Phase 1 human trial of autologous bone marrow-hematopoietic stem cell transplantation in patients with decompensated cirrhosis.
OBJECTIVE
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.


CONCLUSIONS
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.
Department of Stem Cells, Royan Institute, PO Box 19395-4644, Tehran, Iran. baharvand50@yahoo.com.
Mehdi
M
Mohamadnejad
Mehrnaz
M
Namiri
Mohamad
M
Bagheri
Seyed Masiha
SM
Hashemi
Hossein
H
Ghanaati
Narges
N
Zare Mehrjardi
Saeed
S
Kazemi Ashtiani
Reza
R
Malekzadeh
Hossein
H
Baharvand
D000328:Adult; D018952:Antigens, CD34 / Q000032:analysis; D001854:Bone Marrow Cells / Q000166:cytology*; D002470:Cell Survival; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006499:Hepatic Artery; D006801:Humans; D008103:Liver Cirrhosis / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D014182:Transplantation, Autologous
D018952:Antigens, CD34