Graft Vs Host Disease
Conditions
Brief summary
Randomized, open-label, multicenter study to investigate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSC) for the treatment of steroid-resistant acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a view to establishing an effective treatment protocol for steroid-resistant aGVHD.
Detailed description
A total of 130 patients with steroid-resistant aGVHD after allo-HSCT are enrolled in this multicenter, randomized, controlled trial. Patients were randomized to UC-MSC + anti-CD25 monoclonal antibodies (mAb) group and anti-CD25 mAb group. The complete response (CR) rate after 4 weeks of treatment in the two groups will be compared. Adverse events are also recorded throughout the study.
Interventions
DRUGUC-MSC
UC-MSC, iv, 1×10\^6 cells/kg, once a week, for 4 weeks.
DRUGAnti-CD25 mAb
Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.
Sponsors
Southern Medical University, China
Third Military Medical University
Sun Yat-sen University
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1.Confirmed diagnosed steroid-resistant aGVHD after allo-HSCT. 2. Neutrophile granulocyte (ANC) ≥ 0.5 x 10\^9/L. 3. Creatinine below 2 times normal upper limit . 4. Willing and able to sign written informed consent.
Exclusion criteria
\- 1. Untoleratation of the treatment. 2. Primary disease are not effectively controlled or are progressing. 3. Active infection (Bacteria, fungi, viruses ). 4. Combined with dysfunction of multiple organ. 5. Female patients who are nursing or pregnant, or who contemplate pregnancy during the study period. 6\. Patients who are deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete remission | 4 weeks after treatment | Complete remission of aGVHD related symptoms and indicators |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | At the end of Week 4 / 8 / 12 / 24 / 52. | The time from randomization to death for any reason ( the last follow-up time for missing patients; end date of follow-up for patients who are live at the end of the study). |
| Rate of partial remission | 4 weeks after treatment | improvement of aGVHD staging in one or more organs without progression in other organs |
| Infusion toxicity | From the beginning of to four hours after every infusion of UC-MSC | Acute toxicity responses include impaired function of heart, kidney and liver |
Countries
China
Outcome results
None listed