The effects of a combination oral spray (Mucosamin®) for the prevention of oral mucositis in pediatric patients undergoing hematopoietic stem cell transplantation: a double blind randomized clinical trial.

PURPOSE: Oral mucositis (OM) is a frequent complication of conditioning regimens for hematopoietic stem cell transplantation (HSCT). Damage to the nuclear and non-nuclear materials of the mucosal cells by the production of Reactive Oxygen Species (ROS) and proinflammatory cytokines could result to development and progression of OM. Previous studies have shown the effectiveness of Mucosamin® oral spray in the management of pain and acceleration of OM healing. The aims of the current study were to evaluate prophylactic effects of Mucosamin® oral spray in reducing the incidence and severity of OM in pediatric patients undergoing allogeneic HSCT. METHOD: The current study was designed as a double-blind, placebo-controlled randomized clinical trial. Sixty patients were enrolled in the study and received placebo or Mucosamin® spray. Patients in both groups used sprays 4 times daily. Product application was begun at the time of initiation of conditioning regimen and was continued for 14 days. RESULTS: Mucosamin® significantly reduced incidence and severity of OM compared to the placebo (P values: 0.027 and 0.035, respectively). This product could also decrease OM duration and delay OM onset (P values: 0.007 and 0.006, respectively). CONCLUSION: Mucosamin® could effectively reduce incidence, severity, and duration of OM and delay OM onset in pediatric patients undergoing allogeneic HSCT. TRIAL REGISTRATION: The study protocol was registered in the Iranian Registry of Clinical Trials under the registry number IRCT20190917044805N1.

Comparison of peripheral blood stem cell transplant with bone marrow transplant in class 3 thalassemic patients.

OBJECTIVES: This study aimed to compare outcome of bone marrow transplant with peripheral blood stem cell transplant in class 3 thalassemic patients. MATERIALS AND METHODS: Respectively, 32 and 20 class 3 thalassemic patients received bone marrow transplant and peripheral blood stem cell transplant from human leukocyte antigen identical sibling donors. Conditioning regimen consisted of busulfan (16 mg/kg) and cyclophosphamide (160 mg/kg) followed by cyclosporine and methotrexate as graft-versus-host disease prophylaxes. RESULTS: Median time to absolute neutrophil count was significantly shorter in the peripheral blood stem cell transplant group (12 vs 23 days); however, there was no significant difference regarding platelet recovery between the 2 groups (20 vs 28 days). Acute graft-versus-host disease occurred in 47% of patients. Chronic graft-versus-host disease developed in 28% of patients which was significantly higher in the peripheral blood stem cell transplant group (P = .06). During 50 months follow-up, thalassemia recurrence, overall survival, and thalassemia-free survival were 17%, 80%, and 65%, respectively, and there were no significant differences between the 2 groups. CONCLUSIONS: These results showed that stem cell transplant is an effective treatment in class 3 thalassemic patients with the outcome relatively similar to bone marrow transplant. Although engraftment time is shorter in peripheral blood stem cell transplant method, it is associated with higher rate of chronic graft-versus-host disease.