Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02258490|
Expanded Access Status : Available
First Posted : October 7, 2014
Last Update Posted : January 17, 2019
|Condition or disease||Intervention/treatment|
|Chronic Myeloid Leukemia Myelodysplastic Syndrome Acute Myeloid Leukemia||Biological: G-CSF mobilized CD34+ selected cells for transplantation|
|Study Type :||Expanded Access|
|Official Title:||Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation to Recipients With Limited Donor Engraftment|
- Biological: G-CSF mobilized CD34+ selected cells for transplantation
Mobilization of Donor: Following screening and enrollment after informed consent, the donor will receive mobilization therapy with G-CSF (10 ug/Kg S/C daily x5-6 days) using the standard National Marrow Donor Program (NMDP) guidelines.
CD34+ selection with CliniMACS device: CD34+ cell selection will be performed according to procedures given in the CliniMACS Users Operating Manual and institutional Standard Operating Procedures (SOPs). If the donor's plasma is not available, CliniMACS buffer will be used.
The Day of CD34+ cell infusion: Immediately after the release tests have been performed and the product passes the release criteria, the patient will receive the final product. No conditioning regimen will be administered prior to cell infusion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258490
|Contact: Edmund Waller, MD, PhDemail@example.com|
|United States, Georgia|
|Emory University/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Contact: Shantoria J. Mayes, MHA 404-778-6547 firstname.lastname@example.org|
|Principal Investigator:||Edmund Waller, MD, PhD||Emory University|