Boramae Hospital Finalizes Advanced Regenerative Clinical Study for Shoulder Rotating Muscle Surgery Using Stem Cell Therapy
Sep 03, 2024
Seoul Metropolitan Government Boramae Hospital, which operates Seoul National University Hospital, announced on the 3rd that it has received final approval from the Ministry of Health and Welfare and the Ministry of Food and Drug Safety for advanced regenerative medical research on 「Rotating cuff rupture and extensive rupture restoration using umbilical cord-derived mesenchymal stem cell therapy」.
Following the 6th Advanced Regenerative Medicine and Advanced Biopharmaceuticals Review Committee's decision on June 27, the Ministry of Food and Drug Safety has finally approved it, and from the second half of this year, Korea University Anam Hospital and Seoul Boramae Hospital will evaluate the safety and effectiveness of umbilical cord-derived stem cell treatments in rotator cuff rupture surgery with a major rupture.
In this clinical study, a high-quality umbilical cord-derived stem cell developed by a research team led by Professor Cho Hyun-chul of Seoul National University's School of Orthopaedic Surgery, is used. Smumpcell is an innovative umbilical cord-derived regenerative medical platform cell that can fundamentally solve variability that may occur in raw materials and manufacturing processes by being able to cultivate an ultra-high amount of stem cells using a unique minimum cubic dining separation method. In addition, 3CX, an independently developed injection-type treatment platform technology, has been used to dramatically improve the quality and ease of use of stem cells.
Seoul Boramae Hospital already received approval from the Ministry of Food and Drug Safety in July for a clinical trial plan (IND) of non-surgical stem cell injection treatment 'Archisostem-Teno' for partial rupture of rotator cuff. Through the approval of this advanced regenerative clinical study, Boramae Hospital is expected to establish itself as the world's first medical institution to apply regenerative medicine using stem cells to actual clinical trials in all disease spectra from partial rupture of rotator cuff to extensive rupture. Through this, it is expected to solidify its position as a leading regenerative medical research institution in the musculoskeletal field.
On the other hand, rotator cuff rupture is a disease in which the rotator cuff, the main tendon that moves the shoulder joint, is worn out and ruptured as it undergoes degenerative changes. This condition is the most important cause of adult shoulder pain, which occurs mainly in people over the age of 50 and is sometimes referred to as 'Fifty shoulder'.
According to statistics from the Ministry of Health and Welfare's Review and Assessment Service, the number of patients in Korea reached about 970,000 as of 2022, and about 1 million surgical treatments are performed annually in the United States. In most cases, patients without any special underlying disease require surgical treatment. Despite good surgical results, a high repulsion rate of up to 90% is pointed out as an unresolved problem.
In fact, most research on rotator cuff rupture is focused on reducing re-crack, and in particular, with the recent rapid increase in rotator cuff surgery, the need to develop new treatments to reduce re-crack is further emphasized. In particular, despite the fact that many studies have been accumulated with the greatest potential of stem cells, there is still no authorized 'stem cell therapy' for rotator cuff rupture worldwide.
Advanced regenerative medicine is an innovative medical field that aims to regenerate or repair damaged body structures or functions to treat the disease fundamentally. In particular, it has the potential to provide new treatment opportunities for severe, rare, and intractable diseases that are difficult to treat with existing drugs. In Korea, an advanced regenerative medical clinical research system has been in operation since 2021, of which only six studies have been conducted on musculoskeletal diseases. In particular, very strict standards have been applied so far that only one high-risk study has been approved so far that it must be qualified at the therapeutic level.
Professor Cho Hyun-chul of Orthopaedic Surgery stated that "Rotator cuff rupture is one of the most rapidly increasing refractory diseases worldwide in incidence and frequency of surgery" and "Despite the good clinical outcomes of surgical treatment, high resurgence was still a problem, especially in the case of greater than major rupture. However, it is expected that this advanced regeneration clinical study of rotator cuff rupture using Smump Cell will significantly reduce the repulsion rate," he said.
