Ignite Creation Date:
2024-07-17 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469411
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-06-12
Brief Title:
Effect of PMSCs and Their Secretome for the Treatment of GvHD
Sponsor:
Tabriz University of Medical Sciences
Organization:
Tabriz University of Medical Sciences
Study Overview
Official Title:
The Effect MSCs Derived From the Placenta and Their Secretome for the Treatment of GvHD A Randomized Clinical Trial
Status:
COMPLETED
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:
GvHD
Brief Summary:
In this clinical trial study 60 patients with GvHD referred to Shahid Qazi Hospital in Tabriz were randomly divided into 2 intervention and control groups n 30 in each that received secretome and distilled water by injection respectively The method of blinding was triple-blinded and all the names and personal information of the patients were coded at the time of data collection and remained completely confidential
Detailed Description:
This study is a safety feasibility and efficacy trial that was conducted on eligible GvHD patients with the diagnosis of expert doctors after obtaining permission from the respected ethics committee and registering the trial at the Iranian Trial Registration Center During the phone call while stating the title and objectives of the study the entry and exclusion criteria were checked If they are eligible they were asked to attend the Ghazi Hospital if they wish to participate in the study In the face-to-face meeting the objectives of the research were fully explained and the study criteria were re-examined The written informed consent was obtained and questionnaires fulfilled three times which include personal-social characteristics medical characteristics appetite questionnaire 24-hour food record Food record and family members At the beginning of the study 50 cc of blood was used to collect serum and to culture and condition mesenchymal stem cells 200 men with GvHD were randomly assigned using random block method using blocks of 4 and 6 and RAS Random Allocation Software and allocation ratio 11 to two groups receiving intravenous secretome with The first protocol 30 people and receiving the mesenchymal stem cells secretome of the second protocol 30 people were allocated and they received the skin spray for 1 year Participants in the first protocol group at the beginning of the study day 3 end of the week the end of the second week and the end of the month 5 times and in the second protocol group at the beginning of the study skin spray were done The secretome of both groups was the same
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 71647 | OTHER_GRANT | None | None |