Safety profile
pleural effusion, tumor, bleeding, cardiac disorder, infection, deaths
ACUTE MYOCARDIAL INFARCTION, PLEURAL EFFUSION, TUMOR, BLEEDING, CARDIAC DISORDER, INFECTION, SEPARATION, COMPLICATIONS
The cell administration procedure was well tolerated, with no or mild discomfort. The cell product injection into the periadventitial arterial walls generated no complications during the first 72 h. Furthermore, no participant exhibited any or serious AEs related to the therapy with auto-BM-MNC or allo-WJ-MSCs (such as infection at the injection site, immunological rejection, or tumor generation) during follow-up.In addition, after bone marrow aspiration, we observed no bleeding, infection, or other complications. Moreover, the separation of the aspirate by Ficoll, its subsequent cell culture, as well as isolation and ex vivo expansion of allo-WJ-MSCs went smoothly.Nevertheless, four deaths, non-related to the treatment, arose while the patients still were participating in the trial. Two participants died in the auto-BMNC group, one from complications resulting from an acute myocardial infarction (follow-up at ten months) and another due to COVID-19 (follow-up at five months). In the allo-WJ-MSC group, one participant died due to pleural effusion (follow-up at ten months), and the other died due to cardiac disorder (follow-up at ten months). Similarly, in the placebo group, one of the participants died due to CLTI complications (follow-up at three months).