Trials / Completed
CompletedNCT02371434
The ONE Study nTreg Trial (ONEnTreg13)
The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation - nTregs Trial
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Prof. Dr. Petra Reinke · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | autologous CD4+CD25+FoxP3+ natural regulat. T cells (nTregs) | autologous CD4+CD25+FoxP3+ natural regulatory T cells (nTregs). nTregs will be infused at escalating doses of 0.5 x 10\^6, 1 x 10\^6, and 2.5-3 x 10\^6 cells/kg body weight in cohorts of three patients each. |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2017-11-01
- Completion
- 2017-11-01
- First posted
- 2015-02-25
- Last updated
- 2020-02-05
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02371434. Inclusion in this directory is not an endorsement.