General Information |
| Summary |
A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of CYP-001 in Combination With Corticosteroids (CS) vs CS Alone for the Treatment of High-Risk Acute Graft Versus Host Disease |
| Clinical trials phase |
Phase 2 |
| Start date (estimated) |
2023-08-31 |
| End date (estimated) |
2026-12-31 |
| Clinical feature |
| Label |
Graft versus host disease |
| Link |
http://www.orpha.net/ORDO/Orphanet_39812 |
| Description |
A rare immune disease characterized by donor-derived immune cells, primarily T cells, recognizing the recipient's tissues as foreign and mounting an immune response against them. It is a significant complication following allogeneic hematopoietic cell transplantation (alloHCT). Graft versus host disease (GVHD) is classified into acute (aGVHD) and chronic (cGVHD) forms. |
|
Administrative Information |
| NCT number |
NCT05643638 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05643638 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT05643638 |
| Sponsors |
Cynata Therapeutics Limited
|
Cells |
| Which differentiated cell type is used |
| Label |
Mesenchymal Stem Cell |
| Link |
http://purl.obolibrary.org/obo/NCIT_C43423 |
| Description |
An undifferentiated stromal cell with the ability to develop into the cells that form distinct mesenchymal tissues; such as bone, muscle, connective tissue, blood vessels, and lymphatic tissue. |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
60 |
