Clinical Trial

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 institutionKyung Hee University Hospital in Gangdong and Bethesda Hospital in Yangsan
Implementation period18 months
Number of subjects12 people
Trial drugAutologous 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

About the Disease Rotator cuff disease is considered a social disease because it tends to progress into a chronic disease and leads to an increase in the direct and indirect costs associated with treatment and rehabilitation and loss of manpower. Most patients complaining of motor impairment accompanied by shoulder pain are diagnosed with adhesive capsulitis of the shoulder or impingement syndrome. The main causes of shoulder pain such as tear in the rotator cuff, shoulder impingement syndrome, adhesive capsulitis, calcification disease, degenerative arthritis are accompanied by similar pain symptoms, and accurate diagnosis is difficult. The biggest causes of shoulder pain are known to be subluxation of the humeral joint, adhesive capsulitis, inflammation and tear of the rotator cuff, subacromial bursitis, supraspinatus and bucephalus brachii diseases, referred pain, stiffness of the muscles around the shoulder, humeral head impingement syndrome, degenerative changes and trauma in the soft tissue of the shoulder joint, shoulder-brachial syndrome, restricted range of motion of the joint, etc. [1] Such various factors have a complex relationship with shoulder pain, thus making it difficult to provide proper treatment and management. [2] Patients’ lack of medical knowledge related to shoulder pain management and treatment causes them to repeatedly place themselves in postures and positions that cause shoulder pain in their day-to-day activities, and inadequate exercise further aggravates the pain and leads to more functional restrictions. This in turn leads to structural change and functional impairment of the shoulder.

About Clinical Trial

Clinical trial Treatment of Rotator Cuff Disease Using Autologous Adipose-Derived Mesenchymal Stem Cells
Implementing institutionSMG-SNU Boramae Medical Center
Implementation period24 months
Number of subjects18people
Trial drugAdipose-derived mesenchymal stem cells
Low dosage: 1x107 cells/3mL
Medium dosage: 5x107 cells/3mL
High dosage: 1x107 cells/3mL
Administration method The area of the rotator cuff is observed with an ultrasound to localize the lesion, indicated by a localized low density area, and to check whether the location is consistent with location determined based on the MRI scan. 1mL of the trial drug should be injected into the rear limit, the intermediate area, and the front limit of the lesion for a total of 3mL.

About Research Background: Parry-Romberg syndrome is a rare disease that is also known as progressive hemifacial atrophy. It causes damage to the epidermis, dermis, subcutaneous adipose tissue, muscles and eventually cartilages and bones. Parry-Romberg syndrome has been treated with dermofat or fat grafting or microvascular free flap transplantation. In this study, it was hypothesized that adipose-derived stem cells can improve the longevity of micro fat grafting through the promotion of angiogenesis. Following micro fat grafting, adipose-derived stem cells were administered or micro fat grafting was performed, and the change in the hemifacial area was measured to assess the utility of adipose-derived stem cells in micro fat grafting for Parry-Romberg syndrome patients. Method: Approval was obtained for the implementation of this study from the Korea Food and Drug Administration (KFDA) and the Institutional Review Board (IRB) of the Asan Medical Center in April 2008. Ten patients with Parry-Romberg syndrome (5 males, 5 females; average age: 28) were recruited between May 2008 and January 2009. Five subjects were treated by micro fat grafting with adipose-derived stem cells, while the other five subjects were treated only by micro fat grafting. The average follow-up observation period was 15 months. Adipose-derived stem cells were obtained from the abdomen by liposuction and cultured for 2 weeks. On day 14, the subjects either received only micro fat grafting or micro fat grafting with administration of adipose-derived stem cells. Following the procedure, the subjects were observed using a 3D camera and by 3D CT imaging for an objective assessment of the volume of the fat graft. Results: Successful results were observed in the five subjects who received micro fat grafting in combination with the administration of adipose-derived stem cells. The longevity of the fat graft was better compared to the control group, which only received micro fat grafting. The mean difference of the hemifacial area of the experimental group decreased from 21.7mL before the procedure to 4.47mL after the procedure. The absorption rate observed in the experimental group was 20.59%. The hemifacial area of the control group, which only received micro fat grafting, decreased from 8.32mL to 3.89mL. The total absorption rate for the control group was 46.81%. The difference between the two groups before and after procedure was statistically significant. Conclusion: Adipose-derived stem cells extend the longevity of fat grafted into the face. Micro fat grafting performed in combination with the administration of adipose-derived stem cells is expected to be useful in treating Parry-Romberg syndrome, without microvascular free flap transplantation.

About the Disease The femoral head refers to the end of the thigh bone in contact with the pelvic bone. Avascular necrosis of the femoral head refers to the disease in which the blood vessel supplying to the femoral head becomes blocked, causing the bone tissue to die. When pressure is applied on the dead bone tissue, fracture and associated pain occur, and it eventually collapses, causing damage to the hip joint. Because avascular necrosis of the femoral head occurs in relatively young people in most cases, a wide range of technologies have been developed to delay or prevent the collapse of the femoral head so as to postpone the artificial joint replacement surgery. However, this approach has not resulted in desirable outcomes in patients whose lesions are relatively large. One of the hypotheses proposed to explain this issue is that there are an insufficient number of osteoblasts necessary for bone reformation. Thus, research has been conducted on the use of stem cells as a supplementary measure.

