Safety of intraparenchymal injection of allogenic placenta mesenchymal stem cells derived exosome in patients undergoing decompressive craniectomy following malignant middle cerebral artery infarct, a pilot randomized clinical trial

Leila Dehghani; Arash Khojasteh; Masoud Soleimani; Saeed Oraee-Yazdani; Saeed Heidari Keshel; Mohammad Saadatnia; Masih Saboori; Alireza Zali; Seyed Mahmoud Hashemi; Reyhane Soleimani

doi:10.4103/ijpvm.ijpvm_441_21

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ORIGINAL ARTICLE

Year : 2022 | Volume : 13 | Issue : 1 | Page : 7

Safety of intraparenchymal injection of allogenic placenta mesenchymal stem cells derived exosome in patients undergoing decompressive craniectomy following malignant middle cerebral artery infarct, a pilot randomized clinical trial

Leila Dehghani¹, Arash Khojasteh¹, Masoud Soleimani², Saeed Oraee-Yazdani³, Saeed Heidari Keshel¹, Mohammad Saadatnia⁴, Masih Saboori⁵, Alireza Zali⁴, Seyed Mahmoud Hashemi⁶, Reyhane Soleimani⁷
¹ Department of Tissue Engineering and Applied Cell Sciences, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
² Department of Tissue Engineering and Applied Cell Sciences, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences; Department of Hematology, Faculty of Medical Sciences Tarbiat Modares University; Medical Nanotechnology and Tissue engineering Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
³ Functional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, Iran
⁴ Department of Neurology, School of Medicine Isfahan University of Medical Sciences, Isfahan, Iran
⁵ Department of Neurosurgery, School of Medicine Isfahan University of Medical Sciences, Isfahan, Iran
⁶ Department of Tissue Engineering and Applied Cell Sciences, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences Department of Immunology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
⁷ Department of Neurology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Correspondence Address:
Arash Khojasteh
Department of Tissue Engineering and Applied Cell Sciences, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran
Iran
Saeed Oraee-Yazdani
Functional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran
Iran

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/ijpvm.ijpvm_441_21

Background: Malignant middle cerebral artery infarct (mMCAI) largely contributes to high mortality and physical disability among adults. Surviving individuals may not have proper outcomes and suffer from severe lasting disabilities. Utilization of stem cells and paracrine factor for regenerative purposes is considered as a potential strategy for patients with neurological deficits. While preclinical stroke studies have shown that mesenchymal stem cells (MSCs) reduce post-treatment neurological deficits and prevent disability and also promote recovery, few randomized clinical trials (RCT) have assessed exosome therapy in humans. Methods: In this RCT, we assessed the safety of intraparenchymal injection placenta MSC-derived Exosome in mMCAI patients with average age of 62 years between January, 2019, till September, 2020. The study was done in a single-center as an open-label RCT, with a 3-months follow-up. Primary outcomes assessed the safety and also disability indexes were followed. Results: Five mMCAI patients were included with mean NIHSS: 17.6 ± 5.02. The mean MRS was 3.25 ± 0.95 in three patients. No serious adverse events were observed. Hematoma or local reaction as excessive edema were not seen at the site of injection. Conclusions: Intraparenchymal implantation of MSC-EXO showed no post-interventional adverse effects in five ischemic stroke patients. It is proposed Local injection Exosome treatment following mMCAI can be safe and in future, it would be applied as a supportive, restorative and preventive treatment in patients who suffer from acute ischemic stroke and post ischemic disability.

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