PMID- 37342380
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230701
IS  - 2228-5881 (Print)
IS  - 2251-7308 (Electronic)
IS  - 2228-5881 (Linking)
VI  - 13
IP  - 2
DP  - 2023 Mar
TI  - The Efficacy and Safety of Intrathecal Autologous Bone Marrow-Derived Mesenchymal 
      Stromal Cells in Amyotrophic Lateral Sclerosis: A Pilot Study.
PG  - 361-367
LID - 10.34172/apb.2023.043 [doi]
AB  - Purpose: Amyotrophic lateral sclerosis (ALS) is an uncommon and aggressive 
      neurodegenerative disorder that influences the lower and upper motor neurons. 
      There are low eligible drugs for ALS treatment; in this regard, supplemental and 
      replacement treatments are essential. There are relative studies in the field of 
      mesenchymal stromal cells (MSCs) therapy in ALS, but the different methods, 
      differently used medium, and difference in follow-up periods affect the outcome 
      treatment. Methods: The current survey is a single-center, phase I clinical trial 
      to evaluating the efficacy and safety of autologous bone marrow (BM)-derived MSCs 
      through intrathecal administration in ALS patients. MNCs were isolated from BM 
      specimens and cultured. The clinical outcome was evaluated based Revised 
      Amyotrophic Lateral Sclerosis Functional Rating (ALSFRS-R) Scale. Results: Each 
      patient received 15+/-3x10(6) cells through subarachnoid space. No adverse events 
      (AEs) were detected. Just one patient experienced a mild headache after 
      injection. Following injection, no new intradural cerebrospinal pathology 
      transplant-related was observed. None of the patients' pathologic disruptions 
      following transplantation were detected by magnetic resonance imaging (MRI). The 
      additional analyses have shown the average rate of ALSFRS-R score and forced 
      vital capacity (FVC) reduction have decreased during 10 months following MSCs 
      transplantation versus the pretreatment period, from -5.4+/-2.3 to -2+/-3.08 ALSFRS-R 
      points/period (P=0.014) and -12.6+/-5.22% to -4.8+/-14.72%/period (P<0.001), 
      respectively. Conclusion: These results have shown that autologous MSCs 
      transplantation reduces the disease's progression and has favorable safety. Trial 
      Registration: This study performed as a phase I clinical trial (code 
      IRCT20200828048551N1).
CI  - (c)2023 The Authors.
FAU - Shamsaei, Gholamreza
AU  - Shamsaei G
AUID- ORCID: 0000-0002-8098-1261
AD  - Department of Neurology, Faculty of Medicine, Ahvaz Jundishapur University of 
      Medical Sciences, Ahvaz, Iran.
FAU - Houshmand, Fatemeh
AU  - Houshmand F
AD  - Department of Neurology, Faculty of Medicine, Ahvaz Jundishapur University of 
      Medical Sciences, Ahvaz, Iran.
FAU - Ahmadzadeh Deylami, Ahmad
AU  - Ahmadzadeh Deylami A
AD  - Department of Hematology, Faculty of Medicine, Ahvaz Jundishapur University of 
      Medical Sciences, Ahvaz, Iran.
FAU - Valizadeh, Armita
AU  - Valizadeh A
AD  - Department of Anatomy, Faculty of Medicine, Ahvaz Jundishapur University of 
      Medical Sciences, Ahvaz, Iran.
FAU - Rafie, Shahram
AU  - Rafie S
AD  - Department of Neurology, Faculty of Medicine, Ahvaz Jundishapur University of 
      Medical Sciences, Ahvaz, Iran.
FAU - Moradi, Maryam
AU  - Moradi M
AD  - Department of Biostatistics and Epidemiology, School of Public Health, Ahvaz 
      Jundishapur University of Medical Sciences, Ahvaz, Iran.
LA  - eng
PT  - Journal Article
DEP - 20220108
PL  - Iran
TA  - Adv Pharm Bull
JT  - Advanced pharmaceutical bulletin
JID - 101578021
PMC - PMC10278208
OTO - NOTNLM
OT  - ALS
OT  - Amyotrophic lateral sclerosis
OT  - MSCs
OT  - Mesenchymal stromal cells
OT  - Transplantation
COIS- The authors declare no conflict of interest. All procedure performs in studies 
      involving human participants were in accordance with the ethical standards of the 
      institutional and/or national research committee and with the 1964 Helsinki 
      Declaration and its later amendments or compare ethical strand.
EDAT- 2023/06/21 13:04
MHDA- 2023/06/21 13:05
PMCR- 2022/01/08
CRDT- 2023/06/21 12:00
PHST- 2021/10/07 00:00 [received]
PHST- 2021/12/29 00:00 [revised]
PHST- 2022/01/07 00:00 [accepted]
PHST- 2023/06/21 13:05 [medline]
PHST- 2023/06/21 13:04 [pubmed]
PHST- 2023/06/21 12:00 [entrez]
PHST- 2022/01/08 00:00 [pmc-release]
AID - 10.34172/apb.2023.043 [doi]
PST - ppublish
SO  - Adv Pharm Bull. 2023 Mar;13(2):361-367. doi: 10.34172/apb.2023.043. Epub 2022 Jan 
      8.