Renowned Stem Cell Researcher Files Study Results With Stemedica

Stemedica Cell Technologies, Inc., (“Stemedica“), a leader in adult stem cell research and manufacturing, received the results today from a Stemedica-sponsored clinical study conducted by renowned stem cell researcher and clinician Professor Philippe Hernigou, MD, Ph.D. The approved clinical study featured Dr. Hernigou’s treatment of non-union bone injuries using autologous stem cells, allogeneic stem cells and comparative traditional treatment therapies.
 

Left to Right: Dr. David Howe, Dr. Nikolai Tankovich, Dr Philippe Hernigou, Dr Michael Bayer
Originally uploaded by Stemedica

 
“The results that Dr. Hernigou presented to our Company’s leadership are both exciting and profound. First of all, the results reaffirm our assumptions about the short and long term safety of adult stem cells in general and our mesenchymal bone marrow stem cell line in particular. Secondarily, study results clearly showcase the regenerative nature of adult stem cell therapy in comparison to other traditional treatments”, said Dr. Nikolai Tankovich, Stemedica’s President and Chief Medical Officer. “We are delighted with the outcomes for this study as well as the insights that someone of Dr. Hernigou’s stature can bring to a study of this kind”, Dr. Tankovich commented.

The year-long study conducted by Dr. Hernigou and his staff included sixty patients who experienced tibia fractures that wouldn’t heal. The study was a part of an on-going, ten year study involving nearly four hundred patients by Dr. Herningou using stem cell therapy and traditional treatment of non-union bones and joints. The Stemedica study results gave clear evidence that the use of adult stem cells provided greater healing capability in a shorter period of time with less infection. “I started treating non-union injuries using autologous stem cells back in 1990. This was followed by the clinical application of allogeneic stem cells seven years later in 1997. Through each and every year of the last seventeen years, and through each and every study I’m involved in, I become more convinced of the important role that adult stem cells play in the healing and bone regeneration process”, said Dr. Hernigou.

Dr. Hernigou, MD, is Chief of the Orthopedic Surgery department at the Henri Mondor Hospital and is a professor of orthopedic surgery at the University of Paris XII, France, a position he has held since 1989. He is regarded as a pioneer, and one of the world’s foremost authorities, in the use of stem cells in orthopedic surgery. Since 1990, Dr. Hernigou has developed new treatments for osteonecrosis first with cementoplasty, then with stem cells and later with growth factors. He has applied these techniques to more than 1,600 patients – from treating osteonecrosis in relation to sickle cell disease to the use of bone marrow grafts in the treatment of delayed unions and non unions. Dr. Hernigou has published more than 200 international scientific publications and has participated in more than 100 scientific conferences all over the world. He is a member of the International Orthopedic society and member of the International Hip Society.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan (at) stemedica.com

Stemedica Announces the Appointment of Carl Bullen as Director of Manufacturing

Stemedica announced today the appointment of Carl Bullen as Director of Manufacturing. Mr. Bullen will be responsible for manufacturing systems and procedures at Stemedica’s San Diego-based manufacturing facility that is built to cGMP standards and is currently pending FDB license. Mr. Bullen has extensive experience in all aspects of cell culture manufacturing as well as the commercialization of new biomedical technologies for United States and European markets.

Carl Bullen, Director of Manufacturing
Originally uploaded by Stemedica

“We are very impressed with Mr. Bullen’s track record of establishing and managing manufacturing systems in progressive technologies. His managerial experience combined with his knowledge of international regulatory requirements is a significant advantage as we prepare to supply our adult allogeneic stem cell lines to preclinical and clinical research centers around the world,” said Dr. Nikolai Tankovich, Stemedica’s President and Chief Medical Officer.

Mr. Bullen has been in the pharmaceutical manufacturing business for the past 16 years having started his career as a Biochemical Technician and progressing to Director of Manufacturing for such companies as IDEC Pharmaceuticals, Biogen Idec, Genentech and Pacira Pharmaceuticals. During the course of his extensive career, Mr. Bullen has employed his innovative thinking and manufacturing experience to develop practical solutions that have supported numerous start-up manufacturing scenarios for some of the world’s foremost biotech companies.

