Study Settings

LM Letizia Mazzini
MG Maurizio Gelati
DP Daniela Celeste Profico
GS Gianni Sorarù
DF Daniela Ferrari
MC Massimiliano Copetti
GM Gianmarco Muzi
CR Claudia Ricciolini
SC Sandro Carletti
CG Cesare Giorgi
CS Cristina Spera
DF Domenico Frondizi
SM Stefano Masiero
AS Alessandro Stecco
CC Carlo Cisari
EB Enrica Bersano
FM Fabiola De Marchi
MS Maria Francesca Sarnelli
GQ Giorgia Querin
RC Roberto Cantello
FP Francesco Petruzzelli
AM Annamaria Maglione
CZ Cristina Zalfa
EB Elena Binda
AV Alberto Visioli
DT Domenico Trombetta
BT Barbara Torres
LB Laura Bernardini
AG Alessandra Gaiani
MM Maurilio Massara
SP Silvia Paolucci
NB Nicholas M. Boulis
AV Angelo L. Vescovi
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Enrollment occurred sequentially, in three cohorts of six patients each. Given the hazard of iatrogenic damage, a risk‐escalation paradigm was adopted 12 for the number of injections and the amount of potential damage leading to neurological side effects. The first group comprised patients with severe lower limb disability (not‐ambulatory), that is, subjects with a lower risk of exacerbated weakness caused by the procedure: Given that the patients in this group showed no signs of iatrogenic damage following the transplant 8, the relevant regulatory bodies approved the recruitment of patients that displayed fair functional autonomy (i.e., ambulatory patients) into the second and third groups. A psychologist assessed the fitness of each patient soon after recruitment. A clinical interview and Minnesota multiphasic personality inventory 2 tests were used to ensure that the participants fully understood that this was a safety trial and that they were aware of all risks associated with the overall procedure.

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