A New Class of Living Therapeutics

Faq

Frequent Asked Questions FAQ

Advancing the field of regenerative medicine with over 10 years of clinical experience

Pure MSCs are human umbilical cord-derived mesenchymal stem cells. Unlike traditional stem cells sourced from bone marrow or adipose tissue, Pure MSCs are harvested from a non-invasive, sustainable source, offering robust proliferation, high scalability, and enhanced biological activity.

Fresh MSCs, like Pure MSCs, maintain higher viability and potency compared to frozen counterparts. Freezing can reduce cell viability to around 70% or less post-thaw, whereas Pure MSCs boast an impressive 95-100% viability, optimizing efficacy for patients.

Stem cell therapy is utilized for tissue regeneration, immune modulation, and reducing inflammation. It aids in healing orthopedic injuries, autoimmune diseases, and inflammatory disorders by promoting tissue recovery and regulating the immune system.

Pure MSCs are produced fresh to order in a cGMP (current Good Manufacturing Practice) lab. The manufacturing occurs at a state-of-the-art facility equipped with FDA-certified clean rooms, ensuring the highest standards of quality and safety.

Pure MSC products are available exclusively to clinics and doctors. However, non-physicians can be referred to qualified partner clinics for brief screenings and potential treatment options.

Pure MSC utilizes allograft tissue cells sourced from human umbilical cord blood donated by screened healthy mothers delivering babies via cesarean sections. Placental donors undergo a rigorous screening qualification process and are tested for infectious diseases, ensuring ethical sourcing and handling.

Pure MSCs are exclusive due to their production process, which involves fresh, never-frozen cells produced in a cGMP lab. This approach ensures higher viability and potency, setting them apart from other products on the market.

  • Limited Availability: Fresh MSCs are often produced on-demand, so availability may be limited compared to frozen stem cells, which are frozen are easier to stockpile and distribute widely.
  • Higher Cost: Producing fresh MSCs in small batches, especially in a cGMP facility, can lead to higher costs, making them a premium option that may be less accessible to all patients or clinics.
  • Shorter Shelf Life: Fresh MSCs have a limited shelf life compared to frozen cells, which can be stored for long periods. This requires precise planning, coordination and logistics, adding complexity to the supply chain.
  • Transportation Challenges: Fresh MSCs require specific handling conditions to maintain viability during transit, such as controlled temperatures, making logistics more challenging than for frozen cells.

 1. Fresh Pure expanded (MSCs) are often considered safer than frozen cord blood stem cells due to the absence of cryoprotective agents like DMSO, which is commonly used in freezing processes. DMSO and other possibly harmful preservatives help frozen cells last longer but can introduce risks of toxicity and adverse reactions in patients.

2. Additionally, frozen cells can suffer cell membrane damage and reduce viability during the freezing and thawing cycle, potentially compromising their therapeutic effectiveness.

3. In contrast, fresh Pure MSCs maintain full viability and potency, avoiding exposure to cryoprotectants and ensuring a more natural, highly effective therapeutic profile, especially in applications requiring high cell activity and responsiveness.

To ensure optimal freshness & effectiveness, for clinics, we recommend planning your Pure MSC purchase at least one week in advance, compared to frozen stem cells which require less lead time. Upon signup, you will receive full details and a certificate showing the fresh harvest date. All MSCs are shipped overnight for next-day morning delivery. If you are a patient, we’ll guide you and refer you to one of our qualified, exclusive clinics based on your specific needs.

Our cGMP facility offers globally harmonized GMP-compliant cell therapy manufacturing infrastructure with controlled flow of personnel and materials and environmental monitoring, ensuring the highest level of quality control and risk mitigation for product manufacturing.

Features of our clean room include:

  • ISO designation Class 7 clean room
  • ISO designation Class 5 BSCs
  • ISO designation Class 8 gown-in/gown-out room
  • Positive pressure
  • Material pass-through
  • Controlled access
  • Dedicated HVAC systems

The Superior Potency of Fresh MSCs in Regenerative Medicine

Fresh vs. Frozen

Imagine choosing between fresh produce and frozen vegetables. Fresh produce is at its peak nutritional value—packed with vitamins and ready to benefit your body immediately. Frozen vegetables, while preserved, often lose nutrients, may contain additives, and don’t match the quality of fresh. Similarly, while frozen stem cells can be stored for longer periods (often 1-2 years), they may not provide the same immediate regenerative benefits and potency as fresh, “ready-to-go” stem cells, which deliver optimal nourishment and are prepared to support the body’s healing and repair processes at peak potency.

