NEUVITAL V Study

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000104
• Date of registration: 30/04/2011
• Primary sponsor: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
• Public title: NEUVITAL V Study
• Scientific title: Comparison of two formulations of human recombinant Granulocyte Colony Stimulator Factor (G-CSF) in peripheral blood cells mobilization.
• Date of first enrolment: 17/11/2007
• Target sample size: 35
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000104-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Open. Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dr. Francisco Hernández Bernal
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

• Name: Dr. Francisco Hernández Bernal
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

Key inclusion & exclusion 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: 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.

Age minimum: 18 years
Age maximum: No limit
Gender: Both

Health Condition(s) or Problem(s) studied

Patients that need peripheral blood cells mobilization for regenerative therapy (chronic wounds, arterial or venous insufficiency, opened fracture).

Intervention(s)

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. Group II (iorLeukoCIM) x 20µg kg daily (divided into 2 sub-doses of 10 mg x kg body weight every 12 hours), subcutaneously for 2 days. At 3 hours after the last dose (administered to each study group) will take count of peripheral blood leukocytes, if it is larger than 20 x 109 / L, the procedure to obtain the parents. If the count is less than the mobilization will continue every 12 hours until the leukocyte count above or up to 5 days of treatment. Treatment will be discontinued in any of the 2 groups if the Leucogram are 50 x 109 / L.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

IG/GCI/MSCP/0701

Source(s) of Monetary Support

Heber Biotec S.A. CIMAB S.A. Cuban Ministry of Public Health.

Secondary Sponsor(s)

Center of Molecular Immunology (CIM), in Havana.