Combination therapy of Epidermal Growth Factor and Growth Hormone-Releasing Hexapeptide in acute ischemic stroke: a phase I/II non-blinded, randomized clinical trial.

Hernández-Bernal F, Estenoz-García D, Gutiérrez-Ronquillo JH, Martín-Bauta Y, Catasús-Álvarez K, Gutiérrez-Castillo M, Guevara-Rodríguez M, Castro-Jeréz A, Fuentes-González Y, Pinto-Cruz Y, Valenzuela-Silva C, Muzio-González VL and 4 more

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Pérez-Saad H, Subirós-Martínez N, Guillén-Nieto GE, Garcia-Del-Barco-Herrera D

Frontiers in neurology4 Apr 2024Cited by 6 (Europe PMC)

PMID38638315PMCIDPMC11024445DOI10.3389/fneur.2024.1303402PepBankPUB-38638315

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Summary

ObjectiveThis study tested the hypothesis that a neuroprotective combined therapy based on epidermal growth factor (EGF) and growth hormone-releasing hexapeptide (GHRP6) could be safe for acute ischemic stroke patients, admitting up to 30% of serious adverse events (SAE) with proven causality.MethodsA multi-centric, randomized, open-label, controlled, phase I-II clinical trial with parallel groups was conducted (July 2017 to January 2018). Patients aged 18-80 years with a computed tomography-confirmed ischemic stroke and less than 12 h from the onset of symptoms were randomly assigned to the study groups I (75 μg rEGF + 3.5 mg GHRP6 i.v., n=10), II (75 μg rEGF + 5 mg GHRP6 i.v., n=10), or III (standard care control, n=16). Combined therapy was given BID for 7 days. The primary endpoint was safety over 6 months. Secondary endpoints included neurological (NIHSS) and functional [Barthel index and modified Rankin scale (mRS)] outcomes.ResultsThe study population had a mean age of 66 ± 11 years, with 21 men (58.3%), a baseline median NIHSS score of 9 (95% CI: 8-11), and a mean time to treatment of 7.3 ± 2.8 h. Analyses were conducted on an intention-to-treat basis. SAEs were reported in 9 of 16 (56.2%) patients in the control group, 3 of 10 (30%) patients in Group I (odds ratio (OR): 0.33; 95% CI: 0.06-1.78), and 2 of 10 (20%) patients in Group II (OR: 0.19; 95% CI: 0.03-1.22); only two events in one patient in Group I were attributed to the intervention treatment. Compliance with the study hypothesis was greater than 0.90 in each group. Patients treated with EGF + GHRP6 had a favorable neurological and functional evolution at both 90 and 180 days, as evidenced by the inferential analysis of NIHSS, Barthel, and mRS and by their moderate to strong effect size. At 6 months, proportion analysis evidenced a higher survival rate for patients treated with the combined therapy. Ancillary analysis including merged treated groups and utility-weighted mRS also showed a benefit of this combined therapy.ConclusionEGF + GHRP6 therapy was safe. The functional benefits of treatment in this study supported a Phase III study.Clinical trial registrationRPCEC00000214 of the Cuban Public Registry of Clinical Trials, Unique identifier: IG/CIGB-845I/IC/1601.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study9

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone9

In this study, GHRP-6 was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking GHRP-6.

