National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Therapeutic Efficacy of MicroRNA-Modified Exosome-Loaded Wharton's Jelly Scaffolds for the Treatment of Chronic Staphylococcus aureus Osteomyelitis in a Rabbit Model

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

1-     Principal investigator: institute and Department missing

2-     Protocol was not reviewed by a science committee?

3-     What is the international funding agency and what is the funding amount?

4-     What is the source of human umbilical cord-derived Wharton’s Jelly (WJ) scaffolds?

5-     How are mesenchymal stem cells isolated from rabbit tissues?

6-     How are the freshly isolated stem cells obtained?

7-     What is the reference for sample size calculation?

8-     Pilot study: there is a discrepancy, researchers say “N’”, then say they will use 5 rabbits as pilot study

9-     What are the 5 groups of the study? and why 10 rabbits in each group?

Comment to the Committee

Informed consent form:

N/A

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