Preliminary Results of Therapy with AM3 in Patients Undergoing Hematopoietic Stem Cell Transplantation.
Authors: Recasens Valle , Rubio-Martinez Araceli , Alfonso Pilar , De Blas Ignacio , Rubio-Felix Daniel , Delgado Pilar , Garcia-Zueco Juan Carlos , Giraldo Pilar 
Published: April 2020

Abstract
Introduction: AM3(Inmunoferon®), is a glycoconjugate of natural origin with immunomodulatory properties indicated in secondary immnunodeficiencies as well as coadjuvant treatment in neoplastic diseases with cellular immunity deficiency.
Aim: To evaluate the influence of AM3 in the biological recovery of immune system in patients undergoing hematopoietic stem cells transplantation (HSCT)(autologous/allogenic). As well as to register the clinical incidences as intercurrent infections and mucositis from day of infusion hematopoietic cells to 90 days postransplantion in patients with and without AM3.
Patients and methods: Group A (cases): Inclusion of 19 consecutive patients undergoing HSCT. April 2004 - June 2005. Inclusion criteria: age ≥ 18 years, first HSCT. and signed consent form. AM3 dose: 20mg/8h orally since infusion day to 90 days postransplantation. Group B (controls): 19 patients consecutively undergoing HSCT. from February 2003- March 2004. Biological evaluation of the immune system recovery: BCC, immunoproteins quantification: IgG, IgA, IgM, C3, C4, lymphoid populations distribution and activity of monocyte biomarkers (chitotriosidase, CCL18/PARC) on days −7, 0,+7,+14,+21,+28,+56,+90. Clinical evaluation and comparing cases/controls of incidence of mucositis severity evaluated according to WHO classification and microbiological documented infectious diseases.
Results: The addition of AM3 as coadjuvant therapy in patients undergoing HSCT reduce significantly the percentage of oral mucositis (63.1% vs 89.5%) (p= 0.025) being those mucositis of less complexity in the first 2 weeks postransplantation. The number of infectious diseases was lower in patients under AM3 therapy (31.5% vs 47.4%) (p= 0.254) (Detailed in table). The recovery of the immune system evaluated by blood cells counts and immunobiomarkers showed a initial recuperation at day +14 in autologous HSCT and at day 21 for allogenic HSCT. The tolerance was satisfactory and only two patients needed discontinue therapy because of digestive intolerance. Wide studies must be performed in order to evaluate the benefit of this coadjuvant therapy. The inclusion of AM3 as a coadjuvant therapy in patients undergoing HSCT is associated with a significant minor percentage of oral mucositis.
This work has been partially sponsored by a grant from FEHHA.
Group A Group B Mean age (range) 44 (18–67) 48 (18–68) Females (%) 6 (31%) 7 (36,8%) Allogenic HSCT (M/F) 4 (21%) (3M/1F) 6 (31,5%) (5M/1F) Autologous HSCT(M/F) 15 (78,9%) (10H/5M) 13(68,4%) (7M/6F) Diagnosis Acute leukemia: 7 (37%), MM 7 (37%), MDS 2 (10%), Hodgkin disease 2nd remission 2 (11%), lymphoblastic lymphoma 1 (5%) Acute leukemia 4 (21%), MM 9 (47%), Hodgkin disease 2nd remission 2 (11%), NHL 4 (21%) Mucositis 12 (63%). Grade I: 1 patient (9%); grade II: 4 (33%); grade III: 4 (33%) 17 (89.5%). Grade II: 1 patient (6%); grade III: 6 (35%); grade IV: 9 (53%) Infectious diseases 6 (31,5%): S. Epidermidis 4 (21%), S. hominis 1 (5%), CMV 2 (10,5%), C. Albicans 1 (5%) 8 (42%): S. coagulase negative 7 (36,8%), S. viridans 1 (5.2%), S. epidermidis 1 (5.2%), Acinetobacter junii 1 (5.2%), Ochrobactrum anthropi 1 (5.2%), P. aeruginosa 1 (5.2%), C. difficile 1 (5.2%), ADN Herpes virus 6: 2 (10.5%), CMV 3 (15.7%), C. albicans 2 (10.5%), C. Krusei 1 (5.2%), P. carinii 1 (5.2%)