None, I. C., None, G. G., None, R. S., None, I. C. & None, M. K. (2025). Efficacy of Cerebroprotein Hydrolysate as a Neuroprotective Agent in Acute Spinal Cord Injury: A Prospective Study. Journal of Contemporary Clinical Practice, 11(11), 638-645.
MLA
None, I.D. C., et al. "Efficacy of Cerebroprotein Hydrolysate as a Neuroprotective Agent in Acute Spinal Cord Injury: A Prospective Study." Journal of Contemporary Clinical Practice 11.11 (2025): 638-645.
Chicago
None, I.D. C., Gaurav G. , Rakesh S. , Ishant C. and Mahim K. . "Efficacy of Cerebroprotein Hydrolysate as a Neuroprotective Agent in Acute Spinal Cord Injury: A Prospective Study." Journal of Contemporary Clinical Practice 11, no. 11 (2025): 638-645.
Harvard
None, I. C., None, G. G., None, R. S., None, I. C. and None, M. K. (2025) 'Efficacy of Cerebroprotein Hydrolysate as a Neuroprotective Agent in Acute Spinal Cord Injury: A Prospective Study' Journal of Contemporary Clinical Practice 11(11), pp. 638-645.
Vancouver
I.D. IC, Gaurav GG, Rakesh RS, Ishant IC, Mahim MK. Efficacy of Cerebroprotein Hydrolysate as a Neuroprotective Agent in Acute Spinal Cord Injury: A Prospective Study. Journal of Contemporary Clinical Practice. 2025 Nov;11(11):638-645.
Background: Spinal cord injury is an extremely serious and world most disasterous type of physical trauma that can have a lasting and significant impact on most aspects of daily life leading to a grievous clinical situation. This can have major functional, medical, financial, social and physiological effect for which there is no effective treatment till today. Anyone who survived from such injury used to live with morbidily and other complication. In case of acute spinal cord injury methylprednisolone is a standard treatment option. It can result in Tetraplegia /quadriplegia, paraplegia and other lifetime disabilities. Cerebroproteinhydrolysate a neuropeptide synthetic preparation having neurotropic and neuroprotective role, being successfully used in the treatment of Alzheimers disease, in acute cerebrovascular strokes, traumatic brain injury with proven benefits. Few studies support its role in spinal cord injury benefits.. Cerebroproteinhydrolysate is a mixture of different neurotrophic factors such as BDNF, GDNF and NGF used to treat the normal SCI our experience showed that Cerebroprotein hydrolysate resulted in good neuroprotection. This prospective study was conducted in the neurosurgery unit of surgery department in Gandhi medical college &Associated Hamidia Hospital Bhopal in this study 240 patients of acute spinal cord injury were enrolled who reported in the emergency department within 8 hours of traumatic injury. We assessed the efficacy and safety of cerebroproteinhydrolysate (cerehenz) in the treatment of traumatic acute spinal cord injury and its outcome. Cerebroproteinhydrolysate treated group was compared to the conventional therapy (controlled) group. There was a statistically significant (p value=0.001) seen in improvement in terms of functional outcome in patients treated with cerebroproteinhydrolysate. These patients have significant motor and partial sensory recovery including the sensations of touch, pressure, vibration and pain: from A to B score on ASIA scale. Initial prehospital management of traumatic acute spinal cord injury is crucial for the morbidity and mortality following acute SCI. For a long time no proper and promising treatment for SCI was available. This study shows that cerebroprotienhydrolaste has beneficial outcomes as immediate neuroprotective therapy and ensuring the spinal cord perfusion pressure augmentation has no complications and the results are promising. Our results suggest that patients with traumatic acute spinal cord injuries when treated with cerebroproteinhydrolysate are benefitted significantly in regards to functional outcome and it can be safely used. The prediction of neurological and functional outcomes after spinal cord injury (SCI) is essential to answer patients' questions regarding their functional potential and to understand the amount of resources required during inpatient rehabilitation and after discharge. Though a large size randomized control trials are required to authenticate its potential benefits.
