Clinical trial NCT00382278: Safety Study of Autologous Stem Cell in Liver Cirrhosis
Official title: Phase 1/2 Study of Autologous Bone Marrow Derived Mononuclear Cells in Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhosis
Keywords: Stem cell
Liver cirrhosis
Cellular therapy
Autologous
Bone marrow
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Financiadora de Estudos e Projetos
First posted: 2006-09-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a fase I/II clinical study to evaluate feasibility, safety and kinetics of cellular therapy with bone marrow-derived mononuclear cells (ABMMC) in patients with liver cirrhosis. All the patients have moderate liver disfunction and a waiting time expectancy of liver transplantation longer than 12 months due their low MELD score. The ABMMC are labeled with 99mTc and infused through the hepatic artery. Scintigraphy is performed 2 and 24 hours after infusion. Patients are submitted to frequent clinical, laboratorial and image evaluation during the follow up period of 12 months.

Detailed description: A one year clinical trial was conducted. Patients had moderate liver dysfunction and a liver transplant was not expected to occur earlier than 12 months, due to low MELD scores. Hepatocellular carcinoma (HCC) and hepatic artery or portal vein thrombosis were excluded by color Doppler ultrasonography (DUS) and 3-phase computed tomography (CT). Under local anesthesia, 100 mL of bone marrow were aspirated from the posterior iliac crest. ABMMC were isolated by density gradient centrifugation in Ficoll-Hypaque gradient, 10% of the cells were labeled with SnCl2-99mTc, and a small fraction was used for cell counting and viability analysis. ABMMC were delivered preferentially in the common hepatic artery by celiac trunk catheterism. Total body scintigraphy (TBS) was performed 3 hours after infusion. Patients were submitted to frequent clinical, biochemical and imaging evaluation during follow up.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis of any origin
* Moderate liver disfunction (Child-Pugh Score=7-10)

Exclusion Criteria:

* Waiting time expectancy of liver transplant shorter than 12 months
* Ongoing hepatic encephalopathy
* Clinically detectable ascitis
* Severe coagulation disorder (INR\>2,0 or platelets count \< 40.000)
* Diagnosis or strong suspicion of cancer (except basocellular)
* Pregnancy or intention to become pregnant during the next 12 months
* Moderate or severe co-morbidity
* Current participation in another clinical trial

Primary outcomes:
measure: Changes in liver function according to Child-Pugh and MELD scores
timeFrame: in days 1,2,7,14,30, 45, 60, 90, 120, 150, 180, 270, 360
measure: Hepatic artery and portal vein thrombosis (doppler ultrasound)
timeFrame: in days 1,2,7,14,90, 180 and 360
measure: Development of liver nodule (ultrasound screening)
timeFrame: in days 1,2,7,14,90, 180 and 360 (US) and in day 360 (CT scan )
measure: Liver related mortality
timeFrame: 360 days
Secondary outcomes:
measure: Body distribution of 99mTc labeled BMDMC (scintigraphy)
timeFrame: after 3 hours of infusion
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Guilherme FM Rezende, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: