NuGenUSA Premium Products

We provide a wide range of products to give you a variety of options for your specific needs.

NuGenUSA -Products

  • NuGenUSA -UC-MSC
  • Mesenchymal Cells
  • 10 Million – 5 ml Vile
  • NuGenUSA – EX
  • 5ml vile
  • 40 Billion/100 Billion
  • Laboratory and cleanroom
  • NovoCyte 3000
  • Production date: 05-21-2018
  • Dry ice pelletizer and components
  • Laboratory technicians in the cleanroom
  • Cell inventory refrigerator
nugen dna
nugen lab

Process Flow Chart

  • Donor

    Donors provide full consent and undergo comprehensive panel testing to determine donor eligibility.

  • Delivery

    The collected tissue and cord blood are securely delivered to the processing site at NuGenUSA laboratory.

  • Cell Counts

    Each batch is analyzed during processing via Flow Cytometry, and Total Nucleated Cell (TNC) count and viability (%) are recorded.

  • Quarantine

    Newly processed allografts are quarantined for a period of two weeks pending during which the tissue is tested for infectious disease and microbial contamination. A Product Analysis Certificate is produced after this period.

  • Collection

    Donated tissue is collected by a licensed professional at the time of birth. Tissue and cord blood are prepared in sterile packaging and readied for overnight transport to our laboratory.

  • Shipment NuGenUSA

    Products are shipped overnight via priority alert shipping on dry ice.

  • Processing

    Upon receipt of tissue, NuGenUSA lab technicians utilize NuGenUSA proprietary methods to process tissue. All processing is done using aseptic technique according to Cgmp Standard Operating Procedures.

  • Cryopreservation

    During processing, a cryopreservative is introduced to the tissue. This allows the tissue to be stored at -800.

  • Release

    Quality assurance identifies the allograft to have passed all required testing, including infectious disease and microbial testing.

  • Physician

    Physicians receive allograft at their facility for use on day of appointment. Product use is determined by and administered by a licensed healthcare professional.

Characteristics of Mesenchymal Cells

**Source**: Umbilical cord tissue—an abundant reservoir of stem cells.

**Capabilities**:

  • Self-renewal and release of trophic factors.
  • Differentiation into osteoblasts, chondrocytes, and adipocytes.
  • Potent immunosuppressive effects.

**Morphology**:

  • Spindle-shaped, fibroblast-like structure.

**Viability**:

  • Pre-thaw: 95%.
  • Post-thaw: 86%.
Characteristics of Mesenchymal Cells

Quality Assurance

Manufactured exclusively from full-term umbilical cords. Comprehensive donor screening includes:

  • Behavioral risk assessments.
  • Physical evaluations.
  • Medical history reviews.
  • Communicable disease testing in compliance with CLIA and 42CFR Part 493 standards.

**Dedication to Excellence**

Our international biotechnology company with 20yrs of experience in the development of clinical products.

NuGenUSA – EX is an allogeneic Warton’s Jelly MSC-derived exosome product. NuGenUSA s manufactured using our proprietary isolation and purification technologies. The natural cell origin of exosomes enables improved efficacy, biocompatibility, and reduced immunogenicity NuGenUSA extensive characterizations such consistency and potency assays provide assurance of quality throughout the production process.

Exosome characterization:

The presence of exosomal markers (CD9, CD63, C81) was confirmed with NanoView.

Exosome characterization