Cerebrolysin

Cerebrolysin (developmental code name FPF-1070) is a mixture of enzymatically treated peptides derived from pig brain whose constituents can include brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), nerve growth factor (NGF), and ciliary neurotrophic factor (CNTF).

Cerebrolysin
Vial of the product
Clinical data
Other namesFPF-1070
Identifiers
CAS Number
DrugBank
UNII

Cerebrolysin has also been studied for potential use with a wide variety of neurodegenerative disorders, though research is preliminary.[1] Cochrane reviews suggest no benefit in the treatment of acute stroke and an increased rate of spontaneous adverse events requiring hospitalization.[2] Conversely, reviews suggest positive effect when cerebrolysin is used with vascular dementia.[3] All Cochrane analyses to date stress that these relationships needed to be confirmed by further high quality clinical trials.

Medical uses

Stroke

Reviews suggest no benefit for treatment of acute ischemic stroke with cerebrolysin, though they also emphasize the need for further high quality studies. In addition, cerebrolysin use was associated with a higher rate of spontaneous adverse events requiring hospitalization.[2] Studies of ischemic stroke in Asian subpopulations also found an absence of benefit.[4]

An early study also suggested a lack of benefit with hemorrhagic stroke related to cerebral aneurysm.[5]

Dementia

Reviews suggest an improvement in cognitive function with cerebrolysin use for vascular dementia, though as with studies on stroke, further high quality research is needed.[3]

Adverse effects

In trials studying the use of cerebrolysin after acute stroke, there was an increased risk of "serious adverse events" requiring hospitalization. These were specifically defined as:

"...any untoward medical occurrence that, at any dose, resulted in death, [was] life‐threatening, required inpatient hospitalisation or resulted in prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, [was] a congenital anomaly/birth defect, or [was] a medically important event or reaction”.[2]

Mechanism of action

In vitro and animal studies suggest neurotrophic effects of cerebrolysin similar to endogenous neurotrophic factors, though its specific molecular pharmacodynamics are not clear.[6] Studies of dementia suggest decreased beta-amyloid deposition.[7]

History

The preparation was allegedly first created in 1949 by Gerhart Harrer, an Austrian professor at the University of Innsbruck.

Cerebrolysin is widely used in Russia, Eastern Europe, China, and other post-Soviet and Asian countries.[2] It has been included on the list of Vital and Essential Medicines (ЖНВЛС) in Russia since 1992.[8]

Cerebrolysin is not a scheduled drug in the United States.[9][10]

Research

Early studies have suggested potential use of cerebrolysin with a wide variety of neurodegenerative disorders, including traumatic brain injury,[11][12] schizophrenia,[13] multiple sclerosis,[14] cerebral palsy[15] and spinal cord injury[16][17] though research is still preliminary.

