Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients with Acute Ischemic Stroke Due to Large Vessel Occlusion in Anterior Circulation: Results of a 3-Month Follow-up of a Prospective, Open Label, Single-Center Study.

Staszewski J, Dębiec A, Strilciuc S, Gniadek-Olejniczak K, Piusinska-Macoch R, Balo D, Harston G, Stępień A, Brzozowski K, Zięcina P, Narloch J, Wierzbicki M, Piasecki P

Translational stroke research6 May 2025Cited by 11 (Europe PMC)

PMID40325343PMCIDPMC12598679DOI10.1007/s12975-025-01355-zPepBankPUB-40325343

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Summary

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Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanNon-randomized trialEfficacy outcome
In stroke patients after thrombectomy, Cerebrolysin increased functional independence at 90 days versus historical controls.
In plain wordsIn stroke patients after thrombectomy, Cerebrolysin increased functional independence at 90 days versus historical controls.
Peptide
Cerebrolysin
Outcome
IncreaseFunctional independence at 90 days
Study
n = 100
Comparator
Propensity-matched historical controls
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30 ml · intravenous · Continued to day 21 (first cycle); second cycle in a recovery phase between 69-90 daysAs given in this study (human).
Measurements
mRS 0-2
68%
Cerebrolysin
mRS 0-2
44%
control
P value for functional independence (mRS 0-2)
0.016
Cerebrolysin versus historical controls; 90 days
Odds ratio for functional independence (mRS 0-2)
2.7
Cerebrolysin versus historical controls; 90 days
95% confidence interval for functional independence odds ratio
1.2 to 6.1
Cerebrolysin versus historical controls; 90 days
Number needed to treat for functional independence
4.2
Cerebrolysin versus historical controls; 90 days
Source sentences
Summary
Patients receiving Cerebrolysin achieved higher rates of mRS 0-2 at 90 days (68% vs. 44%, p = 0.016, OR 2.7, 95% CI 1.2-6.1; NNT: 4.2)
2 context sentences(design, population, supporting numbers)
Summary · context
A single-center, prospective, open-label, single-arm study with blinded outcome assessment of 50 consecutive patients with moderate-to-severe AIS treated with MT ≤ 6 h of stroke onset followed by Cerebrolysin (30 ml iv within 8 h of onset and continued to day 21, first cycle)
Summary · context
and in a recovery phase (between 69-90 days, second cycle) compared to 50 historical controls matched by propensity scores.
Report a problemFND-4032534301
02HumanNon-randomized trialSafety outcome
In stroke patients after thrombectomy, Cerebrolysin reduced secondary intracerebral hemorrhage risk versus historical controls.
In plain wordsIn stroke patients after thrombectomy, Cerebrolysin reduced secondary brain hemorrhage risk versus historical controls.
Peptide
Cerebrolysin
Outcome
DecreaseSecondary intracerebral hemorrhage
Study
n = 100
Comparator
Propensity-matched historical controls
Outcome group
Adverse events · Nervous system and cognition
Studied dose
30 ml · intravenous · Continued to day 21 (first cycle); second cycle in a recovery phase between 69-90 daysAs given in this study (human).
Measurements
Secondary ICH
14%
Cerebrolysin
Secondary ICH
40%
control
P value for secondary ICH
0.02
Cerebrolysin versus historical controls; secondary ICH
Relative risk of secondary ICH
0.37
Cerebrolysin versus historical controls; secondary ICH
95% confidence interval for secondary ICH relative risk
0.14 to 0.95
Cerebrolysin versus historical controls; secondary ICH
Source sentences
Summary
had reduced risk of secondary ICH (14% vs. 40%, p = 0.02; RR 0.37, 95% CI 0.14-0.95)
2 context sentences(design, population, supporting numbers)
Summary · context
A single-center, prospective, open-label, single-arm study with blinded outcome assessment of 50 consecutive patients with moderate-to-severe AIS treated with MT ≤ 6 h of stroke onset followed by Cerebrolysin (30 ml iv within 8 h of onset and continued to day 21, first cycle)
