25M hUCT-MSC Vial — Research-Grade Biologic for Licensed Professionals

About This Product

Stem Nova Network's 25M hUCT-MSC vial contains 25 million human umbilical cord tissue–derived mesenchymal stem cells per vial, sourced exclusively from first-pregnancy Wharton's Jelly donors. Supplied as a research-grade biologic for licensed medical professionals only.

These products are not FDA-approved drugs or therapeutic agents and are not intended to diagnose, treat, cure, or prevent any disease or condition. All clinical decisions are at the sole discretion of the licensed practitioner.

About UCT-MSC Sourcing

Mesenchymal stem cells can be derived from multiple tissue sources including bone marrow, adipose tissue, and perinatal tissues such as umbilical cord Wharton's Jelly. UCT-MSCs sourced from Wharton's Jelly are derived from perinatal tissue collected at birth from screened donors. This sourcing approach is associated with several manufacturing characteristics documented in the published literature:

• Perinatal origin — source cells carry no accumulated environmental exposure from adult donors
• Low MHC-II expression — documented on lot-specific flow cytometry CoA
• High proliferative capacity — consistent with published UCT-MSC characterization data
• Standardized sourcing — screened first-pregnancy donors with full family history review and maternal blood workup produce more consistent lot-to-lot product characteristics than variable adult donor sources

These are sourcing and manufacturing characteristics. They are not clinical outcome claims.

Product Specifications

• Cell Type: Human Umbilical Cord Tissue MSCs (hUCT-MSC)
• Cell Count: 25,000,000 cells per vial — lot-documented
• Volume: 1 mL
• Post-Thaw Viability: 97% (lot-documented — industry minimum ≥70%)
• CD90 Expression: 100% — flow cytometry confirmed (ISCT standard ≥80%)
• CD166 Expression: 100% — flow cytometry confirmed (ISCT standard ≥80%)
• Endotoxin: 0.935 EU/mL — tested per USP <85> (spec ≤10 EU/mL)
• Sterility: Negative — tested per 21 CFR 610.12
• Mycoplasma: Negative at ≤0.02
• Full viral panel: HCV, HIV, HBV, HTLV, CMV, EBV, HHV, HPV, B19 — all Negative
• Preservation: Cryopreserved in LN₂ vapor phase ≤ -140°C
• Shipping: Dry ice — validated cold chain
• Sourced from an AATB-accredited, FDA-registered tissue establishment operating under cGTP standards (21 CFR Part 1271)
• Lot-specific Certificate of Analysis with every order

Quality & Testing

Every lot is tested and released with a lot-specific Certificate of Analysis covering cell count, post-thaw viability, flow cytometry marker expression (CD90, CD166), sterility, endotoxin, mycoplasma, and a full nine-marker viral screening panel.

Sourcing from an AATB-accredited, FDA-registered tissue establishment operating under cGTP standards (21 CFR Part 1271) are manufacturing and facility credentials. They do not constitute FDA approval of this product for any therapeutic indication. The only FDA-approved stem cell products in the United States are blood-forming stem cells derived from umbilical cord blood for limited hematopoietic uses. This product is not approved for orthopedic, spinal, neurologic, or any other clinical indication.

How to Order

25M hUCT-MSC vials are available to licensed medical professionals only. Credential verification is required prior to purchase.

1. Apply for wholesale access at stemnovanetwork.com/apps/wpdapp
2. Credential verification completed within 24 hours in most cases
3. Once approved, wholesale pricing and volume tiers are unlocked immediately
4. Lot-specific CoA provided with every order

Contact partners@stemnovanetwork.com or call 281-541-0047 with any questions.

Frequently Asked Questions

What are the storage and handling requirements?
Store in LN₂ vapor phase at ≤ -140°C upon receipt. Ship on dry ice — transfer to LN₂ storage immediately on arrival if not being used within 24 hours. Once thawed, do not refreeze. Use immediately per your clinical protocol.

Is a Certificate of Analysis included with every order?
Yes. Every wholesale order ships with a lot-specific CoA covering cell count, viability, flow cytometry (CD90, CD166), sterility, endotoxin, mycoplasma, and the full nine-marker viral panel. Documentation is available on request before purchase as well.

What is the mycoplasma specification?
Stem Nova UCT-MSC lots are tested to a mycoplasma threshold of ≤0.02 — documented on the lot-specific CoA.

What is the difference between UCT-MSCs and bone marrow or adipose-derived MSCs?
The primary differences are sourcing characteristics. UCT-MSCs are derived from perinatal Wharton's Jelly tissue from screened donors. Bone marrow and adipose-derived MSCs come from adult donors and are subject to donor age and health variability. These are product sourcing and manufacturing characteristics, not clinical outcome claims.

Is this product FDA-approved?
No. This product is not an FDA-approved drug or therapeutic agent. The only FDA-approved stem cell products in the United States are blood-forming stem cells derived from umbilical cord blood for limited hematopoietic uses. This product is supplied as a research-grade biologic for licensed professional use only.

What does cell washing involve and when is it required?
UCT-MSC vials are cryopreserved in DMSO. For certain administration routes, cell washing to remove the cryoprotectant prior to use is required. SNN-CP-002 UCT-MSC Cell Washing & Preparation Protocol is available to enrolled wholesale accounts upon request.

Regulatory Notice

This product is supplied as a research-grade biologic for licensed professional use only. It is not an FDA-approved drug or therapeutic agent and is not intended to diagnose, treat, cure, or prevent any disease or condition. All clinical decisions including patient selection, dosing, and route of administration are at the sole discretion and professional responsibility of the licensed practitioner in accordance with applicable federal and state regulations including 21 CFR Part 1271.