Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The research content involving the use of hAESCs for the prevention of aGVHD after HSCT has completed the IND application for treating the said condition. Therefore, an application is submitted to terminate this research project.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a parallel controlled clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.
This study is a controlled trial, with 18 subjects enrolled in the experimental group or the control group. The study will consist of four phases, including screening phase, preparation phase, hAESCs treatment phase and observational follow-up period. The cell dose of the experimental group was 1x10^6 cells/kg and the control group is infused placebo (the composition was the same as hAESCs injection excipients, but did not contain hAESCs). The infusion of hAESCs/placebo at the day before HSCT and 7th days after HSCT.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hAESCs | Experimental | Intravenous infusion of hAESCs to 9 subjects at the day before HSCT and 7th days after HSCT. The dose is 1×10^6 cell/kg. |
|
| placebo (cell preservation solution) | Placebo Comparator | Intravenous infusion of placebo (cell preservation solution with no hAESCs) to other 9 subjects at the day before HSCT and 7th days after HSCT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human amniotic epithelial stem cells(hAESCs) | Biological | Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation (hAECs-GVHD) |
| Measure | Description | Time Frame |
|---|---|---|
| Follow up closely after intravenous hAESCs therapy to monitor Adverse Event/Serious Adverse Event(AE/SAE) | AE occurring throughout the study period will be evaluated using the CTCAE V5.0 standard. AE/SAE and AESI were evaluated after first hAESCs infusion by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions and evaluate the safety of the study. hAESCs intravenous infusion is followed up and monitored closely, mainly including vital signs, physical examination, ECOG, electrocardiogram, blood biochemistry, blood RT, urine RT, coagulation laboratory test, imaging examination, type, frequency and severity of AE. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of acute graft-versus-host disease in patients | Occurrence and severity (grade) of Graft-versus-host disease after hAECs infusion | 1 year |
| Immune reconstitution 6 months before and after hematopoietic stem cell transplantation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaojun Huang | Nanfang Hospital, Southern Medical University | Study Chair |
Not provided
Not provided
The study plans to recruit 18 participants who meet the criteria and is divided into two groups with 9 subjects individually. Infusion of hAESCs/placebo at the day before HSCT and 7th days after HSCT.
Not provided
Not provided
Not provided
Not provided
| placebo (cell preservation solution) | Biological | Same dose placebo (cell preservation solution) injections as control group |
|
10 days(d) before hematopoietic stem cell transplantation and 1d, 7d±2, 14d±2, 21d±2, 28d±2, 3 month(m) ± 2 days , 6 m ± 2 days, testing expression of immune cells
| 6 months |
| Hematopoietic stem cell transplantation was performed 10 days before and 1 d, 7 d ±2, 14 d ±2, 21 d±2, 28 d ±2 after transplantation The amount of cytokines in plasma was measured | The amount of cytokines in plasma was measured: TGF-b | 1 month |
| Incidence of CMV and EBV infection | Hematopoietic stem cell transplantation after 7 days ±2, 14 days ±2, 21 days±2, 28d±2, 2M±2 days, 3M±2 days, 6M±2 days, 12M±2 days; | 1 year |