Clinical Trial of Ischemic Stroke

Ischemic stroke is a condition where there is one or more blockages in the blood vessels in the brain. These blockages lead to the death of brain cells due to impaired blood flow (Chugh, 2019).

Brain cells die due to lack of oxygen supply caused by blocked blood flow. The death of these cells can result in disability. Ischemic stroke is the second leading cause of death worldwide and also causes disability in its sufferers. In Indonesia, stroke is one of the most common causes of death, with a stroke prevalence rate of 12.1 per 1000 population (Riskesdas, 2018).

Standard treatment for ischemic stroke is tailored to the severity and location of the blood vessel blockage in the brain. The first treatment administered is reperfusion, which restores blood flow through the use of medications like R-TPA (Recombinant- Tissue Plasminogen Activator). Reperfusion aims to dissolve blood clots that block blood vessels. However, this reperfusion has limitations as it is only effective in ischemic strokes within less than 4.5 hours, making less than 5% of cases eligible for this RTPA candidacy (Fonarow et al, 2011).

The type of therapy that has gained attention in recent years due to its effectiveness is stem cell therapy. Ischemic stroke itself can be treated with stem cell therapy through the induction of new brain cells formation and can also provide neurotrophic factors that will reduce inflammation in the brain. (Cunningham et al., 2018). One type of stem cell that can be a choice is Mesenchymal Stem Cell (MSC).

 

MSC can originate from the human umbilical cord tissue, commonly referred to as Umbilical Cord Mesenchymal Stem Cells (UC-MSC). UC-MSC has the capability to differentiate into specific cells such as neurons (brain cells). Therefore, it is predicted that the use of UC-MSC could support the formation of new neurons to replace those lost due to stroke. It is hoped that these new neurons can restore lost motor functions caused by stroke (Cunningham et al., 2018). In addition to MSCs, the growth medium of stem cells, also known as Conditioned Medium (CM), also holds potential for ischemic stroke therapy because it produces similar molecules to MSCs, although its effects may not last as long as MSCs.

 

At present, ProSTEM, alongside the research team led by Dr. Muhammad Agus Aulia, SpBS, is conducting a clinical trial entitled "Neurogenesis Induction Neurogenesis dengan Kombinasi Conditioned Medium and Umbilical-derived Mesenchymal Stem Cell as a Novel Strategy for Ischemic Stroke' at Gatot Subroto Hospital, Central Jakarta, with ethical approval number: 23/III/KEPK/2022. It is hoped that this research will enhance services in the field of neurology, particularly in stroke therapy

References :

1  Chugh C. (2019). Acute Ischemic Stroke: Management Approach. Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine, 23(Suppl 2), S140–S146. https://doi.org/10.5005/jp-journals-10071-23192

2  Cunningham, C. J., Redondo-Castro, E., & Allan, S. M. (2018). The therapeutic potential of the mesenchymal stem cell secretome in ischaemic stroke. Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism, 38(8), 1276–1292. https://doi.org/10.1177/0271678X18776802

3 Fonarow GC, Smith EE, Saver JL, Reeves MJ, Bhatt DL, Grau-Sepulveda MV, et al. 2011. Timeliness of Tissue-Type Plasminogen Activator Therapy in Acute Ischemic Stroke: Patient Characteristics, Hospital Factors, and Outcomes Associated With Door-to-Needle Times Within 60 Minutes. Circulation. 123 (7) :750–8.

4 Riskesdas (Riset Kesehatan Dasar). (2018). Hasil Utama RISKESDAS 2018. https://kesmas.kemkes.go.id/assets/upload/dir_519d41d8cd98f00/files/Hasil-riskesdas-2018_1274.pdf

For research criteria and registration requirements, please refer to the following link :

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