Summary · context
and in a recovery phase (between 69-90 days, second cycle) compared to 50 historical controls matched by propensity scores.
Report a problemFND-4032534302
03HumanNon-randomized trialEfficacy outcome
In stroke patients after thrombectomy, Cerebrolysin reduced NIHSS scores on day 7 versus historical controls.
In plain wordsIn stroke patients after thrombectomy, Cerebrolysin reduced neurological deficit scores on day 7 versus historical controls.
Peptide
Cerebrolysin
Outcome
DecreaseNIHSS at day 7
Study
n = 100
Comparator
Propensity-matched historical controls
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30 ml · intravenous · Continued to day 21 (first cycle); second cycle in a recovery phase between 69-90 daysAs given in this study (human).
Measurements
NIHSS day 7 median
3
Cerebrolysin group
NIHSS day 7 median
6
Control group
NIHSS IQR
4
Cerebrolysin; day 7
NIHSS IQR
9
Historical controls; day 7
P value for NIHSS scores
0.01
Cerebrolysin versus historical controls; day 7
Source sentences
Summary
and had lower NIHSS on day 7 (median [IQR]: 3 [4] vs. 6 [9], p = 0.01).
2 context sentences(design, population, supporting numbers)
Summary · context
A single-center, prospective, open-label, single-arm study with blinded outcome assessment of 50 consecutive patients with moderate-to-severe AIS treated with MT ≤ 6 h of stroke onset followed by Cerebrolysin (30 ml iv within 8 h of onset and continued to day 21, first cycle)
Summary · context
and in a recovery phase (between 69-90 days, second cycle) compared to 50 historical controls matched by propensity scores.
Report a problemFND-4032534303
04HumanNon-randomized trialEfficacy outcome
In stroke patients after thrombectomy, Cerebrolysin increased Barthel Index scores at 30 days versus historical controls.
In plain wordsIn stroke patients after thrombectomy, Cerebrolysin increased daily activity scores at 30 days versus historical controls.
Peptide
Cerebrolysin
Outcome
IncreaseBarthel Index at 30 days
Study
n = 100
Comparator
Propensity-matched historical controls
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
30 ml · intravenous · Continued to day 21 (first cycle); second cycle in a recovery phase between 69-90 daysAs given in this study (human).
Measurements
Barthel Index at 30 days median
77
Cerebrolysin group
Barthel Index at 30 days median
63
Control group
Barthel Index IQR
32
Cerebrolysin; 30 days
Barthel Index IQR
50
Historical controls; 30 days
P value for Barthel Index scores
0.03
Cerebrolysin versus historical controls; 30 days
Source sentences
Summary
There was a significant difference in Barthel Index scores between the Cerebrolysin group and the control group at 30 days (median [IQR]: 77 [32] vs. 63 [50], p = 0.03) and at 3 months (86 [22] vs. 75 [29], p = 0.01) primarily driven by the increase in the mobility and transfer components.
2 context sentences(design, population, supporting numbers)
Summary · context
A single-center, prospective, open-label, single-arm study with blinded outcome assessment of 50 consecutive patients with moderate-to-severe AIS treated with MT ≤ 6 h of stroke onset followed by Cerebrolysin (30 ml iv within 8 h of onset and continued to day 21, first cycle)
Summary · context
and in a recovery phase (between 69-90 days, second cycle) compared to 50 historical controls matched by propensity scores.
Report a problemFND-4032534304
05HumanNon-randomized trialEfficacy outcome
In stroke patients after thrombectomy, Cerebrolysin increased Barthel Index scores at 3 months versus historical controls.
In plain wordsIn stroke patients after thrombectomy, Cerebrolysin increased daily activity scores at 3 months versus historical controls.
Peptide
Cerebrolysin
Outcome
IncreaseBarthel Index at 3 months
Study
n = 100
Comparator
Propensity-matched historical controls
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
