x Linked Combined Immunodeficiency Clinical Trial
Official title:
cliniMACs HUD for T Cell Depletion
| NCT number | NCT02915406 |
| Other study ID # | 20160472 |
| Secondary ID | |
| Status | No longer available |
| Phase | N/A |
| First received | September 23, 2016 |
| Last updated | August 12, 2017 |
| Verified date | August 2017 |
| Source | University of Miami |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
This protocol is designed to enable access to related or unrelated CD34 cells manufactured using the CliniMACS (Miltenyi) under the HUD designation for patients needing T cell depleted allogeneic grafts for hematopoietic stem cell transplant (HSCT). This will include patients with inherited immunodeficiency disorders as well as patients with malignancies, bone marrow failure, and other rare diseases amenable to HSCT. Finally, patients with poor graft function and Graft Versus Host Disease(GVHD) after a previous HSCT may require a boost of T-cell depleted donor Peripheral Blood Stem Cell (PBSCs) or bone marrow cells that are CD34 selected using the CliniMACS device ENROLLMENT BY INVITATION ONLY
| Status | No longer available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A to 65 Years |
| Eligibility |
Inclusion Criteria: severe combined immune deficiency need for stem cell boost Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Miami | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Miami | Jackson Health System |
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