World J Surg Surg Res | Volume 1, Issue 1 | Research Article | Open Access
Hans U. Baer1*, Siufui Hendrawan2, Suryadi The3, Syafruddin AR. Lelosutan4, Salim G2, Toni Lindl5, Stephanie Mathes6, Ursula Graf-Hausner7, Ursula Weber1, Randall Watson8 and Barlian Sutedja3
1Center of Abdominal Surgery, Hirslanden Clinic, University of Bern, Switzerland
2Tarumanagara Human Cell Technology Laboratory, Tarumanagara University, School of Medicine, Indonesia
3Department of Surgery, Gading Pluit Hospital, Indonesia
4Department of Internal Medicine, Gading Pluit Hospital, Indonesia
5IAZ - Institute for Applied Cell Culture, Germany
6University of Zurich, Center of Dental Medicine, Switzerland
7Zurich University of Applied Sciences, Tissue Engineering/Drug Development (TEDD), Switzerland
8Medical Writer, Limmatstrasse, Switzerland
*Correspondance to: Hans U. Baer
Fulltext PDFBackground and
Aim: Cultured human autologous hepatocyte matrix implants have been used to treat chronic liver cirrhosis with some success and are a promising method to counter liver damage. The options afforded by hepatocyte transplant are of special importance as this may prolong or improve the lives of patients waiting for a transplant. We assessed the safety of implanted scaffold cultured hepatocytes upon patient survival in a modified phase 1 trial.
Methods: We present here the first ethically approved in human study of autologous hepatocyte matrix implantation for the treatment of predominantly viral hepatitis induced cirrhosis. The study was performed in patients with longstanding liver disease at a single center in Jakarta, Indonesia. Liver segments and pancreatic tissue from each patient were taken and processed to single hepatocytes and islets of Langerhans, respectively. The single cells were co-seeded onto PLA scaffolds, cultured, and transplanted back into the patient. We performed pre-implantation diagnosis and measured clinical disease severity scores (CTP and MELD) and liver function (albumin, bilirubin, ammonia, cholinesterase levels). In our small cohort, the procedure was generally safe.
Results: The small patient number prevented any statistical assessment of efficacy. For some patients we observed clinically relevant improvements of liver function. Some patients showed improvements in stamina, endurance to physical stress, reduced frequency of hospitalization and incidence of encephalopathy, GI bleeding, ascites, and esophageal varices.
Conclusion: Although limited in power for statistical significance, the present work presents sufficient data to warrant pursuing a phase 2 follow-up study.
Chronic liver disease; Autologous hepatocyte matrix implant; PLLA matrix
Baer HU, Hendrawan S, The S, Lelosutan SAR, Salim G, Lindl T, et al. Intracorporeal Autologous Hepatocyte Matrix Implant for the Treatment of Chronic Liver Disease: A Modified Clinical Phase I Study. World J Surg Surgical Res. 2018; 1: 1067.