General Information |
| Summary |
Evaluate the efficacy of induced pluripotent stem cell-derived exosomes (iPSC-Exos) for the treatment of stable vitiligo. |
| Description |
This study aims to evaluate the efficacy and safety of iPSC-Exos in the treatment of localized stable vitiligo. iPSC-Exos have been found to possess the ability to promote cell survival, proliferation, and repair, potentially improving skin pigmentation in vitiligo patients by modulating the survival and function of melanocytes.
This study will consist of 2 parts, with part 1 being a dose-escalation study and part 2 being an expanded safety study based on part 1 findings.
A traditional 3+3 dose escalation design will be implemented in part 1. Cohort 1: receive 1×10^8 particles per time; cohort 2: 3×10^8 particles per time and cohort 3: 9×10^8 particles per time.
In part 2, 20 subjects will be randomized in a 1:1 ratio [exosome (n=10) or exosome placebo (n=10)]. The dose level will be determined by Data Safety Monitoring Board based on part 1. |
| Clinical trials phase |
Early Phase 1 |
| Start date (estimated) |
2025-02-05 |
| End date (estimated) |
2026-11-17 |
| Clinical feature |
| Label |
vitiligo |
| Link |
http://purl.obolibrary.org/obo/DOID_12306 |
| Description |
An autoimmune disease that causes depigmentation of patches of skin resulting from loss of function or death of melanoctyes.; OMIM mapping confirmed by DO. [LS]. |
|
Administrative Information |
| NCT number |
NCT06810869 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06810869 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06810869?term=NCT06810869 |
| Public contact |
| Email |
18755377606@163.com |
| Public email |
18755377606@163.com |
| First name |
Li |
| Last name |
Lin |
| Phone |
+ 8618755377606 |
| City |
Wuhu |
| Country |
|
| Address freetext |
The Second Affiliated Hospital of Wannan Medical College |
|
| Sponsors |
The Second Affiliated Hospital of Wannan Medical College
|
Cells |
Recruitment |
| Recruitment Status |
Not yet recruiting |
| Estimated number of participants |
29 |
