Safety and Efficacy of Cerebrolysin in Infants with Communication Defects due to Severe Perinatal Brain Insult: A Randomized Controlled Clinical Trial

Abstract

Background and PurposeThe neuroregenerative drug Cerebrolysin has demonstrated efficacy in improving cognition in adults with stroke and Alzheimer's disease. The aim of this study was to determine the efficacy and safety of Cerebrolysin in the treatment of communication defects in infants with severe perinatal brain insult.MethodsA randomized placebo-controlled clinical trial was conducted in which 158 infants (age 6-21 months) with communication defects due to severe perinatal brain insult were enrolled; 120 infants completed the study. The Cerebrolysin group (n=60) received twice-weekly Cerebrolysin injections of 0.1 mL/kg body weight for 5 weeks (total of ten injections). The placebo group (n=60) received the same amount and number of normal saline injections.ResultsThe baseline Communication and Symbolic-Behavior-Scale-Developmental Profile scores were comparable between the two groups. After 3 months, the placebo group exhibited improvements in the social (p<0.01) and speech composite (p=0.02) scores, with 10% and 1.5% increases from baseline, respectively. The scores of the Cerebrolysin group changed from concern to no concern, with increases of 65.44%, 45.54%, 358.06%, and 96.00% from baseline in the social (p<0.001), speech (p<0.001), symbolic (p<0.001), and total (p<0.001) scores.ConclusionsCerebrolysin dramatically improved infants' communication especially symbolic behavior which positively affected social interaction. These findings suggest that cerebrolysin may be an effective and feasible way equivalent to stem cell therapy.

Human Umbilical Cord Blood CD34-Positive Cells as Predictors of the Incidence and Short-Term Outcome of Neonatal Hypoxic-Ischemic Encephalopathy: A Pilot Study

“…Predicting the occurrence and short-term outcome in neonates with HIE is particularly important for initiating and monitoring appropriate management 3. This has become even more important with the current availability of effective neuroprotective strategies such as therapeutic hypothermia and the administration of nerve growth factor 456. This may prove even more valid with the envisioned use of other, mainly pharmacological neuroprotective agents and strategies 7.…”

A Clinical Trial Evaluating the Safety and Efficiency of Cerebrolysin in Children with Autism Spectrum Disorders

“…Cerebrolysin is able to reduce the neurotoxicity, inhibit the free radical production, activate the microglia, trigger the neurotrophic activity, promote the neuronal budding, enhance the cellular life expansion, and improve the neurogenesis after cerebral stroke (14). It improved language development and com¬munication, and notably, symbolic behavior in infants with severe perinatal brain insult (15). Crebrolysin effect has also been confirmed in acute ischemic stroke treatment, autism and vascular dementia, and other neurodegenerative disorders (16).…”

“…Drug was administered 0.1 cc/Kg via intramuscular route (15,19), three days a week in the first month. In the second month, first to fourth week the patients received 2, 2, 1, and 1 injection per week (Figure 1).…”

“…Cerebrolysin is generally safe and well-tolerated by children. Adverse drug reactions are usually mild and may include: Flue-like syndrome, confusion, anxiety, agitation, diarrhea, and vomiting (15,(18)(19)(20). Autism spectrum disorders have disabling effects on different aspects of parents' life.…”

Clinical neurorestorative progresses in cerebral palsy

“…After 3 months, the scores of the cerebrolysin group showed an increase of 65.44%, 45.54%, 358.06%, and 96.00% from baseline in the social skills, speech, symbolic behavior, and total scores, respectively. 10 Similarly, a point injection of cerebrolysin given for 8 years to a child with CP resulted in significant functional and cognitive improvement. 11 The underlying mechanism of action of gangliosides is similar to that of cerebrolysin.…”