Health Condition 1: D561- Beta thalassemia Health Condition 2: D570- Hb-SS disease with crisis
Conditions
Interventions
Intervention1: Single arm study.No comparator agent.
Infusion of regulatory T cells
: Infusion of regulatory T cells derived from leukapheresis product of the hematopoeitic stem cell donor before and
Sponsors
Manashi Chakrabarti Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1)First Transplantation 2)Diagnosis of Hemoglobinopathy 3)No major organ dysfunction
Exclusion criteria
Exclusion criteria: 1)Patients with uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms) within 1 month prior to conditioning. Patients with febrile illness or suspected minor infection should await clinical resolution prior to starting conditioning. 2)Patients seropositive for the human immunodeficiency virus (HIV) 3)Patient with active Hepatitis B or C determined by serology and/or NAAT not on treatment 4)Active hepatitis, bridging fibrosis or cirrhosis on liver biopsy (biopsy required for patients on chronic transfusion therapy for > 1 year and evidence of iron overload with ferritin >1000 ng/mL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Engraftment by Day 30. 2) Incidence of grade IIâ??IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation 3) Incidence of Post-Transplantation Hemophagocytic Syndrome Timepoint: 3 months 6 months one year | — |
Secondary
| Measure | Time frame |
|---|---|
|  Incidence and severity of chronic GVHD at 1 year and 2 years  Incidence of TRM at all visits throughout the study  Incidence and severity of acute infusional toxicities  Graft failure from Day 0 to Day 28 Timepoint: 3 months 6 months one year two years | — |
Countries
India
Contacts
Public ContactDr Suparno Chakrabarti
Manashi Chakrabarti Foundation
Outcome results
None listed