N/A
Completed N=5
Adult Stem Cell Therapy in Liver Insufficiency
Source: ClinicalTrials.gov NCT00147043 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants With Serious Adverse Events Related to Injection — 0 Participants
Summary
In order to determine the clinical application potential of adult stem cells we propose to investigate the safety and toxicity of infusing adult stem cells in the hepatic artery or portal vein of five patients with chronic liver insufficiency and to identify any clinical benefit if such occurs.
Objectives:
1. To assess safety and treatment related toxicities
2. To determine clinical benefit or deterioration by monitoring changes in liver function
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events Related to Injection |
— | — |
| SECONDARY Improvement in Liver Function |
5 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female aged from 20 years to 65 years Evidence of chronic liver failure Abnormal serum albumin and/or bilirubin and/or prothrombin time Unsuitable for liver transplantation WHO performance status <2 Women of childbearing potential may be included but must use a reliable and appropriate contraceptive method Life expectancy of at least three months Ability to give informed consent
Exclusion Criteria
- Patients aged below 20 years or above 65 years Pregnant or lactating women Patients with recent recurrent gastrointestinal bleeding Spontaneous bacterial peritonitis Evidence of active infection HIV infection Patients unable to give informed consent
Data sourced from ClinicalTrials.gov (NCT00147043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.