Patients that need peripheral blood cells mobilization for regenerative therapy (chronic wounds, arterial or venous insufficiency, opened fracture).
Conditions
Interventions
Treatment with G-CSF was administered as random list, as follows: Group I (Hebervital) x 20µg kg daily (divided into 2 sub-doses of 10 mg x kg body weight every 12 hours), subcutaneously for 2 days. G
Sponsors
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
Center of Molecular Immunology (CIM), in Havana.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age major than 18 years old. 2.Informed consent. 3.Patients requiring peripheral blood cells mobilization. 4.ANC within normal limits before inclusion (ANC = 3 x 109/L). 5.Platelet Blood Count within normal limits before inclusion (PBC = 150 x 109/L).
Exclusion criteria
Exclusion criteria: 1.Allergic reaction to GCSF or their ingredients. 2.Malignancies. 3.Chronic or acute liver disease: Bilirrubin >17 micromol/L, SGPT y/o SGOT 1.5 times over their limits, alcalin Fosfatasa 2.5 x upper normal limit (44-147 UI/L). 4.Previous chemotherapy or radiotherapy, 4 weeks before the inclusion. 5.Serious psychiatric disorder or other limitation that contraindicates informed consent or study evaluations. 6.Bone marrow disorder that affect mobilization. 7.Un controlled chronic disease: heard disease, Renal insufficiency, Liver disease, Diabetes Mellitus. 8.Infection that contraindicate some phases of transplant. 9.Young women without effective contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CD34+ cells count in aphaeresis, during the aphaeresis. CD34+ cells count in peripheral blood, before mobilization, after the 4th doses and at the end of treatment if it is extended. | — |
Secondary
| Measure | Time frame |
|---|---|
| White Blood Count (WBC), before mobilization, daily during treatment and before the aphaeresis. Absolute Neutrophil Count (ANC), before inclusion, daily until the end of treatment. Mononuclear cells in peripheral blood and aphaeresis, before inclusion, daily until the end of treatment. Aphaeresis volume, during aphaeresis. | — |
Countries
Cuba
Contacts
Public ContactDr. Francisco Hernández Bernal
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
Outcome results
None listed