Open AccessIntraportal Infusion of Bone Marrow Mononuclear or CD133 + Cells in Patients With Decompensated Cirrhosis: A Double‐Blind Randomized Controlled Trial
Author(s) -
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
Publication year - 2016
Publication title -
stem cells translational medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.781
H-Index - 71
eISSN - 2157-6580
pISSN - 2157-6564
DOI - 10.5966/sctm.2015-0004
Subject(s) - medicine , peripheral blood mononuclear cell , bone marrow , randomized controlled trial , double blind , cirrhosis , gastroenterology , pathology , chemistry , in vitro , biochemistry , alternative medicine , placebo
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.