3. ALDAGEN: www.aldagen.com
ALDAGEN is a biotechnology company advancing a pipeline of clinical-stage regenerative therapies. The Company has three product candidates in clinical development for chronic heart failure, critical limb ischemia and pediatric metabolic disorders and malignancies. ALDAGEN's therapeutics are produced by a proprietary technology platform that selects potent, adult stem and progenitor cells for therapeutic use. The platform yields a broad range of therapeutic cells that can be used rapidly, without culture or expansion. These therapeutic cell populations have shown impressive potential to replace lost, damaged or diseased tissues in animal models and are now being tested in human clinical trials. To support clinical development, the Company has established efficient and effective quality, manufacturing, and regulatory operations that satisfy FDA regulations. The Company has established a Class 10,000 clean room for GMP manufacture of its clinical-stage therapies at its site in Durham, N.C. The manufacturing suite is fully validated and is supported by environmental monitoring and quality control activities. ALDAGEN's experienced management team, unique technology and strong intellectual property position provide solid footing for the Company to become a leader in regenerative medicine.
The field of stem cell therapy has exploded recently. Much excitement has been generated over growing evidence that various stem cell populations have potential to differentiate into most or all of the cell types found in the body, thus providing the first source of replacement cell and tissue therapy. The challenge has been converting these bench-top observations into commercially feasible and near-term clinically significant products. One of the biggest problems has been obtaining large enough numbers of functional cells for clinical use. While cell lines generated from embryonic stem cells might provide an expandable source of therapeutic cells, political and ethical debates have limited research in this area. Adult stem cells isolated from human bone marrow or peripheral blood can provide a good alternative source of therapeutic replacement cells. Up to now, a major obstacle has been obtaining the right kind of stem cell population for tissue regeneration application in large enough numbers to produce the desired therapeutic effect. Different companies have struggled to design culture conditions that allow the expansion of adult stem cell populations without changing their ability to differentiate fully into all cell types. To date, no company has been successful.
Aldagen, Inc
2810 Meridian Parkway Suite 148
Durham, NC 27713
919-484-2571
Fax 919-484-8792
