Trials / Completed
CompletedNCT01795573
Ex-vivo Expanded Donor Regulatory T Cells for Prevention of Acute Graft-Versus-Host Disease
Phase I Trial of Ex-vivo Expanded Donor Regulatory T Cells for Prevention of Acute Graft-Versus-Host Disease
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
Clinical trial of allospecific regulatory t cells (Tregs) for prevention of acute graft-versus-host disease (GVHD) in human leukocyte antigen (HLA) identical sibling transplants.
Detailed description
To evaluate the safety of sirolimus based immune suppression and ex-vivo expanded donor regulatory T cells for the prevention of acute graft-versus-host disease following allogeneic hematopoietic cell transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Cultured Treg cells | Co-culturing of recipient dendritic cells and donor Treg. Treg administration will occur 2 days before the allogeneic stem cell transplant (i.e. day -2 with reference of day 0 as stem cell infusion date). |
Timeline
- Start date
- 2014-10-29
- Primary completion
- 2020-08-14
- Completion
- 2020-08-14
- First posted
- 2013-02-20
- Last updated
- 2022-11-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01795573. Inclusion in this directory is not an endorsement.