Potensi Sel Punca Wharton's Jelly — Mengembalikan Cahaya Bagi Pasien Buta dan Terapi Autisme

In this exclusive discussion, Dr. Angerina Tiah from the 23 Century International Life Science Centre shares profound insights into the transformative potential of Wharton's Jelly stem cells in treating degenerative diseases, blindness, and autism. The discussion also addresses international safety standards (cGMP, PIC/S) and the vision for the medicalization of stem cell therapies for global accessibility.

From Bone Marrow to Umbilical Cord: Why Wharton's Jelly is Chosen?

Dr. Shimizu:This time, I'm going to ask a question that might be of public concern, and let's continue the conversation casually while answering all your questions later.

Currently, in Malaysia, Wharton's Jelly-derived stem cells are the most widely utilized. However, historically, bone marrow-derived stem cells were deemed superior. Could you please explain why the focus has shifted to Wharton's Jelly?

Dr. Angerina Tiah:Of course. About 50 years ago, the first stem cells discovered in the world were bone marrow stem cells. These cells were initially used to provide the hematopoietic cells (blood-forming cells) needed by leukemia patients.

Leukemia is a blood cancer. Patients typically undergo chemotherapy, which damages numerous hematopoietic cells. Consequently, a bone marrow transplant of hematopoietic cells is required to regenerate red blood cells, white blood cells, and platelets.

Further research demonstrated that bone marrow is indeed highly valuable for stem cell research. However, over time, scientists realized that the umbilical cord (particularly Wharton's Jelly) is a much more ideal source of stem cells.

From the umbilical cord, we can readily extract mesenchymal stem cells (MSCs), not solely hematopoietic cells. These mesenchymal stem cells can differentiate into a variety of cell types—from knee cartilage and skin epithelial cells to retinal cells for patients with vision loss, and even cardiac muscle cells.

Most importantly, umbilical cord stem cells are cells from a newborn baby (zero days old). These cells are much younger and possess a significantly higher differentiation capacity compared to stem cells from adult bone marrow.

For example, if an individual is currently 40 years old, the stem cells from their bone marrow also reflect that chronological age. In contrast, cells from the umbilical cord remain young and vital. Research also indicates that the number of stem cells in bone marrow decreases with age — with perhaps only 40% remaining by age 40, and less than 5% by age 70.

Therefore, obtaining stem cells in sufficient quantity and quality from the bone marrow of older adults is highly challenging. This constitutes one of the primary reasons why Wharton's Jelly has become the preferred choice.

Restoring Light: An Inspiring Case of Blindness Treatment

Dr. Shimizu:Can you share an impressive clinical case from your work with blind patients?

Dr. Angerina Tiah:Certainly. We launched a new clinical application for blind patients about two years ago, and have performed approximately 100 intraocular injections on patients who have lost their sight for over 30 years.

Most of our patients are affected by retinitis pigmentosa (RP), an inherited genetic disorder that causes progressive vision loss with age. One of the most remarkable cases involved a male patient who was diagnosed at the age of 4 and received our treatment at the age of 36 — meaning he had lived in complete blindness for 32 years.

A single injection of Mesenchymal Stem Cells (MSCs) was administered into the subtenon space (behind the eye). Within 24 hours, this patient was able to perceive light for the first time in their life. The injection was performed at 3:00 PM, and upon waking the following morning at 7:00 AM, the patient reported perceiving light.

Still possessing visual memories from age four, he correctly identified "Green!" when his mother asked, "What color is this?" This was truly inspiring. Following several subsequent treatments with Wharton's Jelly-derived stem cells, his vision has continued to improve significantly.

Dr. Shimizu:I happened to meet this patient many times during their treatment. We even visited the King of Penang to give a report before the injection. Witnessing the transformation from darkness to light was truly amazing and heartwarming.

New Approach to Autism Therapy

Dr. Shimizu:We also heard that 23 Century has achieved very impressive results in the treatment of children with autism. Could you explain the approach?

