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Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation

NCT02258490 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2022-03-15

No results posted yet for this study

Summary

Allogeneic hematopoietic stem cell transplantation (HSCT) is an established form of treatment for hematological abnormalities. Poor graft function, occurs when there poor donor engraftment. A second infusion of unselected donor hematopoietic stem cells (HSC) can result in improvement, but can potentially increase the incidence of graft versus host disease. Cluster of differentiation 34+ (CD34+) selected stem cells depleted of T-cells is an attractive alternative for treatment of poor graft function as it may be associated with less Graft versus Host Disease (GVHD) and enhanced count recovery. The investigators are using the Miltenyi CliniMACS device and CD34 cell selection reagents for the preparation of allogeneic hematopoietic progenitor cell (HPC) transplants for patients who have had prior stem cell transplants and require a stem cell "boost" from the original donor.

Conditions

Interventions

BIOLOGICAL

G-CSF mobilized CD34+ selected cells for transplantation

After screening and enrollment, donor will receive mobilization therapy with G-CSF (10 ug/Kg S/C daily x5-6 days) using standard National Marrow Donor Program guidelines. CD34+ cell selection will be performed according to procedures given in CliniMACS Operating Manual and institutional Standard Operating Procedures. If storage after CD34+ selection is necessary, product will be kept in a monitored refrigerator. During storage, leukocyte concentration should not exceed 2 x 108 cells/ml using platelet poor plasma to adjust cell concentration. If donor's plasma is not available, CliniMACS buffer will be used. Cell processing will be performed by personnel trained by Miltenyi on CliniMACS system prior to initiation of clinical product selection. After tests are performed and product passes release criteria, patient will receive final product. No conditioning regimen will be administered prior to cell infusion.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Edmund Waller, MD, PhD · Emory University

Eligibility

Min Age
17 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02258490 on ClinicalTrials.gov