References
  1. Windisch M, Gschanes A, Hutter-Paier B (1998). "Neurotrophic activities and therapeutic experience with a brain derived peptide preparation". Ageing and Dementia. Journal of Neural Transmission. Supplementa. Vol. 53. pp. 289–98. doi:10.1007/978-3-7091-6467-9_25. ISBN 978-3-211-83114-4. PMID 9700665.
  2. Ziganshina, LE; Abakumova, T; Hoyle, CH (14 July 2020). "Cerebrolysin for acute ischaemic stroke". The Cochrane Database of Systematic Reviews. 7 (9): CD007026. doi:10.1002/14651858.CD007026.pub6. PMC 7387239. PMID 32662068.
  3. Cui, S; Chen, N; Yang, M; Guo, J; Zhou, M; Zhu, C; He, L (11 November 2019). "Cerebrolysin for vascular dementia". The Cochrane Database of Systematic Reviews. 2019 (11). doi:10.1002/14651858.CD008900.pub3. PMC 6844361. PMID 31710397.
  4. Heiss, WD; Brainin, M; Bornstein, NM; Tuomilehto, J; Hong, Z; Cerebrolysin Acute Stroke Treatment in Asia (CASTA), Investigators. (March 2012). "Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial". Stroke. 43 (3): 630–6. doi:10.1161/STROKEAHA.111.628537. PMID 22282884. S2CID 26004422.
  5. Woo, PYM; Ho, JWK; Ko, NMW; Li, RPT; Jian, L; Chu, ACH; Kwan, MCL; Chan, Y; Wong, AKS; Wong, HT; Chan, KY; Kwok, JCK (3 November 2020). "Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage". BMC Neurology. 20 (1): 401. doi:10.1186/s12883-020-01908-9. PMC 7607674. PMID 33143640.
  6. Plosker, GL; Gauthier, S (2009). "Cerebrolysin: a review of its use in dementia". Drugs & Aging. 26 (11): 893–915. doi:10.2165/11203320-000000000-00000. PMID 19848437.
  7. Masliah E, Díez-Tejedor E (2012). "The pharmacology of neurotrophic treatment with Cerebrolysin: brain protection and repair to counteract pathologies of acute and chronic neurological disorders". Drugs Today. 48 (Suppl A): 3–24. doi:10.1358/dot.2012.48(Suppl.A).1739716 (inactive 31 July 2022). PMID 22514792.{{cite journal}}: CS1 maint: DOI inactive as of July 2022 (link)
  8. распоряжением Правительства РФ от 7 декабря 2011 года № 2199-р
  9. Rogers, Steve (29 October 2020). "Nicholasville compounding pharmacy, owner plead guilty to distribution". ABC 36 News.
  10. "Nicholasville Compounding Pharmacy and Its Owner Sentenced for Unlawful Distribution of Prescription Drugs Unlawful Distribution of Prescription Drugs". www.justice.gov. 24 February 2021.
  11. Ghaffarpasand, F; Torabi, S; Rasti, A; Niakan, MH; Aghabaklou, S; Pakzad, F; Beheshtian, MS; Tabrizi, R (2019). "Effects of cerebrolysin on functional outcome of patients with traumatic brain injury: a systematic review and meta-analysis". Neuropsychiatric Disease and Treatment. 15: 127–135. doi:10.2147/NDT.S186865. PMC 6311329. PMID 30643411.
  12. El Sayed, I; Zaki, A; Fayed, AM; Shehata, GM; Abdelmonem, S (April 2018). "A meta-analysis of the effect of different neuroprotective drugs in management of patients with traumatic brain injury". Neurosurgical Review. 41 (2): 427–438. doi:10.1007/s10143-016-0775-y. PMID 27539610. S2CID 3980956.
  13. Xiao, S; Xue, H; Li, G; Yuan, C; Li, X; Chen, C; Wu, HZ; Mitchell, P; Zhang, M (February 2012). "Therapeutic effects of cerebrolysin added to risperidone in patients with schizophrenia dominated by negative symptoms". The Australian and New Zealand Journal of Psychiatry. 46 (2): 153–60. doi:10.1177/0004867411433213. PMID 22311531. S2CID 206397952.
  14. Khabirov, FA; Khaybullin, TI; Granatov, EV; Shakirzianova, SR (2016). "[Effect of cerebrolysin on remyelination processes in multiple sclerosis patients in stage of relapse regression]". Zhurnal Nevrologii I Psikhiatrii Imeni S.S. Korsakova. 116 (12): 48–53. doi:10.17116/jnevro201611612148-53. PMID 28139626.
  15. Nasiri, J; Safavifar, F (June 2017). "Effect of cerebrolysin on gross motor function of children with cerebral palsy: a clinical trial". Acta Neurologica Belgica. 117 (2): 501–505. doi:10.1007/s13760-016-0743-x. PMID 28074392. S2CID 3805375.
  16. Allam, AFA; Abotakia, TAA; Koptan, W (July 2018). "Role of Cerebrolysin in cervical spondylotic myelopathy patients: a prospective randomized study". The Spine Journal. 18 (7): 1136–1142. doi:10.1016/j.spinee.2017.11.002. PMID 29155000. S2CID 23283518.
  17. Menon PK, Muresanu DF, Sharma A, Mössler H, Sharma HS (2012). "Cerebrolysin, a mixture of neurotrophic factors induces marked neuroprotection in spinal cord injury following intoxication of engineered nanoparticles from metals". CNS Neurol Disord Drug Targets. 11 (1): 40–9. doi:10.2174/187152712799960781. PMID 22229324.
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