The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial

The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial Publisher Pubmed

Zarrabi M¹ ; Akbari MG² ; Amanat M³ ; Majmaa A⁴ ; Moaiedi AR⁵ ; Montazerlotfelahi H⁶ ; Nouri M⁷ ; Hamidieh AA⁸ ; Badv RS⁹ ; Karimi H¹⁰ ; Rabbani A¹¹ ; Mohebbi A¹² ; Rahimidehgolan S¹³ ; Rahimi R¹⁴ Show All Authors

Zarrabi M¹
Akbari MG²
Amanat M³
Majmaa A⁴
Moaiedi AR⁵
Montazerlotfelahi H⁶
Nouri M⁷
Hamidieh AA⁸
Badv RS⁹
Karimi H¹⁰
Rabbani A¹¹
Mohebbi A¹²
Rahimidehgolan S¹³
Rahimi R¹⁴
Dehghan E¹⁵
Vosough M¹
Abroun S¹⁶
Shamsabadi FM¹⁷
Tavasoli AR⁹
Alizadeh H¹⁸
Pak N¹⁸
Zamani GR⁹
Mohammadi M⁹
Javadzadeh M¹⁹
Ghofrani M¹⁹
Hassanpour SH²⁰
Heidari M⁹
Taghdiri MM¹⁹
Mohseni MJ²¹
Noparast Z²²
Masoomi S²³
Goudarzi M²⁴
Mohamadpour M⁴
Shodjaee R¹
Samimi S¹⁴
Mohammad M²⁵
Gholami M¹⁴
Vafaei N²⁶
Koochakzadeh L²⁷
Valizadeh A²⁶
Malamiri RA²⁸
Ashrafi MR⁹

Source: BMC Neurology Published:2022

Abstract

Introduction: The current multi-center, randomized, double-blind study was conducted among children with cerebral palsy (CP) to assess the safety and efficacy of umbilical cord blood mononuclear cell (UCB-MNC). We performed the diffusion tensor imaging to assess the changes in the white matter structure. Methods: Males and females aged 4 to 14 years old with spastic CP were included. Eligible participants were allocated in 4:1 ratio to be in the experimental or control groups; respectively. Individuals who were assigned in UCB-MNC group were tested for human leukocyte antigen (HLA) and fully-matched individuals were treated with UCB-MNCs. A single dose (5 × 106 /kg) UCB-MNCs were administered via intrathecal route in experimental group. The changes in gross motor function measure (GMFM)-66 from baseline to one year after treatment were the primary endpoints. The mean changes in modified Ashworth scale (MAS), pediatric evaluation of disability inventory (PEDI), and CP quality of life (CP-QoL) were also evaluated and compared between groups. The mean changes in fractional anisotropy (FA) and mean diffusivity (MD) of corticospinal tract (CST) and posterior thalamic radiation (PTR) were the secondary endpoints. Adverse events were safety endpoint. Results: There were 72 included individuals (36 cases in each group). The mean GMFM-66 scores increased in experimental group; compared to baseline (+ 9.62; 95%CI: 6.75, 12.49) and control arm (β: 7.10; 95%CI: 2.08, 12.76; Cohen’s d: 0.62) and mean MAS reduced in individuals treated with UCB-MNCs compared to the baseline (-0.87; 95%CI: -1.2, -0.54) and control group (β: -0.58; 95%CI: -1.18, -0.11; Cohen’s d: 0.36). The mean PEDI scores and mean CP-QoL scores in two domains were higher in the experimental group compared to the control. The imaging data indicated that mean FA increased and MD decreased in participants of UCB-MNC group indicating improvements in white matter structure. Lower back pain, headaches, and irritability were the most common adverse events within 24 h of treatment that were related to lumbar puncture. No side effects were observed during follow-up. Conclusions: This trial showed that intrathecal injection of UCB-MNCs were safe and effective in children with CP. Trial Registration: The study was registered with ClinicalTrials.gov (NCT03795974). © 2022, The Author(s).

