Publications
Stem Cell Therapy: Autologous vs. Allogeneic Approaches
(1) What Are Stem Cells?
Stem cells are undifferentiated or partially differentiated cells, serving as the fundamental building blocks of life. During human development, starting from the single fertilized egg (a totipotent stem cell), they continuously divide and differentiate to form the basis of our body's tissues and organs. Even in adulthood, stem cells persist within the body including in adipose tissue, bone marrow, and peripheral blood to maintain self-renewal and differentiation. Their crucial role is to replace cells damaged due to natural causes, external forces, or disease. With continuous advancements in technology, stem cells are now widely applied for therapeutic use, holding significant potential in the fields of regenerative medicine, tissue repair, and disease treatment.
(2) What Is Stem Cell Therapy? Clinical Modalities and Applications
In clinical practice, Stem Cell Therapy (also known as Regenerative Medicine) involves a treatment process where cells are professionally processed prior to administration. The stem cells must be harvested from the human body and undergo rigorous processing, such as purification, isolation, culture, and quality testing. This meticulous processing ensures the quality of the final cell-based product before it is administered into the patient's body to repair damaged tissues, modulate the immune system, and promote the regeneration of organs and tissues.
Types and applications of stem cell therapy:
|
Comparison Items |
Hematopoietic Stem Cells (HSCs) |
Mesenchymal Stem Cells (MSCs) |
Induced-Pluripotent Stem Cells (iPSCs) |
|
Common Sources |
l Bone Marrow l Peripheral Blood l Umbilical Cord Blood |
l Adipose Tissue (Fat) l Umbilical Cord l Bone Marrow |
l Adult somatic cells (e.g., Peripheral Blood Mononuclear Cells, Skin Fibroblasts) |
|
Tumorigenic Risk |
Low（If the donor is of advanced age, epigenetic defects may lead to genomic instability） |
Very Low (A review statistical analysis of 217 studies reported no tumor formation) |
High (Current technologies involve the introduction of oncogenes, if quality control is insufficient, may result in teratoma formation.) |
|
Allogeneic Transplantation Risk (Immunogenicity) |
High (Requires HLA matching) |
Low (Low risk of immune rejection) |
Moderate (It may necessitate immunosuppression or MHC knock-out technology to mitigate immune rejection.) |
|
Overall Safety Risk |
Moderate |
Low |
High |
|
Common Indications |
l Hematological Diseases (e.g., Leukemia, Aplastic Anemia) |
l Degenerative Diseases (e.g., Osteoarthritis, Stroke, Liver Cirrhosis, Myocardial Infarction). l Rheumatoid Arthritis. l Graft-versus-Host Disease (GVHD; Organ Transplant Rejection). |
l Retinal Degenerative Diseases l Parkinson's l Spinal Cord Injury l Amyotrophic Lateral Sclerosis (ALS) |
|
Clinical Application Cases |
Most Common (Most Mature Technology) |
Numerous (Fastest Growing Segment) |
Moderate (Rapid Growth in Recent Years) |
MSCs currently have the broadest clinical application and are driving the fastest market expansion within the field of regenerative medicine, positioning them as the most widely used cell therapy today. Furthermore, MSCs possess an extensive history of research and boast an exceptionally high safety profile, supported by numerous clinical safety evidence. Coupled with their multi-lineage differentiation capabilities, which allow for a wide range of disease treatments, MSCs are the cell type predominantly utilized in the majority of open cell therapy technologies and cell product development efforts internationally.
(3) Cell Therapy Classification: Autologous vs. Allogeneic
Beyond the source type, cell therapy is further classified into autologous and allogeneic treatments:
◎ Autologous Stem Cell Therapy
Autologous transplantation refers to stem cell therapy derived from the patient him/herself. This process requires tissue to be harvested from the patient and subsequently prepared in a laboratory. The preparation involves a minimum of two weeks for procedures such as isolation, culture, testing, and packaging, before the final product is delivered to the medical facility for clinical application.
Currently, GWOXI Stem Cell new drugs (i.e., GXHPC1® and GXNPC1®) are both classified as autologous stem cell therapies. Furthermore, Taiwan's current Regenerative Medicine Act primarily authorizes the clinical use of autologous stem cell treatments. However, because autologous cell therapy is essentially "customized manufacturing," the need for intricate preparation procedures and multiple quality checks for every batch result in a relatively high treatment cost.
◎ Allogeneic stem cell therapy
Allogeneic transplantation refers to stem cell therapy derived from a healthy donor. Currently, the primary type of allogeneic stem cell utilized remains the Mesenchymal Stem Cell. Due to the very low expression of HLA-DR on the surface of MSCs, the risk of immune rejection is minimal when the cells are prepared under rigorous manufacturing procedures. Consequently, the clinical application of allogeneic MSCs is becoming increasingly widespread, with common applications including orthopedic joint treatments (e.g., knee osteoarthritis).
