Stem Cells — Topics
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Legal Aspects of Stem Cell Research and Therapy International Use of Stem Cells In most countries, use of stem cells is not specifically regulated. They would be seen as a medication that a physician can use as he is trained. StemTech Labs has plans to set up anti-aging and medical treatment clinics in Bahamas, Canada, Puerto Rico, and other locales easily accessible to U.S.A. patients. As the supply of stem cells improves, existing spas and clinics are likely to begin using stem cells. U.S.A. – Use of Stem Cells More severely ill patients, who have difficulty traveling, would benefit from availability of stem cells in the U.S.A. In the U.S.A., there are no current special regulations regarding the use of stem cells for treatment of humans. Customs officials have told us that there are restrictions against importing animal cells without a license (disease free), but no such restrictions for human cell lines. Many physicians in the U.S.A. want to use stem cells, but cannot, due to the lack of an FDA approved source. This limitation can be bypassed by allowing the physicians to join our research team, letting them do research on the clinical application of stem cells in their own practices. Some U.S.A. physicians have collaborating physicians in Mexico, especially Tijuana, who provide U.S.A.-source stem cells to patients there. TITLE 21 part 1271 of the US FDA law The mesenchymal and umbilical cord blood stem cells used in this study are human cells, tissues, or cellular and tissue-based products (HCT/Ps) as defined in 21 CFR § 1271.3(d). Under 21 CFR Part 1271, HCT/Ps are not subject to licensure or IND requirements if certain criteria are met (21 CFR § 1271.10). These requirements include autologous use (use by the cell donor), or if used for other patients, the HCT/Ps must be “not more than minimally manipulated” and labeled for use for “homologous use only”. They may also not be used for a purpose requiring their “metabolic” activity. StemLab S.A. mesenchymal and umbilical cord stem cells shipped to the United States of America have not been “more than minimally manipulated”. StemLab S.A. labels and intends its cells which are used within the United States of America only for homologous and non-metabolic purposes. StemLab S.A. does not interfere with the practice of medicine by individual physicians who use StemLab products, and who may do so according to their own medical training and informed choice. Research – U.S.A. In the U.S.A., federal funding for embryonic stem cells is restricted to a few established lines of cells, to avoid the Federal Government paying for destruction of human embryos. No other restrictions are known for stem cells research, public or private. Research – U.S.A. – FDA The Federal Food and Drug Administration does not regulate individual physician practice. Individual physicians can do research and create their own treatments or devices, under the FDA regulations. FDA regulates MANUFACTURED medications, drugs, devices. It also controls whether new drugs are acceptable for interstate commerce.
Individual physicians can use their own preparations of materials in their own practices, without FDA interference. StemTech Labs can provide raw materials, ie, human stem cells of various types, and let individual physicians use them as they see fit. Research—IRB Research with human subjects in the U.S.A. is subject to oversight of an Institutional Review Board (IRB). StemTech Labs will soon have such an IRB, Our client physicians can join it, or any other stem cell IRB, and their stem cell research using human subjects will be totally legal in the U.S.A. In Ecuador In Ecuador, local medical research and practice is controlled by a university. We have connections for cooperation with such a University, as far as collecting donor cords, doing research and production, and setting up a clinic for administration of stem cell products. We will experience an increasing need for trained technicians and physicians. One university has requested that we set up a post-graduate program in stem cell technologies. Local administration of stem cells by StemTech Labs in Ecuador is done by, and under the authority of, a local licensed physician. In Puerto Rico An excellent clinical researcher in Puerto Rico will be working with us in validating our products and procedures. He has several other physicians anxious to begin production of stem cells locally, when we open our production and research laboratory there.. In South Africa There are at least two stem cell clinics in South Africa. One is building a satellite clinic in the Seychelles. They want a lab there, have government approval for it, and we are in the beginning stages of negotiations to build the lab for them. They have a good world-wide internet presence, but do not make their own cells. Cost of cells is included in a vacation package to the Seychelles: $24,000. In Costa Rica A good U.S.A. researcher had a successful stem cell practice in Costa Rica. This practice has since been shut down by the Costa Rican government. We suspect pressure from international drug manufacturers, and other international powers to the north. In Dominican Republic Fetal stem cells from Eastern Europe are administered by a U.S.A. company, using Dominican physicians. They provide monthly clinics, 20-40 patients daily for two days. Cost of administration: $25,000. In Ukraine Advanced stem cell researchers in Ukraine provide fetal stem cell injections there to Westerners for $25,000 per injection. They have been doing research in stem cells and cryobiology for over 20 years. In China China has many stem cell programs. One of the leading programs is nerve cell progenitor cells from the nose injected into spinal cord lesions. Others include nerve cell progenitor cells for Cerebral Palsy and other pediatric brain problems, and Adult muscle stem cells into heart muscle. O T H E R T O P I C S Clinical Experience | Legal Aspects | Modern Miracle
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