About Clinical Trial

Clinical trial Treatment of Avascular Necrosis of the Femoral Head Using Autologous Adipose-Derived Stem Cells
Implementing institutionSMG-SNU Boramae Medical Center
Implementation period24 months
Number of subjects15 people
Trial drugAutologous adipose-derived mesenchymal stem cells (1.0x108 cells/3mL)
Administration method Drilling of bone to the subchondral bone in the area of the lesion
Administer the trial drug using a C-arm, an imaging scanner intensifier, and use a collagen bone plug
Patients are to use crutches or a crane for 6 weeks after surgery

About the Disease Alzheimer’s disease is a representative type of cortical dementia accompanied by progressive and irrevocable cognitive impairment, as described by Alois Alzheimer in 1907. The development of this disease is substantially influenced by age, gender, family history and cephalic damage. There are some cases in which the onset of Alzheimer’s disease occurs in the 40s or 50s, but it is mostly observed in elderly people aged over 65. Alzheimer’s disease is characterized by gradual neuronal degeneration in the central nervous system, and cognitive impairment at a broad level. It accounts for an estimated 60% percent of all dementia cases, and it is considered a major disease affecting the elderly population. A fundamental treatment solution is yet to be developed for this particular disease, but drugs, which can alleviate the symptoms and delay the progress of the disease, have been used in clinical settings. The most common drugs used inhibit the acetylcholinesterase; although this type of drug cannot completely prevent the progress of the disease, it can delay the progress by 6 months to 2 years.

About Clinical Trial

Clinical trial A Clinical Study of the Safety and Effectiveness of Intravenous Injections of Autologous Adipose-Derived Mesenchymal Stem Cells in Alzheimer’s Patients
Implementing institutionGachon University Gil Hospital
Implementation period30 weeks
Number of subjects60people
Trial drugTrial drug: Autologous adipose-derived mesenchymal stem cells (2.0x108 cells/20mL)
Comparison drug: Aricept (Donepezil Hydrochloride)
Administration methodComparison drug: 4-week administration of 5mg of Aricept, 20-week administration of 10mg of Aricept
Trial drug: 10 intravenous injections at a 2-week interval

About Research Background: Critical limb ischemia (CLI) is difficult to treat with the conventional vascular bypass surgery or percutaneous vascular interventions. In this study, adipose-derived mesenchymal stem cells were administered into the muscles of CLI patients to assess the safety and effectiveness. Method and results: 15 male CLI patients were registered for this study. During the 6-month follow-up observation period, complications from the intramuscular injections of adipose-derived mesenchymal stem cells were not observed. 66.7% of the subjects showed clinical improvement. Five of the subjects received minor amputation during the follow-up observation period, and the amputated areas were completely healed. After 6 months of treatment, there were improvements in the pain level and claudication distance. Digital subtraction angiography (DSA) was performed before treatment and 6 months after treatment, and the results showed significant generation of blood vessels along the damaged blood vessels. Conclusion: Intramuscular injections of adipose-derived mesenchymal stem cells were found to be a safe procedure that can induce angiogenesis in CLI patients.

About the Disease Spinal cord damage is typically caused by injury, and it can lead to irreversible quadriplegia, paraplegia or sensory impairment. With the advances in medicine, there have been a growing number of spinal cord injury patients recovering from various complications, but there are no treatment measures with visible effects on neural damage, except for the conservative treatment approaches such as physical therapy. In the acute phase, pexis may be performed to fix the fractured vertebra or a restricted use of steroidal agents may be instructed. However, there are limitations in restoring the neurological function. There has long been research to discover new treatment methods for spinal cord injuries, but no effective treatment methods have been developed thus far. Accordingly, there is active research on the use of stem cells for regeneration of neurocytes and axons.

About Clinical Trial

Clinical trial A Clinical Study of the Safety and Effectiveness of Intravenous Injections of Autologous Adipose-Derived Mesenchymal Stem Cells in Spinal Cord Injury Patients
Implementing institutionKorea University Anam Hospital
Implementation period10 months
Number of subjects15 people
Trial drugIntravenous injections: 2x108 cells/20mL
Spinal cavity injections: 5x107 cells/2mL
Localized injections into the spinal cord: 2x107 cells/1mL
Administration methodThe subjects registered for this clinical trial are to be administered the trial drug as follows:
1. 2x108 autologous adipose-derived mesenchymal stem cells shall be administered into the veins.
2. 5x107autologous adipose-derived mesenchymal stem cells shall be administered into the spinal cavity.
3. 2x107autologous adipose-derived mesenchymal stem cells shall be administered into the spinal cord.
4. It shall be performed for a total of 3 times at a 1-month interval (for #1 and #2).
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