Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463847
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-04-22
Brief Title:
Phase I Clinical Trial of UC-MSCs in the Treatment of Knee Osteoarthritis
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Single Center Open-label Dose-increasing Phase I Clinical Trial of UC-MSCs for the Treatment of Knee Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In recent years the incidence rate and disability rate of osteoarthritis have continued to grow and it has become a common chronic disease of elderly patients second only to the three highs and poses a continuous threat to Chinas medical and health system and public health system Knee osteoarthritis is the main type of osteoarthritis ranking 11th in global disability diseases and 38th in disability adjusted life year loss causing significant economic burden to patients families and society At present most of the treatment methods for KOA have limited efficacy only relieving pain symptoms and cannot prevent cartilage damage and other tissue damage in the joints Due to the limitations of adverse events there is still no optimal treatment plan for KOA Most studies believe that autologous mesenchymal stem cell transplantation is a new treatment method with good efficacy and good repair effect for mild to moderate cartilage defects Given that there is currently no optimal treatment plan for KOA human umbilical cord mesenchymal stem cell injection has potential development value and is of great significance for the treatment of KOA patients
Detailed Description:
Osteoarthritis OA is a chronic inflammatory disease of the bone and joints characterized by degenerative destruction of articular cartilage subchondral bone sclerosis and osteophyte formation and peripheral soft tissue inflammation and proliferation Knee Osteoarthritis KOA which is negative and highly active is the most common Currently there are approximately 1 billion KOA patients worldwide with approximately 150 million patients in China and the incidence rate increases with age The clinical manifestation of KOA is repeated and prolonged bone and joint pain which seriously affects the patients quality of life ultimately leading to joint structural damage and loss of function causing a significant burden on individuals families and society At present there is a lack of effective treatment methods for KOA both domestically and internationally and there is an urgent need to research new treatment strategies to meet clinical needs Numerous studies have shown that local inflammation of the joint cavity and apoptosis of articular chondrocytes are the main pathological mechanisms of knee osteoarthritis Therefore the key to treating KOA is to inhibit the local inflammatory response of bone joints promote chondrocyte regeneration repair damaged joint surfaces and restore their normal structure and function
Mesenchymal Stem Cells MSCs are the most widely studied pluripotent stem cells It exists in various tissues has multidirectional differentiation potential homing effect and powerful paracrine function can regulate tissue microenvironment promote damaged tissue repair through cell replacement promote in-situ cell regeneration anti-inflammatory and immune regulation and other mechanisms Therefore mesenchymal stem cell therapy has become the focus of KOA new therapy research A large number of studies have shown that MSCs can be induced to differentiate into stable mature chondrocytes that can express proteoglycan and type II collagen Fluorescently labeled MSCs could still be detected 10 weeks after injection into the joint cavity of osteoarthritis model animals suggesting that MSCs homed in the injured articular cartilage tissue and participated in the regeneration and repair of the injured tissue The effectiveness of MSCs therapy for KOA has been demonstrated in osteoarthritis models in different animals including rats rabbits sheep pigs and monkeys MSCs from different sources can effectively inhibit the inflammatory response and chondrocyte injury in model animals and stimulate the regeneration and repair of injured chondrocytes
In this study three dose groups are preset which are low-dose group 5106 cells25mL medium-dose group 1107 cells25mL high-dose group 2107cells25mL 9 to 18 subjects will be recruited and will be sequential from the low-dose group to the high-dose group according to the 33 dose escalation principle At least 3 subjects are enrolled in each group for the safety and tolerability test of single administration After the last subject in each dose group completes the DLT observation period the sponsor and the researcher jointly confirm the safety tolerance of the subjects in the previous dose group and only after the safe tolerance is determined can the subjects enter the next dose group so as to evaluate the safety and tolerance of human umbilical cord mesenchymal stem cell injection in the treatment of knee osteoarthritis Recommend appropriate cell therapy dose RP2D for Phase II clinical trials
Mesenchymal Stem Cells MSCs are the most widely studied pluripotent stem cells It exists in various tissues has multidirectional differentiation potential homing effect and powerful paracrine function can regulate tissue microenvironment promote damaged tissue repair through cell replacement promote in-situ cell regeneration anti-inflammatory and immune regulation and other mechanisms Therefore mesenchymal stem cell therapy has become the focus of KOA new therapy research A large number of studies have shown that MSCs can be induced to differentiate into stable mature chondrocytes that can express proteoglycan and type II collagen Fluorescently labeled MSCs could still be detected 10 weeks after injection into the joint cavity of osteoarthritis model animals suggesting that MSCs homed in the injured articular cartilage tissue and participated in the regeneration and repair of the injured tissue The effectiveness of MSCs therapy for KOA has been demonstrated in osteoarthritis models in different animals including rats rabbits sheep pigs and monkeys MSCs from different sources can effectively inhibit the inflammatory response and chondrocyte injury in model animals and stimulate the regeneration and repair of injured chondrocytes
In this study three dose groups are preset which are low-dose group 5106 cells25mL medium-dose group 1107 cells25mL high-dose group 2107cells25mL 9 to 18 subjects will be recruited and will be sequential from the low-dose group to the high-dose group according to the 33 dose escalation principle At least 3 subjects are enrolled in each group for the safety and tolerability test of single administration After the last subject in each dose group completes the DLT observation period the sponsor and the researcher jointly confirm the safety tolerance of the subjects in the previous dose group and only after the safe tolerance is determined can the subjects enter the next dose group so as to evaluate the safety and tolerance of human umbilical cord mesenchymal stem cell injection in the treatment of knee osteoarthritis Recommend appropriate cell therapy dose RP2D for Phase II clinical trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None