“What inspires me about my new role at Stemedica is the opportunity to expand and improve manufacturing systems and processes in a cutting edge environment like the one offered at Stemedica. I am eager to bring my detailed knowledge and experience in building new manufacturing capabilities to Stemedica as they transition from research and development into full scale manufacturing. The set-up of first-time manufacturing is complex and it is an exciting prospect to work with the great minds here at Stemedica. Together, we will create the means to extend the benefits of stem-cell research and therapies to an ever widening audience”, said Mr. Bullen.

Mr. Bullen will report directly to Dr. Alex Kharazi, Vice President of Medical Research at Stemedica. “The appointment of Carl Bullen is a significant step in our progress towards supporting clinical trials of our products in the United States and other locations around the world. As we complete the final steps in the certification process with California’s Food & Drug Board and evolve toward the manufacturing of allogeneic clinical grade product for external clients as well as for our own clinical trials, it is fundamental to have someone of Carl’s biomedical manufacturing expertise working for the organization”, said Dr. Kharazi.

CIRM Completes Briefing Visit to Stemedica

San Diego, California (STEMEDICA) March 2, 2009 — Leadership of the California Institute for Regenerative Medicine (“CIRM”) completed a two part visit to Stemedica Cell Technologies, Inc. (“Stemedica”) to tour its manufacturing facility, R&D lab and corporate headquarters.

Left to Right: Dr. Kharazi, Dr. Lipton,
Robyn Garcia (Stemedica Quality Control Director),
Dr. Tankovich, Dr. Trounson
Originally uploaded by Stemedica

“I was glad to have the opportunity to visit Stemedica and get to know more about its leadership, plans for the future and to see first hand the assets and potential they represent to the stem cell movement in California”, said Dr. Alan Trounson, President of CIRM. “We want to have strong working relationships with all sectors of California’s stem cell industry, including for-profit companies like Stemedica.”

Prior to Dr. Trounson’s visit, Dr. Marie Csete, CIRM’s Chief Scientific Officer had the opportunity to visit Stemedica’s manufacturing facility and R&D laboratory. “We’re delighted to see Stemedica make the effort to secure a clinical grade manufacturing license from the State of California. We believe this capability will aid numerous organizations in California and around the world in their efforts to manufacture stem cell products for clinical application”, said Dr. Csete.

“We were pleased to have Dr. Trounson and Dr. Marie Csete visit our facilities and receive a briefing from our leadership”, said Dr. Maynard Howe, Stemedica’s Vice Chairman & CEO. “We continue to play a pivotal role in the evolution of the stem cell industry in California and believe a supportive working relationship with CIRM is an essential part of this process.

Stuart Lipton, M.D., Ph.D., Scientific Director and Senior Vice President of the Del E. Webb Center for Neuroscience, Aging and Stem Cell Research at the Burnham Institute for Medical Research, San Diego, CA, joined Dr. Trounson during his visit to Stemedica’s manufacturing facility. “I was impressed with the progress that Stemedica has made on the licensing process for clinical grade allogeneic stem cell manufacturing and am excited about expanding our research relationship with the Stemedica team. Having a manufacturing resource like this in California will be a great asset to our entire research community. I anticipate that many CIRM-funded stem cell research institutions will take advantage of Stemedica’s manufacturing facility that will soon become FDB (Food & Drug Board) cGMP licensed.”

Dr. Nikolai Tankovich, Stemedica’s President and Chief Medical Officer organized the visits for Dr. Trounson, Dr. Csete and Dr. Lipton. “We’re delighted that these outstanding leaders within California’s stem cell movement took the time to find out more about Stemedica and our plans to lead this industry from a manufacturing standpoint. We will continue to seek the wise counsel of CIRM in an effort to align our efforts with theirs. In addition, we are expanding our collaborative research efforts with the Burnham Institute for Medical Research and several other California stem cell research institutions”, said Dr. Tankovich.

About Stemedica Cell Technologies, Inc.:
Stemedica Cell Technologies Inc. (http://www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California.

About CIRM:
The California Institute for Regenerative Medicine (CIRM) was established in 2005 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. To date, the CIRM governing board has approved 229 research and facility grants totaling more than $614 million, making CIRM the largest source of funding for human stem cell research in the world. For more information, please visit http://www.cirm.ca.gov.

Media Contact for Stemedica: Dave McGuigan at dmcguigan (at) stemedica.com.