Trial Outcomes & Findings for A Phase I/II Safety and Tolerability Dose Escalation Study of Autologous Stem Cells to Patients With Liver Insufficiency (NCT NCT00655707)
NCT ID: NCT00655707
Last Updated: 2019-10-31
Results Overview
To determine the maximum tolerated dose of autologous adult stem cells when infused into either the hepatic artery or the portal vein.
COMPLETED
PHASE1/PHASE2
5 participants
12 months
2019-10-31
Participant Flow
The planned dose escalation design did not work due to low participants number. All participants received similar dose of Autologous expanded CD34+ cells .
Participant milestones
| Measure |
Treatment
Autologous CD34+ cells
Autologous Expanded CD34+ Haemopoietic cells: Autologous expanded CD34+ cells obtained by leukapheresis on a single occasion by infusion into the hepatic artery or portal vein.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Autologous CD34+ Cells
n=5 Participants
Patients enrolled in the study underwent 5 days of treatment with G-CSF to mobilise CD34+ cells, followed by leukapheresis to obtain CD34+ cells.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsTo determine the maximum tolerated dose of autologous adult stem cells when infused into either the hepatic artery or the portal vein.
Outcome measures
| Measure |
Autologous CD34+ Cells
n=5 Participants
Autologous Expanded CD34+ Haemopoietic cells: Autologous expanded CD34+ cells obtained by leukapheresis on a single occasion by infusion into the hepatic artery or portal vein.
|
|---|---|
|
Number of Patients Who Tolerated the Maximum Dose
|
5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsTo assess the safety of ascending doses of autologous adult stem cells when introduced into either the hepatic artery or the portal vein and to determine the maximum tolerated dose of stem cells.
Outcome measures
| Measure |
Autologous CD34+ Cells
n=5 Participants
Autologous Expanded CD34+ Haemopoietic cells: Autologous expanded CD34+ cells obtained by leukapheresis on a single occasion by infusion into the hepatic artery or portal vein.
|
|---|---|
|
Number of Participants Without Specific Treatment Related Side Effect
|
5 Participants
|
Adverse Events
Autologous CD34+ Cells
Serious adverse events
| Measure |
Autologous CD34+ Cells
n=5 participants at risk
Autologous Expanded CD34+ Haemopoietic cells: Autologous expanded CD34+ cells obtained by leukapheresis on a single occasion by infusion into the hepatic artery or portal vein.
|
|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
20.0%
1/5 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Autologous CD34+ Cells
n=5 participants at risk
Autologous Expanded CD34+ Haemopoietic cells: Autologous expanded CD34+ cells obtained by leukapheresis on a single occasion by infusion into the hepatic artery or portal vein.
|
|---|---|
|
Immune system disorders
Fever
|
80.0%
4/5 • Number of events 4 • 12 months
|
|
Surgical and medical procedures
Pain
|
80.0%
4/5 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
5/5 • Number of events 5 • 12 months
|
|
Hepatobiliary disorders
Jaundice
|
20.0%
1/5 • Number of events 4 • 12 months
|
|
Hepatobiliary disorders
Ascites
|
60.0%
3/5 • Number of events 3 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place