GWOXI Stem Cell new drugs(i.e., GXCPC1® and GXIPC1®) are both categorized as allogeneic stem cell therapies. A significant advantage of allogeneic stem cells is their "off-the-shelf" usability. By sourcing cells from an appropriate working cell bank, large scale, single batch preparation can substantially reduce complex processing and testing costs. Therefore, the price is relatively more affordable compared to autologous stem cell therapy, thereby increasing the accessibility for patients.
|
Comparison Item |
Autologous Stem Cell Therapy |
Allogeneic Stem Cell Therapy |
|
Source |
The patient's own tissue |
Tissue from a healthy donor |
|
Testing Methods |
Requires mandatory infectious disease testing (including: HIV, HBV, HCV, RPR) |
Requires screening in accordance with the " Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products" |
|
Risk |
l Very Low |
l Mesenchymal Stem Cells (MSCs): Low l Hematopoietic Stem Cells (HSCs): Moderate l Induced Pluripotent Stem Cells (iPSCs): High |
|
Treatment Cost |
High (Customized Manufacturing) |
Low (Single-batch, Large-scale Manufacturing) |
|
Advantages |
l High safety profile due to autologous source l Can be used in certain high-risk injection locations (e.g., intracerebral injection, intrahepatic injection) |
l Off-the-shelf usability (immediate use) l Lower cost due to large-scale manufacturing |
(4) Scope and Current Status of Stem Cell Therapy and Clinical Applications
According to a research report published by Global Data, the global market size for cell and gene therapy reached $8.7 billion in 2024 and is projected to surge to $76.03 billion by 2030, reflecting a remarkable Compound Annual Growth Rate (CAGR) of 44% during this period.
Excluding oncology treatments (which are primarily within the immune cell application domain), stem cells are predominantly applied in the following sequence of therapeutic areas: metabolic syndromes, hematological disorders, central nervous system (CNS) disorders, immunology, musculoskeletal disorders, gastrointestinal disorders, and ophthalmic diseases. These areas collectively constitute approximately 48.4% of the total market.
Furthermore, data released by the Alliance for Regenerative Medicine (ARM) organization indicates that as of the first half of 2025, the global count of regenerative medicine product development companies has reached 2,070, with a total of 1,905 clinical trials underway and an overall investment scale of $5 billion. Regulatory authorities in the US and Europe have sequentially granted approvals for applications targeting ophthalmic and metabolic diseases, with numerous cardiovascular disease products also poised for launch. It is anticipated that both the US and Europe will each grant market authorization to 5 to 6 cell therapy products during 2025.
Domestic Clinical Application Status (Taiwan)
Regarding domestic cell therapy applications, the Taiwan Ministry of Health and Welfare's (MOHW) 2024 Cell Therapy Annual Report reveals that stem cell therapies (excluding immune cell treatments for cancer) are most frequently applied in Taiwan for the following conditions, in order: knee osteoarthritis, knee cartilage defects, spinal cord injury, chronic wounds or wounds unhealed for over six weeks, and the filling and repair of skin defects (wrinkles, indentations, and scars). The vast majority of these therapeutic applications utilize adipose derived and bone marrow derived MSCs.
According to Taiwan MOHW, the following table provides a concise summary of the available application scope for certain source of cell and MSCs-derivatives (excluding cancer treatment) across various fields without new drug license:
| Item | Indications |
| Autologous Adipose Derived Stem Cell Therapy | Chronic wounds or difficult wounds unhealed for over six weeks Large area burns or skin trauma exceeding twenty percent of the total body surface area Subcutaneous and soft tissue defects Degenerative arthritis and knee cartilage defects |
| Autologous Fibroblast Therapy | Skin defects: Filling and repair of wrinkles, indentations (pockmarks), and scars |
| Autologous Bone Marrow Mesenchymal Stem Cell Therapy | Degenerative arthritis and knee cartilage defects Spinal cord injury |
| Autologous Chondrocyte Therapy | Knee cartilage defects |
| Mesenchymal Stem Cell Derivatives (Exosomes) | Cosmetics: Dermal applications |
The available stem cell therapy shown in above table still require to be conducted by: 1. Qualified hospital/clinics and physicians (completed 16 credits for regenerative medicine program curriculum syllabus); 2. Qualified manufacturer (GTP grade). However, the new drug developer still need to apply clinical trial to get market license if they adopt advanced technology (patented) and treat diseases out of the table.
(5) Stem Cell CDMO | Recommendation of GWOXI Stem Cell
GWOXI Stem Cell currently has multiple clinical trial products involving Mesenchymal Stem Cells (MSCs) underway in Taiwan. Notably, its products utilizing adipose-derived stem cells for the treatment of Chronic Stroke and Osteoarthritis have progressed to Phase III clinical trials.
GWOXI Stem Cell has strategically established production lines for both autologous and allogeneic cell therapies, possessing proprietary stem cell technology (secured >120 patents worldwide until October 2025), GTP and PIC/S GMP facility to provide manufacturing and production services. This positions the company as a leader in the domestic regenerative medicine sector.
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