Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382278
Status:
TERMINATED
Last Update Posted:
2008-04-03
First Post:
2006-09-28
Brief Title:
Safety Study of Autologous Stem Cell in Liver Cirrhosis
Sponsor:
Universidade Federal do Rio de Janeiro
Organization:
Universidade Federal do Rio de Janeiro
Study Overview
Official Title:
Phase 12 Study of Autologous Bone Marrow Derived Mononuclear Cells in Liver Cirrhosis
Status:
TERMINATED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Other authors showed the same metabolic effect may be obtained when BMMC are delivered peripherally with lower risk and cost than through hepatic artery
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is a fase III 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None