In this End Stage Renal Disease (ESRD) patients who need Erythropoietin (epo) hormone will get it by a small implant of skin using their own skin, the implant will be treated in the laboratory and programmed to secrete Epo. The implant secretes the patients own epo minimizing the need for injections for a period of up to 6 months.
This will be a Phase I-II, open-label, single-center, uncontrolled, tailored dose study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center. Subjects will undergo similar study procedures and evaluations; however each patient will receive his or her own individually targeted dose of EPO delivered via EPODURE Biopumps. The targeted dose may vary between 20IU/kg/d to 65IU/kg/d based on each patient's weight, the historical average EPO amount administered and historical Hb levels including at least the 3 months prior to inclusion in the study. The objective is maintaining Hb levels within the target range of 10-12 g/dl.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Subcutan implantation of autologous skin graft after ex-vivo treatment
Subcutan implantation of autologus skin graft after ex-vivo treatment
Hg maintenance with in the range of 10-12 gr/dl for the duration of 6 month
A Phase I-II, open-label. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center. Subjects will undergo similar study procedures and evaluations; however each patient will receive his or her own individually targeted dose of EPO delivered via EPODURE Biopumps. The targeted dose may vary between 20IU/kg/d to 65IU/kg/d based on each patient's weight, the historical average EPO amount administered and historical Hb levels including at least the 3 months prior to inclusion in the study. The objective is maintaining Hb levels within the target range of 10-12 g/dl.
Time frame: 6 months
REDUCING THE AMOUNT OF EXOGENOUS EPO ADMINISTRATION
The biopumps are expected to secret sufficient Epo to support the Hb lebel in the desired range of 10-12 gr/dl
Time frame: During the first 6 months of evaluation
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