30 ml · intravenous · Continued to day 21 (first cycle); second cycle in a recovery phase between 69-90 daysAs given in this study (human).
Measurements
Barthel Index at 3 months median
86
Cerebrolysin group
Barthel Index at 3 months median
75
Control group
Barthel Index IQR
22
Cerebrolysin; 3 months
Barthel Index IQR
29
Historical controls; 3 months
P value for Barthel Index scores
0.01
Cerebrolysin versus historical controls; 3 months
Source sentences
Summary
There was a significant difference in Barthel Index scores between the Cerebrolysin group and the control group at 30 days (median [IQR]: 77 [32] vs. 63 [50], p = 0.03) and at 3 months (86 [22] vs. 75 [29], p = 0.01) primarily driven by the increase in the mobility and transfer components.
2 context sentences(design, population, supporting numbers)
Summary · context
A single-center, prospective, open-label, single-arm study with blinded outcome assessment of 50 consecutive patients with moderate-to-severe AIS treated with MT ≤ 6 h of stroke onset followed by Cerebrolysin (30 ml iv within 8 h of onset and continued to day 21, first cycle)
Summary · context
and in a recovery phase (between 69-90 days, second cycle) compared to 50 historical controls matched by propensity scores.
Report a problemFND-4032534305
06HumanNon-randomized trialEfficacy outcome
In stroke patients after thrombectomy, Cerebrolysin independently predicted favorable outcomes at 3 months in multivariate analysis.
In plain wordsIn stroke patients after thrombectomy, Cerebrolysin was linked to favorable outcomes at 3 months in multivariate analysis.
Peptide
Cerebrolysin
Outcome
IncreaseFavorable outcomes adjusted association
Study
n = 100
Comparator
Propensity-matched historical controls
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30 ml · intravenous · Continued to day 21 (first cycle); second cycle in a recovery phase between 69-90 daysAs given in this study (human).
Measurements
Odds ratio
7.5
Multivariate analysis
95% confidence interval for multivariate favorable outcome odds ratio
1.8 to 30.9
Cerebrolysin; multivariate analysis; 3 months
Source sentences
Summary
Multivariate analysis identified Cerebrolysin as an independent predictor of favorable outcomes at 3 months (OR 7.5, 95% CI 1.8-30.9), particularly in patients with diabetes (interaction OR 9.6, 95% CI 1.01-92).
2 context sentences(design, population, supporting numbers)
Summary · context
A single-center, prospective, open-label, single-arm study with blinded outcome assessment of 50 consecutive patients with moderate-to-severe AIS treated with MT ≤ 6 h of stroke onset followed by Cerebrolysin (30 ml iv within 8 h of onset and continued to day 21, first cycle)
Summary · context
and in a recovery phase (between 69-90 days, second cycle) compared to 50 historical controls matched by propensity scores.
Report a problemFND-4032534306
07HumanNon-randomized trialSafety outcome
In stroke patients after thrombectomy, mortality at 30 days did not differ significantly between Cerebrolysin and historical controls.
In plain wordsIn stroke patients after thrombectomy, mortality at 30 days did not differ significantly between Cerebrolysin and historical controls.
Peptide
Cerebrolysin
Outcome
No significant changeMortality at 30 days
Study
n = 100
Comparator
Propensity-matched historical controls
Outcome group
Mortality · Whole body
Studied dose
30 ml · intravenous · Continued to day 21 (first cycle); second cycle in a recovery phase between 69-90 daysAs given in this study (human).
Measurements
Mortality
2%
Cerebrolysin
Mortality
6%
control
P value for mortality
> 0.1
Cerebrolysin versus historical controls; 30 days
Source sentences
Summary
The overall mortality rates at 30 and 90 days were similar in both groups (2% vs 6% and 8% vs 12%, p > 0.1).
2 context sentences(design, population, supporting numbers)
Summary · context
