Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568653
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula in Colorectal Surgery Department of Imam Khomeini Hospital Complex A Non-randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if human placenta mesenchymal stem cells MSC-derived exosomes work to treat complex perianal fistula in adults without Crohns disease The safety of this treatment will also be learned The main questions it aims to answer are
Does treatment with MSC-derived exosomes lower the number of fistula recurrences in participants
Is treatment with MSC-derived exosomes safe We will compare treatment with MSC-derived exosomes to the routine treatment which is fistulotomy surgery to close the fistula alone to see if MSC-derived exosomes work better to treat complex fistula
Participants will
Undergo fistulotomy plus MSC-derived exosome injections or fistulotomy alone
Visit the clinic the week after surgery and then every 4 weeks for checkups and tests
Does treatment with MSC-derived exosomes lower the number of fistula recurrences in participants
Is treatment with MSC-derived exosomes safe We will compare treatment with MSC-derived exosomes to the routine treatment which is fistulotomy surgery to close the fistula alone to see if MSC-derived exosomes work better to treat complex fistula
Participants will
Undergo fistulotomy plus MSC-derived exosome injections or fistulotomy alone
Visit the clinic the week after surgery and then every 4 weeks for checkups and tests
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None