Acute steroid-resistant graft-versus-host disease. Acute graft-versus-host disease
Conditions
Interventions
Intervention group: Patients diagnosed with grade II to IV acute Graft Versus Host Disease (aGVHD), whose response to treatment with corticosteroids equal or more than 2 milligram per kilogram (mg/kg)
Sponsors
Omid cell and tissue tech
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with grade II to IV acute Graft versus host disease (GVHD) whose response to treatment with corticosteroids equal to or more than 2 milligrams per kilogram is poor, and the disease symptoms progress in three days or have stable disease for five days Patients over 18 years old Patients of both sexes Signed written informed consent
Exclusion criteria
Exclusion criteria: Patients who have recurrence of the main disease (cancer) Patients who, in the differential diagnosis of clinical symptoms, have causes other than acute graft versus host disease (aGVHD) indicating the patient, such as patients with symptoms Sinusoidal Obstruction Syndrome (SOS), maculopapular skin rashes with drug or viral causes or Engraftment Syndrome, viral diarrheas, etc Patients who have been prescribed Infliximab The presence of an active uncontrolled infection, including a significant bacterial, fungal, viral or parasitic infection that requires treatment Presence of recurrent primary malignancy, or those treated for recurrence after Hematopoietic Cell Transplantation (HCT), or those who may require rapid removal of immunosuppression as pre-emergency treatment of primary recurrence Have unresolved venous occlusion disease Patients who have any underlying or current medical or psychiatric problems that the researcher thinks may be a disorder (uncontrolled infection, cardiovascular failure, and pulmonary pressure) Patients who have any allergy to blood products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of acute Graft Versus Host Disease (aGVHD) and infection. Timepoint: 7, 21 and 28 days after injection. Method of measurement: History, Physical exam, and lab test.;Overall Remission Rate (ORR). Timepoint: 7, 21 and 28 days after injection. Method of measurement: Assessed using the Glusburg (based on GvHD grade). | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS). Timepoint: 48 weeks after exosome infusion. Method of measurement: Assessed using the Graft-versus-Host Disease Working Committee.;Duration of Response (DOR). Timepoint: 48 weeks after exosome infusion. Method of measurement: Assessed using the Graft-versus-Host Disease Working Committee. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMasoud Soleimani
Omid cell and tissue tech
Outcome results
None listed