Trial Outcomes & Findings for Adult Stem Cell Therapy in Liver Insufficiency (NCT NCT00147043)
NCT ID: NCT00147043
Last Updated: 2019-10-03
Results Overview
Incidence of serious adverse event related to injection with the study participants
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Day 1 to Day 60
Results posted on
2019-10-03
Participant Flow
Participants were sequentially recruited to the study from January 2005 to June 2005
Participant milestones
| Measure |
Autologous Stem Cells
Pre-treatment with Granulocyte-Colony Stimulating Factor (G-CSF) to mobilise CD34+ cells Leukapheresis procedure to extract mobilised CD34+ cells Cultured CD34+ cells administered via hepatic artery of portal vein
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adult Stem Cell Therapy in Liver Insufficiency
Baseline characteristics by cohort
| Measure |
Autologous Stem Cells
n=5 Participants
Male or female aged from 20 years to 65 years with evidence of chronic liver failure, abnormal serum albumin and/or bilirubin and/or prothrombin time
|
|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Gender · Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Gender · Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
|
Count of Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 60Incidence of serious adverse event related to injection with the study participants
Outcome measures
| Measure |
Autologous Stem Cells
n=5 Participants
Male of Female participants aged from 20-65 years old with chronic liver failure Abnormal liver function 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 3 monthsAbility to give informed consent
|
|---|---|
|
Number of Participants With Serious Adverse Events Related to Injection
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 60Number of participant that have liver function improvement in liver function
Outcome measures
| Measure |
Autologous Stem Cells
n=5 Participants
Male of Female participants aged from 20-65 years old with chronic liver failure Abnormal liver function 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 3 monthsAbility to give informed consent
|
|---|---|
|
Improvement in Liver Function
|
5 Participants
|
Adverse Events
Autologous Stem Cells
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place