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Published on: March 14, 2011
Allogeneic transplantation of selected peripheral CD34+ cells with controlled CD3+ cells add-back in high-risk
M Markiewicz1, J Hołowiecki, J Wojnar
1Department of Hematology and Bone Marrow Transplantation, Silesian Medical University, Katowice, Poland.
Insights
Allogeneic transplantation using CliniMACS-selected peripheral CD34+ cells is effective for high-risk patients. This method, with controlled CD3+ cell add-back, shows good engraftment and tolerability, leading to patient remission.
Area of Science:
- Hematology
- Transplantation immunology
- Cell therapy
Background:
- Allogeneic stem cell transplantation is a critical treatment for high-risk hematologic malignancies and other conditions.
- Graft failure and graft-versus-host disease (GVHD) remain significant challenges, particularly in patients with multiple risk factors.
- Peripheral blood stem cells (PBSCs) are commonly used, but selection methods aim to optimize safety and efficacy.
Purpose of the Study:
- To evaluate the feasibility and outcomes of allogeneic transplantation using CliniMACS-selected peripheral CD34+ cells.
- To assess the safety and engraftment potential of this approach in high-risk patients.
- To determine the effectiveness of controlled CD3+ cell add-back for ensuring proper engraftment.
Main Methods:
- Eight high-risk patients received allogeneic transplantation of CliniMACS-selected peripheral CD34+ cells from sibling, related, or unrelated donors.
- Conditioning regimens included myeloablative (n=7) or nonmyeloablative (n=1) protocols.
- Immunosuppression involved Cyclosporine A (CsA), Methotrexate (Mtx), and/or Anti-thymocyte globulin (ATG); CD3+ cells were added back as needed.
Main Results:
- CliniMACS selection achieved high CD34+ cell recovery (74%) and purity (97%).
- Satisfactory regeneration times were observed in 87.5% of patients (ANC > 0.5 g/L on day +26, Plt > 50 g/L on day +32).
- Five patients (62.5%) survived and remained in remission with a median follow-up of 815 days; severe GVHD occurred in 37.5% after nonselected cell transplantation.
Conclusions:
- Allogeneic transplantation of CliniMACS-selected peripheral CD34+ cells with controlled CD3+ cell add-back is feasible and effective.
- The procedure is well-tolerated and offers a viable therapeutic option for high-risk patients.
- This approach demonstrates potential for improved outcomes in challenging transplantation scenarios.
Abstract:
We evaluated the feasibility of allogeneic transplantation of CliniMACS-selected peripheral CD34+ cells from siblings (four patients: AML-M4, M2, CLL, MDS); nonoptimal related donors (two patients: AML-M4, CML); and unrelated donors (two patients: CML, ALL, both without engraftment after preceding URDBMT). All patients had high-risk of aGVHD and/or graft failure due to multiple transplantation risk factors. Conditioning treatment was myeloablative (n=7) or nonmyeloablative (n=1). Immunosuppression consisted of CsA (n=8), Mtx (n=5), ATG (n=4). Selected CD34+ cells were transplanted (average 3.91 x 10(6)/kg, range 1.29 to 7.27 x 10(6)/kg) together with 0.01 to 0.5 x 10(7) CD3+ cells/kg to assure proper engraftment. The remaining CD34-negative fraction was cryopreserved for further CD3+ cell add-back. Average recovery and purity of CD34+ cells following CliniMACS selection were 74% and 97%. No severe complications were observed in the first 100 days. Regeneration times were satisfactory in seven of eight patients (87.5%) with ANO > 0.5 g/L and Plt > 50 g/L reached on average on days +26 and +32 (range 15 to 29 and 15 to 67), respectively. In three patients (37.5%) T-lymphocytes were added-back one to three times (due to low numbers of initially transfused CD3+ cells in two patients, in one patient with PRCA caused by ABO incompatibility). One to four additional transplantations of nonselected peripheral cells were performed on days +28 to +270 in consequence of infections (CMV-two patients; parvovirus-one patient), poor regeneration and residual disease (one patient) and prolonged transfusion dependency (one patient). Severe aGVHD grade III or IV developed in three patients (37.5%) following the nonselected cells transplantation. Finally, five patients (62.5%) are alive and in remission (median follow-up 815 days). We conclude that allogeneic transplantation of selected peripheral CD34+ cells (CliniMACS) with controlled add-back of CD3+ cells is an effective, well, tolerated procedure in high-risk patients.
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