CODE OF

ETHICS

Stemell, Inc. is a professional organization dedicated to leadership, education, service, research, manufacturing, and integrity involving practices when interacting with medical professionals, clinics, bio-therapeutics centers, and the public.

All members of Stemell, Inc. pledge to adhere to the following codes, principles, and good-faith practices:

• We strongly support voluntary tissue and blood donation and informed choice. We offer public education on the benefits of allograft and autograft quality products. We provide information regarding donation and transplantation options. We respect the decisions of donors and donor families.

• As stewards of the gifts of allograft transplants and their therapeutic purposes, we are responsible for acting in accordance with the wishes of medical professionals.

• We cooperate with colleagues to assure a coordinated approach in seeking and verifying documents of authorization and obtaining information necessary to screen all potential donors.

• We honor and treat with respect the gifts of donated human tissue and strive to optimize use in order to save lives and improve the quality of life for patients who require transplants.

• We protect the confidentiality of donors, donor families, and recipients by releasing information only with proper authorization or as required to support public safety or legal obligations.

• We provide information to the FDA or any appropriate agency about how donors’ gifts were used by tracing medical professionals who use our products for the benefit of their patients.

• We strive to provide and maintain the highest quality of service and products in accordance with current scientific knowledge, established standards of care, and advancing technologies.

• We share knowledge and advances that may improve the quality, safety, and effectiveness of our allograft and autograft products.

• We act with the highest level of integrity and are committed to fair, just, equitable, and legal standards of behavior in all relations with donors, medical professionals, transplant recipients, and other members of the tissue and stem cell community.

• We promote our products and services in a manner that honors each donor and the donor’s bereaved family members and respects the gift of human tissue.

• To maintain public confidence in tissue banking, stem cell technology, and allograft transplants, we ensure that our relationships with healthcare professionals and our business partnerships are structured to reflect these values and the altruism on which donation is founded.

• We respond in times of need to help meet shortages of transplant allografts.

• We promote and move toward AATB, FDA tissue establishment and California public health and relations and HIPAA, good laboratory practice(s), good tissue practice(s), and good manufacturing practice(s) standards, accreditation, and certification of personnel.

All members of Stemell, Inc. pledge to adhere to the following ethical principles:

• Recover cells and tissues in a manner that respects the expectation of how they will be used.

• Provide tissue forms that meet the medical needs of patients and clinicians with reimbursement for services that reflects the cost of providing finished tissue allografts that are safe and of high quality.

• Treat, deliver, and distribute allografts in ways that maximize usefulness to medical professionals and the patient community.

• Avoid distributing cells in a discriminatory manner.

• Seek the cooperation of healthcare professionals in transplant and recovery activities in a manner that will not diminish public confidence in transplants and stem cell technology.

All members of Stemell, Inc. pledge to adhere to the following good-faith practices when advertising services:

• Consider carefully the public perception of the advertisement and avoid terms that cheapen the concept of the “gift of life.”

• Consider the impact of the advertisement on public confidence in tissue banking, allograft, and autograft transplant.

• Be truthful, provide accurate information, and avoid unfounded or misleading statements.

• Utilize the code of ethics of Stemell, Inc. as a guideline, where appropriate.

• Emphasize community support for, and avoid advertisements that undermine community support of, tissue donation, allograft transplant, and stem cell technology in general.

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.