At Cryo-Cell, we are continually evaluating ways to improve the quality of our stem cell products to ensure that our specimens are the best in the industry. We have developed a new and improved kit for collection and transportation of cord blood and tissue that provides up to 30 times the protection from extreme temperatures as compared to other kits currently used in the industry. Stem Cells lose viability and functionality when exposed to extreme temperatures. Dangerously hot and cold temperatures can occur in the birthing center, courier vehicles, holding facilities, airports and cargo holds. Safeguarding the cells requires a kit with excellent insulating properties as well as a responsible medical courier.
Stem cells lose viability when exposed to extreme hot or cold temperatures. Many studies have demonstrated that warm temperatures as low as 106°F irreversibly damage stem cells after just 30 minutes exposure(2-6). These temperatures can easily occur on a hot day in a closed car or on an airport tarmac. This presents a challenge when stem cells are collected at remote locations for transportation to a centralized processing facility. A two-pronged approach is required to ensure that the temperature is consistently maintained:
- utilizing a transportation container that will provide adequate thermal protection
- partnering with a medical courier company that will prevent unnecessary exposure to extreme temperatures during transport.
Our process for determining quality
- Determine the scope and performance of cord blood collection/transportation kits currently used in the industry.
- Utilize this information to design an improved kit with enhanced temperature control while containing size and cost.
- Test worst-case scenario of the new design in an authentic setting.
- Identify a medical courier partner with an exceptional track record and commitment to quality.
Competitor deficiencies
- Most collection/transportation kits used do not provide any insulating materials to protect the stem cell products and cannot prevent extreme temperature excursions.
- Not all companies partner with reliable medical couriers that minimize exposure to extreme temperatures while the stem cells are in the courier’s hands.
Step above the rest
We utilized the information from our study to create a collection/transportation kit for cord blood and tissue that provides 30-fold more temperature control than most kits currently used in the family cord blood banking industry.
Our new kit has the following features:
- It is small and compact, approximately 12 inches square, and weighs less than 5 lbs.
- It utilizes state-of-the-art gel packs containing “phase change material” which requires no refrigeration or freezing, yet provides maximum temperature control.
- It includes an internal indicator that continuously monitors the temperature during transportation and alerts us if a temperature excursion occurs.
The ultimate test
We put our kit to the ultimate test by shipping it to our furthest international affiliate in the western hemisphere, Santiago, Chile. The kit was shipped back and forth to Chile three consecutive times without opening; thus, extending the transport route six times normal. Ambient daily high temps in Tampa and Santiago averaged in the upper 80s°F (32°C) range. The internal temperature of our kit remained well within normal range (4-30°C) the entire time, demonstrating exceptional ability to control temperature excursions and protect the stem cells.
Conclusions
Cryo-Cell has taken another initiative to ensure that the stem cells we store for our families will provide maximum function when and if they are needed in the future by:
- ensuring our kits provide superior protection from extreme temperatures during transport
- partnering with the industry leader medical courier to expedite the process and minimize temperature exposure during transportation
References
- Yamaguchi M, Fujihara M, Wakamoto S, Sakai H, Takeoka S, Tsuchida E, Hamada H, Azuma H, Ikeda H. (2009) ASAIO J. 55(3):200-205.
- Wierenga, PK, Setroikomo, R, Kamps, G, Kampinga, HH and Vellenga, E (2003) Exp Hematology 31(5):421-7.
- Wierenga, PK, Brenner, MK and Konings, AWT (1998) Bone Marrow Transplantation 21:73-78.
- Symonds, RP, Wheldon, TE, Clarke, B and Bailey, G (1981) Br. J. Cancer 44:682-691.
- Elkon, D, Sabio, H, Pinizzotto, M, Sigurdsson, M and Baker, DG (1984) Cancer 54(9): 1973-1976.
- Elkon, D, Sabio, H, McGrath, E and Baker, D. (1981) Cancer Research 41:1812-1816.
While cord blood stored at birth is a 100% match for the child, in cases of certain genetic diseases, utilizing cells from a donor, whether a relative or unrelated individual without the same genetic mutations, is required.