Controlled primary neoplasia disease Cancer Controlled primary neoplasia disease
Conditions
Interventions
The presence of bone marrow-derived liver committed stem cells, immunophenotyping as D34+/Lin-/CXCR4+/SDF1+ stem cells, were previously investigated by flow cytometry in the peripheral blood of 9 adul
Sponsors
State University of Campinas (Brazil)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years 2. Controlled primary neoplasia disease 3. Absence of clinical, laboratorial and radiological evidence of tumor metastasis
Exclusion criteria
Exclusion criteria: 1. Chronic hepatic insufficiency 2. Hepatic encephalopathy 3. Coagulopathy 4. Presence of hepatoblastoma 5. Disseminated intravascular coagulation 5. Renal or cardiac insufficiency 5. Acute infection 6. Sepsis (defined by the criteria of the Society of Critical Care Medicine and American College of Chest Physicians, 1992) 7. Those enlisted for liver transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness of recruitment and release of bone marrow-derived liver-committed stem cells to the peripheral blood by granulocyte colony stimulating factor (GCSF) bone marrow mobilization at improving remnant liver recovery in patients undergoing extensive liver resections. The recruitment and release of bone marrow-derived liver-committed stem cells was measured by flow cytometry analysis with specific labeled antibodies: IgG FITC/ IgG PE; CD45 Percp; CD14 FITC CD33 APC; CD34 APC; CD19 FITC ; CD3 PE; cySDF1 Alexa fluor 488; CD184 PE(CXCR4); cyCD184 PE, disposed for the analyses as: cySDF1 Alexa fluor 488/ CD184 PE/ CD45 Percp/ CD34 APC; CD14 FITC/ CD34 PE/ CD45 Percp/ CD33 APC and CD19 FITC/ CD3 PE/ CD45 Percp/ CD34 APC. Flow cytometry analyses were performed on days 0, 5, 10-15, and 30. Results on day 0 were compared with results obtained from nine adult healthy volunteers, with the same median age as the eligibility patients. The improving remnant liver recovery was analyzed by a 64-slice Scanner CT. Pre surgery CT analysis was performed with four consecutive acquisitions (pre and post contrast medium injection). Post surgery analysis was carried out on days 10, 30 and 60, one acquisition, post contrast medium injection, during portal phase. The following parameters were used; voltage 120 kVp, current of 200-275 mAs, and section thickness of 5 mm in order to optimize liver volumetry analyses. Results were analyzed by two radiologists specialized in liver images. CT results were analyzed by Vitrea Advanced Software. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient clinical and laboratory exams were performed during the recruitment phase and on day 0 before GCSF/NaCl 0.9% administration, and days 5, 10 and 60. The following exams were performed: Hemoglobin (Hb); Hematocrit (HT); Leucocytes; Platelets; Albumin; Prothrombin Time/international normalized ratio (PT/INR); Activated partial tromboplastin time/ratio (APTT/R), aspartate aminotransferase (AST) alanine amino transferase (ALT); alkaline phosphatase (Alkaline Phos); gamma glutamil transferase (GGT); urea (U); creatinine (C); glycemia (mg/dL) and ferritin. Some clinical and laboratorial data were also analyzed post surgery on day 10: days spent in the Intensive Care Unit (ICU), bleeding volume during the surgeries, and blood usage. | — |
Countries
Brazil
Outcome results
None listed