Clinical Trial Results:
Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction using Bone Marrow Mononuclear Cells</full-title-trial
Summary
|
|
EudraCT number |
2008-004625-42 |
Trial protocol |
DE |
Global end of trial date |
02 Nov 2016
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
07 Oct 2020
|
First version publication date |
07 Oct 2020
|
Other versions |
|
Summary report(s) |
2008-004625-42-#1777-AlsterStemCells final report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
KardioPII
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Asklepios Kliniken Hamburg GmbH
|
||
Sponsor organisation address |
Ruebenkamp 226, Hamburg, Germany, 22307
|
||
Public contact |
Dr. Kai Jaquet, ASKLEPIOS proresearch, k.jaquet@asklepios.com
|
||
Scientific contact |
Dr. Kai Jaquet, ASKLEPIOS proresearch, k.jaquet@asklepios.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
25 Oct 2012
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
11 Oct 2010
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
02 Nov 2016
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
Can transendocardial injection of BMNC be used safely in patients with symptomatic heart failure?
|
||
Protection of trial subjects |
Bone marrow aspiration as well as minimal invasive catheter based mapping and cell injection procedure of/into left ventricle were performed under sedation.
|
||
Background therapy |
Besides cell therapy treatment patients received optimal standard cardiologic therapy (medication) according to at that time validated medical guidelines. | ||
Evidence for comparator |
The results were compared to a matched control group of revascularised, post-STEMI patients with optimal standard therapy. | ||
Actual start date of recruitment |
15 Jan 2009
|
||
Long term follow-up planned |
Yes
|
||
Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
12 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Germany: 23
|
||
Worldwide total number of subjects |
23
|
||
EEA total number of subjects |
23
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
21
|
||
From 65 to 84 years |
2
|
||
85 years and over |
0
|
|
||||||||||
Recruitment
|
||||||||||
Recruitment details |
Between January 2009 and July 2010 all patients admitted to the cardiology department at St. Georg Hospital for acute STEMI were assessed regarding EF following successful revascularisation by pri¬mary percutaneous coronary intervention (PCI). Patients aged <80 years and baseline measurements of EF <45% (CMR) assessed at least one week after PCI wi | |||||||||
Pre-assignment
|
||||||||||
Screening details |
EF <45% (CMR) assessed at least one week after PCI with additional symptoms of heart failure (NYHA Class ≥II) as well as NT-proBNP levels >250 pg/ml despite successful revascularisation were eligible. | |||||||||
Pre-assignment period milestones
|
||||||||||
Number of subjects started |
23 | |||||||||
Number of subjects completed |
23 | |||||||||
Period 1
|
||||||||||
Period 1 title |
screening period (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
|
|||||||||
Blinding used |
Not blinded | |||||||||
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
Arm title
|
cell therapy arm | |||||||||
Arm description |
Patients receiving BMNC cell therapy. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Bone marrow mononuclear cells (BMNC)
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Concentrate and solvent for solution for injection
|
|||||||||
Routes of administration |
Intramuscular use, Percutaneous use
|
|||||||||
Dosage and administration details |
15-20 injections of concentrated BMNC (100 μl each) were performed; in total, 220±42*106 cells/patient were injected.
|
|||||||||
Arm title
|
control group | |||||||||
Arm description |
control group | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
non-treated control group
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
control group
|
|||||||||
Pharmaceutical forms |
Injection
|
|||||||||
Routes of administration |
Intracardiac use
|
|||||||||
Dosage and administration details |
This is the "Placebo Group". Ethical committee prohibited injection of placebo (saline). Therefore this is a non-treatment goup.
|
|||||||||
|
|
|
|||
End points reporting groups
|
|||
Reporting group title |
cell therapy arm
|
||
Reporting group description |
Patients receiving BMNC cell therapy. | ||
Reporting group title |
control group
|
||
Reporting group description |
control group |
|
|||||||||||||
End point title |
increase of EF | ||||||||||||
End point description |
Significant increase of EF (+7.9±1.5%, p=0.001) while the control group showed no Change.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
12 months
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
non-parametric Wilcoxon rank-sum test | ||||||||||||
Statistical analysis description |
Significance within each group (cell therapy, control group) was assessed by the Kolmogorov-Smirnov test followed by a one-sample t-test with “no change” (Δ=0) as the hypothetical value. Significance of ΔEF between the groups was analysed by the non-parametric Wilcoxon rank-sum test.
|
||||||||||||
Comparison groups |
cell therapy arm v control group
|
||||||||||||
Number of subjects included in analysis |
23
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|
|||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
12 months
|
||||||||||||||||||||||||||||||
Adverse event reporting additional description |
During visit after 6 and 12 months
|
||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||
Dictionary name |
ClinicalTrials.gov | ||||||||||||||||||||||||||||||
Dictionary version |
PRS
|
||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||
Reporting group title |
cell therapy group
|
||||||||||||||||||||||||||||||
Reporting group description |
Group of patients receiving cell therapy | ||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |