Current status of clinical trial registrations in tissue
engineering based on ClinicalTrials.gov

doi:10.3969/j.issn.2095-4344.2612

Abstract

Abstract:

BACKGROUND: There is an imbalance between supply and demand for tissues and organs. Therefore, it is crucial to actively carry out basic research regarding tissue engineering and accelerate relevant clinical transformation.

OBJECTIVE: To analyze the status of clinical trials registrations in tissue engineering and to provide reference and evidence support for clinical transformation research in tissue engineering.

METHODS: Clinical trial data from the ClinicalTrials.gov were collected. Bibliometrics and mathematical statistics methods were adopted to analyze the status of clinical trial registration in tissue engineering from various aspects, including registration quantities, indications, sponsors, and stages.

RESULTS AND CONCLUSION: There were 434 records of clinical trial registrations regarding tissue engineering worldwide, 65 of which were in China. Over half of the records were randomized controlled trials in China or in the world, and no Chinese institutions have participated in the 18 international multi-center clinical trials worldwide. These clinical trials covered a total of 57 indications all over the world and 37 indications in China, mainly concentrated in the fields of bone and cartilage, teeth, and skin. There were 275 sponsors all over the world, 33 of which were in China. Most of the clinical trials were in phase 1/phase 2. Through analyzing the status of clinical trial registrations regarding tissue engineering, there were less clinical transformation applications in tissue engineering. Although China had the second largest number of registrations in the world, there was still a certain gap with the United States. There were a certain number of clinical trials with high evidence levels, but no products with high potential value in the international market. More concerns were paid onto clinical transformation research in research institutions and medical institutions. Clinical applications mainly focused on the treatment of defects or functional defects in bone and cartilage, teeth and skin, which were mainly in the stage of safety or efficacy evaluation.

Key words: tissue engineering, ClinicalTrials.gov, clinical trials, registration status

CLC Number:

Lu Yan, Zhang Ting, Ouyang Zhaolian. Current status of clinical trial registrations in tissue engineering based on ClinicalTrials.gov[J]. Chinese Journal of Tissue Engineering Research, 2020, 24(17): 2742-2751.

Figures/Tables 15

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