You're Putting This in Your Body. Here's the Proof.
Most biologics come with a brochure. Ours come with lab results. Every vial is independently tested and documented before it ever ships β and you can see those results before your treatment.
Five Things We Verify
What We Check. In Plain English.
Every lot goes through five non-negotiable quality gates before it ships. If it doesn't pass all five, it doesn't leave our facility.
It's sterile.
Before your vial ships, an independent lab confirms there is zero microbial contamination. No bacteria. No fungi. No foreign organisms of any kind. This test has no gray zone β it either passes completely or the lot is quarantined.
Direct Inoculation Β· 21 CFR 610.12The particle count is real.
The number of exosomes in your vial is verified by instrument β not estimated. We use ZetaView NTA technology that physically counts particles and measures their size. What's on the label is what's in the vial.
NTA Β· ZetaView InstrumentationThe cells arrive alive.
For stem cell treatments, viability is everything. Dead or degraded cells don't do anything. Our hUCT-MSC stem cells consistently arrive at 97%+ viability β confirmed by automated cell count before release. That's not a target. That's a hard minimum.
β₯ 70% Required Β· 97% ActualIt's clean of the things that matter.
Every lot is screened for 12 pathogens β including HIV, Hepatitis B and C, HPV, CMV, and Epstein-Barr β before release. Every single result must come back negative. One positive result stops the entire lot.
12-Pathogen Panel Β· All NegativeSomeone independent checked it.
Our internal quality control isn't enough β and we don't pretend it is. Every lot is verified by a qualified third-party laboratory with no financial stake in the result. Two sets of eyes. Both must agree before anything ships.
Dual-Lab COA VerifiedYou can verify all of this yourself.
Every patient can request the Certificate of Analysis for the specific lot being administered in their treatment. Not a sample report. Not a template. The actual results for your actual vial.
Request COA BelowWhy This Matters
What Our Standards Mean for Your Safety
Most people traveling abroad for biologics have no idea what's actually in the vial. Here's what our documentation model protects you from.
No mystery particle counts
Suppliers who advertise "60 billion exosomes" without NTA verification are giving you a marketing number, not a measured one. Ours is measured with ZetaView instrumentation on every lot.
No undisclosed ingredients
Our products are xeno-free β manufactured without animal-derived components. What's in the vial is documented. What isn't in it is documented too.
No undetected contamination
Sterility testing using direct inoculation β the regulatory standard for biological products β catches contamination that simpler testing methods miss. It's the same standard used for FDA-approved biologics.
No guesswork on pathogen screening
Our 12-pathogen panel goes beyond what most suppliers screen for. We test for HIV, HBV, HCV, HTLV, CMV, EBV, HHV, HPV, B19, Mycoplasma, Retroviral, and Adventitious agents on every lot.
No degraded stem cells
Viability testing confirms your stem cells are alive and functional when they arrive, not just when they left the lab. Cold-chain integrity is verified at every step of transit.
Full traceability from donor to treatment
Every vial carries a unique lot number that traces back to the donor eligibility documentation, manufacturing batch record, and both sets of lab results. Nothing is anonymous.
Manufacturing Credentials
What Our Certifications Actually Mean
Credentials matter β but only if you know what they represent. Here's what each one means in plain terms.
AATB Accredited
The American Association of Tissue Banks accreditation is the gold standard in tissue banking. Only facilities with rigorous SOPs, donor eligibility programs, and quality systems earn this designation.
Gold StandardFDA-Registered Facility
Our tissue establishment is registered with the FDA under 21 CFR Part 1271. This is a federal record β not a claim. Our facility is known to and subject to oversight by the FDA.
Federal RecordcGTP Compliant
Current Good Tissue Practices are the FDA's federal manufacturing framework for human cellular products. cGTP compliance governs everything from donor screening to finished product release.
21 CFR Part 1271NTA-Verified Particle Count
Nanoparticle Tracking Analysis using ZetaView instrumentation physically counts and sizes particles in each lot. Every number on our COA is measured β not estimated, not extrapolated.
Instrument VerifiedUSA Manufactured
Every product is manufactured in the United States with full lot-level chain-of-custody documentation from donor to your treatment. No overseas sourcing. No undocumented supply chain.
Full TraceabilityLab Data
The Actual Results
Below is representative release testing data from our most recent lots. Every patient can request the specific COA for their treatment vial.
| Assay | Plain English | Method | Spec | Result | What This Means |
|---|---|---|---|---|---|
| Sterility | No contamination | Direct Inoculation | No Growth | No Growth | Zero bacteria, fungi, or microbes. The vial is clean. |
| Mycoplasma | Bacterial contamination | PCR Detection | Negative | Negative | No mycoplasma bacteria present β a common contaminant in cell culture. |
| Endotoxin | Bacterial toxin level | LAL Kinetic | < 0.005 EU/mL | < 0.005 | Bacterial toxin level is at the lowest measurable threshold. Meets the most stringent standard. |
| Particle Concentration | Exosome count per mL | ZetaView NTA | 6.0 Γ 10ΒΉβ° P/mL | 6.0 Γ 10ΒΉβ° | 60 billion exosomes per mL β counted by instrument, not estimated. |
| Mean Particle Size | Exosome size confirms identity | ZetaView NTA | Exosome range | 134.0 nm | 134 nanometers β squarely within the size range of genuine exosomes (30β200nm). |
| Total Protein | Protein content confirms potency | Bradford Assay | Per specification | 4,824.6 ΞΌg/mL | High protein content confirms a rich, potent exosome preparation. |
| EV Origin | Confirms human stem cell source | Source Documentation | hUCT-MSC | Human UCT-MSC | Sourced from human umbilical cord tissue mesenchymal stem cells β fully documented. |
Request Your COA
See the Proof for Yourself
Every patient can request the Certificate of Analysis for their specific treatment lot. Enter your details below and we'll send it to your inbox.
Important: The information on this page is for educational purposes only. Stem Nova products are distributed exclusively to licensed medical professionals for use in accordance with applicable regulations. These products have not been evaluated or approved by the FDA to diagnose, treat, cure, or prevent any disease. All clinical decisions are made by the treating physician.