PRODUCT SPECIFICATIONS,

SAFETY AND HANDLING

Storage

Stemell products can be stored for prolonged periods of time before use. 10% DMSO has been added to cell products to minimize cell death while freezing. Stemell’s cryopreserved products are stored in containers specifically designed and tested for extremely low temperatures at long time intervals. Products should be stored in liquid nitrogen at -135°C. The cells are warrantied for 6 months from the date of receipt if stored at -135°C or colder. Storage of cells at -80°C for less than one month should maintain cell viability but is not covered by the warranty.

Sample Collection

All samples are collected at nearby partner hospitals or clinics. Samples are then quickly processed in our on-site laboratory in the city of San Juan Capistrano to achieve maximum viability and quality. Stemell cells are frozen at -1°C/minute in a -80°C freezer, and then transferred to liquid nitrogen.

Thawing Instructions

Materials

• Frozen Stemell Vial containing cells
• Desired medium warmed to 37°C
• Sterile 50 mL centrifuge tube
• Water bath warmed to 37°C
• 70% ethanol
• DNase I

1. Place the vial into the 37°C water bath. You may consider leaving the vial in a sealed plastic bag to reduce the chance of contamination. Perform this step immediately after removing the vial from the dry ice in the shipment or after removing the vial from your liquid nitrogen storage.

2. Quickly thaw the cells in less than a minute by gently swirling the vial in the water bath until only a small bit of ice remains. Do NOT vortex the cells at any point while thawing, and work quickly to maximize cell viability.

3. Wipe the vial with 70% ethanol and transfer it to a laminar flow hood.

4. Gently mix the cells by inverting the vial. Measure the cell suspension volume in the vial.

5. Aliquot 10 μL of cell suspension from the vial using aseptic technique; have a separate person proceed with the cell count and viability measurement using the counting Instructions provided. Important: This cell viability/counting step is required to ensure the quantity of cells provided. Thawing and counting must be completed simultaneously with two people to ensure accurate measurements in the cell count and to maintain product viability. Be sure to count the cells at this step, before washing, because you will lose cells in the wash.

6. Transfer the cell suspension to the sterile centrifuge tube containing DNase I, which will prevent cell clumping. For mononuclear cells, use cell suspension. DNase I is not necessary if cells are to be lysed for protein or DNA/RNA extraction.

7. Rinse the remaining cells from the vial with 1 mL warmed medium. Slowly add this suspension to the centrifuge tube with the cells in a dropwise fashion, 1 drop every 5 seconds, while gently swirling the tube.

8. Add 15–20 mL warmed medium to the cells. Gently mix by inverting the closed tube.

9. Wash the cells by centrifuging at room temperature, 300 rcf for 10 minutes, with low brake.

10.Check the supernatant for clarity, and check the bottom of the tube for a complete cell pellet. Carefully remove the supernatant with a pipette, leaving a small volume so as to not disturb the pellet. Resuspend the

11. Again add 15–20 mL warmed medium and perform the wash step once more.

12.Gently resuspend the cells in warmed medium. They are now ready for use.
Important: Be aware that cell loss is expected and may be up to 30% during thaw and wash steps. Recovery rates vary depending on technique.

superior

viability

3rd party product testing and comparison has shown that Stemell yields 38% more live cells on average at 5.25% (post-thaw) compared to other products at 3.2% live cells and less; some Stemell batches report even higher results.

3rd party testing results from DRIK LLC available upon request.

N

14 diseases tested

Infectious Disease

HIV I and II

HTLV I and II

Hepatitis B

Hepatitis C

Chagas Disease

Syphilis

Chlamydia

Cytomegalovirus

West Nile Virus

Gonorrhea

Lyme Disease

safety &

sterility

Stemell products are registered with the FDA, Tissue Bank, NIH and FWA. We operate out of a Certified Class 100 Clean Room and follow GMP, GLP & GTP good manufacturing practices. All Stemell products are tested for microbial and viral pathogens.

We test for 14 diseases instead of the standard 8 and provide you with the official results for each order.

free training &

marketing support

In addition to our premium product offerings, Stemell provides various marking tools for your practice  and ongoing support. As your partner in regenerative therapy, we offer a personable and customized approach.

Become a preferred Stemell distributor today.  

How to Order

Initial registration is required to place your first order. Visit our registration and ordering page.

Questions?

Please use the form below if you have any questions regarding our products, how they can be utilized in patient care or how to become a distributor. For a faster response, feel free to call us at 949-481-1344.

 

 

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.