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How We Source Our Stem Cells — APEX Stem Cells
Source Transparency — 7-Step Protocol

From Donated Birth Tissue
to Your Patient's Treatment

Every vial of APEX™ umbilical cord stem cells follows a strict, fully documented process — from a screened, consenting donor to your IV line. No mystery. No shortcuts. Full traceability at every step.

APEX Stem Cells
apexstemcells.com
B2B Regenerative Supply
13
Disease Screens
14
Day Sterility Test
3.65×10¹¹
Exosomes / mL
−80°C
Cold Chain
100%
Batch Tested
1
Step 01 · Enrollment

Pregnant Mother Voluntarily Enrolls

A healthy pregnant mother voluntarily enrolls in a birth tissue donation program and provides informed written consent to donate her placenta and umbilical cord after delivery. This is entirely altruistic — no compensation is provided to the donor.

✦ 100% voluntary donation
2
Step 02 · Screening

Strict Donor Eligibility Screening

The donor undergoes comprehensive medical screening. Requirements are strict — only a small percentage of applicants qualify. Key disqualifying factors:

  • Receipt of the COVID-19 vaccine
  • Any communicable disease or active infection
  • Adverse pregnancy or medical history
⚠️ Most applicants are disqualified at this stage
3
Step 03 · Delivery

Planned Cesarean Section Delivery

The baby is delivered via planned Cesarean section in a sterile hospital environment. This controlled method ensures the placenta and umbilical cord are collected under optimal conditions with minimal contamination risk. The mother and baby are entirely unaffected by the collection process.

🏥 Sterile, controlled environment
4
Step 04 · Collection

Placenta & Umbilical Cord Collected

Immediately after delivery, the placenta and umbilical cord are collected by trained personnel under sterile conditions and placed into a controlled cold environment for transport. Temperature and time are logged throughout — the cold chain documentation begins at this exact moment.

❄️ Cold chain documentation begins here
5
Step 05 · Processing

MSCs Extracted from Wharton's Jelly

Inside a certified cGMP lab, mesenchymal stem cells (MSCs) are extracted from Wharton's Jelly — the gelatinous connective tissue inside the umbilical cord, uniquely rich in regenerative cells. For APEX IV, the cells are concentrated 4× for maximum therapeutic potency — the highest yield available from any birth tissue source.

🧬 4× concentrated for APEX™ IV ✦ Highest MSC yield of any birth tissue
6
Step 06 · Independent Lab Testing

Every Batch Tested Before It Ships

Before any product is released, it's independently tested by Eurofins DPT (CLIA-certified) and Ohio University Innovation Center. Nothing ships until every test passes:

  • 13 infectious disease screens — HIV, Hep B & C, CMV, Syphilis, West Nile & more — all Non-Reactive
  • 14-day sterility test (USP <71>) — No Growth confirmed
  • Endotoxin testing — <0.100 EU/mL, well below safety threshold
  • Exosome particle count — 3.65 × 10¹¹ per mL by Nanoparticle Tracking Analysis
  • Growth factor concentrations — 6 key proteins measured & documented
📋 Certificate of Analysis issued for every lot
7
Step 07 · Arrives at Your Practice

Vials Arrive Frozen — COA on Top of the Box

Approved vials are filled, cryogenically frozen at −80°C, sealed in insulated cryo packaging, and shipped directly to your practice. When the box arrives, the signed Certificate of Analysis is placed right on top of the packaging — printed, signed by the lab director, and ready to verify before you touch a single vial.

📄
Certificate of Analysis — Every Shipment, Every Lot
Covers infectious disease results, sterility, endotoxin levels, lot number, expiration date, and lab director signature. Keep on file for every patient treatment.
🔒 Full traceability: donor → vial → patient
🇺🇸
U.S. Sourced Only
Domestic donors
📋
FDA 21 CFR Part 1271
Birth tissue compliant
🔬
cGMP Manufacturing
Good mfg. practices
❄️
Cold Chain Verified
Maintained at −80°C
🔒
Full Traceability
Donor to IV line
This document is intended for licensed healthcare providers and is for informational purposes only. It does not constitute medical advice. APEX Stem Cells products are HCT/P tissues regulated under FDA 21 CFR Part 1271 and are not FDA-approved for the diagnosis, treatment, cure, or prevention of any specific disease. For practitioner use only. Individual outcomes vary. © 2026 APEX Stem Cells. All rights reserved.
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