01HumanNot a test of GHRP-6 aloneRandomized controlled trialOther
In the stroke trial, compliance with the safety hypothesis exceeded 0.90 in each group.
In plain wordsIn the stroke trial, compliance with the safety hypothesis exceeded 0.90 in each group.
Peptide
GHRP-6
Outcome
Not applicableSafety hypothesis compliance
Study
n = 36
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Compliance with the safety hypothesis
> 0.9 ratio
each group
Source sentences
Summary
Compliance with the study hypothesis was greater than 0.90 in each group.
4 context sentences(design, population, supporting numbers)
Summary · context
This study tested the hypothesis that a neuroprotective combined therapy based on epidermal growth factor (EGF) and growth hormone-releasing hexapeptide (GHRP6) could be safe for acute ischemic stroke patients, admitting up to 30% of serious adverse events (SAE) with proven causality.
Summary · context
A multi-centric, randomized, open-label, controlled, phase I-II clinical trial with parallel groups was conducted (July 2017 to January 2018).
Summary · context
Patients aged 18-80 years with a computed tomography-confirmed ischemic stroke and less than 12 h from the onset of symptoms were randomly assigned to the study groups I (75 μg rEGF + 3.5 mg GHRP6 i.v., n=10), II (75 μg rEGF + 5 mg GHRP6 i.v., n=10), or III (standard care control, n=16).
Summary · context
Combined therapy was given BID for 7 days.
In this study, GHRP-6 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking GHRP-6.
Show in the study text Report a problemFND-3863831504
02HumanNot a test of GHRP-6 aloneRandomized controlled trialSafety outcome
In ischemic stroke patients, EGF plus GHRP6 Group I had serious adverse events in 30%, versus 56.2% with standard care.
In plain wordsIn stroke patients, serious adverse events occurred in 30% with Group I combination therapy versus 56.2% with standard care.
Peptide
GHRP-6
Outcome
DecreaseSerious adverse events, Group I
Study
n = 26
Comparator
Standard care control
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Serious adverse events
30%
Group I
Odds ratio
0.33 ratio
Group I versus control
Source sentences
Summary
SAEs were reported in 9 of 16 (56.2%) patients in the control group, 3 of 10 (30%) patients in Group I (odds ratio (OR): 0.33; 95% CI: 0.06-1.78)
3 context sentences(design, population, supporting numbers)
Summary · context
A multi-centric, randomized, open-label, controlled, phase I-II clinical trial with parallel groups was conducted (July 2017 to January 2018).
Summary · context
Patients aged 18-80 years with a computed tomography-confirmed ischemic stroke and less than 12 h from the onset of symptoms were randomly assigned to the study groups I (75 μg rEGF + 3.5 mg GHRP6 i.v., n=10), II (75 μg rEGF + 5 mg GHRP6 i.v., n=10), or III (standard care control, n=16).
Summary · context
Combined therapy was given BID for 7 days.
In this study, GHRP-6 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking GHRP-6.
Show in the study text Report a problemFND-3863831501
03HumanNot a test of GHRP-6 aloneRandomized controlled trialSafety outcome
In ischemic stroke patients, EGF plus GHRP6 Group II had serious adverse events in 20%, versus 56.2% with standard care.
In plain wordsIn stroke patients, serious adverse events occurred in 20% with Group II combination therapy versus 56.2% with standard care.
Peptide
GHRP-6
Outcome
DecreaseSerious adverse events, Group II
Study
n = 26
Comparator
Standard care control
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Serious adverse events
20%
Group II
Odds ratio
0.19 ratio
Group II versus control
Source sentences
Summary
SAEs were reported in 9 of 16 (56.2%) patients in the control group, 3 of 10 (30%) patients in Group I (odds ratio (OR): 0.33; 95% CI: 0.06-1.78), and 2 of 10 (20%) patients in Group II (OR: 0.19; 95% CI: 0.03-1.22)
3 context sentences(design, population, supporting numbers)
Summary · context
A multi-centric, randomized, open-label, controlled, phase I-II clinical trial with parallel groups was conducted (July 2017 to January 2018).
Summary · context
Patients aged 18-80 years with a computed tomography-confirmed ischemic stroke and less than 12 h from the onset of symptoms were randomly assigned to the study groups I (75 μg rEGF + 3.5 mg GHRP6 i.v., n=10), II (75 μg rEGF + 5 mg GHRP6 i.v., n=10), or III (standard care control, n=16).
Summary · context
Combined therapy was given BID for 7 days.
In this study, GHRP-6 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking GHRP-6.
