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World J Gastroenterol. Jun 28, 2007; 13(24): 3359-3363
Published online Jun 28, 2007. doi: 10.3748/wjg.v13.i24.3359
Phase 1 human trial of autologous bone marrow-hematopoietic stem cell transplantation in patients with decompensated cirrhosis
Mehdi Mohamadnejad, Mehrnaz Namiri, Mohamad Bagheri, Seyed Masiha Hashemi, Hossein Ghanaati, Narges Zare Mehrjardi, Saeed Kazemi Ashtiani, Reza Malekzadeh, Hossein Baharvand
Mehdi Mohamadnejad, Mohamad Bagheri, Hossein Ghanaati, Saeed Kazemi Ashtiani, Reza Malekzadeh, Digestive Disease Research Center, Shariati Hospital, Medical Sciences/ University of Tehran, Tehran, Iran
Mehdi Mohamadnejad, Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences, Tehran, Iran
Mehrnaz Namiri, Seyed Masiha Hashemi, Narges Zare Mehrjardi, Hossein Baharvand, Department of Stem Cells, Royan Institute, Tehran, Iran
Author contributions: All authors contributed equally to the work.
Correspondence to: Hossein Baharvand, Department of Stem Cells, Royan Institute, PO Box 19395-4644, Tehran, Iran. baharvand50@yahoo.com
Telephone: +98-21-22172330 Fax: +98-21-22409314
Received: February 24, 2007
Revised: April 10, 2007
Accepted: April 16, 2007
Published online: June 28, 2007
Abstract

AIM: To evaluate safety and feasibility of autologous bone marrow-enriched CD34+ hematopoietic stem cell Tx through the hepatic artery in patients with decompensated cirrhosis.

METHODS: Four patients with decompensated cirrhosis were included. Approximately 200 mL of the bone marrow of the patients was aspirated, and CD34+ stem cells were selected. Between 3 to 10 million CD34+ cells were isolated. The cells were slowly infused through the hepatic artery of the patients.

RESULTS: Patient 1 showed marginal improvement in serum albumin and no significant changes in other test results. In patient 2 prothrombin time was decreased; however, her total bilirubin, serum creatinine, and Model of End-Stage Liver Disease (MELD) score worsened at the end of follow up. In patient 3 there was improvement in serum albumin, porthrombin time (PT), and MELD score. Patient 4 developed radiocontrast nephropathy after the procedure, and progressed to type 1 hepatorenal syndrome and died of liver failure a few days later. Because of the major side effects seen in the last patient, the trial was prematurely stopped.

CONCLUSION: Infusion of CD34+ stem cells through the hepatic artery is not safe in decompensated cirrhosis. Radiocontrast nephropathy and hepatorenal syndrome could be major side effects. However, this study does not preclude infusion of CD34+ stem cells through other routes.

Keywords: Cirrhosis, Bone marrow, Stem cell, Transp-lantation, Quality of life, Model of End-Stage Liver Disease score