Human Lymphangiogenic Endothelial Cells Derived from Pluripotent Stem Cells with Matrix or Scaffold as Curative Therapy for Secondary Lymphedema Complications of Breast, Gynecological and Other Cancer Treatment
Acquired or secondary lymphedema, the chronic and progressive swelling of an extremity due to trauma to the lymphatic vascular system, is a frequent complication of treatment for cancer. Although most well-documented for breast cancer, with incidence rates of 4% to 70% (depending on methods of assessment and length of follow-up), studies have also reported rates of 20% for gynecologic and 10% for genitourinary cancers and 16% for melanoma. Lymphedema has been called “one of the most dreaded sequelae of breast cancer treatment” due to cosmetic deformity, limited mobility, chronic inflammation, pain and fatigue, lifelong attention to symptom alleviation, and increased medical cost burdens. Currently, there is no advanced pharmacologically-based treatment, and this disorder is known to exact a psychosocial toll that negatively impacts quality of life and survivorship. We will address this huge unmet medical need by producing a novel therapeutic to restore normal lymphatic vessel function in lymphedema patients. Our target product will consist of highly purified pro-lymphatic endothelial cells (cells forming lymphatic vessels) derived from pluripotent stem cells by a process we can already make substantially compatible with FDA guidelines and scale up to anticipated clinical dose levels. This will be combined with a proprietary hydrogel matrix (already under development in clinical-grade form) that can be safely implanted under the skin by physicians after lymphedema onset.
According to a recent report by the American Cancer Society in collaboration with the National Cancer Institute (NCI), along with recent statistics of NCI’s Surveillance, Epidemiology, and End Results (SEER) Program, a continuing overall decline in cancer mortality rates over past decades has led to an estimated 13.7 million cancer survivors in the U.S. as of mid-2012, with almost 18 million survivors projected by 2022. Female breast cancer survivors alone currently account for around 22% of this total, and with roughly 12% of the U.S. population, California harbors a large and growing number of survivors. Preserving an adequate quality of life after cancer treatment and managing healthcare costs related to treatment complications will have increasingly important implications for our state’s healthcare infrastructure and economy. Acquired lymphedema is a chronic, progressive, presently incurable, psychosocially debilitating complication of cancer treatment that negatively impacts both survivorship and healthcare costs. We are attempting to develop a therapeutic candidate able to effect regenerative repair of lymphatic vessels damaged by cancer treatment that resulted in lymphedema. This will consist of specialized endothelial cells that we derive from stem cells and combine with a proprietary hydrogel matrix that can be safely implanted under the skin any time after the onset of lymphedema. This could have beneficial impacts in an area of major unmet medical need.