DONOR 

ELIGIBILITY

Each Stemell umbilical cord blood and umbilical cord tissue donor completes a series of questions to ensure that the donor does not have a medical history that places her at an increased risk for the transmission of infectious disease. Qualified staff and our quality assurance department will review the medical history of the donor.

The donor undergoes a physical examination by a healthcare professional that includes a blood draw for serology testing. Additionally, an umbilical cord tissue sample will be taken. The sample will be cultured following recovery and will be analyzed to detect the presence of any bacterial and fungal contaminants. All test results for serology, aerobic and anaerobic bacteria, fungi, slowly growing bacteria, infectious disease, and all the other Stemell donor parameters are reviewed prior to the release of any allografts. Only allografts from donors with acceptable test results and acceptable parameters in conformance with Stemell standards, as well as the standards of all state and federal regulatory bodies, will be released. Stemell umbilical cord blood and umbilical cord tissue donors will recover in U.S.-based hospitals.

Stemell has devoted numerous resources and energy to ensuring that all our donors are fully screened for any risk of infectious disease. Also, all of Stemell’s allograft products are specifically processed to ensure the dual goals of maximizing patient safety and retaining the native characteristics of the cord blood and cord tissues.

To ensure patient safety, screening and testing are performed for each donor. Donor screening includes a review of both the donor’s medical history and social history to ensure that the donor has not engaged in behaviors that place her at an increased risk for the transmission of infectious disease and to ensure that the donor has not shown signs or symptoms of illnesses.

Donor Screening

The donated human umbilical cord tissue/blood has been determined to be suitable for transplantation by a licensed physician: the Medical Director of the U.S-based tissue bank. The donor has been deemed free of risk factors for and clinical evidence of infection due to relevant communicable diseases and other exclusionary disease conditions through review of donor records, including medical/behavior risk assessment, medical records, and a recent physical examination.

Additionally, testing of a qualified blood sample indicates that the donor is nonreactive or negative for the following communicable disease markers:

 

  • Lyme disease
  • HIV I
  • HIV II
  • HTLV I
  • HTLV II
  • Hepatitis B
  • Hepatitis C
  • Syphilis
  • HBV
  • West Nile Virus
  • Chagas Disease (T-Cruzi)
  • CMV

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.