Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05912712
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-22
First Post:
2023-05-15
Brief Title:
Autologous Platelet-rich Plasma PRP and Thrombin Coagulum for the Topical Treatment of Rectal Mucosal Ulcers
Sponsor:
Xijing Hospital of Digestive Diseases
Organization:
Xijing Hospital of Digestive Diseases
Study Overview
Official Title:
Safety And Efficacy Study of Autologous Platelet-rich Plasma PRP and Thrombin Coagulum for the Topical Treatment of Rectal Mucosal Ulcers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
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:
Ulcerative colitis UC is a chronic persistent inflammatory disease The lesions are mainly confined to the large intestine and continuously affect the rectum and part or all of the colon Its histological characteristics are diffuse neutrophil infiltration in the lamina propria of the colon mucosa mucosal erosion ulcer cryptitis and crypt abscess The most common clinical manifestations are abdominal pain diarrhea and bloody mucopurulent stool accompanied by extraintestinal manifestations such as mouth skin joints and eyes Severe lesions can be complicated by toxic megacolon intestinal perforation lower gastrointestinal hemorrhage intraepithelial neoplasia and cancer so surgical treatment is necessary Studies have reported that UC patients have a 10-year cumulative recurrence risk of 70-80 nearly 50 of patients require UC-related hospitalization and the 5-year risk of re-hospitalization is 50 The 5-year and 10-year cumulative risk of patients undergoing colectomy is 10-15 which dramatically endangers the health of patients and reduces the quality of life of patients
Currently the commonly used medical treatment drugs for UC patients include 5-aminosalicylic acid topical and systemic glucocorticoids immunomodulators anti-tumor necrosis factor drugs and other biological agents The most commonly used optimization methods are drug escalation therapy and combining drugs with different mechanisms The real-world data results of an initial population-based cohort study from six Asian countries showed that the endoscopic mucosal healing rate of patients with ulcerative colitis in the first year of diagnosis was 382 and the histological mucosal healing rate was 231 It can be expected that the mucosal healing rate of patients with moderate to severe UC may be lower Long-term chronic recurrent diseases may lead to poorer quality of life extended hospital stays heavier financial burdens and more physical and mental pain Therefore optimizing the treatment plan for patients with moderate to severe UC needs more exploration and research
Autologous Platelet-rich plasma A-PRP is A platelet-rich concentrate obtained by centrifugation of whole blood As a concentrated source of autologous platelets they contain a large number of Growth factors GF and cytokines such as platelet-derived Growth factor PDGF transforming growth factor βTGF-β vascular endothelial growth factor VEGF and epithelial growth factor EGF which regulate cell function Such as attachment macrophage migration proliferation and differentiation promote extracellular matrix accumulation and ultimately improve tissue healing and regeneration At the same time A-PRP has A lower risk of adverse reactions such as immune rejection and allergy due to its isolation from autologous blood
After PRP is induced by activators such as calcium and thrombin activated platelets degranulate immediately and secrete multiple high concentrations of growth factors 70 of the growth factors can be released within 10 minutes of activation and more than 95 can be released within the first hour Platelet-rich Gel PG which can embed growth factors to improve clinical efficacy keeps platelets and their release products in the target wound area and promotes healing
Although the safety and efficacy of PRP still need to be fully confirmed by large-scale clinical trials its sound effect has been verified in many clinical practices and basic scientific research in cell culture and animal models At present it mainly includes the treatment of oral and maxillofacial external musculoskeletal system plastic skin and chronic wounds such as pressure ulcers venous leg ulcers diabetic foot ulcers etc They can be mixed into bone grafts sprayed on soft tissue surfaces as a biofilm or made into eye drops
The use of PRP in intestinal mucosal ulcers has rarely been reported There are no prospective randomized studies of its clinical use in patients with ulcerative colitis Therefore we planned to conduct a prospective randomized double-blind controlled clinical trial to investigate the efficacy and safety of repeated treatment with autologous platelet-rich plasma gel on an intestinal mucosal ulcer in patients with moderate to severe UC involving the rectum in Xijing Hospital China IBD Regional Center To provide a new option for remission induction therapy in patients with moderate to severe ulcerative colitis
Currently the commonly used medical treatment drugs for UC patients include 5-aminosalicylic acid topical and systemic glucocorticoids immunomodulators anti-tumor necrosis factor drugs and other biological agents The most commonly used optimization methods are drug escalation therapy and combining drugs with different mechanisms The real-world data results of an initial population-based cohort study from six Asian countries showed that the endoscopic mucosal healing rate of patients with ulcerative colitis in the first year of diagnosis was 382 and the histological mucosal healing rate was 231 It can be expected that the mucosal healing rate of patients with moderate to severe UC may be lower Long-term chronic recurrent diseases may lead to poorer quality of life extended hospital stays heavier financial burdens and more physical and mental pain Therefore optimizing the treatment plan for patients with moderate to severe UC needs more exploration and research
Autologous Platelet-rich plasma A-PRP is A platelet-rich concentrate obtained by centrifugation of whole blood As a concentrated source of autologous platelets they contain a large number of Growth factors GF and cytokines such as platelet-derived Growth factor PDGF transforming growth factor βTGF-β vascular endothelial growth factor VEGF and epithelial growth factor EGF which regulate cell function Such as attachment macrophage migration proliferation and differentiation promote extracellular matrix accumulation and ultimately improve tissue healing and regeneration At the same time A-PRP has A lower risk of adverse reactions such as immune rejection and allergy due to its isolation from autologous blood
After PRP is induced by activators such as calcium and thrombin activated platelets degranulate immediately and secrete multiple high concentrations of growth factors 70 of the growth factors can be released within 10 minutes of activation and more than 95 can be released within the first hour Platelet-rich Gel PG which can embed growth factors to improve clinical efficacy keeps platelets and their release products in the target wound area and promotes healing
Although the safety and efficacy of PRP still need to be fully confirmed by large-scale clinical trials its sound effect has been verified in many clinical practices and basic scientific research in cell culture and animal models At present it mainly includes the treatment of oral and maxillofacial external musculoskeletal system plastic skin and chronic wounds such as pressure ulcers venous leg ulcers diabetic foot ulcers etc They can be mixed into bone grafts sprayed on soft tissue surfaces as a biofilm or made into eye drops
The use of PRP in intestinal mucosal ulcers has rarely been reported There are no prospective randomized studies of its clinical use in patients with ulcerative colitis Therefore we planned to conduct a prospective randomized double-blind controlled clinical trial to investigate the efficacy and safety of repeated treatment with autologous platelet-rich plasma gel on an intestinal mucosal ulcer in patients with moderate to severe UC involving the rectum in Xijing Hospital China IBD Regional Center To provide a new option for remission induction therapy in patients with moderate to severe ulcerative colitis
Detailed Description:
None
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