The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation - nTregs Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Incidence of biopsy-confirmed acute rejection (BCAR) within 60 weeks of organ transplantation
Study Overview
Brief Summary
The aim of this trial is to collect evidence of the safety of administering autologous CD4+CD25+FoxP3+ natural regulatory T cells (nTregs) to living-donor renal transplant recipients. In addition, the study will determine whether post-transplant nTregs infusion allows a tapering of conventional maintenance immunosuppression within 60 weeks after transplantation.
Detailed Description
The ONE Study aims to explore the feasibility, safety and efficacy of regulatory cell therapies as adjunct immunosuppressive treatments in the context of living-donor renal transplantation.The clinical trial presented here (ONEnTreg13) will test autologous, polyclonally expanded CD4+CD25+FoxP3+ nTregs as a somatic cell-based medicinal product.
The objective of this study is to determine whether administration of nTregs to recipients of living-donor kidney transplants is safe and able to polarize the immunological response of the recipient away from graft rejection and towards graft acceptance, allowing a reduction in the doses of pharmacological maintenance immunosuppression.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of biopsy-confirmed acute rejection (BCAR) within 60 weeks of organ transplantation
Time Frame: 60 weeks
Incidence of infectious complications associated with cell administration.
Time Frame: 60 weeks
Incidence of embolic pulmonary complications and other embolic events.
Time Frame: 60 weeks
Incidence of immune responses resulting in anaphylactic reactions, cardiovascular compromise or other acute organ failure.
Time Frame: 60 weeks
Biochemical disturbances associated with the cell infusion.
Time Frame: 60 weeks
Over-suppression of the immune system assessed by the incidence of opportunistic infections, especially, CMV, EBV and polyoma virus.
Time Frame: 60 weeks
Over-suppression of the immune system assessed by the incidence of neoplasia.
Time Frame: 60 weeks
Secondary Outcomes
- Prevention of acute rejection will be secondarily assessed by measuring(60 weeks)
- Incidence of patients treated for subclinical acute rejection on the basis of histopathological findings(60 weeks)
- Prevention of chronic graft dysfunction (chronic rejection or IF/TA) will be assessed by clinical (impairment of GFR) and histopathological (Banff staging) measures.(60 weeks)
- Incidence of post-transplant dialysis, inclusion on the transplant waiting list or retransplantation following graft loss through rejection (acute or chronic).(60 weeks)
- Avoidance of drug-related complications by immunosuppressant reduction will be assessed by the incidence of reported adverse drug reactions.(60 weeks)
Investigators
Prof. Dr. Petra Reinke
Professor of Nephrology
Charite University, Berlin, Germany