This clinical trial will be conducted from the second half of this year for patients with rotator cuff rupture and extensive rupture at Korea University Anam Hospital and Boramae Hospital. If the effectiveness of stem cells is confirmed in this clinical study, it is expected to become the world's first new treatment that can be continuously used for patients through advanced regenerative medical treatment plans in the future.
Following the 6th Advanced Regenerative Medicine and Advanced Biopharmaceuticals Review Committee's decision on June 27, the Ministry of Food and Drug Safety has finally approved it, and from the second half of this year, Korea University Anam Hospital and Seoul Boramae Hospital will evaluate the safety and effectiveness of umbilical cord-derived stem cell treatments in rotator cuff rupture surgery with a major rupture.
In this clinical study, a high-quality umbilical cord-derived stem cell developed by a research team led by Professor Cho Hyun-chul of Seoul National University's School of Orthopaedic Surgery, is used. Smumpcell is an innovative umbilical cord-derived regenerative medical platform cell that can fundamentally solve variability that may occur in raw materials and manufacturing processes by being able to cultivate an ultra-high amount of stem cells using a unique minimum cubic dining separation method. In addition, 3CX, an independently developed injection-type treatment platform technology, has been used to dramatically improve the quality and ease of use of stem cells.
Seoul Boramae Hospital already received approval from the Ministry of Food and Drug Safety in July for a clinical trial plan (IND) of non-surgical stem cell injection treatment 'Archisostem-Teno' for partial rupture of rotator cuff. Through the approval of this advanced regenerative clinical study, Boramae Hospital is expected to establish itself as the world's first medical institution to apply regenerative medicine using stem cells to actual clinical trials in all disease spectra from partial rupture of rotator cuff to extensive rupture. Through this, it is expected to solidify its position as a leading regenerative medical research institution in the musculoskeletal field.
On the other hand, rotator cuff rupture is a disease in which the rotator cuff, the main tendon that moves the shoulder joint, is worn out and ruptured as it undergoes degenerative changes. This condition is the most important cause of adult shoulder pain, which occurs mainly in people over the age of 50 and is sometimes referred to as 'Fifty shoulder'.
According to statistics from the Ministry of Health and Welfare's Review and Assessment Service, the number of patients in Korea reached about 970,000 as of 2022, and about 1 million surgical treatments are performed annually in the United States. In most cases, patients without any special underlying disease require surgical treatment. Despite good surgical results, a high repulsion rate of up to 90% is pointed out as an unresolved problem.
In fact, most research on rotator cuff rupture is focused on reducing re-crack, and in particular, with the recent rapid increase in rotator cuff surgery, the need to develop new treatments to reduce re-crack is further emphasized. In particular, despite the fact that many studies have been accumulated with the greatest potential of stem cells, there is still no authorized 'stem cell therapy' for rotator cuff rupture worldwide.
Advanced regenerative medicine is an innovative medical field that aims to regenerate or repair damaged body structures or functions to treat the disease fundamentally. In particular, it has the potential to provide new treatment opportunities for severe, rare, and intractable diseases that are difficult to treat with existing drugs. In Korea, an advanced regenerative medical clinical research system has been in operation since 2021, of which only six studies have been conducted on musculoskeletal diseases. In particular, very strict standards have been applied so far that only one high-risk study has been approved so far that it must be qualified at the therapeutic level.
Professor Cho Hyun-chul of Orthopaedic Surgery stated that "Rotator cuff rupture is one of the most rapidly increasing refractory diseases worldwide in incidence and frequency of surgery" and "Despite the good clinical outcomes of surgical treatment, high resurgence was still a problem, especially in the case of greater than major rupture. However, it is expected that this advanced regeneration clinical study of rotator cuff rupture using Smump Cell will significantly reduce the repulsion rate," he said.
This clinical trial will be conducted from the second half of this year for patients with rotator cuff rupture and extensive rupture at Korea University Anam Hospital and Boramae Hospital. If the effectiveness of stem cells is confirmed in this clinical study, it is expected to become the world's first new treatment that can be continuously used for patients through advanced regenerative medical treatment plans in the future.
|
bellho@sportschosun.com
