TREGeneration Goals and Objectives
Our project aims to treat tissue and organ damage associated with acute (aGVHD) and, mostly, chronic graft versus host disease (cGVHD) after hematopoietic stem cell transplantation (HSCT) by the infusion of regulatory T lymphocytes (Treg) purified from the peripheral blood of the original hematopoietic stem cell donor.
The TREGeneration study proposes the following objectives and goals:
- Development according to GMP standards of different Treg cell products from HSCT donors for infusion into patients with steroid-refractory aGVHD and cGVHD (Work Package 1)
- Evaluate the safety, toxicity and efficacy of infusing different populations of donor Treg into patients with steroid-refractory aGVHD and cGVHD (Work Package 2)
- Evaluate the effect of donor Treg infusion in reversal of tissue damage due to aGVHD and cGVHD (Work Package 3)
- Evaluate the effect of donor Treg infusion in the immune function of patients with aGVHD and cGVHD (Work Package 3)
- In vivo tracking of specific TCR clonotypes of naive and memory Treg, CD4+ non-Treg (Tcon) and CD8+ T cells by Next Generation Sequencing in patients with aGVHD and cGVHD (Work Package 4)