Transplantation of human fetal biliary tree stem/progenitor cells into two patients with advanced liver cirrhosis

BMC Gastroenterology

Domenico Alvaro⁹  Eugenio Gaudio⁸  Lola Reid¹  Adolfo Francesco Attili²  Mario Bezzi⁶  Luciano Bresadola⁶  Filippo Maria Salvatori⁶  Camilla Aliberti⁴  Carlo Bastianelli⁴  Rosanna Venere⁷  Manuela Gatto⁷  Alessia Torrice⁷  Cristina Napoli⁷  Alice Fraveto⁷  Roberto Brunelli⁴  Daniela Bosco⁵  Massimo Rossi³  Pasquale Bartolomeo Berloco³  Paolo Onori⁸  Marianna Nuti⁵  Rossella Semeraro⁷  Antonio Franchitto⁹  Hassan Rahimi⁵  Chiara Napoletano⁵  Raffaele Gentile⁷  Guido Carpino^1,10  Vincenzo Cardinale⁷ 

[1] Department of Cell Biology and Physiology, Program in Molecular Biology and Biotechnology, UNC School of Medicine, Chapel Hill 27599, NC, USA;Department of Clinical Medicine, Sapienza University of Rome, Rome 00185, Italy;Department of General Surgery and Organ Transplantation, Viale del Policlinico 155, Rome 00161, Italy;Department of Gynecologic-Obstetric and Urologic Sciences, Viale Regina Elena 324, Rome 00161, Italy;Department of Experimental Medicine, Viale Regina Elena 324, Rome 00161, Italy;Department of Radiological Sciences, Viale Regina Elena 324, Rome 00161, Italy;Department of Medico-Surgical Sciences and Biotechnologies, Polo Pontino, Sapienza University of Rome, Corso della Repubblica 79, Latina 04100, Italy;Department of Anatomical, Histological, Forensic Medicine and Orthopedics Sciences, Via Alfonso Borelli 50, Rome 00185, Italy;Eleonora Lorillard Spencer-Cenci Foundation, Rome 00100, Italy;Department of Movement, Human and Health Sciences, Division of Health Sciences, University of Rome “Foro Italico”, Rome 00151, Italy

关键词: Clinical trial;    Stem cell therapy;    Cirrhosis;    Human biliary tree stem/progenitor cells;   

Others  :  1121748
DOI  :  10.1186/s12876-014-0204-z

 received in 2014-07-21, accepted in 2014-11-19,  发布年份 2014

【 摘 要 】

Background

Efforts to identify cell sources and approaches for cell therapy of liver diseases are ongoing, taking into consideration the limits recognized for adult liver tissue and for other forms of stem cells. In the present study, we described the first procedure of via hepatic artery transplantation of human fetal biliary tree stem cells in patients with advanced cirrhosis.

Methods

The cells were immune-sorted from human fetal biliary tree by protocols in accordance with current good manufacturing practice (cGMP) and extensively characterized. Two patients with advanced liver cirrhosis (Child-Pugh C) have been submitted to the procedure and observed through a 12 months follow-up.

Results

The resulting procedure was found absolutely safe. Immuno-suppressants were not required, and the patients did not display any adverse effects correlated with cell transplantation or suggestive of immunological complications. From a clinical point of view, both patients showed biochemical and clinical improvement during the 6 month follow-up and the second patient maintained a stable improvement for 12 months.

Conclusion

This report represents proof of the concept that the human fetal biliary tree stem cells are a suitable and large source for cell therapy of liver cirrhosis. The isolation procedure can be carried out under cGMP conditions and, finally, the infusion procedure is easy and safe for the patients. This represents the basis for forthcoming controlled clinical trials.

【 授权许可】

   
2014 Cardinale et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

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