FAQs
Where do your MSCs come from?
1
Our mesenchymal stem cells are harvested from donated umbilical cords via scheduled cesarean sections. The women donating their umbilical cords undergo rigorous health screenings to ensure we are using the most active and viable umbilical cord stem cells.
Are your products FDA approved?
2
Our products are not FDA-approved drugs or FDA-approved treatments for any disease or medical condition. Human cell and tissue products may be subject to different FDA regulatory pathways depending on the specific product, its processing, and its intended use.
Certain HCT/Ps may qualify for regulation solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271 when all applicable criteria are met. Section 361 regulation is not the same as FDA approval, and regulatory status must be evaluated on a product-specific basis.
Our products may be considered for research, investigational, or other legally permissible uses, depending on the specific product and circumstances. We do not represent our products as FDA-approved therapies or guarantee clinical outcomes.
We believe the responsible approach is transparency over hype—providing product characterization, testing, and supporting documentation while clearly distinguishing scientific research from established clinical indications.
The science continues to evolve, and so does the regulatory landscape. Our commitment to transparency remains constant.
Regulatory requirements are product- and use-specific. Healthcare professionals and institutions are responsible for determining appropriate use and complying with applicable federal, state, and local requirements.
How do you ensure safety?
3
We ask our donors 210 medical history questions in addition to sending 10% of each batch out for 3rd party testing. If one fails, we discard the entire batch.
How are products shipped and stored?
4
Our products are shipped overnight on dry ice for next-business-day arrival, helping maintain appropriate temperature during transit.
A −80°C freezer is not required if the product is ordered for immediate use. Clinics can coordinate delivery for the day before the planned administration and keep the product on dry ice until it is prepared according to the applicable product instructions.
For clinics that plan to stock products for future use, a −80°C freezer is recommended/required for applicable cryopreserved products, according to the product-specific storage requirements.
Each shipment includes applicable product documentation, including lot information, expiration details, and COA (Certificate of Analysis) documentation.
Shipping cost: $150 per shipment, regardless of order size. Bulk pricing may be available upon request.
Is there risk of rejection?
5
UC-MSCs do not express major histocompatibility complex (MHC) antigens of the class II subtype and contain low levels of MHC molecules of the class I subtype. UC-MSCs also lack the co-stimulatory molecules essential for immune detection, including CD40, CD80, and CD86.
What you’ll typically see on a certificate of analysis (COA):
Positive markers: CD73, CD90, CD105
Negative markers: CD34, CD45, CD14, CD19, HLA-DR (which corresponds to MHC II)
Baseline state (fresh or minimally cultured UC-MSCs):
MHC class I: low to moderate expression
MHC class II: negative or very low
This is part of why they’re considered “immune-privileged” or “immune-evasive”, making them attractive for allogeneic (donor-derived) use.
Thus, MSCs generally have low immunogenicity and can avoid immune rejection by the recipient, which serves as the foundation for their successful application without needing to match the donor to the recipient.