A Phase II Dose Escalation Study of Intraarterial (Hepatic) Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells (Stempeucel®) in Patients with Alcoholic Liver Cirrhosis
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Abstract & Keywords
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A: Very Good
Q: Is the goal explicitly stated in the Introduction? Is its formulation clear and unambiguous?
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A: Very Good
Tools and Methods
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Discussion & Conclusion
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Comments: The Discussion establishes that it is safe and feasible to administer stempeucel® at a dose of 2.5 million body weight through the hepatic artery in alcoholic liver cirrhosis patients (ALC) and the procedure was well tolerated in most of the patients. The complications which have developed in this study is similar to other studies involving hepatic catherization. The Discussion also illustrates the possible reasons for the infection in the cell group as compared to the control group. Efficacy was observed in the quality of life of patients who received 2.5 million cells/ kg dose of stempeucel®. The Discussion highlights that cell therapy should probably be attempted at an earlier stage like alcoholic hepatitis. The study concludes that stempeucel® was safe and well tolerated. Also, statistically significant improvement in Short Form-36 score: bodily pain, mental component summary, vitality and social functioning was seen in 2.5M group.
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A: Very Good
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Figures & Tables
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Further comments on the paper
Comments: This phase II, parallel-group, randomized, open-label, first of its kind dose-finding study aims at assessing the safety and feasibility of administering stempeucel® through the hepatic artery in case of alcoholic liver cirrhosis (ALC). It also assesses possible efficacy and dose-response. Certain treatment-emergent adverse events were observed but most of them were not related to stempeucel®. The findings show that it is safe and feasible to administer stempeucel® through the hepatic artery in ALC at a dose of up to 2.5 million cells/kg body weight and administration of higher doses may not be safe due to limited efficacy seen at this dose and higher risk of complication at 5 million cells/kg dose group. The study has a few limitations such as the cells were not traced within the body using radioactive technology, follow-up liver biopsy data was not obtained, the placebo injection or sham intervention was not given to the control group, the sample size of 20 individuals at each dose level is insufficient for meaningful detection of efficacy, biomarkers of liver regeneration were not used to understand the possible mechanisms of action. The appropriate dose and response of administering cell therapy have to be investigated in future studies.
The authors should look into the following discrepancy in the manuscript:
1. The Abstract states that there were sixty participants in the study population while it is mentioned in the Results “Of the 69 patients screened, 40 were enrolled in the study” and the same has been stated in Figure 1.
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A: Corrections - Suitable for publishing after corrections
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Corresponding AuthorPawan Kumar Gupta
Stempeutics Research Pvt. Ltd., Manipal Hospitals Whitefield Pvt. Ltd., Bengaluru, Karnataka, India
Article TypeResearch Article
Publication historyReceived: Wed 14, Apr 2021
Accepted: Thu 29, Apr 2021
Published: Thu 13, May 2021
Copyright© 2023 Pawan Kumar Gupta. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Hosting by Science Repository.