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Style	Citing Format
MLA	Zarrabi M, et al.. "The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial." BMC Neurology, vol. 22, no. 1, 2022, pp. -.
APA	Zarrabi M, Akbari MG, Amanat M, Majmaa A, Moaiedi AR, Montazerlotfelahi H, Nouri M, Hamidieh AA, Badv RS, Karimi H, Rabbani A, Mohebbi A, Rahimidehgolan S, Rahimi R, Dehghan E, Vosough M, Abroun S, Shamsabadi FM, Tavasoli AR, ... Ashrafi MR (2022). The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial. BMC Neurology, 22(1), -.
Chicago	Zarrabi M, Akbari MG, Amanat M, Majmaa A, Moaiedi AR, Montazerlotfelahi H, Nouri M, et al.. "The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial." BMC Neurology 22, no. 1 (2022): -.
Harvard	Zarrabi M et al. (2022) 'The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial', BMC Neurology, 22(1), pp. -.
Vancouver	Zarrabi M, Akbari MG, Amanat M, Majmaa A, Moaiedi AR, Montazerlotfelahi H, et al.. The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial. BMC Neurology. 2022;22(1):-.
BibTex	@article{ author = {Zarrabi M and Akbari MG and Amanat M and Majmaa A and Moaiedi AR and Montazerlotfelahi H and Nouri M and Hamidieh AA and Badv RS and Karimi H and Rabbani A and Mohebbi A and Rahimidehgolan S and Rahimi R and Dehghan E and Vosough M and Abroun S and Shamsabadi FM and Tavasoli AR and Alizadeh H and Pak N and Zamani GR and Mohammadi M and Javadzadeh M and Ghofrani M and Hassanpour SH and Heidari M and Taghdiri MM and Mohseni MJ and Noparast Z and Masoomi S and Goudarzi M and Mohamadpour M and Shodjaee R and Samimi S and Mohammad M and Gholami M and Vafaei N and Koochakzadeh L and Valizadeh A and Malamiri RA and Ashrafi MR}, title = {The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial}, journal = {BMC Neurology}, volume = {22}, number = {1}, pages = {-}, year = {2022} }
RIS	TY - JOUR AU - Zarrabi M AU - Akbari MG AU - Amanat M AU - Majmaa A AU - Moaiedi AR AU - Montazerlotfelahi H AU - Nouri M AU - Hamidieh AA AU - Badv RS AU - Karimi H AU - Rabbani A AU - Mohebbi A AU - Rahimidehgolan S AU - Rahimi R AU - Dehghan E AU - Vosough M AU - Abroun S AU - Shamsabadi FM AU - Tavasoli AR AU - Alizadeh H AU - Pak N AU - Zamani GR AU - Mohammadi M AU - Javadzadeh M AU - Ghofrani M AU - Hassanpour SH AU - Heidari M AU - Taghdiri MM AU - Mohseni MJ AU - Noparast Z AU - Masoomi S AU - Goudarzi M AU - Mohamadpour M AU - Shodjaee R AU - Samimi S AU - Mohammad M AU - Gholami M AU - Vafaei N AU - Koochakzadeh L AU - Valizadeh A AU - Malamiri RA AU - Ashrafi MR TI - The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial JO - BMC Neurology VL - 22 IS - 1 SP - EP - PY - 2022 ER -

Style

Citing Format

MLA

Zarrabi M, et al.. "The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial." BMC Neurology, vol. 22, no. 1, 2022, pp. -.

APA

Zarrabi M, Akbari MG, Amanat M, Majmaa A, Moaiedi AR, Montazerlotfelahi H, Nouri M, Hamidieh AA, Badv RS, Karimi H, Rabbani A, Mohebbi A, Rahimidehgolan S, Rahimi R, Dehghan E, Vosough M, Abroun S, Shamsabadi FM, Tavasoli AR, ... Ashrafi MR (2022). The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial. BMC Neurology, 22(1), -.

Chicago

Zarrabi M, Akbari MG, Amanat M, Majmaa A, Moaiedi AR, Montazerlotfelahi H, Nouri M, et al.. "The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial." BMC Neurology 22, no. 1 (2022): -.

Harvard

Zarrabi M et al. (2022) 'The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial', BMC Neurology, 22(1), pp. -.

Vancouver

Zarrabi M, Akbari MG, Amanat M, Majmaa A, Moaiedi AR, Montazerlotfelahi H, et al.. The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial. BMC Neurology. 2022;22(1):-.

BibTex

@article{ author = {Zarrabi M and Akbari MG and Amanat M and Majmaa A and Moaiedi AR and Montazerlotfelahi H and Nouri M and Hamidieh AA and Badv RS and Karimi H and Rabbani A and Mohebbi A and Rahimidehgolan S and Rahimi R and Dehghan E and Vosough M and Abroun S and Shamsabadi FM and Tavasoli AR and Alizadeh H and Pak N and Zamani GR and Mohammadi M and Javadzadeh M and Ghofrani M and Hassanpour SH and Heidari M and Taghdiri MM and Mohseni MJ and Noparast Z and Masoomi S and Goudarzi M and Mohamadpour M and Shodjaee R and Samimi S and Mohammad M and Gholami M and Vafaei N and Koochakzadeh L and Valizadeh A and Malamiri RA and Ashrafi MR}, title = {The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial}, journal = {BMC Neurology}, volume = {22}, number = {1}, pages = {-}, year = {2022} }

RIS

TY - JOUR
AU - Zarrabi M
AU - Akbari MG
AU - Amanat M
AU - Majmaa A
AU - Moaiedi AR
AU - Montazerlotfelahi H
AU - Nouri M
AU - Hamidieh AA
AU - Badv RS
AU - Karimi H
AU - Rabbani A
AU - Mohebbi A
AU - Rahimidehgolan S
AU - Rahimi R
AU - Dehghan E
AU - Vosough M
AU - Abroun S
AU - Shamsabadi FM
AU - Tavasoli AR
AU - Alizadeh H
AU - Pak N
AU - Zamani GR
AU - Mohammadi M
AU - Javadzadeh M
AU - Ghofrani M
AU - Hassanpour SH
AU - Heidari M
AU - Taghdiri MM
AU - Mohseni MJ
AU - Noparast Z
AU - Masoomi S
AU - Goudarzi M
AU - Mohamadpour M
AU - Shodjaee R
AU - Samimi S
AU - Mohammad M
AU - Gholami M
AU - Vafaei N
AU - Koochakzadeh L
AU - Valizadeh A
AU - Malamiri RA
AU - Ashrafi MR
TI - The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Individuals With Spastic Cerebral Palsy: A Randomized Double-Blind Sham-Controlled Clinical Trial
JO - BMC Neurology
VL - 22
IS - 1
SP -
EP -
PY - 2022
ER -

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