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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).

For More Info:
http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm285223.pdf

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Testimonials

  • Stem Cell Treatment or Hip Surgery

    Stem Cell Treatment or Hip Surgery

    I have grade IV osteoarthritis (severe loss of cartilage leading to bone rubbing on bone) of my right hip. I have seen 3 orthopedic doctors, all of which have said I need to have surgery for hip replacement. Additional options for treatment were limited. As a nurse, and at my age, having seen both good and bad outcomes following hip replacement, and also knowing hip replacement is not without risk, I chose to seek other options of treatment for myself.

    Read more
  • AUTISM a stem cell treatment success

    AUTISM a stem cell treatment success

    Andrew is thriving. We have seen and continue to see major improvements. He has matured beyond anything I can explain (I have had to rapidly adjust my parenting as I now have a much older & more sophisticated child), his comprehension (perhaps better to say his ability to express and act upon his comprehension) is now age appropriate.

    Read more
  • Hello

    owen_pic

    Hello, When we came from Cancun the first week we noticed an improvement in eye contact. It improved about 70%. His attention improved about 50% and he was more in our world when it comes to understand what it happening around him. He lost some of his attention for the last two weeks but it is still better than it was prior stem cells and even Janik BIs therapist say it is easier to work with Janik in ABA because his eye contact is better and his focus is also better."

    Read more
  • Owen, happy again

    Owen-pic-2

    Well Owen is happy again, which is the biggest improvement. He is laughing and giggling again. His eye contact has improved and he is playing with toys again. All of these things had stopped. I`m so happy that he is happy. ( His Mom)Read more

News

  • Interview with Dr. Ernesto Gutierrez from the World Stem Cells Clinic by Healthcare Elsewhere show with John Cote on iTunes!:

    October 13th, 2014

    October 11, 2014 Dr. Gutierrez is the medical director and president of the World Stem Cells Clinic in Cancun, Mexico. The clinic was established i

     

    Read more

  • Educating Medical Professionals &Patients on Stem Cell Advancements with Dr. Ernesto Gutierrez:

    October 9th, 2014

    Dr. Ernesto Gutierrez, M.D. was interviewed recently for the Healthcare Elsewhere show with John Cote on iTunes! They discussed several things from pa

     

    Read more

  • Doctors Seminars – Stem Cell and Regenerative Medicine Procedures for Orthopedics, Musculoskeletal and Sports Medicine Doctors Training Seminar December 4-5-6th, 2014:

    October 5th, 2014

    Doctors Seminars

    Stem Cell and Regenerative Medicine Procedures for Orthopedics,

     

    Read more

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.