QUALITY

CONTROL

Manufacturing of therapeutic regenerative cellular and cell-free products requires a wide range of quality control to certify the identity, quality, and safety of the cells. Here we describe the Stemell quality control process to heighten the manufacturing of our StemL™ product lines.

  1. Carefully count cells with a state-of-the-art device purchased by Stemell to deliver our best services and products to our medical professionals and patients.
  2. Analyze the cells using a laser-impedance-based biophysical technology machine.
  3. Sort cells by targeted biomarkers’ detection.
  4. Use a state-of-the-art automated system to count and monitor precisely red blood cells; hemoglobin B; and white blood cells such as T-cells, B-cells, etc. in order to make sure our samples are not contaminated with any red blood cells or granulocytes that can cause body immune rejection and a series of life-threatening emergencies during transplant. Due to our unique technology, we are able to remove 98% to 100% of HGB and red blood cells from the samples.

As a result, Stemell monitors the process precisely via three steps:

  1. Use an FDA-approved automated device to determine the hemoglobin and hematocrit levels.
  2. Run multiple assays, which will measure stem cell potency, identity, quality, and integrity.
  3. Analyze the cell population by sorting the cells.
    And more.

We set up additional epigenetic assays to confirm consistency of our manufactured StemL™ products and distinguish these products from other adherent stromal cells such as mesenchymal stromal cells (MSC). All Stemell products are uncultured, serum-free, xeno-free, bovine–free, and screened for any microbial and fungal pathogens.

Stemell’s allograft products are manufactured diligently under sterile conditions and in a fully protected environment to enhance product safety from microbiological and viral transmission or any other contaminations. All products are manufactured in fully certified Class 100 clean rooms. Our trained technicians operate under good laboratory practices, good tissue practices, and good manufacturing practices, as well as regulations and requirements, in order to make sure the company maintains the highest standards in concert with our vision and quality promises.

Stemell focuses on three critical elements as far as quality:

  1. Viability of the product (cellular products)
  2. Safety of the product 
  3. Sterility of the product

Disclaimer

For Medical Professional Viewing Only

 

Stemell, Inc. does not claim that therapy using StemL products cures or prevents any condition, disease or injury. All statements and opinions provided are for educational and informational purposes only, and we do not diagnose or provide medical or legal advice.

Individuals interested in any cellular or cell-free regenerative medicine therapy are urged to review all pertinent information and do their own research and due diligence before choosing to participate in any therapies. Please consult with your physician for further information and be sure to discuss any potential risks.

Please understand that Stemell, Inc. is a supplier only. Stemell, Inc. is not a sponsor, and Stemell, Inc. is not claiming to cure or treat any disorder or condition.

This site was intended for education purposes only and strictly for use by medical professionals. The FDA recently re-confirmed, there is only one registered stem cell product, and while there is enormous promise in stem cell therapies, and thousands of ongoing experimental applications trying to establish efficacy, these are not at the point where they would meet the scientific standard.

The FDA has stated:
Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications.
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm

This site is not intended for consumers.
If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.

“There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body.” Cells in a different environment may multiply, form tumors, or may leave the site you put them in and migrate somewhere else. If you are considering having stem cell treatment in another country, learn all you can about regulations covering the products in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country that—unlike the U.S.—may not require clinical studies designed to demonstrate that the product is safe and effective. FDA does not regulate stem cell treatments used solely in countries other than the United States and typically has little information about foreign establishments or their stem cell products.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm

Stem cell therapies have enormous promise, but the science in each use is still in the developmental stage. Professional judgment and expertise is needed in using stem cells for any therapeutic use, and we urge anyone embarking on the use of stem cell therapies to consult the national health data bases to evaluate current information from clinical trials and the FDA websites on human tissue should also be consulted to get its current evaluation of any therapy.