EUVITAL V Study
- Conditions
- Patients that need peripheral blood cells mobilization for regenerative therapy (chronic wounds, arterial or venous insufficiency, opened fracture).
- Registration Number
- RPCEC00000104
- Lead Sponsor
- Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 35
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.