Dr. Angerina Tiah:Yes, we have successfully treated many children with autism, both from Malaysia and internationally. We use UC-MSC (umbilical cord mesenchymal stem cell) injections.

Upon entering the body, mesenchymal stem cells initially exert a potent anti-inflammatory effect. This is critically important because the brains of children with autism frequently exhibit chronic inflammation—a state often likened to an ongoing internal "conflict." This persistent neuroinflammation significantly impedes their ability to concentrate and engage in social interactions.

With the resolution of this inflammation, facilitated by stem cells, children demonstrate improved concentration. Furthermore, stem cells can differentiate into new neural cells, thereby enhancing neural plasticity (the brain's capacity to adapt and form new connections). This combined anti-inflammatory and neuroplastic effect leads to significant improvements in concentration, cognitive behavior, and responsiveness in autistic children.

Anti-Inflammatory Mechanisms of Wharton's Jelly Stem Cells

Dr. Shimizu:All stem cells have anti-inflammatory effects, but we've heard that Wharton's Jelly stem cells have extraordinary anti-inflammatory capabilities. Could you explain further?

Dr. Angerina Tiah:Absolutely. Mesenchymal stem cells from Wharton's Jelly have a highly superior anti-inflammatory capacity. Specifically, they promote the secretion of anti-inflammatory cytokines such as TGF-β (transforming growth factor beta) and IL-10 (interleukin 10), which suppress inflammatory reactions throughout the body.

Furthermore, they inhibit the release of IFN-γ (interferon-gamma), a key trigger of excessive inflammation. They also promote the proliferation of regulatory T cells, which regulate the entire T-cell response and suppress uncontrolled inflammation.

Through these mechanisms, Wharton's Jelly stem cells effectively modulate the immune system while providing potent anti-inflammatory effects. These effects are particularly evident in autoimmune diseases such as rheumatoid arthritis, where we observe significant improvements by suppressing autoantibody production.

International Security Standards: The Foundation of Trust

Dr. Shimizu:Safety is a primary concern for everyone. How does 23 Century ensure the highest safety standards in stem cell production?

Dr. Angerina Tiah:In Malaysia, we follow PIC/S (Pharmaceutical Inspection Co-operation Scheme) standards, which include 72 international regulatory bodies, including the US FDA. We have built a GMP (Good Manufacturing Practice) laboratory that fully complies with these PIC/S standards.

Our laboratory has obtained the highest-level license for human cell manufacturing, known as CGMP (Current Good Manufacturing Practice). This license enables us to produce CGTP (Cell and Gene Therapy Products). The CGMP standard ensures that the entire manufacturing process adheres to international standards and the most stringent cleanroom specifications.

As a result, our stem cell product has been recognized as Clinical Grade, meeting the highest quality and safety standards for human use.

Dr. Shimizu:The important philosophical difference here is that 23 Century not only adheres to safety standards, but also builds infrastructure that anticipates the future approval status of medicines. This ensures that treatment can be accessed by more people through health insurance.

Stem Cell Quality: Rigorous Standards, Superior Products

Dr. Shimizu:How do you define "quality" in stem cells?

Dr. Angerina Tiah:Our quality standards are very stringent. From the outset, we screen prospective pregnant donors to ensure there is no history of genetic diseases. We conduct comprehensive blood tests, and only umbilical cords from full-term C-section deliveries are accepted.

Infants must achieve an Apgar score of 8 or higher (a measure of newborn health). In cases of preterm delivery or low birth weight, the sample will be rejected.

In our laboratory, we exclusively use GMP-grade or clinical-grade raw materials, not research-grade materials. We limit cell passages to a maximum of 4. If cells do not meet our quality standards, the batch is discarded, not sold.

Dr. Shimizu:This is very important — most other companies would try to sell everything they produce. But 23 Century is truly committed to quality, not volume. From 15 cm of umbilical cord, you can produce about 30-50 dose packages, but only if each batch meets strict quality standards. This is truly remarkable.