Show in the study text Report a problemFND-3863831502
04HumanNot a test of GHRP-6 aloneRandomized controlled trialSafety outcome
In ischemic stroke patients, two serious adverse events in one Group I patient were attributed to EGF plus GHRP6.
In plain wordsIn stroke patients, two serious adverse events in one Group I patient were attributed to the combination treatment.
Peptide
GHRP-6
Outcome
Not applicableTreatment-attributed serious adverse events
Study
n = 10
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Treatment-attributed serious adverse events
2 events
Group I
Patients with treatment-attributed events
1 patients
Group I
Source sentences
Summary
only two events in one patient in Group I were attributed to the intervention treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
A multi-centric, randomized, open-label, controlled, phase I-II clinical trial with parallel groups was conducted (July 2017 to January 2018).
Summary · context
Patients aged 18-80 years with a computed tomography-confirmed ischemic stroke and less than 12 h from the onset of symptoms were randomly assigned to the study groups I (75 μg rEGF + 3.5 mg GHRP6 i.v., n=10), II (75 μg rEGF + 5 mg GHRP6 i.v., n=10), or III (standard care control, n=16).
Summary · context
Combined therapy was given BID for 7 days.
In this study, GHRP-6 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking GHRP-6.
Show in the study text Report a problemFND-3863831503
05HumanNot a test of GHRP-6 aloneRandomized controlled trialEfficacy outcome
In ischemic stroke patients, EGF plus GHRP6 showed favorable NIHSS evolution at both follow-up assessments, with moderate to strong effects.
In plain wordsIn stroke patients, combination therapy showed favorable neurological score changes at both assessments, with moderate to strong effects.
Peptide
GHRP-6
Outcome
Direction not reportedNIHSS at 90 and 180 days
Study
n = 36
Comparator
Standard care control
Analysis
Secondary
Outcome group
Neuroprotection · Nervous system and cognition
Source sentences
Summary
Patients treated with EGF + GHRP6 had a favorable neurological and functional evolution at both 90 and 180 days, as evidenced by the inferential analysis of NIHSS, Barthel, and mRS and by their moderate to strong effect size.
3 context sentences(design, population, supporting numbers)
Summary · context
A multi-centric, randomized, open-label, controlled, phase I-II clinical trial with parallel groups was conducted (July 2017 to January 2018).
Summary · context
Patients aged 18-80 years with a computed tomography-confirmed ischemic stroke and less than 12 h from the onset of symptoms were randomly assigned to the study groups I (75 μg rEGF + 3.5 mg GHRP6 i.v., n=10), II (75 μg rEGF + 5 mg GHRP6 i.v., n=10), or III (standard care control, n=16).
Summary · context
Combined therapy was given BID for 7 days.
In this study, GHRP-6 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking GHRP-6.
Show in the study text Report a problemFND-3863831505
06HumanNot a test of GHRP-6 aloneRandomized controlled trialEfficacy outcome
In ischemic stroke patients, EGF plus GHRP6 showed favorable Barthel index evolution at both follow-up assessments, with moderate to strong effects.
In plain wordsIn stroke patients, combination therapy showed favorable Barthel index changes at both assessments, with moderate to strong effects.
Peptide
GHRP-6
Outcome
Direction not reportedBarthel index at 90 and 180 days
Study
n = 36
Comparator
Standard care control
Analysis
Secondary
Outcome group
Exercise and physical function · Nervous system and cognition
Source sentences
Summary
Patients treated with EGF + GHRP6 had a favorable neurological and functional evolution at both 90 and 180 days, as evidenced by the inferential analysis of NIHSS, Barthel, and mRS and by their moderate to strong effect size.
3 context sentences(design, population, supporting numbers)
Summary · context
A multi-centric, randomized, open-label, controlled, phase I-II clinical trial with parallel groups was conducted (July 2017 to January 2018).
Summary · context
Patients aged 18-80 years with a computed tomography-confirmed ischemic stroke and less than 12 h from the onset of symptoms were randomly assigned to the study groups I (75 μg rEGF + 3.5 mg GHRP6 i.v., n=10), II (75 μg rEGF + 5 mg GHRP6 i.v., n=10), or III (standard care control, n=16).
Summary · context
Combined therapy was given BID for 7 days.
In this study, GHRP-6 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking GHRP-6.
