Click here for an article on how Johns Hopkins researchers use a type of stem cells from human adipose tissue to chase migrating cancer cells.
Celltex is finalizing our new laboratory in Houston, where our offices are located. We are happy to report that construction is finished and final quality check and certifications are being conducted. Stay tuned for details on our new facility. With the … read more
While Celltex will continue to operate as a stem cell banking and multiplication facility, we are also finalizing partnerships with hospitals in Mexico to allow clients to receive their banked stem cells. We are working with both FDA and COFEPRIS … read more
Human adipose tissue-derived mesenchymal stem cells improve cognitive function and physical activity in aging mice The same cell culture technology used in the Celltex process was used for this study, published in the Journal of Neuroscience Research. Human fat derived … read more
Celltex Featured in Bloomberg Businessweek, click here to read the full article.
Celltex proud to sponsor First Annual Houston Stem Cell Summit The Houston Stem Cell Summit was a great success with an extraordinary lineup of keynote speakers from across the nation. The 2-day conference highlighted the latest research using adult stem … read more
Celltex Therapeutics Corporation has officially responded to the FDA regarding the agency’s September 24, 2012 letter.
Celltex respects the agency’s authority, granted by the federal Food, Drug, and Cosmetic ACT (FDCA) and the Public Health Service (PHS) Act. While Celltex respectfully disagrees with the positions outlined in the September 24 letter, Celltex believes that this technology’s therapeutic potential can be brought to fruition as a biological drug as the agency states. Although the regulatory requirements for a biological drug are excessive for an autologous mesenchymal stem cell therapy such as Celltex’s, Celltex will follow the agency’s request to treat the Mesenchymal Stem Cell (MSC) product as a biological drug and develop Investigational New Drug (IND) submissions for clinical trials.
As the September 24 letter is an advisory opinion, not final agency action on the issues it raises, Celltex’s response letter serves to explain why its product is not in violation of the FDCA and the PHS Act. Celltex has also requested an in-person meeting with FDA for an in-depth discussion of critical points raised for the first time in the September 24 letter. Upon completion of a thorough examination of all relevant information, Celltex believes FDA will determine that Celltex’s stem cell technology can operate in compliance as an HCT/P-only product.
Celltex Therapeutics Corp. announced today that it has received a letter, dated Sept. 24, 2012, from the U.S. Food and Drug Administration. The letter stated the agency’s opinion that the process Celltex uses to multiply adult stem cells is subject to FDA regulation as biological drug manufacturing. The issue is a key one as stem cell therapy for patient care outside of an academic institution is a new frontier, yet there are a variety of technologies being used throughout the United States, often creating complex legal and regulatory questions. read more
Celltex Therapeutics Corporation Expands Laboratory Operations and Adds Depth to Its Management Team
Celltex Therapeutics Corporation, a leader in regenerative medicine services, today announced the appointments of Andrea Ferrenz, Executive Vice President, Legal Counsel, and Jane Shen Young, Manufacturing Research Scientist. Ferrenz’s primary responsibility will be overseeing operations, including compliance with federal and state regulatory agencies. Young’s primary responsibility will be research and development of manufacturing processes and products in regenerative science.read more
After an invitation from Celltex Therapeutics Corp., the Food and Drug Administration (FDA) visited the Celltex laboratory for two weeks in April, 2012. The FDA studied Celltex operations in depth in accordance with the “good tissue practices” (GTP) standards, as it routinely does with inspections of facilities such as Celltex which are registered pursuant to 21 CFR Part 1271. In their close-out report given to Celltex on the last day of their visit, the FDA had 14 main observations that it requested Celltex resolve.read more