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Dr. Ernesto Gutierrez
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Allogeneic Stem CellscGTP requirements govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps in a way that prevents the introduction, transmission, or spread of communicable diseases by HCT/Ps (§ 1271.150(a)).4 Manufacture, as defined in
§ 1271.3(e), means, but is not limited to, any or all steps in the recovery, processing, storage, labeling, packaging or distribution of any human cell or tissue, and the screening or testing of the cell or tissue donor. Under § 1271.145, you must recover, process, store, label, package, and distribute HCT/Ps, and screen and test cell and tissue donors, in a way that prevents the introduction, transmission, or spread of communicable diseases. Under § 1271.150(a), communicable diseases include, but are not limited to, those transmitted by viruses, bacteria, fungi, parasites, and transmissible spongiform encephalopathy agents.

What Are Core CGTP Requirements?

• Core CGTP requirements (§ 1271.150(b)) are those requirements that directly relate to preventing the introduction, transmission, or spread of communicable disease by HCT/Ps. The core CGTP requirements include requirements for:
• Facilities (§ 1271.190(a) and (b));
• Environmental control (§ 1271.195(a));
• Equipment (§ 1271.200(a));
• Supplies and reagents (§ 1271.210(a) and (b));
• Recovery (§ 1271.215);
• Processing and process controls (§ 1271.220);
• Labeling controls (§ 1271.250(a) and (b));
• Storage (§1271.260(a) through (d));
• Receipt, predistribution shipment, and distribution of an HCT/P (§ 1271.265(a) through (d)); and
• Donor eligibility determinations, donor screening, and donor testing
(§§ 1271.50, 1271.75, 1271.80, and 1271.85).

Other CGTP requirements discussed in this guidance support the core CGTP requirements (e.g., the required records management system in § 1271.270(b)). Although we have identified core CGTP requirements, you must follow all CGTP requirements (§ 1271.150(a).

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Be sure to visit our Blog!

    • There is a wealth of information available on Stem Cell therapy and the emerging field in general. Many of our patients have asked me to present further information and give them a working knowledge of the terms and general information necessary to understand the industry. Under the Stem Cell Glossery section of our website are some of the most used terms. A posting of additional resources will be present shortly.

      Please note that we will be posting a number of clips for this purpose. In our YouTube area check for the updates. A recent lecture series given at the Annual Gathering of Mensa 2011 will be included.

      Recently a number of clinics have begun selling "cells" for treatments. The treatments are via IV and all sorts of claims are being made. The idea of the franchise of stem cell centers is the opposite of personalized medicine and clearly not the direction that I feel will benefit the majority of patients.

      As a consumer the buyer beware "caveat emptor " needs to be heightened in the competitive environment of questionable practices by "cell" salesman/women.
*DISCLAIMER: As with any medical treatment, no guarantees or claim of cures are made as to the extent of the response to treatment. Results vary from patient to patient, even with a similar diagnosis, as the body's internal status is unique to each individual patient. Because of this fact we cannot offer, infer or suggest that there is any certainty of a given outcome. Many of our treatments are not currently FDA approved. We do not use embryonic or fetal cells in any of our treatments.