refractory acute graft versus host disease (aGvHD)
Conditions
Interventions
Intervention group:mesenchymal stem cells (umbilical cord) for injection
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 14 - 70 years (including 14 and 70 years old), no gender limit; 2. Patients who have aGvHD after transplantation of allogeneic hematopoietic stem cells (umbilical cord blood, bone marrow or mobilized peripheral blood) whose primary disease is a malignant hematological disease; 3. Patients who have undergone preventive treatment with at least one drug such as Calcineurin inhibitor (Cyclosporine or Tacrolimus), PTcy, CD25 monoclonal antibody or ATG before allogeneic hematopoietic stem cell transplantation but still develop aGvHD; 4. Steroid hormone-resistant grade II to grade IV (MAGIC standard) aGvHD patients, which is the condition is still progressing after 3~5 days of steroid medication, or have no improvement after 5~7 days, or not meet CR standard in 28 days, the standard dose is 1~2 mg/kg/d of methylprednisolone or prednisolone; or patients with acute GvHD reactivation in the course of steroid hormone administration that cannot be reduced or reduced; 5. All subjects and their partners have no birth plans within 6 months from screening to the end of the trial and agree to take effective non-drug contraceptive measures during the trial period; 6. The patient or adult family members agree to participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to cattle-derived products; 2. Patients with solid tumors; 3. Those who have a history of alcohol or drug abuse within 6 months; 4. Participated in other drug trials in the past 1 months; 5. Participated in CAR-T trials in the past 3 months; 6. Patients with clinically significant and unstable arrhythmia; 7. Have a history of immunodeficiency, such as HIV positive, or other congenital immunodeficiency diseases; 8. APTT > 2.5 x ULN or PT > 2.5 x ULN (without anticoagulant therapy); 9. Patients with active hepatitis B (HBsAg positive, detection of HBV DNA titer in peripheral blood >= 1 x 10^3 IU/mL) and/or hepatitis C; 10. Pregnant and lactating women (Pregnancy was diagnosed by blood pregnancy test/urine pregnancy test and/or obstetric ultrasound); 11. Other life-threatening serious complications considered by the researcher as potential or interfering with the evaluation of this study [such as severe active infection, especially severe pneumonia (the diagnostic criteria of severe pneumonia refer to the diagnostic criteria of 2007 American Society of infectious diseases / American Thoracic Society for adult severe pneumonia), severe heart failure (NYHA grade IV), pulmonary hypertension] or mental diseases; 12. Any problems that are not conducive to subjects receiving treatment in the research center and understanding the informed consent form, or any condition that the researcher believes is not in the best interests of the subjects (such as damage to health) and is judged by the researcher to be unsuitable for entering the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any adverse events related to MSCs during the clinical study;Maximum tolerant dose (MTD);Dose limited toxicity (DLT); | — |
Secondary
| Measure | Time frame |
|---|---|
| the improvement of aGvHD target organ involvement level; | — |
Countries
China
Contacts
Public ContactHan Zhibo
Tianjin Amcellgene Engineering Co., Ltd.
Outcome results
None listed