ISSN:1061-6128    

DOI:10.1089/scd.1.1998.7.1

年代:1998

数据来源: MAL

ISSN:1061-6128    

DOI:10.1089/scd.1.1998.7.3

年代:1998

数据来源: MAL

ISSN:1061-6128    

DOI:10.1089/scd.1.1998.7.5

年代:1998

数据来源: MAL

摘要:

The increase in the number of patients treated with high-dose chemotherapy/autologous stem cell transplantation (HDC/ASCT) for solid tumor malignancies has generated concern about the infusion of tumor cell contamination in the graft. In an effort to study so-called minimal residual disease (MRD) in the HDC/ASCT setting, a variety of assay methods have been used. Although these assays vary in terms of sensitivity and specificity of tumor detection, they are in agreement as to the presence and viability of tumor cells in ASCT grafts. A growing body of evidence indicates that MRD is present in ASCT grafts from neuroblastoma, breast cancer, and ovarian cancer patients. More importantly, several retrospective studies have determined that the infusion of tumor cells with the ASCT graft is strongly associated with post-ASCT relapse. Gene-marking studies have directly demonstrated that infused tumor cells are present at sites of disease relapse. Thus, the issue of tumor contamination of autologous grafts is an area of growing concern. This review article details the current status of MRD in solid tumor malignancies, with emphasis on assay methodology, clinical utility, and clinical relevance in transplantation medicine.

ISSN:1061-6128    

DOI:10.1089/scd.1.1998.7.9

年代:1998

数据来源: MAL

摘要:

Although placental blood has recently become a new source of hematopoietic progenitors for marrow replacement, limited attention has been given to systems suitable to ensure the short-term and long-term quality of placental blood units used for transplantation. In this article, we describe a quality system for placental blood banking developed in accord with ISO 9002 norms at Milano Cord Blood Bank. The quality system is the organizational structure, procedures, processes, and resources needed to implement quality management. ISO 9002 is a model for quality assurance in production, installation, and servicing, which includes a number of clauses providing guidance for the implementation of the quality system. The quality system was started by the bank medical director with step 1: the general quality plan, which included (a) the written description of mission, objectives, technical and organizational policies, and staff organization chart of the placental blood bank, (b) the definition and acquisition of adequate financial, human, and structural resources, (c) the appointment of a quality system head independent from the production laboratory and reporting directly to the medical director. Tasks of the quality system head were (a) to identify the placental blood banking process together with the placental blood bank personnel, (b) to implement a documentation plan finalized at the production and maintenance of (i) the quality manual, which provides a summary on how the bank operates with a quality system in compliance with the ISO 9002 clauses, (ii) the general procedures (or quality system procedures), which provide more detail on selected clauses, including at least those prescribed by the ISO 9002 standard, (iii) the operative procedures (or process procedures), which describe in detail the process of placental blood banking and how technical activities must be performed, (iv) the work instructions, which provide stepwise descriptions of individual activities, (v) records/forms for data collection and storage, (c) to identify quality indicators, (d) to start a regular internal audit, (e) to report audit results to the medical director for review. This was followed by step 2: the job descriptions, staff training, and qualification; step 3: the documentation plan; step 4: the internal audit plan; step 5: the launch of the quality system, and step 6: the assessment by an external team from an accredited third-party organization and final certification for compliance to ISO 9002. The quality system, which must be maintained and undergo external audit at regular intervals so that certification is confirmed, ensures the high probability that placental blood units provided to clinicians conform regularly to predefined levels of quality.

ISSN:1061-6128    

DOI:10.1089/scd.1.1998.7.19

年代:1998

数据来源: MAL

摘要:

Determination of absolute numbers of CD34-expressing cells is critical in the setting of peripheral blood stem and progenitor cell transplantation/reinfusion. The diagnostic value of the parameter, CD34-expressing cells/μl, has been validated. A survey of CD34-expressing cells has been integrated into a series of flow cytometry proficiency testing surveys (reticulocytes, lymphocytes, leukemia, and lymphoma) that we have established in Germany. Commercially available, modified, stabilized myeloblastic leukemia cells (KGla cell line) spiked at different numbers into two normal blood samples were sent out, and report forms were returned from 50 of 58 participants. With a predicted percentage of CD34-expressing cells of 0.5% (sample A) and of 0.25% (sample B), the respective mean values analyzing data from 44 participants returning the completed forms were 0.49% (sample A) and 0.29% (sample B). The coefficients of variation were 57% and 83%, respectively. Engineered samples based on normal blood and on commercially available stabilized modified KGla cells seem to be reliable material for external quality assessment surveys of CD34-expressing cells

ISSN:1061-6128    

DOI:10.1089/scd.1.1998.7.37

年代:1998

数据来源: MAL

摘要:

We have previously reported a more than 50% risk of insufficient harvests (<2 x 106CD34+ cells/kg) following a fixed timing of leukapheresis in an unselected patient population collected for autologous stem cell transplantation. The failures were easily identified as patients who had80,000 CD34+ cells/ml can be harvested succesfully by only one procedure, and (c) that low-level mobilizers with<40,000 CD34+ cells/ml still have a high risk of inadequate harvests. In summary, the optimized timing strategy is effective, but there is still room for improvement. First, new potent priming procedures for low-level and bad mobilizers are required, and second, algorithms to reduce the leukapheresis volume and time for high-level mobilizers should be established.

