As Seen on National Television · All Access with Andy Garcia
The physician-grade standard in MSC exosomes.
Ethically sourced, cGMP-manufactured in an FDA-registered U.S. facility, and third-party COA tested — supplied cold-chain to licensed practitioners and researchers.
All Access with Andy Garcia.
BioRegenEx and real patient recoveries — featured on the national PBS broadcast.
How MSC exosomes deliver their signal.
Secreted by mesenchymal stem cells, each exosome ferries proteins, lipids, and RNA to recipient cells — where its cargo is released and regenerative signaling begins.
Research Use OnlyHuman Umbilical Cord Stem Cell Derived MSC Exosomes
100 Billion exosomes · 5 mL sterile saline vial
Physician-administered MSC-derived exosomes in sterile saline, cGMP-manufactured in an FDA-registered U.S. facility, independently batch-tested by Eurofins and/or ZenBio, and released with a per-lot Certificate of Analysis. Every label carries a batch / lot number so each vial traces back to its COA.
- 100 Billion exosomes per 5 mL vial, in sterile saline
- Human umbilical cord (Wharton's Jelly) MSC source — screened, ethically sourced
- cGMP-manufactured in an FDA-registered U.S. facility
- Every batch independently tested by Eurofins and/or ZenBio — Certificate of Analysis per lot, batch / lot number on every label
- Quality program held to Section 351(a) biologics standards (PHS Act)
- Shipped cold-chain to licensed practitioners and research clinics
How physicians and research clinics administer the vials, under their own protocols and clinical judgment.
Systemic infusion in sterile saline under physician supervision.
Targeted delivery to joints, tendons and soft tissue.
Inhaled delivery studied in respiratory and lung research.
Topical ophthalmic delivery explored in eye and retinal research.
Research Use OnlyHuman Umbilical Cord Stem Cell Derived MSC Exosome Hydrogel
100 Billion / 15 mL · 200 Billion / 30 mL
A professional topical exosome gel formulated with MSC-derived exosomes, cytokines and growth factors. Stable at room temperature for up to 18 months, with a batch / lot number on every unit.
- 100 Billion exosomes — 15 mL
- 200 Billion exosomes — 30 mL
- Stable at room temperature for up to 18 months
- Formulated with MSC-derived exosomes, cytokines and growth factors
- Every batch independently tested by Eurofins and/or ZenBio; batch / lot number on every unit, COA on request
Professional topical applications in aesthetic, dermatology and wound-care practices.
The exosome research library
How Do Exosomes Work? The Science of Cell-to-Cell Signaling
Read article → QualityHow to Read a Certificate of Analysis (CoA) for MSC Exosomes
Read article → SourcingRed Flags When Buying Exosomes: How to Vet a Supplier
Read article → RegulatoryAre Exosomes FDA Approved? The 2026 Physician Guide to FDA Regulation
Read article → RegulatorySection 361 vs Section 351: Why Exosomes Are Regulated as Biologics
Read article → DosingUnderstanding MSC Exosome Dosing: Particle Count vs. Protein Concentration
Read article → ComparisonsExosomes vs Growth Factors: Understanding the Difference
Read article → For ClinicsExosomes for Orthopedic & Sports Recovery Clinics: A Sourcing Guide
Read article →Learn the science, live.
Free online sessions at 7:30 PM Central on how exosome material is characterized, what a Certificate of Analysis actually shows, and what the published research does and does not support. Open to everyone — physicians, clinical teams, researchers, and anyone who wants to understand the subject. General education, not medical advice.
Patient stories
Watch real patients share their recovery journeys — featured on PBS, All Access with Andy Garcia.
Cell-free signaling, precisely sourced.
MSC-derived exosomes (30–150 nm) carry growth factors, cytokines, proteins, lipids, and RNA. They are cell-free and non-replicating, derived from screened Wharton’s Jelly MSCs and cGMP-manufactured.
Explore Exosome Therapy →Areas under active research
Stem cell-derived exosomes are not FDA-approved for medical treatment and are supplied exclusively for research purposes, including:
Frequently asked questions
What are MSC-derived exosomes?
Mesenchymal stem cell (MSC)-derived exosomes are nanoscale extracellular vesicles (roughly 30–150 nm) that carry signaling cargo such as proteins, lipids, and microRNA. They are cell-free (acellular) — not stem cells — and are studied in research for their role in cell-to-cell communication.
What does BioRegenEx supply?
BioRegenEx supplies characterized, research-use-only (RUO) MSC-derived exosomes produced under cGMP-aligned processes, with per-lot quality documentation including a Certificate of Analysis (CoA), particle size and concentration, and sterility & endotoxin screening — shipped cold-chain controlled.
Are BioRegenEx exosomes FDA-approved?
No. MSC-derived exosomes are not FDA-approved to diagnose, treat, cure, or prevent any disease and are supplied for research use only. Facility registration and a cGMP-aligned process describe a quality approach — they are not FDA approval or endorsement of any product.
Do you provide a Certificate of Analysis?
Yes. Every batch is tested by independent laboratories — Eurofins and/or ZenBio — and each lot is supplied with a Certificate of Analysis and characterization data so your team can verify identity, concentration, and purity. Explore the published science in our Exosome Research Library.
Who does BioRegenEx work with?
We supply physicians, clinics, and researchers sourcing characterized research-use-only MSC exosomes. To discuss supply and documentation, partner with BioRegenEx.
Begin your research with material worthy of it.
Physicians, clinics, and researchers partner with us for characterized, documented MSC exosomes — supplied for research use only.