COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH:
Working… Menu

Intrahepatic Reinfusion of CD133+ Stem Cells in Cirrhotic Patients (Cirrhosis133)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
University of Bologna

Brief Summary:

OBJECTIVE(S): Primary:

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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Intervention Details:
  • Biological: autologous highly purified CD133+ stem cells (SCs)
    Intrahepatic reinfusion in cirrhotic patients

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent
  • Age >18 years
  • Karnofsky score >70% or WHO <1
  • Adequate renal (serum creatinine < 2 mg/dl) and pulmonary (Sat O2 >96%) function
  • Diagnosis of advanced, end-stage liver disease defined by a Mayo Model for End Stage Liver Disease (MELD) score between 17 and 25. Patients with the following liver disease etiologies will be enrolled in the study: chronic viral hepatitis B, chronic viral hepatitis C, chronic viral hepatitis D, alcoholic cirrhosis (without alcohol active consumption), primary sclerosing cholangitis, primary biliary cirrhosis, Wilson's disease, genetic hemochromatosis or iron over-load cirrhosis, cirrhosis due to non alcoholic steato-hepatitis.

Eligibility for orthotopic liver transplantation (OLT) is not a contraindication to enter in the clinical study. Patients in waiting list for OLT transplantation will not be withdrawn and will be transplanted as soon as a suitable donor will become available.Their MELD score will remain that recorded prior SCs infusion in case of improvement following the experimental procedure.

The presence of cirrhosis related symptoms, like ascites, peripheral edema, recurrent gastrointestinal tract bleeding, recurrent encephalopathy do not represent major contraindications to be enrolled into the study.

The patients may be considered eligible when clinically stable.

Exclusion Criteria:

  • HIV positivity
  • Pregnant or nursing females
  • Current uncontrolled infection
  • Intercurrent organ damage
  • Diagnosis of hepatocarcinoma
  • Complete portal thrombosis
  • Severe impairment of coagulative function (PT< 30%, INR>2.5, Platelets < 40x109/L) that would contraindicate arteriography
  • Grade IV splenomegaly
  • Budd-Chiari Syndrome with sovrahepatic vein thrombosis and cirrhosis of unknown origin will not be included in the study

Information from the National Library of Medicine

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 identifier (NCT number): NCT01025622

Layout table for location contacts
Contact: Roberto M Lemoli, MD +390516363680
Contact: Pietro Andreone, MD +390516363817

Layout table for location information
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   
Principal Investigator: Roberto M Lemoli, MD         
Sponsors and Collaborators
University of Bologna
Layout table for investigator information
Principal Investigator: Roberto M Lemoli, MD University of Bologna
Additional Information:
Layout table for additonal information
Responsible Party: Roberto M. Lemoli, MD, University of Bologna Identifier: NCT01025622    
Other Study ID Numbers: 2009-011783-10
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: October 29, 2010
Last Verified: October 2010
Keywords provided by University of Bologna:
Stem Cells
Liver Cirrhosis
Cell Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases