Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924373
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-05-17
Brief Title:
Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Parallel Placebo-controlled Study to Evaluate Efficacy and Safety of Local Injection of Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients
Status:
RECRUITING
Status Verified Date:
2023-05
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:
The primary objectiveTo evaluate the efficacy of different administration protocols of human dental pulp mesenchymal stem cells for the treatment of chronic periodontitis patients
The secondary objectiveTo evaluate the safety of different administration protocols of human dental pulp mesenchymal stem cells for the treatment of chronic periodontitis patients
The exploratory objectiveTo investigate the effects of human dental pulp mesenchymal stem cells on biomarkers in gingival crevicular fluid in chronic periodontitis patients
The secondary objectiveTo evaluate the safety of different administration protocols of human dental pulp mesenchymal stem cells for the treatment of chronic periodontitis patients
The exploratory objectiveTo investigate the effects of human dental pulp mesenchymal stem cells on biomarkers in gingival crevicular fluid in chronic periodontitis patients
Detailed Description:
This is a multicenter randomized double-blind parallel placebo-controlled study including three treatment groups which are single-dose group two-dose group low-dose and two-dose group high-dose The patients of single-dose group will receive only one dose on day 1 D1 and the patients of two-dose groups will receive one dose on D1 and D90 respectively 68 participants will be enrolled in each group and be randomized 31 to receive human dental pulp mesenchymal stem cells hDP-MSCs or placebo normal saline Participants in the single-dose group and the two-dose group high-dose will receive local injection of 10 107 hDP-MSCs 06mL normal saline suspension periodontal defect site or 06mL normal saline periodontal defect site and participants in the two-dose group low-dose will receive local injection of 10 106 hDP-MSCs 06mL normal saline suspension periodontal defect site or 06mL normal saline periodontal defect site All participants will receive basic periodontal treatment simultaneously
Dosing interval the dosing interval is set at 89 days which is based on the results of preclinical trials of hDP-MSCs the improvement of periodontitis observed on D90 after hDP-MSCs administration and good safety profile in phase 1 clinical trial
Dosing interval the dosing interval is set at 89 days which is based on the results of preclinical trials of hDP-MSCs the improvement of periodontitis observed on D90 after hDP-MSCs administration and good safety profile in phase 1 clinical trial
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