ISSN:1061-6128    

DOI:10.1089/scd.1.1998.7.45

年代:1998

数据来源: MAL

摘要:

Peripheral blood progenitor cells (PBPC) reside within the mononuclear cell (MNC) component of the blood and can be collected using a number of apheresis devices, including the Fenwal CS3000 Plus Blood Cell Separator. Increased MNC collection efficiency, therefore, may reduce the number of aphereses required to achieve collection goals. In this study, patients were divided into groups by absolute MNC count to determine the effect of interface detector offset (I/O) adjustment on MNC collection efficiency. Apheresis products from 104 procedures collected using a standard I/O setting of 100 were compared with 121 collections for which the I/O setting was adjusted according to the preapheresis MNC count. Adjustment of the I/O setting in this manner had no statistically significant impact on the per kilogram dose of MNC collected. The data did show that MNC collection efficiency was reduced as both the MNC count and I/O setting increased, as the collection efficiency was greatest for patients with the lowest peripheral MNC counts and was inversely correlated with the preapheresis MNC count. Although contamination of the product with platelets was drastically reduced at higher I/O settings, there was a concomitant rise in RBC contamination. We conclude that a standard setting of 100 is preferable to adjustment of the I/O setting as a function of the preapheresis MNC count.

ISSN:1061-6128    

DOI:10.1089/scd.1.1998.7.53

年代:1998

数据来源: MAL

摘要:

Large-volume leukapheresis (LVL), defined as the processing of at least three blood volumes in a single session for peripheral blood progenitor cell (PBPC) collection, was performed in 32 small children weighing ≤25 kg, aged 10 months to 8 years, with a variety of malignancies. Harvesting of PBPC was started after 4 days of cytokine (G-CSF, 12 μg/kg s.c.) alone. Procedures were performed using a continuous flow blood cell separator (COBE Spectra). The automated program of lymphocytapheresis was modified to achieve a collection rate of 0.9 ml/min. The extracorporeal line was primed with a unit of a packed red blood cells before the procedure. Acid citrate dextrose (ACD) was used as anticoagulant with an ACD inlet ratio of 1:14 and an ACD infusion rate of 1.1 ml/min/L of total blood volume. The inlet flow ranged between 6 and 35 ml/min (median 20 ml/min). A total of 37 apheresis procedures were performed (median 1, range 1-3). In 84% of patients, a single apheresis yields the minimum number of PBPC cells required for transplantation. No consistent side effects were observed, and LVL was well tolerated by children. A median of 7.7 x 108kg MNC, 5.4 x 106/kg CD34+, and 6.2 x 104/kg CFU-GM per apheresis were harvested. Patients with neuroblastoma had a significantly lower yield than other patients. To date, 27 patients have been transplanted after myeloablative treatment, and rapid and sustained engraftment was achieved in all cases. The number of CD34+ cells infused was highly correlated with engraftment kinetics. LVL can be safely and easily performed in small children, allowing adequate PBPC collection for transplantation with rapid hematologic recove

ISSN:1061-6128    

DOI:10.1089/scd.1.1998.7.63

年代:1998

数据来源: MAL

摘要:

Ex vivo expanded CD34+ progenitor cells from fresh or cryopreserved primate bone marrow, induced to granulocytic differentiation with growth factors, were investigated to determine whether myeloid cells produced in liquid cultures have the normal biologic functions needed for the treatment of patients with neutropenia following high-dose chemotherapy or therapeutic or accidental radiation exposure. Human and simian (baboons or macaques) CD34+ cells were cultured with granulocyte-colony stimulating factor (G-CSF), stem cell factor (SCF), interleukin-1 (IL-1), IL-3, and IL-6, and assessed at 14 days of culture for their capacity to respond to different functional tests. Immunostaining revealed that humanex vivoexpanded cells contained myeloperoxydase (MPO, 82% ± 8%) and lactoferrin (LF, 30% ± 6%) in their granules. Maturation of cultured cells was associated with stimulated chemotactic responsiveness and respiratory burst activity (Superoxide anion and hydrogen peroxide production) in expansions from human, baboon, and macaque CD34+ progenitor cells. Mature cells obtained fromex vivoexpansion of selected cryopreserved human bone marrow CD34+ cells presented reduced but significant functional activities (chemotactic responsiveness and hydrogen peroxide production) when compared with human peripheral blood neutrophils. The validation of nonhuman primateex vivoexpansion systems may permit their use as models of irradiation. The feasibility ofex vivoexpansion from cryopreserved bone marrow cell samples may offer considerable opportunity for banking bone marrow for autologous transfusio

ISSN:1061-6128    

DOI:10.1089/scd.1.1998.7.69

年代:1998

数据来源: MAL