Secretome: More Than Just Exosomes

Dr. Shimizu:Currently, there is a lot of talk about exosomes in the Japanese market. How does secretome differ, and why did 23 Century choose to produce a complete secretome instead of just exosomes?

Dr. Angerina Tiah:This is an important question. Exosomes are just one component of the secretome. The secretome includes:

• Extracellular vesicles
• Microvesicles
• Exosome
• Chemokines and cytokines
• Growth factor

Exosomes function as a "commander," dispatching instructions such as "initiate repair here." However, for actual repair to be carried out, an "execution army" is required, comprising growth factors like Epidermal Growth Factor (EGF) and Fibroblast Growth Factor (FGF). Exosomes alone are insufficient.

Most laboratories extract only exosomes, discarding other components. 23 Century produces a complete secretome, with all components working synergistically for maximal regenerative results.

Secretome Manufacturing Process: Commitment to Excellence

Dr. Shimizu:How does 23 Century produce secretome, especially compared to standard laboratories?

Dr. Angerina Tiah:A standard laboratory starts by cultivating healthy mesenchymal stem cells. During cultivation, the cells release secretome into the medium (a pink-colored liquid that contains phenol red and other proteins that cannot be injected into the human body).

Typically, laboratories harvest stem cells for commercial purposes and discard the conditioned medium, thereby forfeiting a significant portion of the inherent benefits. Conversely, some laboratories exclusively extract and commercialize exosomes.

The 23rd Century took a fundamentally different approach:

1. We harvested healthy mesenchymal stem cells (passage 4).
2. We dispose of initial culture media, as do all laboratories.
3. Subsequently, we subjected the stem cells to controlled stress to maximize secretome release.
4. We isolated this secretome, rich in all its components.
5. We discard suboptimal stem cells (despite the financial implications, our commitment to quality is paramount).
6. We process the secretome to remove contaminants and concentrate active components.
7. We store it in liquid form (rather than lyophilized) to maintain maximal biological activity.

By prioritizing the extraction of therapeutic essence over the simple processing of raw material, we develop secretome with maximum therapeutic potential.

Dr. Shimizu:In Japan, there are no regulatory standards like cGMP. Products produced carelessly often circulate. But 23 Century is truly committed to quality, safety, and efficacy. This is why we trust them completely.

Why liquid, not freeze-dried?

Dr. Shimizu:In Japan, most secretome products are freeze-dried (lyophilized). Why does 23 Century still use liquid form?

Dr. Angerina Tiah:We have verified that the proteins in the secretome are very stable in liquid form, even at room temperature. There is no need to freeze-dry because the proteins remain stable.

Conversely, the freeze-drying process can remove water from protein structures and reduce their biological activity. By storing the secretome in liquid form, we maintain maximum therapeutic potential.

The verification of ambient temperature stability has been completed, and additional data collection is ongoing. The findings demonstrate that quality remains preserved under ambient conditions; consequently, there is no justification for lyophilization, which could potentially compromise efficacy.

Vision: Global Medicalization and Accessibility

Dr. Shimizu:What is 23 Century's vision for the future of stem cell therapy?

Dr. Angerina Tiah:Our main goal is to obtain official drug approval for our stem cell product as a biologic therapy. We have completed the first-stage application and are awaiting approval.

If approved as a medicine, we can manufacture at scale, reducing costs and making this therapy accessible to a wider patient population. We can also secure health insurance coverage.

We have invested millions of dollars in our manufacturing infrastructure. Our extensive international certifications, including the recently acquired Halal certification, enable patients from diverse religious backgrounds to confidently access our care.

Our mission is to disseminate this technology and knowledge among developed nations, including Japan, to ensure the widespread global accessibility of regenerative treatments.

Dr. Shimizu:We believe that in the next few years, this technology will be widely recognized. Thank you for sharing this incredible vision with all of us.