Keywords
Cerebroproteinhydrolysate
Neuroprotection
Paraplegia
Spinal Cord Injury (SCI)
Blood Spinal Cord Barrier (BSCB)
Methylprednisolone
Tetra / Quadriplegia.
INTRODUCTION
Spinal cord injury (SCI) is a debilitating disease and can occur following motor vehicle accidents or falls. Depending on the magnitude and severity, SCI could result in the quadriplegia/ tetraplegia, paraplegia and other lifetime disabilities [1, 2]. Anyone who survived from such injury used to live with morbidity and other complications such as breathing problems, blood clots, kidney failure, urinary problem & pressure sores, DVT and constipation etc. SCI can occur at any age but it is most frequent in young adult age group ie productive age group between 20-45 years. Spinal cord injury is mostly either traumatic but same time it can also be nontramatic also.
Traumatic injuries are caused by (RTA) Road traffic accident, Domestic work related accidents, sport’s injury and stab injuries etc. [3, 4]. While the nontramatic SCI can be caused by infections, cyst or tumours and osteoporosis etc. Spinal cord injury (SCI) is either complete or incomplete. In complete spinal cord injury the normal spinal cord is disrupted which can result from contusion, compression, penetrating or maceration of the spinal cord. The spinal cord lesion consists of. Neuronal injury, blood vessel injury, central grey matter bleeding, spinal cord oedema and dural injury. Following SCI, damage to the nerve cell, nerve fibres and supporting cells continues within the spinal cord after hours and continues for several days or even for weeks, this is the secondary damage[5]. During secondary spinal cord damage there is blood flow changes (damage blood flow) at the level of injury, excessive release of the neurotransmitters (Glutamate), inflammatory response, attack of free radicals on neurons and neuronal apoptosis. During the delayed secondary spinal cord injury the treatment may reduce the extent of damage and disability like methlepredinisolone given continuously within 8 hours of the injury. Methlepredinisolone improves recovery (NASCIS trial I, II, III). The immediate surgical treatment is to remove the compressing element, correction of misalignment and stabilization of the spine. We present the beneficial role of Cerebroprotein Hydrolysate (Cerehenz) as Neuroprotection in Acute Spinal Cord Injury[6-8].
Table-1: Demographics of subjects
Variables Results (N=240)
Age : mean + s.d. (years) 45.23 + 13.78
Gender (male:female) (n) 198:42
Post-injury time : mean + s.d. (months) 51.52+47.87
Stages : subacute/chronic (n) 42P:198
Level of injury (tetraplegia:paraplegia) (n) 98:142
AIS (A:b:C:D) (n) 104:11:54:71
Abbreviation: AIS, ASIA impairment scale.
AIMS AND OBJECTIVE
The aim of the study is to assess the efficacy and safety of the cerebroproteinhydrolysate and to assess the clinical outcome in the patients included in present study, whether there is difference in the outcome with regards to the standard treatment including methylprednisolone versus cerebroprotein hydrolysate. The methylprednisolone is an anti-inflammatory drug and is effective when administered within 8 hours of the injury however there are various limitation of this drug [5, 6]. In severe SCI with complete paralysis the higher doses of methylprednisolone are given which result in several complications such as muscles weakness, blood clot in the veins and /or no improvement in the injury. Cerebroprotein hydrolysate (Cerehenz) a promising drug in the treatment of SCI which is available for clinical use induces Neuroprotection and help in regeneration of neurons. Higher doses of cerebroproteinhydrolysate are effective in the SCI patients.
MATERIALS AND METHODS
240 patients of traumatic spinal cord injury were enrolled in the present study this study included patients with acute traumatic spinal cord injury who reported in the emergency/ casualty department and admitted within 8 hours of the injury. After admissions and primary management complete neurological evaluation was done with x-ray, CT scan and /or Magnetic resonance imaging (MRI) in a period of 60 month from a total of 240 patients with traumatic spinal cord injuries two groups were made, each group consist of 120 patients. Group I the control group received usual conventional treatment Methlepredinisolone+methylcobalamine andsupportive treatment and the group II (study group) patients received intravenous cerebro- protein hydrolysate 60 mg 12hourly for a period of 21 days and a protocol of intravenous fluids to ensures the spinal cord perfusion presence augmentation.
