Developmental Strategy for Stem Cell Therapy Products in Regulatory Considerations / 한양의대학술지

Expectation that stem cell therapy products will prove better and more effective in treating a variety of medical conditions continues to drive expanding research efforts. Stem cell therapy products consist of, or are derived from, populations of stem cell progenitors. They are complex and dynamic biological therapies which are highly regulated for safety and efficacy as biological products. The Korea Food Drug Administration (KFDA) is the legal authority responsible to regulate stem cell therapy products as stipulated by the Pharmaceutical Affairs Act. In this article, the regulatory review process used by the KFDA to assess the safety and effectiveness of novel stem-cell therapy products is described. The agency regularly updates and re-evaluates recommendations applicable to production and testing of stem cell therapy products based on the accumulation of scientific and clinical experiences.

Bipolar Pulsed Radiofrequency Denervation of Third Occipital Nerve in Patient with Cervicogenic Headache: A case report / 대한통증학회지

Pulsed or conventional radiofrequency (RF) denervation of the third occipital nerve (TON) is considered to be a safe and effective alternative for the treatment of pain originating from the cervical 2-3 facet joint, including cervicogenic headache. However, proper positioning of the RF probe in the TON can be difficult and time consuming due to the possible involvement of various lesions along the target nerve. We found that bipolar RF is easier to perform and more convenient than unipolar RF when administering a lumbar medial branch block. Here, we report the successful treatment of a patient with a cervicogenic headache by pulsed RF (PRF) denervation of the TON, using a bipolar probe. We believe that bipolar PRF denervation of the TON is an effective alternative to unipolar RF or PRF for the treatment of pain originating from the cervical 2-3 facet joint.

Intracerebral Hemorrhage after Vesicolitholapaxy under Spinal Anesthesia: A case report / 대한마취과학회지

Intracerebral hemorrhage is a rare complication of spinal anesthesia. We report a case in a 83-year-old man with a history of Alzheimer dementia who underwent vesicolitholapaxy with spinal anesthesia and midazolam sedation. Until 1 hour after the end of anesthesia and operation he did not regain his consciousness. Immediate computerized tomogram of brain revealed a left frontal intracerebral hemorrhage. An emergency craniectomy was performed to remove the hematoma. Patients with prolonged recovery of consciousness after spinal anesthesia with midazolam sedation require neurologic and radiologic monitoring to rule out the possibility of intracranial complications.