Intraportal Infusion of Bone Marrow Mononuclear or CD133+ Cells in Patients With Decompensated Cirrhosis: A Double-Blind Randomized Controlled Trial. (10th December 2015)

• Record Type: Journal Article
• Authors: Mohamadnejad, Mehdi; Vosough, Massoud; Moossavi, Shirin; Nikfam, Sepideh; Mardpour, Soura; Akhlaghpoor, Shahram; Ashrafi, Mandana; Azimian, Vajiheh; Jarughi, Neda; Hosseini, Seyedeh-Esmat; Moeininia, Fatemeh; Bagheri, Mohamad; Sharafkhah, Maryam; Aghdami, Nasser; Malekzadeh, Reza; Baharvand, Hossein
• Is Part Of: Stem cells translational medicine. Volume 5:Number 1(2016)
• Page Start: 87
• Page End: 94
• Publication Date: 2015-12-10
• Subjects: Cirrhosis -- Hematopoietic stem cell -- Regenerative medicine -- Cell-based therapy; Stem cells -- Periodicals; Regenerative medicine -- Periodicals; Periodicals; 616.0277405
• DOI: 10.5966/sctm.2015-0004
• Languages: English
• ISSNs: 2157-6564

Abstract

Abstract: : The present study assessed the effects of intraportal infusions of autologous bone marrow-derived mononuclear cells (MNCs) and/or CD133 + cells on liver function in patients with decompensated cirrhosis. We randomly assigned 27 eligible patients to a placebo, MNCs, and/or CD133 + cells. Cell infusions were performed at baseline and month 3. We considered the absolute changes in the Model for End-Stage Liver Disease (MELD) scores at months 3 and 6 after infusion as the primary outcome. The participants and those who assessed the outcomes were unaware of the treatment intervention assignments. After 6 months, 9 patients were excluded because of liver transplantation ( n = 3), hepatocellular carcinoma ( n = 1), loss to follow-up ( n = 3), and death ( n = 2). The final analysis included 4 patients from the CD133 + group, 8 from the MNC group, and 6 from the placebo group. No improvement was seen in the MELD score at month 6 using either CD133 + cells or MNC infusions compared with placebo. However, at month 3 after infusion, a trend was seen toward a higher mean absolute change in the MELD score in patients who had received CD133 + cells compared with placebo (−2.00 ± 1.87 vs. −0.13 ± 1.46; p = .08). No significant adverse events occurred in the present study. A transient improvement in the MELD score was observed in subjects treated with CD133 + cells but not in the MNC or placebo group. Although the study was not powered to make definitive conclusions, the data justify further study of CD133 + therapy in cirrhotic patients. Significance: Cell therapy is a new approach in liver disease. Several clinical experiments have been reported on the safety of bone marrow-derived stem cells to treat liver disorders. However, the effectiveness of these approaches in the long-term follow-ups of patients initiated controversial discussions among the scientific community. A double-blind randomized controlled trial was designed to address this concern scientifically. A transient improvement in the patients' signs occurred; however, for a sustainable result, more work is needed. The results of multiple administrations of cells reported in the present study can be compared with the results from other single-injection studies. Abstract : The present study assessed the effects of intraportal infusions of autologous bone marrow-derived mononuclear cells (MNCs) and/or CD133 + cells on liver function in patients with decompensated cirrhosis in a double-blind randomized controlled trial. No significant adverse events occurred in the present study. A transient improvement in the Model for End-Stage Liver Disease score was observed in subjects treated with CD133 + cells but not in the MNC or placebo group. Although the study was not powered to make definitive conclusions, the data justify further study of CD133 + therapy in cirrhotic patients.