With the establishment of our new facility, Celltex’s cell manufacturing, quality control and quality assurance teams are also growing. We are in the midst of adding technicians and managers with experience in stem cell culture and cGMP compliance. For those interested in joining the Celltex team, please click here.

We are excited about working with premier medical facilities in Latin America and will be announcing specific details in the near future.

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 mesenchymal stem cells were delivered intravenously and into the brains (intracerebroventricularly) of 18-month-old mice once or four times at 2-week intervals. Transplantation of the stem cells improved both locomotor activity and cognitive function in the aged animals and also with recovery of acetylcholine levels in brain tissues. Transplanted cells differentiated into neurons and, in part, into astrocytes and produced choline acetyltransferase proteins. Transplantation of the stem cells restored microtubule-associated protein 2 in brain tissue and enhanced Trk B expression and the concentrations of brain-derived neurotrophic factor and nerve growth factor. These results indicate that human fat derived stem cells differentiate into neural cells in the brain microenvironment and can restore physical and cognitive functions of aged mice not only by increasing acetylcholine synthesis but also by restoring neuronal integrity that may be mediated by growth/neurotrophic factors.

Park, D., Yang, G., Bae, D. K., Lee, S. H., Yang, Y.-H., Kyung, J., Kim, D., Choi, E.-K., Choi, K.-C., Kim, S. U., Kang, S. K., Ra, J. C. and Kim, Y.-B. (2013), Human adipose tissue-derived mesenchymal stem cells improve cognitive function and physical activity in ageing mice. J. Neurosci. Res., 91: 660–670. doi: 10.1002/jnr.23182
†
D. Park and G. Yang contributed equally to this work.

Photo by Thomas Prior for Businessweek

Celltex Featured in Bloomberg Businessweek, click here to read the full article.

Photo by Tyler Ruddick for Culturemap

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 cell therapies. Unlike other similar venues, this meeting focused on commercializing therapies, openly discussing regulatory issues and patient rights.

Governor Rick Perry, consistent champion of adult stem cell therapies, gave the keynote address and asserted his commitment to the field. Watch the keynote address here.

Dr. Arnold Caplan of Case Western University, considered to be “father” of mesenchymal stem cells, gave the opening address and was followed by distinguished researchers, Dr. James T. Willerson and Dr. Doris Taylor of the Texas Heart Institute, Dr.Silvio Itescu, CEO of Mesoblast, Dr. Randal Mills, CEO of Osiris Therapeutics and of course, our very own, Dr. Stanley Jones and David Eller.

The highlight of the event was the patient panel in which patients who benefited from adult stem cell therapies could share their stories. Each testimony was a reminder of the impact and importance of the work this industry.

“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’s letter to the FDA can be found here.

As we work with the FDA, Celltex will continue to make advances on the frontier of regenerative medicine. Thus, Celltex is now proceeding with all of the appropriate  steps to develop the necessary pre-market testing, including clinical trials for specific disease and conditions.  Please contact us if you have any questions about this process.

October 1, 2012 – HOUSTON, TX – 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.

David Eller, CEO and President of Celltex, stated:

Celltex makes identical copies of an individual’s own stem cells and therefore should not be subject to FDA regulation as drugs. However, the FDA said our process causes the cells to be considered biological drugs and thus is subject to those regulations. We respectfully but firmly disagree with the FDA and intend to contest the agency’s opinion within its administrative procedures.  We are considering all options as we work with the agency toward a resolution.

FDA’s letter also repeats its earlier observations from an April inspection of Celltex’s laboratory. While Celltex provided detailed responses in April, May, June, July and August, now FDA tells us it needs more information.  We will answer FDA’s questions in whatever detail the agency requests.”

We will meet FDA’s requirements, no matter how high the hurdles may be, to ensure access to this technology.  Celltex remains fully committed to advance the most promising new field in human health in decades — regenerative medicine. We also remain committed to doing so safely, and we will continue to comply with federal and state agency requirements.

As we work with the FDA, Celltex will continue to make advances on the frontier of regenerative medicine, and we expect to have several significant announcements in the coming weeks on these matters:

• Celltex is preparing Investigational New Drug (IND) clinical trials focused on the effectiveness of adult autologous stem cells for specific conditions, such as multiple sclerosis, osteoarthritis and macular degeneration.

• Enrollment in Celltex’s current clinical trials has reached the goal of 200 patients who received their own stem cells from their physician-investigators. Data collection and analysis have commenced, and results are expected to be published in 2013. This will represent the largest, and potentially the most important, adult autologous mesenchymal stem cell study conducted in the United States.

“Celltex is committed to developing the promise of regenerative medicine into a reality for doctors and their patients,” Mr. Eller said. “We sponsor clinical trials to better understand the therapeutic impact and monitor the safety of adult stem cell therapy, and we are confident that our research will help implement effective treatments for patients suffering from a variety of medical conditions.”