Funding for this research was provided by:
The trial was sponsored by Hanshi Pharmaceutical Co., Ltd., Beijing, China. (2016-07001)
Received: 22 February 2017
Accepted: 12 January 2018
First Online: 2 March 2018
Ethics approval and consent to participate
: The protocol will be carried out in accordance with the Declaration of Helsinki, and has been approved by the ethics committee of the Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan. It was registered with the Clinical Trial Registry (ExternalRef removed, registration number NCT02772289) on 10 May 2016. Before recruitment, the purpose of the trial, benefits, and risks will be described in detail to each participant. Moreover, all participants must sign an inform consent form before participation in the trial. They will be introduced to the main aspects of the study by trained research investigators. The information will be entered in a case report form.
: Not applicable
: The authors declare that they have no competing interests. The experimental product with MSCs and the placebo with hydrogel are provided without charge by Health-Biotech Pharmaceutical Co., Ltd., Beijing, China, which has had no role in designing the trial, and will not be involved in collection, management, analysis, interpretation of data, manuscript preparation and submission, or the final report and its publication, and does not have ultimate authority over any of these actions.
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