Intrahepatic Reinfusion of CD133+ Stem Cells in Cirrhotic Patients (Cirrhosis133)
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|ClinicalTrials.gov Identifier: NCT01025622|
Recruitment Status : Unknown
Verified October 2010 by University of Bologna.
Recruitment status was: Recruiting
First Posted : December 3, 2009
Last Update Posted : October 29, 2010
To assess the safety of the intrahepatic reinfusion of increasing numbers of autologous highly purified CD133+ stem cells (SCs) to patients with end-stage liver disease. Safety will be evaluated as the incidence of adverse event (graded according to WHO) and clinically significant abnormal laboratory value following reinfusion of SCs.
To assess the feasibility of the immunomagnetic selection of autologous CD133+ cells collected with leukapheresis from the peripheral blood (PB) of patients with end-stage liver disease, previously mobilized with G-CSF. To assess the effects of the intrahepatic reinfusion of highly purified CD133+ cells on residual hepatic function of the patients.
Twelve patients will be enrolled. At first, G-CSF at 7.5µg/Kg/b.i.d. will be administered subcutaneously (sc) from day 1 until the completion of peripheral blood stem cells (PBSC) collection. Harvest of bone marrow (BM)-derived PBSC will begin on day + 4 only if the concentration of CD133+ cells is > 8/uL and will be continued until the collection of the target cell dose: 0.5 x 106 CD133+ cells/Kg for the first 2 cohorts of patients; 1 x 106 CD133+ cells/Kg for cohort 3 and 2 x 106 CD133+ cells/Kg for cohort 4 (see below for definitions). PB mononuclear cells obtained from mobilized standard-volume leukapheresis will be incubated with Macs colloidal superparamagnetic CD133 microbeads and CliniMacs device will be used for the positive selection of CD133+ cells under good manufacturing practice (GMP) conditions. Cryopreservation and storage in liquid nitrogen will be performed according to standard procedures. At least 4 weeks after SC mobilization and collection, up to 40 mL of single cell suspension of highly purified autologous CD133+ cells, obtained after rapid thawing, will be infused through the hepatic artery by transfemoral or transbrachial arteriography. Infusion time will be lower than 15ml/min to avoid thrombi formation. The entire procedure will be performed under anesthesiological control. According to modified Fibonacci's increment rule, highly purified G-CSF-mobilized CD133+ cells will be administered to patients starting from 5x104/Kg patient's body weight and increased every 3 patients. The maximum infused cell dose will be 1x106/kg. G-CSF at 5µg/Kg/day will be administered sc for 3 days after the reinfusion of SCs (day 0 to day +2).
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis||Biological: autologous highly purified CD133+ stem cells (SCs)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Intrahepatic Reinfusion of Highly Purified CD133+ Stem Cells in Patients With End-Stage Liver Disease|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||June 2012|
- Biological: autologous highly purified CD133+ stem cells (SCs)
Intrahepatic reinfusion in cirrhotic patients
- Safety: Incidence of adverse events (graded according to WHO). Incidence of clinically significant abnormal laboratory values following reinfusion of highly purified CD133+ cells. [ Time Frame: 1 year ]
- Effects of the intrahepatic reinfusion of highly purified CD133+ SCs on residual hepatic function of the patients: Child-Turcotte-Pugh and MELD score. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025622
|Contact: Roberto M Lemoli, MDfirstname.lastname@example.org|
|Contact: Pietro Andreone, MDemail@example.com|
|Azienda Ospedaliera-Universitaria, Policlinico S. Orsola-Malpighi,||Active, not recruiting|
|Bologna, Italy, 40138|
|Azienda Ospedaliera-Universitaria, Policlinico S. Orsola-Malpighi||Recruiting|
|Bologna, Italy, 40138|
|Contact: Roberto M Lemoli, MD +390516363680 firstname.lastname@example.org|
|Principal Investigator: Roberto M Lemoli, MD|
|Principal Investigator:||Roberto M Lemoli, MD||University of Bologna|