In conclusion, fresh Pure MSCs are like the fresh produce – they are at their highest potency and effectiveness, with full cell activity intact. This is crucial in regenerative treatments because fresh MSCs are more responsive and ready to start healing tissues, reducing inflammation, and promoting cell repair right away. The high potency and viability of fresh Pure MSCs can be especially important when patients are looking for optimal results in recovery and healing.

Why Fresh MSCs Delivers Superior Regenerative Power

Quality Over Quantity

“The Misconception of Cell Quantity in Regenerative Medicine”

A common misconception in regenerative medicine is that a higher total cell count automatically translates to better results. This isn’t necessarily true. The effectiveness of stem cell therapy depends on the quality and viability of the cells, not just their quantity.

Fresh Mesenchymal Stem Cells (MSCs):

At PURE MSC, we use pure, concentrated, expanded, and cultured MSCs. These cells are meticulously prepared to ensure they are viable, live, and active—ready to work immediately upon administration. This focus on high-quality cells ensures optimal therapeutic benefits, such as supporting tissue repair, reducing inflammation, and promoting healing.


Why “More Is Better” Doesn’t Always Apply:

People often overlook that not all cells are created equal. While a larger number of cells could be beneficial if they are all pure MSCs, this is rarely the case with many commonly available products. For example:

  • Many products use cryo-frozen stem cells that lose potency during freezing and thawing.
  • These products often contain a high proportion of non-regenerative cells, cellular debris, and other components, diluting their overall effectiveness.

In contrast, less of a pure, high-quality product like fresh MSCs can often provide better results than more of a lesser-quality, frozen product. The key is in the concentration and viability of the regenerative cells delivered.


Frozen Cord Blood Stem Cells:

Cord blood stem cell products, particularly frozen ones, often boast high total cell counts. However, these numbers can be misleading because:

  • After freezing and thawing, a significant portion of the cells are no longer viable or effective.
  • These products often contain non-regenerative components that dilute their therapeutic potential compared to pure, expanded MSCs.

Additional Components Found in Frozen Cord Blood Products:

  1. Red Blood Cells:
    Non-regenerative and can potentially cause inflammation.
  2. Immune Cells (T Cells, B Cells, NK Cells):
    While critical for immune responses, they do not contribute to tissue repair and may exacerbate inflammation.
  3. Cellular Debris:
    Damage during freezing and thawing produces fragments of dead cells, reducing treatment effectiveness.
  4. Cytokines and Growth Factors:
    Present in varying amounts; some may stimulate inflammation rather than promote healing.
  5. Exosomes and Microparticles:
    Found in lower concentrations and potency compared to those derived from fresh MSCs.
  6. Plasma Proteins and Other Blood Components:
    These dilute the concentration of regenerative cells and add no direct benefit to tissue repair.

The PURE MSC Difference:

At PURE MSC, we prioritize quality over inflated numbers. Our fresh MSCs offer a purer, more targeted therapy, ensuring that every cell delivered is regenerative and viable. This focus on quality provides:

  • A higher concentration of active, working cells.
  • Immediate effectiveness without the compromises associated with frozen products.

Unlike products with inflated total cell counts that rely on non-regenerative components, PURE MSC’s fresh stem cells maximize therapeutic benefit by emphasizing quality over quantity.

The Superior Potency of Fresh MSCs in Regenerative Medicine

The Truth About Cell Counts

In a “30 million” or “60 million” cord blood stem cell product, only a fraction consists of MSCs:

  • 30 million cell product: Often contains as few as 300,000 to 600,000 MSCs, with the remaining 95-98% being non-regenerative cells and debris.
  • 60 million cell product: May contain approximately 600,000 to 1.2 million MSCs on average.

These low MSC count, hidden within a high “total cell count,” label and price can be misleading, as it does not reflect the regenerative potential of the product. Fresh MSCs provide a targeted and potent therapy, ensuring patients receive a higher concentration of viable, ready to work regenerative cells.

So, it’s better to rely on a PURE, FRESH source of stem cells that are specifically designed to work rather than mixing in frozen cells that won’t offer the same effectiveness.

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