These patients are examined for other injures also and proper care of airway, breathing and circulation was taken i.e. fluids hydration is looked properly.
Source of data
All Consecutive Spinal Cord Injury (SCI) patients admitted in the neurosurgery unit of department of Surgery from July 2017- June 2022 at Gandhi Medical College & Associated Hamidia Hospital, Bhopal are included in this study.
Inclusion criteria:
All Spinal cord injury (SCI) patients who reported in emergency / casualty ward within 8 hours of injury were admitted in the neurosurgery unit of surgery department.
Exclusion criteria:
• Head injury patients were totally excluded - Patients with deranged consciousness/altered sensorium.
• Patients with abdominal trauma. - Patients not giving consent, non-cooperative attendee.
• Immunocompromised patients (e.g. H.I.V patients).
OBSERVATIONS
SCI is most common in younger age group in productive between 20-45 years. Males are more susceptible for spinal cord injury and males are majority in number (202 & 38 females) in present study. Majority of cases of spinal cord injury in our study are because of road traffic injury followed by fall from height. All Cervical injury patients had tetraplegia / quadraplegia, dorsal injury patients & dorsolumbar injury patients had paraplegia. Out of 240 patients in cerebroprotienhydrolaste treated group. 64 patients were of cervical injury, 156 patients were of dorsal injury and 20 patients were of dorsolumbar injury (D11 - L1). 112 patients with complete SCI received usual treatment: Methlepredinisolone and surgery for decompression, stabilization, and realignment of the spine and twenty eight patients (only A score on ASIA scale) received cerebroprotienhydrolaste and a protocol of intravenous fluids ensures the spinal cord perfusion pressure augmentation. Group 1 patients who received conventional Methylprednisolone no significant motor improvements were observed but late sensory improvement was seen after 6 months.
Group 2 patients who received cerebroprotienhydrolaste in dose of 60 mg two times per day minimum for 3 weeks (21 days), significant motor improvement was observed along with sensory improvement.
RESULTS
We have compared the cerebroproteinhydrolysate group to the conventionally treated group (controlled Group). There was a statistically significant (P value = 0.001) improvement was seen in terms of functional outcome in patients who were treated with cerebroprotien hydrolysate. These patients have significant motor and partial sensory recovery including the sensation of Touch, Pressure, vibration and pain: from A to B scale on ASIA scale. The patients with complete spinal cord injury the complete sensory recovery, restoration of sensation of passive legs movement, return of bladder control and return of both patellar reflex. The possible mechanism of cerebroprotienhydrolysate induced Neuroprotection in Spinal Cord injury probably is that cerebroproteinhydrolysate results in marked reduction in blood spinal cord barrier (BSCB) breakdown and edema formation in normal patients after SCI. there are many Neurotrophic factors such on BDNF, GDNF,CNTF or NGF [7,8] which can be used to treat the normal injures but in case of Spinal cord injury (SCI) cerebroproteinhydrolysate induces the neuroprotection, in combination of various neurotrophic factors, aminoacids, vitamins macronutrients and antioxidant enzymes. Cerebroprotein hydrolysate significantly reduces the blood spinal cord barrier(BSCB) permeability reduces the water content and also reduces the extent of neuronal cell damage inside the cord, therefore dose related cerebroprotein hydrolysate induces neuroprotection inside the cord. Data suggest that a higher dose of cerebroprotein hydrolysate has good results.
DISCUSSION
Immediate hospitalization and early treatment for spinal cord injury within eight hours of injury is of upmost importance, patients with complete spinal cord injury have bleak chances of recovery.
