Stemedica Cell Technologies, Inc., a leader in adult stem cell research and manufacturing, announced that Lee Ann Laurent-Applegate PD & MER has joined Stemedica's Scientific Advisory Board. In this capacity, she will help Stemedica advance the clinical development of a proprietary whole cell bio-processing and cellular delivery system for burn and wound management.
San Diego, CA (PRWEB) April 15, 2009 -- Stemedica Cell Technologies, Inc., ("Stemedica"), a leader in adult stem cell research and manufacturing, announced that Lee Ann Laurent-Applegate PD & MER has joined Stemedica's Scientific Advisory Board. In this capacity, she will help Stemedica advance the clinical development of a proprietary whole cell bio-processing and cellular delivery system for burn and wound management.
Dr. Applegate is Head of the Cellular Therapy Unit for Swiss Hospital Centre Hospitalier Universitaire Vaudois ("CHUV") which is associated with the University of Lausanne in Lausanne, Switzerland. Dr. Applegate has served in various leadership positions at CHUV for the past nineteen years and is regarded as one of the world's foremost authorities in the administration of cellular delivery systems, having worked with the application of proprietary cell applications for burns and wound care since 1991. Dr. Applegate's current research interests center around wound healing and tissue repair through the dynamic application of proteins and tissue engineering.
Working in conjunction with dermatologist/ angiologist Dr. Albert-Adrien Ramelet, and Dr. Wassim Raffoul, head of the CHUV Burn Center, Dr. Applegate has completed both Phase I and Phase II clinical trials in Switzerland for the treatment of pediatric burns and chronic wounds. Her methodology included using a proprietary cell formulation administered through an all natural, gauze-like scaffold construct. During the clinical trials, pediatric burn patients treated with whole cell bioengineered tissue showed significant clinical improvement over traditional grafting techniques. In patients participating in the trial - all of whom had full thickness (second & third degree) burns - the need for a surgical grafting procedure was eliminated. Therefore, participating patients were not subject to the application of staples, glue, or biopsies for autoculture. Burn wounds healed without sharp lines of tissue demarcation and without contracture. Finally, treatment was accomplished in one step, and in large part, done as outpatient treatment. The team's results provide strong evidence that use of Dr. Applegate's proprietary cell technology in tissue repair provides measurable advantages over the use of skin grafts and drug compounds.
"We've learned from experience with pediatric burns that flexibility and movement of a repaired area (like the fingers of a hand) are often very limited after a skin graft." said Dr. Applegate. "This is not the case when we apply our proprietary technology. Patients participating in our trials also reported diminished pain compared to other treatment applications that are available today. These clinical trials provide clear and compelling evidence that the natural healing powers of our cell formulations are often the very best option for dealing with pediatric burns and certain types of chronic wounds."
"We're delighted to have finalized this working relationship with Dr. Applegate. She is an extraordinary researcher," said Roger J. Howe PhD, Executive Chairman for Stemedica. "Her scientific and medical advancements for treating pediatric burns are unparalleled. We're honored to be working with Dr. Applegate and her team in advancing burn treatment and wound care therapy using cell technology."
Stemedica will work with Dr. Applegate as she advances her proprietary cell treatment for pediatric burns and wound care into a Phase III trial in Switzerland. In turn, Dr. Applegate will assist Stemedica in securing FDA clearance for an IND ("Investigative New Drug") and Phase I clinical trial in the United States for the same applications. Noting why she chose Stemedica, Dr. Applegate said, "Stemedica's commitment to innovative cell product development and its reputation for high quality cell processing is exactly what I was looking for in a partner. I have conducted due diligence on all the best players in this space and find that Stemedica shares my vision to deliver the highest quality care to those who need it the most."
Nikolai Tankovich MD, PhD, Stemedica's President and Chief Medical Officer, stated, "We believe our collaborative work with Dr. Applegate's Phase III clinical trial in Switzerland will be an excellent first step in demonstrating our innovative cell development capabilities along with our manufacturing strengths in the marketplace. Further, we believe the compelling results from Dr. Applegate's Phase I and Phase II clinical trials in Switzerland will be very helpful to Stemedica as we advance our burn and wound care efforts with the FDA here in the United States. Finally, the working agreement with Dr. Applegate comes at an opportune time for Stemedica as we recently announced the opening of our international operations, Stemedica International, in Lausanne, Switzerland which is also where Dr. Applegate is headquartered."
Stemedica anticipates approaching the FDA for an IND to conduct a Phase I clinical trial in the next few months. Dr. Applegate's Phase III clinical trial in Switzerland is scheduled to begin this fall.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. (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 (dot) com
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