Clinical Trial Results:
A randomized, prospective, double-blind study with placebo to evaluate the efficacy of treatment of patients with angina resistant to pharmacological treatment and induced myocardial ischemia without possibility of effective revascularization, using isolated from bone marrow, autological CD133+ cells administered directly into the muscle of left ventricle. REGENT-VSEL Study.
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Summary
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EudraCT number |
2011-005435-98 |
Trial protocol |
PL |
Global end of trial date |
05 Sep 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Apr 2022
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First version publication date |
25 Apr 2022
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Other versions |
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Summary report(s) |
Circ Res Publication secondary publication |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
version_2.0_dated_19.04.2011
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01660581 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Śląski Uniwersytet Medyczny W Katowicach
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Sponsor organisation address |
Poniatowskiego 15, Katowice, Poland,
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Public contact |
Katarzyna Bigosińska , Śląski Uniwersytet Medyczny W Katowicach, 48 322088804, kbigosinska@sum.edu.pl
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Scientific contact |
Wojciech Wojakowski, III Division of Cardiology, 48 322523930, wwojakowski@sum.edu.pl
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Nov 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Sep 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Sep 2016
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
1. Assessment of influence of direct administration of isolated from bone marrow, autological CD133+ cells on improvement of myocardial perfusion and function and decrease of occurrence of symptomatic angina of patients with angina resistant to pharmacological treatment without possibility of effective revascularization
2. Assessment of therapy safety
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Protection of trial subjects |
personal data protection, during each invasive procedure appropriate local or general anesthesia was used, patients had access to 27/4 emergency consulting
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Background therapy |
Maximum tolerated doses of angina pharmacotherapy for at least 2 weeks Seconadary prevention of CAD (statins), beta blockers or CCB, Antihypertensive therapy when appropriate Revascularization | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Apr 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 31
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Worldwide total number of subjects |
31
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EEA total number of subjects |
31
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
12
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From 65 to 84 years |
19
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85 years and over |
0
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Recruitment
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Recruitment details |
The screening was based on angina symptoms according to the CCS classification and validated by stress test when applicable. | |||||||||
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Pre-assignment
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Screening details |
90 pateints with refractory angina screened, 52 did not meet inclusion criteria, 7 declined | |||||||||
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Period 1
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Period 1 title |
period 1 (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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active | |||||||||
Arm description |
CD133+ cells | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
CD133+ cells
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection
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Routes of administration |
Injection
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Dosage and administration details |
The dosing ranges were 2.8×106 and 5.3×106 cells
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Arm title
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control | |||||||||
Arm description |
placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection
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Routes of administration |
Injection
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Dosage and administration details |
placebo - equal volume to active arm
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Baseline characteristics reporting groups
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Reporting group title |
period 1
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
active
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Reporting group description |
CD133+ cells | ||
Reporting group title |
control
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Reporting group description |
placebo | ||
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End point title |
change of myocardial perfusion by 99mTc-MIBI SPECT at 4 months after cell/placebo injection | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
4 months after treatment
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Statistical analysis title |
statistical analysis | |||||||||
Statistical analysis description |
All analyses were performed according to the intention-to-treat scheme. Categorical variables were presented as numbers and percentages. Continuous variables were expressed as mean±standard deviation (SD) or median and interquartile range. Differences between groups were compared using the Student’s or the Welch’s t test depending on the equality of variances for normally distributed variables. The MannWhitney U test was used for non-normally distributed continuous variables. Normality was asses
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Comparison groups |
active v control
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
12 months
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
active
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| none | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/27903568 http://www.ncbi.nlm.nih.gov/pubmed/30211929 |
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