Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438809
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-23
Brief Title:
Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
Sponsor:
Jiangsu Topcel-KH Pharmaceutical Co Ltd
Organization:
Jiangsu Topcel-KH Pharmaceutical Co Ltd
Study Overview
Official Title:
Safety and Preliminary Efficacy of Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
Status:
RECRUITING
Status Verified Date:
2024-06
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:
A Phase III study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis
Detailed Description:
Radiation therapy is frequently used to treat pelvic cancers such as anal cervical prostate and rectal cancer While effective in controlling local tumors it can also cause collateral damage to the gastrointestinal tract The rectum is particularly vulnerable to radiation damage due to its fixed position in the pelvis In the acute phase radiation can lead to proctitis an inflammatory condition characterized by mucosal ulceration edema and loss of microvilli Patients typically present within three months of radiation therapy with symptoms like diarrhea urgency and tenesmus Chronic radiation proctitis can either follow the acute phase or appear after a symptom-free period typically 8 to 12 months post-radiation treatment This chronic condition results from radiation-induced small-vessel injury causing ischemia obliterative endarteritis fibrosis and neovascularization Rectal bleeding is a common symptom of chronic radiation proctitis
Clinical studies have demonstrated that mesenchymal stem cell MSC treatment offers significant benefits including anti-inflammatory immune modulation and tissue repair effects Recent research indicates that intralesional injection of MSC is effective in treating radiation proctitis reducing pain and bleeding without causing severe adverse events This suggests that MSC treatment could be a promising option for radiation proctitis
This is a phase III study designed to evaluate the safety and preliminary efficacy of MSC treatment for radiation proctitis Patients will be followed up for 24 months after treatment
Clinical studies have demonstrated that mesenchymal stem cell MSC treatment offers significant benefits including anti-inflammatory immune modulation and tissue repair effects Recent research indicates that intralesional injection of MSC is effective in treating radiation proctitis reducing pain and bleeding without causing severe adverse events This suggests that MSC treatment could be a promising option for radiation proctitis
This is a phase III study designed to evaluate the safety and preliminary efficacy of MSC treatment for radiation proctitis Patients will be followed up for 24 months after treatment
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?:
False
Is an FDA AA801 Violation?:
None