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.
