Amniotic Stem Cell Allograft
Over the last two years, Dr. Barry Jarnagin, M.D., FACOG of the Center for Pelvic Health located in Franklin, Tennessee has been treating women with pudendal neuralgia using a commercially available amniotic injectable allograft. Dr. Jarnagin has submitted a study for publication on 64 patients which revealed a significant response for over 90%, with 67% of these women having complete resolution of their symptoms. Some patients had ongoing symptoms for nearly two years. Most of these patients had previously been treated unsuccessfully, (including pudendal nerve entrapment (PNE) surgery), and had symptoms for over 20 years prior to treatment. Dr. Jarnagin has treated over 150 patients using amniotic allograft injections and the response rate is consistent with the findings in the study.
Dr. Jarnagin does not treat men due to American Board of Obstetrics and Gynecology regulations, but is hoping to work with other healthcare providers to offer this treatment to men in the future.
Two Patient Model:
Dr. Jarnagin describes two patient profiles;
1. those who are acute with a one-time specific event
2. and those who have a multi-factorial medical condition.
Typically, a Patient may have a specific event that triggered their symptoms such as a hysterectomy or vaginal delivery, where they woke up with pudendal nerve pain, or, they may have multi-factorial issues such as chronic anatomic problems that contribute to their symptoms. An analogy would be a patient who has an isolated bone fracture that completely heals versus an osteoporotic patient with a disease requiring ongoing and indefinite medical management.
Patients with multi-factorial conditions related to other symptoms may need on-going complimentary treatments to deal with other issues, and may not be as likely to have complete resolution of pelvic pain symptoms as a patient that has a one-time specific event with no additional accompanying symptoms.
A patient with post-hysterectomy pain on one side of the pudendal nerve with no concomitant symptoms had complete resolution after one injection.
The Procedure is performed in an Ambulatory Surgical Setting. The Patient is placed in the lithotomy position and palpated using the ischial spine as a landmark, injecting 1cm below the landmark. The Patient is sedated. Dr. Jarnagin delivers the amniotic allograft injection into the area of Alcock’s canal vaginally. Pain relief usually occurs in 6-8 weeks.
Patients who fit the “acute model” as described earlier are likely to need only one (1) injection, unless significant, but not complete resolution occurs, in which case a subsequent injection may be needed. The patient with chronic pain and associated co-morbidities may need a repeat dose if the initial injection provides moderate relief, but the nerve becomes irritated again, and symptoms return.
Mechanism of Action:
It is believed that the exosomes, tiny micro-vesicles found in the amniotic fluid, release micro RNA’s (miRNA) that target and mediate pain following injury or disease.
Who is a Candidate
Dr. Jarnagin evaluates the patient’s medical history and performs a thorough pelvic exam. It is important to diagnose and solve all associated problems that occur in chronic pelvic pain patients. To specifically diagnose pudendal neuralgia, a thorough exam of the pelvic floor is performed palpating the muscles, nerves and bladder. A patient would be an ideal candidate for a therapeutic injection if there exists tenderness along the course of the nerve at Alcock’s canal.
Pudendal Neuralgia v. Spinal Radiculopathy
Patients who exhibit evidence of spinal Radiculopathy or related back disease are referred to a Spine doctor.
Dr. Jarnagin is not aware of any side effects or downside to amniotic allograft injections. Amniotic tissue and fluid is immune privileged. He has had one patient that exhibited an adverse reaction due to developing new symptoms, but the new symptoms were more likely due to associated co-morbidities. None of his patients have experienced injuries due to needle sticks.
This therapy is reimbursement eligible by all insurance companies based on the patients plan of coverage. Please speak to you healthcare provider.