Primary Outcome Measures:
- Changes in liver function according to Child-Pugh and MELD scores [ Time Frame: in days 1,2,7,14,30, 45, 60, 90, 120, 150, 180, 270, 360 ] [ Designated as safety issue: Yes ]
- Hepatic artery and portal vein thrombosis (doppler ultrasound) [ Time Frame: in days 1,2,7,14,90, 180 and 360 ] [ Designated as safety issue: Yes ]
- Development of liver nodule (ultrasound screening) [ Time Frame: in days 1,2,7,14,90, 180 and 360 (US) and in day 360 (CT scan ) ] [ Designated as safety issue: Yes ]
- Liver related mortality [ Time Frame: 360 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Body distribution of 99mTc labeled BMDMC (scintigraphy) [ Time Frame: after 3 hours of infusion ] [ Designated as safety issue: No ]
Intervention Details:
Procedure: Autologous bone marrow-derived mononuclear cells infusion
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. At least 100 millions of mononuclear-enriched BMC suspended in 20 mL of saline were delivered preferentially in the common hepatic artery by celiac trunk catheterism.
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.