helping girls with premature ovarian insufficiency
Female childhood cancer survivors are a growing patient population developing premature ovarian insufficiency (POI). This is due to toxicities associated with cancer treatments that adversely affect hormone levels and ovarian functionality before puberty, leading to delayed physical and psychosocial development in young girls and to chronic health issues later in life.
Currently, the only available treatment is hormone replacement therapy, which is not designed for adolescent girls and is inadequate for physiological puberty induction.
University of Michigan researcher, Ariella Shikanov, Ph.D., Associate Professor in Biomedical Engineering, is developing a novel polymer capsule that will contain functioning ovarian tissue from a healthy donor and transplant it into adolescent girls with POI. This will restore the patient’s ovarian endocrine function and return physiological balance without using synthetic hormones.
The immuno-isolation capsule can be easily placed under the skin, and is designed to accommodate structural and functional changes in the encapsulated ovarian tissue during the menstrual cycle, support follicle growth and expansion, and allow for the exchange of hormones. It prevents the patient’s immune cells from infiltrating the implant, which minimizes the chance of tissue rejection, while still allowing the diffusion of nutrients and oxygen.
Hormone Replacement Therapy (HRT), the current treatment for POI, was designed to treat postmenopausal symptoms and is inadequate for physiological puberty induction. It only delivers two of the approximately dozen hormones normally secreted from the ovary and can affect the rate of bone development, insulin, and fat storage regulation. There is also a lack of data in regards to long-term safety use of HRT in children.
The design of the immuno-isolating device is tuned to the unique physiology of ovarian tissue. It uses an optimized dual-layer biomaterial capsule to deliver natural ovarian tissue which secretes hormones that interact with endocrine organs and control muscular-skeletal development at physiological rates.
This new device would provide an easy-to-remove method of transplanting donor ovarian tissue that would deliver all the hormones present in the ovary and help restore physiological balance without using synthetic hormones. The capsule accommodates structural and functional changes in ovarian tissue associated with development, providing a crucial advantage over rigid encapsulation systems.
- Intellectual Property – one patent is submitted and is under review at the patent office; one invention disclosure for tolerance induction is submitted
- Commercialization Strategy – Develop technology through start-up formation, with the goal of acquisition by a strategic when the technology is mature
- Regulatory Pathway – Conducting FDA Pre-Submission meeting to determine regulatory strategy for this product
- Product Launch Strategy – Initial indication for female childhood cancer survivors with POI. Potential for expansion to perimenopausal women, transgender patients, and fertility preservation.
- Capsule design – optimize the biomaterial formulation and geometry to support implantation of human tissues in animal models
- Optimize the amount of donor tissue delivered to support implant efficacy and longevity
- First-in-human enabling GLP animal studies to assess safety in animal preclinical model
- Conduct an FDA Pre-Submission meeting to determine path to first-in-human clinical trials