LEXINGTON After 30 years of private practice as an OB/GYN, Magdalene Karon, MD, decided to supplement her practice and get back to the science behind the medicine by finding groundbreaking applications for birth tissue, placental tissue, and amniotic fluid. As the only physician in Kentucky and one of only two nationwide applying regenerative medicine to gynecology, she has become a pioneer in the field. “You know, somebody has got to make the first step, and I feel like I’m the one who is trying to do it,” Karon states.
Birth tissues and amniotic fluid have several curative properties including preventing infection, promoting healing, reducing the risk of adhesion, decreasing inflammation, and stimulating the immune system. In addition, amniotic fluid does not contain antigens, therefore there is no fear of the patient having an adverse reaction or rejecting it. In the words of Karon, “You can’t beat Mother Nature. It’s amazing what it creates. And anything synthetic-made is not as good as what nature makes.”
Karon first began utilizing regenerative sources by applying biological patches during pelvic prolapse procedures, then became interested in the use of amniotic fluid for tissue regeneration and pain reduction. Currently, she uses the fluid to treat the debilitating pelvic pain of pudendal neuralgia. Karon is also enthusiastic about the employment of amniotic fluids in the treatment of advanced endometriosis. Karon explained, “I can combine it with my robotic surgery. I use a laser to remove the endometrioses, then at the same time I can inject the amniotic fluid into the ovaries to help regenerate ovarian function. Then we can spray the amniotic fluid to prevent adhesions, and we can also inject it in the nerves to help with the pain. It has incredible applications.”
Karon is passionate about preserving and properly storing this commodity. “Thank goodness there are now companies harvesting these products during elective C-sections, cryopreserving, and making it available to be used in clinical applications,” she says. One of these companies is BioD, who supplies Karon with the biological resources needed to continue her research in “the future of healing.” At BioD, the birth tissues and fluid are collected aseptically by the laboratory team and are then tested to ensure viability and safety.
Karon’s ability to explore new applications was made possible in part by the 21st Century Cures Act, which was enacted under President Obama in 2016. The act modified the FDA drug approval process and eased the requirements for new indications on existing drugs. In Karon’s words, the act “allows us to continue using things that are safe and have been used, and not have to seek FDA approvals or expensive regulations.”
Long used in wound and burn care, amniotic fluid and birth tissue are indicated for tissue regeneration, so in that capacity can be applied to any part of the body in any specialty. A variety of physicians are beginning to use amniotic fluid, including those in orthopedics, ophthalmology, and neurology.
Up until now, Karon has been funding her own research but will be applying for a National Institutes of Health grant to help in the compilation of data and development of studies for clinical application. She will then publish a retrospective study to show the success rates in gynecological applications. Two of the ways these results can be measured is by tracking the incidence of increased fertility in those with endometriosis and the substantial reduction of pain in those with pudendal neuralgia.
To Karon, the use of birth tissues and amniotic fluid in gynecology only makes logical sense. “In my specialty, I feel like ‘let’s put it back where it came from.’” In closing, she adds, “It is still in early stages, but very exciting”
You can’t beat Mother Nature. It’s amazing what it creates. And anything synthetic-made is not as good as what nature makes.– Dr. Magdalene Karon