures, expecting to be cured or treated, despite the risk of being exploited by unproven therapies (Zakrzewski et al., 2019). The practice of traveling to other countries with lax or no regulations in search of experimental or untested stem cell therapy is known as “stem cell tourism,” and it is a subset of medical tourism in this study. This is also known as health tourism, which will invalidate and reduce the availability of sufficient data for RMT in Malaysia for detailed comparisons with other hospitals. Some treatments (RMT) are conducted in private hospitals where the staff or organization does not report the data of RMT performed, thereby limiting the data collection and comparison with the government hospitals. Some Malaysians will find a hospital that has advanced technology in other countries to treat the disease. This might be one of the limitations of RMT in Malaysia following the limitation in the data obtained.

Many research projects on stem cells have lately been allowed in Malaysia. However, they are still in the early stages of development due to a lack of funds, specialized equipment, and skilled personnel. These limitations might explain why RMT is not yet widely known in Malaysia. Research on stem cells could be easily interrupted when funds are lacking. Skilled personnel is needed to perform stem cell research and increase the use of RMT in medicine to treat diseases.

One of the currently ongoing research projects that shows potential and great promise in clinical applications of RMT in Malaysia is therapeutic cloning. Therapeutic cloning, also known as somatic cell nuclear transfer, is a method for producing versatile stem cells without the need for fertilized eggs. The nucleus, which contains the genetic material, is removed from the unfertilized egg. Furthermore, the nucleus of a donor’s cell is also removed. The donor nucleus is injected into the egg to replace the exteriorized nucleus in a procedure known as nuclear transfer. Allowing the egg to divide results in the formation of a blastocyst. This procedure produces a line of stem cells that is genetically identical to the donor’s cells. Some researchers believe that stem cells obtained by therapeutic cloning have advantages over those derived from fertilized eggs. This is because cloned cells are less likely to be rejected once transplanted back into the donor and may allow researchers to precisely examine how a disease develops. Notably, this research has not yet been successful and is still ongoing. In recent investigations, researchers have modified the therapeutic cloning technique to create human pluripotent stem cells. Researchers are still looking into the possibility of human therapeutic cloning.

Regenerative medicine therapy in Malaysia has numerous potentials to be developed and applied in clinical settings. These RMTs can be used to treat diseases, especially fatal chronic diseases. After decades of research, stem cell therapy is proving to be a tremendous game-changer in medicine. The capacity of stem cells is increasing with each trial, yet there are still numerous challenges to solve. Nevertheless, stem cells have a huge impact on regenerative medicine and transplantation. Untreatable neurodegenerative illnesses might be successfully treated using stem cell therapy in the near future. The use of a patient’s own cells is possible thanks to induced pluripotency. Tissue banks are gaining popularity as they collect cells that can be used in regenerative medicine to fight present and future ailments. Medical practitioners and scientists are better able to extend human life than at any other point in history owing to stem cell therapy and all of its restorative effects (Zakrzewski et al., 2019).

There are many more technological advances to be explored in RMT and applied in Malaysian clinical settings. Numerous ongoing research and clinical trials have shown the potential of clinical applications of RMT in Malaysia. The most popular and well-known RMT in Malaysia is cell therapy. Mesenchymal stem cells (MSCs) are widely used in the country to treat chronic diseases while MSC-based iCell treatments are being studied in several clinical trials. MSCs are heterogeneous and numerous sources are employed to separate and create these cell populations for clinical trials. Important perspectives on the different nature of the MSCs populations in use clinically and their various sources have been critically addressed recently (Bianco et al., 2013).

Given that RMT is still relatively a new field, the results from early clinical studies need to be understood so that others can learn from them. Overall, it appears that substantial investment and funding have been injected in preclinical research and clinical trials, but only a sliver of success has been obtained thus far. On the other hand, clinical reports will continue to evolve and general trends will emerge. It is apparent that limbal stem cells have developed, neural stem cells are promising for regenerative repair, pluripotent stem cells have shown exceptional potential in regenerative medicine, and MSCs are presently the most popular cell type in clinical trials. These studies continue to receive extensive interest due to news coverage and patient expectations of significant benefits (Trounson and McDonald 2015). Several studies are ongoing in Malaysia, and the findings will depict the great potential and increase the country’s status as one of the popular countries contributing ideas on regenerative medicine to be used in clinical settings.