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Who We Are

Re-gen Active Lab is an FDA-registered 361 tissue establishment Facility dedicated to developing human umbilical cord and amniotic membrane–derived biomolecules.

We partner with FDA-registered and AABB-accredited cord banks and only source tissue from live, full-term, scheduled C-section births in U.S. hospitals. Each donor undergoes comprehensive screening and testing to ensure tissue eligibility and compliance.

What We Manufacture

Our products are derived from human umbilical cord and amniotic membrane tissues and contain a diverse array of naturally occurring biomolecules, including:

Exosomes, Proteins, Peptides, Growth factors, and Other bioactive molecules.

These components are preserved and manufactured under strict environmental and process controls to ensure quality, reproducibility, and safety.

Our Standards

Our products are manufactured in a certified ISO Class 3 cleanroom, with ISO Class 7 supporting areas. Every step of the process is designed for:

  • Controlled environments – validated air, pressure, and particulate monitoring.
  • Batch consistency – reproducible protocols for every production cycle.
  • Independent testing – third-party labs perform USP <71> sterility testing and USP <85> endotoxin analysis on each batch.

With process controls and environmental monitoring in place, we maintain an uncompromising commitment to quality.

Our Promise

At Re-gen Active Lab, our mission is to manufacture the highest quality, safest biomolecule-rich products from umbilical cord and amniotic membrane tissue.
We focus on:

  • Rigorous donor screening
  • Transparent sourcing and traceability
  • Regulatory compliance (FDA 361)
  • Third-party validated quality control

Why Choose Us

  • FDA-registered tissue establishment
  • AABB-accredited partners for cord sourcing
  • Certified cleanrooms(ISO Class 3 & 7)
  • Third-party sterility & endotoxin testing
  • Proven expertise in regenerative tissue science

Trusted by clinics and research organizations nationwide, we provide the confidence that every batch is manufactured with the highest standards.

Safety, Screening & Testing

We go beyond facility standards by implementing rigorous screening and testing at every step before a batch is released.


Ethical, Regulated Sourcing

We partner exclusively with AABB-accredited and FDA-registered cord banks in the United States to source human umbilical cord and amniotic membrane tissue. Our partners follow strict federal and industry requirements for donor eligibility and traceability.


Donor Eligibility & Tissue Recovery

Only tissue from healthy, full-term, live C-section births in U.S. hospitals is accepted. All donors undergo comprehensive medical, behavioral, and social screening to determine eligibility in line with regulatory best practices.


Infectious Disease Testing

Maternal blood is tested for a comprehensive panel of infectious disease markers as part of donor eligibility determination. These include:

  • West Nile Virus (WNV)
  • Chagas Disease (Trypanosoma cruzi)
  • Hepatitis B Core Antibody (HBcAb)
  • Hepatitis B Surface Antigen (HBsAg)
  • Hepatitis B Virus NAT (HBV NAT)
  • Hepatitis C Virus Antibody (HCV Ab)
  • Hepatitis C Virus NAT (HCV NAT)
  • HIV-1/2 Antibody & NAT
  • Human T-Lymphotropic Virus (HTLV-I/II)
  • Syphilis Serology (STS)
  • Cytomegalovirus (CMV)
  • Zika Virus

Only tissue meeting all eligibility and screening requirements is used as source tissue in our products.


Process Control & Testing Before Release

In addition to environmental and process controls in our ISO Class 3 cleanroom (with ISO Class 7 support), each batch undergoes:

  • Key extracellular components, exosomes, and biomolecules are quantitatively assessed to ensure batch-to-batch consistency.
  • Third-party USP <71> sterility and USP <85> endotoxin analysis

All results are reviewed against FDA 21 CFR 1271 criteria before final batch release.

Get in Touch

Important Disclaimer

Re-gen Active Lab manufactures human tissue–based products regulated under section 361 of the Public Health Service Act and 21 CFR Part 1271. These products are not intended to diagnose, treat, cure, or prevent any disease. All products are distributed exclusively for use by licensed professionals in accordance with applicable regulations.