US Stem Cell Inc (USRM)

[TruthSpeaker12]

Hot off the press: https://www.practicalpainmanagement.com/resources/news-and-research/fda-issues-more-policies-facilitate-innovation-regenerative-medicine

"On November 16, 2017, two new guidance documents were issued to build a policy framework on regenerative medicine designed to “spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy,”1-4 according to a Food and Drug Administration (FDA) press release.

These regulatory guidelines continue to expand the FDA’s risk-based regulatory approach. The documents propose a process for ensuring the safety and effectiveness of regenerative medicine therapies and aim to support development in this growing area of medicine to improve patient care.1-4 These guidance documents also define the process in which the FDA intends to enforce safety measures on products that have significant safety concerns.

Stems cells and tissues can be engineered to replaced diseased tissues and organs.
Stems cells reflect the potential of regenerative medicine.

“We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones, new genes can be introduced into the body to combat disease, and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine,” said Scott Gottlieb, MD, FDA Commissioner, in a press release.

“The current FDA Commissioner seems to understand that stem cells and regenerative medicine are the future of medicine, and he is moving quickly to enact appropriate guidelines,” Jay Joshi, MD CEO and medical director of the National Pain Centers in Vernon Hills, Illinois, told Practical Pain Management.

Finalizing 2 Policies on Regenerative Practices
The two new final guidance documents address stem cell and tissue products taken from and then used in the same person and more clearly define “minimal manipulation” and “homologous use.”1,2

The first guidance addresses human tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. The FDA clarifies which regulations must be followed for autologous use of cells or tissues. In particular, the FDA is detailing the exceptions that exist for tissues or cells that are used in the same individual during the same procedure.1

The second guidance is directed to manufacturers, healthcare providers and the FDA staff that work with human cells, tissues, and cellular and tissue-based products. This guidance clarifies the definitions of “minimal manipulation” and “homologous use” so that stakeholders know which regulation their product falls under and whether they need certain approvals.2

Draft Guidance for Advanced Therapy Devices
The two new draft guidance documents address the regulatory application process for devices used in regenerative medicine advanced therapies (RMATs) and the expedited programs available for RMAT designation.3.4

The first draft guidance, “Evaluation of devices used with regenerative medicine advanced therapies,” clarifies how the FDA will evaluate devices used in the recovery, isolation or delivery of RMATs. It is meant to help streamline the process of regulatory approval for combination device and cell or tissue products used in procedures with RMATs.3

The 21st Century Cures Act created the regenerative medicine advanced therapy designation. This designation can be used to speed up the review of cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products. The second draft guidance released addresses the expedited approval process for regenerative medicine therapies for serious or life-threatening diseases or conditions. It clarifies details to expedite the application for regenerative medicine therapies and the new RMAT designation program.4

Both of these draft guidance documents have a 90-day comment period prior to the FDA issues final guidance documents."


I won't gloss over the fact that the article once more speaks about those "unscrupulous actors" or stem cell clinics, while reporting on the new developments. However, I would like to point out that if you know what you own, you know that we do not fall into that category. Notice as well that they have stopped using our name in that spiel. Hmmmmmmmmm......