About the disease Cerebral palsy is caused by non-progressive injury to an underdeveloped brain accompanied by a single or multiple flaws in the musculoskeletal system, and ultimately results in deterioration of the motor function and sensory integration. The damage to the motor function and sensory integration in cerebral palsy patients makes it difficult for them to carry out day-to-to activities such as walking and dressing on their own. Such challenges in the daily routines do not simply signify a problem in the physical function of the individual concerned, but they can also become obstacles in interacting with other people and adapting to one’s environment. Above all, motor skills are essential for school-aged children to learn how to write and draw, and the development of fine motor skills is necessary to carry out daily activities such as brushing one’s teeth, changing one’s clothes and brushing one’s hair, for instance. Thus, in addition to physical damage, poor development of motor skills in childhood can restrict one’s ability to carry out normal daily activities and to be involved in academic activities, and can also cause difficulties in social interactions. Ultimately, it may become a major factor that prevents the affected individual from living an independent life. For treatment of cerebral palsy, various types of physical therapy are provided in the field of rehabilitative medicine to exercise the joints and promote motor development. Children affected by this disease may engage in “functional training,” in which they are asked to repeat large movements, fine movements of the hands or day-to-day activities to the best of their abilities, or assistive devices such as may be used to promote the function or prevent deformity. In addition, there is a surgical approach to treat deformity or spasticity, and it is selective dorsal rhizotomy, performed by neurosurgeons on patients with spastic cerebral palsy. However, this method can actually aggravate the symptoms for those with rigidity cerebral palsy or athetosis, so accurate diagnosis necessary before determining the suitable treatment method for the patient. A drug therapy involving repeated injections of Baclofen, a muscle relaxant, into the spinal cavity has been proposed in the U.S.A and other countries. However, it has not yet been introduced in Korea due to the issue of high costs.
About Clinical Trial
|Clinical trial||A Clinical Study of the Safety and Effectiveness of Intravenous Injections of Autologous Adipose-Derived Mesenchymal Stem Cells in Cerebral Palsy Patients|
|Implementing institution||Kyung Hee University Hospital in Gangdong and Bethesda Hospital in Yangsan|
|Implementation period||18 months|
|Number of subjects||12 people|
|Trial drug||Autologous adipose-derived mesenchymal stem cells (0.5x108 cells/5mL)|
|Administration method||Select the dosage according to the body weight determined at the time of screening, and dilute the substance with 50mL of physiological saline solution per syringe for intravenous injection.
Dosage by body weight is as follows:
- Under 15kg: 0.5x108 cells, a total of 1 syringe
- Between 15 and 25kg: 1x108 cells, a total of 2 syringes
- Over 25kg: 1.5x108 cells, a total of 3 syringes