Show in the study text Report a problemFND-3863831506
07HumanNot a test of GHRP-6 aloneRandomized controlled trialEfficacy outcome
In ischemic stroke patients, EGF plus GHRP6 showed favorable mRS evolution at both follow-up assessments, with moderate to strong effects.
In plain wordsIn stroke patients, combination therapy showed favorable disability score changes at both assessments, with moderate to strong effects.
Peptide
GHRP-6
Outcome
Direction not reportedmRS at 90 and 180 days
Study
n = 36
Comparator
Standard care control
Analysis
Secondary
Outcome group
Exercise and physical function · Nervous system and cognition
Source sentences
Summary
Patients treated with EGF + GHRP6 had a favorable neurological and functional evolution at both 90 and 180 days, as evidenced by the inferential analysis of NIHSS, Barthel, and mRS and by their moderate to strong effect size.
3 context sentences(design, population, supporting numbers)
Summary · context
A multi-centric, randomized, open-label, controlled, phase I-II clinical trial with parallel groups was conducted (July 2017 to January 2018).
Summary · context
Patients aged 18-80 years with a computed tomography-confirmed ischemic stroke and less than 12 h from the onset of symptoms were randomly assigned to the study groups I (75 μg rEGF + 3.5 mg GHRP6 i.v., n=10), II (75 μg rEGF + 5 mg GHRP6 i.v., n=10), or III (standard care control, n=16).
Summary · context
Combined therapy was given BID for 7 days.
In this study, GHRP-6 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking GHRP-6.
Show in the study text Report a problemFND-3863831507
08HumanNot a test of GHRP-6 aloneRandomized controlled trialSafety outcome
In ischemic stroke patients, EGF plus GHRP6 showed higher survival at 6 months than standard care.
In plain wordsIn stroke patients, combination therapy showed higher survival at 6 months than standard care.
Peptide
GHRP-6
Outcome
IncreaseSurvival at 6 months
Study
n = 36
Comparator
Standard care control
Outcome group
Mortality · Whole body
Source sentences
Summary
At 6 months, proportion analysis evidenced a higher survival rate for patients treated with the combined therapy.
3 context sentences(design, population, supporting numbers)
Summary · context
A multi-centric, randomized, open-label, controlled, phase I-II clinical trial with parallel groups was conducted (July 2017 to January 2018).
Summary · context
Patients aged 18-80 years with a computed tomography-confirmed ischemic stroke and less than 12 h from the onset of symptoms were randomly assigned to the study groups I (75 μg rEGF + 3.5 mg GHRP6 i.v., n=10), II (75 μg rEGF + 5 mg GHRP6 i.v., n=10), or III (standard care control, n=16).
Summary · context
Combined therapy was given BID for 7 days.
In this study, GHRP-6 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking GHRP-6.
Show in the study text Report a problemFND-3863831508
09HumanNot a test of GHRP-6 aloneRandomized controlled trialEfficacy outcome
In ischemic stroke patients, ancillary analysis of merged EGF plus GHRP6 groups showed benefit on utility-weighted mRS.
In plain wordsIn stroke patients, an additional analysis of combined treatment groups showed a benefit on utility-weighted disability scores.
Peptide
GHRP-6
Outcome
Direction not reportedUtility-weighted mRS
Study
n = 36
Comparator
Standard care control
Outcome group
Exercise and physical function · Nervous system and cognition
Source sentences
Summary
Ancillary analysis including merged treated groups and utility-weighted mRS also showed a benefit of this combined therapy.
3 context sentences(design, population, supporting numbers)
Summary · context
A multi-centric, randomized, open-label, controlled, phase I-II clinical trial with parallel groups was conducted (July 2017 to January 2018).
Summary · context
Patients aged 18-80 years with a computed tomography-confirmed ischemic stroke and less than 12 h from the onset of symptoms were randomly assigned to the study groups I (75 μg rEGF + 3.5 mg GHRP6 i.v., n=10), II (75 μg rEGF + 5 mg GHRP6 i.v., n=10), or III (standard care control, n=16).
Summary · context
Combined therapy was given BID for 7 days.
In this study, GHRP-6 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking GHRP-6.
Show in the study text Report a problemFND-3863831509

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Version 2Current
21 Oct 2026, 15:58 UTC
Study results updated
Version 1
9 Oct 2026, 03:13 UTC
First added · source update from Europe PMC

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