A single-center, prospective, open-label, single-arm study with blinded outcome assessment of 50 consecutive patients with moderate-to-severe AIS treated with MT ≤ 6 h of stroke onset followed by Cerebrolysin (30 ml iv within 8 h of onset and continued to day 21, first cycle)
Summary · context
and in a recovery phase (between 69-90 days, second cycle) compared to 50 historical controls matched by propensity scores.
Report a problemFND-4032534308
08HumanNon-randomized trialSafety outcome
In stroke patients after thrombectomy, mortality at 90 days did not differ significantly between Cerebrolysin and historical controls.
In plain wordsIn stroke patients after thrombectomy, mortality at 90 days did not differ significantly between Cerebrolysin and historical controls.
Peptide
Cerebrolysin
Outcome
No significant changeMortality at 90 days
Study
n = 100
Comparator
Propensity-matched historical controls
Outcome group
Mortality · Whole body
Studied dose
30 ml · intravenous · Continued to day 21 (first cycle); second cycle in a recovery phase between 69-90 daysAs given in this study (human).
Measurements
Mortality
8%
Cerebrolysin
Mortality
12%
control
P value for mortality
> 0.1
Cerebrolysin versus historical controls; 90 days
Source sentences
Summary
The overall mortality rates at 30 and 90 days were similar in both groups (2% vs 6% and 8% vs 12%, p > 0.1).
2 context sentences(design, population, supporting numbers)
Summary · context
A single-center, prospective, open-label, single-arm study with blinded outcome assessment of 50 consecutive patients with moderate-to-severe AIS treated with MT ≤ 6 h of stroke onset followed by Cerebrolysin (30 ml iv within 8 h of onset and continued to day 21, first cycle)
Summary · context
and in a recovery phase (between 69-90 days, second cycle) compared to 50 historical controls matched by propensity scores.
Report a problemFND-4032534309
09HumanNon-randomized trialEfficacy outcome
In stroke patients after thrombectomy, the favorable outcome association with Cerebrolysin was particularly strong in patients with diabetes.
In plain wordsIn stroke patients after thrombectomy, the favorable outcome link with Cerebrolysin was particularly strong in patients with diabetes.
Peptide
Cerebrolysin
Outcome
IncreaseDiabetes interaction for favorable outcomes
Study
n: not reported in source
Comparator
Propensity-matched historical controls
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30 ml · intravenous · Continued to day 21 (first cycle); second cycle in a recovery phase between 69-90 daysAs given in this study (human).
Measurements
Interaction odds ratio
9.6
Diabetes interaction
95% confidence interval for diabetes interaction odds ratio
1.01 to 92
Diabetes interaction for favorable outcomes; 3 months
Source sentences
Summary
Multivariate analysis identified Cerebrolysin as an independent predictor of favorable outcomes at 3 months (OR 7.5, 95% CI 1.8-30.9), particularly in patients with diabetes (interaction OR 9.6, 95% CI 1.01-92).
2 context sentences(design, population, supporting numbers)
Summary · context
A single-center, prospective, open-label, single-arm study with blinded outcome assessment of 50 consecutive patients with moderate-to-severe AIS treated with MT ≤ 6 h of stroke onset followed by Cerebrolysin (30 ml iv within 8 h of onset and continued to day 21, first cycle)
Summary · context
and in a recovery phase (between 69-90 days, second cycle) compared to 50 historical controls matched by propensity scores.
Report a problemFND-4032534307

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · source ClinicalTrials.gov (opens in a new tab)

Status unknownPhase 3NCT04904341

Efficacy of Cerebrolysin Treatment as an add-on Therapy to Mechanical Thrombectomy in Acute Ischemic Stroke.

Military Institute od Medicine National Research Instituten = 501 Jan 2021 to est. 31 Dec 2024

Stroke, Ischemic · Stroke, Acute · Stroke Sequelae

Trial page ClinicalTrials.govUpdated 24 Aug 2022

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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