If the surgical treatment is needed must be done, the decompression by removing the compressing element, gross alignment must be corrected and spinal stabilization must be done preferably within a period of eight hours[9]. Niklas Marklund said about the Spinal Cord regeneration that “The current treatment option for patients with SCI are limited and the Neurosurgeon is crucial in the initial management, including the medical stabilization and the timing of surgical treatment “Also he showed that” initial prehospital management of SCI should follow the ATLS Principle including stabilization, airway management and blood pressure control[10-11]. In specialized center and in intensive care unit (ICU), there is improvement in patients management with reduction in morbidly with aggressive management of secondary abuse/ insult” Methylprednisolone is not standard of care anymore “optional at the last although could still be considered in view of the lake of other treatment options. Patients with traumatic lesions were significantly younger. They were more often men, but this difference disappeared in the group below 50 years; this is in line with recent epidemiological studies that showed an increased percentage of women in the traumatic SCI population.
Motor scores at admission and discharge, cerebroproteinlysate traumatic SCI patients tended to present a slightly better recovery who were treated with the current recommendation is to treat all the patients of Spinal Cord injury according to the local protocol. If steroids are recommended they should be started within 8 hours of the injury with the protocol of methylpredinisolone ie 30 mg/kg as a bolus in 15 minutes and then 5-4 mg/kg/hr for a period of 23 hours and this infusion to be started 45 minutes after the bolus[12-13].
The prime and main aim in the management of spinal cord injury is to minimise the direct effect of trauma on spinal cord and to stop or abolish the secondary spinal cord injury,
Mechanism of action of CerebroProtein Hydrolysate
• Neuroprotection –Excitotoxicity , Reduces oxidative stress
• Neurogenesis and Neuron survival
• Neuronal plasticity
• Improves spinal cord perfusion
• Modulation of signaling pathway
• Controls and enhances the growth and functioning of nerve cell.
• Anti-inflammatory effects, antiapotosis.
Reported Benefits
• Small peptides in CPH mimic endogenous neurotropic factors which are crucial for promoting neuronal survival and growth.
• Functional recovery
• Reduces neurological deficit.
• Improved activities of daily living
• Safety profile.
Considerations:
• Need further research
• Dose dependent effect.
CONCLUSION
Initial prehospital management of traumatic acute spinal cord injury is crucial for the morbidity and mortality following acute SCI. For a long time no proper and promising treatment for SCI was available. This study shows that cerebroprotienhydrolaste has beneficial outcomes as immediate neuroprotective therapy and ensuring the spinal cord perfusion pressure augmentation has no complications and the results are promising. Our results suggest that patients with traumatic acute spinal cord injuries when treated with cerebroproteinhydrolysate are benefitted significantly in regards to functional outcome and it can be safely used.
An efficient treatment in spinal cord lesions must combine more main approaches; - minimising the initial damage and protecting surviving neurons neuroprotection, efficient treatment in spinal cord removing barriers: after the injury the scar tissue gradually fills the damaged area and it is an impenetrable barrier and it does not allow regenerating nerve fibres to pass through. blocking factors which inhibit neural regeneration
modulation of inflammatory response following spinal cord injury,
Neurotrophins and growth factors play an important role in development of the central nervous system and several neurotrophicfactors induce neuroprotection in traumatic spinal cord injuries. Understanding the mechanisms by which adult stem cells produce growth factors and the effect of components of the spinal cord injury milieu to stimulate growth factor production and to promote spinal cord lesion repair are very significant issues.
A combination of stem cells therapy / with neurotrophins is a novel aspect of ''treatment in spinal cord injury and it will attenuate the neurological damage and could help restore the normal function of spinal cord.
Though a large size randomized control trials are required to authenticate the potential benefits of the Cerebroprotein Hydrolysate (Cerehenz) in Acute spinal cord injury.
ABBREVIATIONS
SCI= Spinal cord injury
NGF= Nerve growth factor
BDNF= Brain derived growth factor
GDNF= Glial cell line derived Neurotrophic factor
BSCB= Blood spinal cord barrier
ATLS= Advance trauma life support
Conflict of Interest: Author declares no conflict of interest.
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