Ascellos® Wharton’s Jelly Stem Cells
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Disclaimer: This page contains content specific to Florida Stem Cell Law, which allows specific licensed physicians to administer stem cell therapies that the U.S. Food and Drug Administration has not approved. The law and the content apply to providers licensed in Florida under Chapter 458 (Medical Doctors) and Chapter 459 (Osteopathic Physicians) acting in the course and scope of their employment.
Florida Stem Cell Compliant Ethically sourced Wharton’s Jelly MSC Stem Cells – Ascellos® SC25
The highest quality, most efficacious, compliant mesenchymal stem cells available.
Wharton’s Jelly mesenchymal stem cells (WJ-MSCs) are multipotent stromal cells isolated from the gelatinous substance within the human umbilical cord known as Wharton’s jelly. These cells are notable for:
- Multipotency: WJ-MSCs can differentiate in vitro into various cell types, such as osteocytes (bone), chondrocytes (cartilage), and adipocytes (fat), but they do not possess pluripotency like embryonic stem cells.
- Surface Markers: They show high expression of MSC markers (CD29, CD44, CD73, CD90, CD105) and lack hematopoietic and endothelial markers (HLA-DR, CD11b, CD14, CD31, CD34, CD45), confirming their MSC identity.
- Immunomodulation: WJ-MSCs are immune-privileged and immune-suppressive, making them ideal for allogeneic (from another person) and xenogeneic (from another species) transplantation. Peer-reviewed data demonstrate that they may modulate the immune response.
- Non-Tumorigenic: These cells do not form tumors and are considered safe for therapeutic applications.
- Proliferation and Stemness: WJ-MSCs have a rapid proliferation rate, high ex vivo expansion capability, and more extended culture longevity than adult MSCs.
- Therapeutic Potential: Their main therapeutic effect is through paracrine signaling—releasing bioactive molecules (the “secretome”) that aid tissue repair, immunomodulation, and reduce inflammation.
- Ethical and Practical Advantages: WJ-MSCs are easily accessible, ethically noncontroversial, and collected from umbilical cords—medical waste that poses no risk or pain to mother or baby.
Overall, Wharton’s Jelly MSCs represent an excellent source of regenerative cells with applications in tissue engineering, immunotherapy, and regenerative medicine.
Essential factors to consider before using Stem Cells in your practice.
No more than doubling 12 times.
In the context of stem cell culture, “doubling no more than 12 times” means that the population of stem cells has undergone no more than 12 rounds of doubling since their initial isolation and culture. Each population doubling represents one complete doubling of the cell number (e.g., from 1,000 to 2,000 cells is one doubling). The population doubling level (PDL) is tracked to measure a cell population’s cellular age or total replication history in vitro.
Tracking and limiting PDL is vital because:
- As stem cells replicate in culture, their function and phenotype can change; they may become less able to differentiate or lose potency.
- Regulatory guidelines often require a maximum acceptable PDL to ensure cell product safety and consistency.
- “No more than 12” indicates cells used should be relatively young (in culture terms), reducing the risk of undesirable changes due to prolonged culturing.
In summary, a PDL limit 12 ensures you’re working with stem cells that have not been excessively expanded, helping maintain desirable biological properties and compliance with best practices in research and clinical settings.
No more than four passages
When dealing with stem cells, the number of passages means that the cell culture has been split and subcultured four times since the initial plating. Each passage is a process where cells are detached (usually with enzymes or mechanical means) and transferred to new culture vessels with fresh growth media. This helps prevent overcrowding and keeps the cells proliferating in optimal conditions. The passage number counts how many times this transfer process has happened to that cell population.
For instance, stem cells at passage four have been through four subculturing rounds since they were initially isolated or thawed from a stock. The passage number is significant because stem cell characteristics—such as their growth rate, differentiation capacity, and phenotype—can change over successive passages and affect efficacy and potency.
What is the Secretome Concentration
In the context of stem cells, “secretome” refers to the complete set of molecules (such as proteins, cytokines, growth factors, exosomes, and other substances) secreted by stem cells into their environment. These molecules are responsible for many beneficial effects of stem cell therapies, including promoting tissue repair, reducing inflammation, and signaling other cells to function or regenerate.
When someone mentions “20 x the secretome,” it typically means that the stem cell product or treatment contains a concentration of secretome components 20 times higher than a baseline, standard, or normal level. This could mean the secretome has been concentrated to be much more potent or is derived from a larger initial number of stem cells, resulting in a higher quantity of the bioactive factors responsible for therapeutic effects.
In summary, “20 x the secretome” indicates a highly concentrated stem cell secretome product that may be intended to have enhanced therapeutic impact compared to a standard secretome preparation.
What media is used to culture the stem cells
Culturing stem cells on human media—meaning media that do not contain animal-derived components (like fetal bovine serum) but instead use human-derived or fully defined and Xeno-free ingredients—offers several significant advantages:
- Reduced risk of immune reactions and disease transmission: Using human or xeno-free media decreases the risk of introducing animal pathogens or triggering unwanted immune responses in clinical applications.
- Greater safety for therapeutic use: Media free of animal components is more suitable for cells intended for human transplantation, improving the likelihood of regulatory approval and patient safety.
- Consistent and reproducible results: Human or fully defined media eliminate the variability in lots of animal serum, ensuring more predictable stem cell behavior and higher reproducibility between experiments and therapeutic batches.
- Compliance with regulatory standards: Regulatory agencies increasingly require Xeno-free, defined culture conditions for cell therapies. Using human media helps streamline translation from laboratory research to clinical application.
- Better mimic of the human physiological environment: Human or defined media can better support stem cells’ desired differentiation and maintenance in ways that are closer to their in vivo conditions.
Overall, human media (or Xeno-free, chemically defined media) provides safety, consistency, and suitability for clinical translation—critical advantages for stem cell research and therapy.
Ascellos® SC25: Ethically Sourced Wharton’s Jelly MSC Stem Cells
Discover the regenerative potential of ethically sourced Wharton’s Jelly MSC Stem Cells. Contact us today to learn more about Ascellos® SC25 and how it can transform your research or clinical applications.