General Information |
| Summary |
An open-label, randomized, controlled clinical trial to explore the efficacy and safety of iMSC in preventing the development of acute graft-versus-host disease of degree III-IV in patients after allogeneic hematopoietic stem cell transplantation. |
| Description |
This is an open-label, randomized, controlled study, enrolled subjects(patients at risk for aGVHD of degree III-IV after allogeneic hematopoietic stem cell transplantation) will be 1:1 randomized to experimental group or control group. Control group will receive conventional aGVHD prophylaxis and the experimental group will receive iMSC injection plus conventional aGVHD prophylaxis, with 28 cases in each group, for a total of 56 subjects. |
| Clinical trials phase |
Early Phase 1 |
| Start date (estimated) |
2025-06-01 |
| End date (estimated) |
2028-03-31 |
| Clinical feature |
| Label |
acute graft versus host disease |
| Link |
http://purl.obolibrary.org/obo/MONDO_0020546 |
| Description |
A syndrome of immunologically mediated tissue damage that may occur following an allogeneic transplant, usually affecting the skin, liver, and GI tract. The onset is usually within one hundred days of transplantation or immunologic manipulation. |
|
Administrative Information |
| NCT number |
NCT06949267 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06949267 |
| Other study identifiers |
| Name |
RJ-BMT-GvHD-001 |
| Description |
Ruijin Hospital |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT06949267 |
Cells |
| Which differentiated cell type is used |
| Label |
mesenchymal stromal cell |
| Link |
http://purl.obolibrary.org/obo/BTO_0003952 |
| Description |
Fibroblast-like cells that can be isolated from a variety of tissues, such as bone marrow, periosteum, trabecular bone, adipose tissue, synovium, skeletal muscle, dental pulp. |
|
Recruitment |
| Recruitment Status |
Not yet recruiting |
| Estimated number of participants |
56 |
