GlobalData:干细胞生命医学应用临床报告英文-2017.6-23页(23页).pdf

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1、 Healthcare Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016 Report Code: GDHC1299EI Published: June 2017 Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016 Reference Code: GDHC1299EI Published: June 2017 Healthcare 2 GlobalData 2

2、017. This product is licensed and is not to be photocopied. 1 Table of Contents 1 Table of Contents . 2 1.1 List of Figures . 3 2 Introduction . 4 2.1 Report Scope . 4 2.2 Methodology . 4 2.3 Organizations Mentioned . 4 3 Stem Cell Therapy Trial Landscape . 5 3.1 Introduction . 5 3.2 Stem Cell Thera

3、py Clinical Trials by Phase and Sponsor Type, 20072016 . 5 3.3 Single-Country and Multinational Stem Cell Therapy Trials, 20072016 . 8 3.4 Average Size of Stem Cell Therapy Clinical Trials, 20072016 . 9 3.5 Stem Cell Therapy Clinical Trials by Therapy Area, 20072016 .11 3.6 Top Indications for Stem

4、Cell Therapy Clinical Trials, 20072016 .12 3.7 Stem Cell Therapy Clinical Trials by Status, 20072016 .14 3.8 Top Sponsors for Stem Cell Therapy Clinical Trials, 20072016 .15 3.9 Top Interventions Investigated in Stem Cell Therapy Clinical Trials, 20072016 .17 3.10 Stem Cell Therapy Clinical Trials b

5、y Country, 20072016 .18 4 Summary . 19 5 About the Authors . 20 5.1 Associate Analyst, Clinical Trials Database .20 5.2 Global Director of Databases and Analytics .20 6 About the Pharmaceutical Clinical Trials Team . 21 7 About GlobalData . 22 7.1 Contact Us .22 7.2 Disclaimer .23 Global Trends in S

6、tem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016 Reference Code: GDHC1299EI Published: June 2017 Healthcare 3 GlobalData 2017. This product is licensed and is not to be photocopied. 1.1 List of Figures Figure 1: Stem Cell Therapy Clinical Trials by Phase , 20072016 . 6 Figure 2: St

7、em Cell Therapy Clinical Trials by Sponsor Type, 20072016 . 7 Figure 3: Stem Cell Therapy Single-Country and Multinational Trials, 20072016 . 8 Figure 4: Average Size of Stem Cell Therapy Clinical Trials, 20072016 . 9 Figure 5: Stem Cell Therapy Clinical Trials by Average Number of Locations, 200720

8、16 . 10 Figure 6: Stem Cell Therapy Clinical Trials by Therapy Area and Sponsor Type, 2007-2016 . 11 Figure 7: Stem Cell Therapy Clinical Trials for the Top Five Indications by Sponsor Type, 20072016 . 12 Figure 8: Stem Cell Therapy Clinical Trials for the Top Five Indications by Phase, 20072016 . 1

9、3 Figure 9: Status of Stem Cell Therapy Clinical Trials by Sponsor Type, 20072016 . 14 Figure 10: Top Industry Sponsors for Stem Cell Therapy Clinical Trials, 20072016 . 15 Figure 11: Top Non-Industry Sponsors for Stem Cell Therapy Clinical Trials, 20072016 . 16 Figure 12: Top Drugs Investigated in

10、Stem Cell Therapy Clinical Trials, 20072016 . 17 Figure 13: Stem Cell Therapy Clinical Trials by Country, 20072016 . 18 Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016 Reference Code: GDHC1299EI Published: June 2017 Healthcare 4 GlobalData 2017. This product is l

11、icensed and is not to be photocopied. 2 Introduction 2.1 Report Scope This whitepaper provides a review of global clinical trials for stem cell therapy initiated between 2007 and 2016. The data for this review were derived from the Clinical Trials Database of GlobalDatas Pharma Intelligence Center.

12、The aim of this paper is to provide analyses of the main features of these trials according to 10-year trends, where relevant. 2.2 Methodology The clinical trials data used for these analyses were extracted from the Clinical Trials Database of GlobalDatas Pharma Intelligence Center. The data include

13、d global interventional trials (94.9%), observational trials (5.0%), and one expanded access clinical trial, all of which had an initiation between January 1, 2007 and December 31, 2016. The Clinical Trials Database of the Pharma Intelligence Center recorded 584 trials that satisfied the above crite

14、ria. The data were analyzed and segmented by sponsor type, trial phases, single or multinational location, size, therapy area, top indications, status, leading industry drugs, and trial locations investigated in the trials. Further analyses were carried out on the dataset to identify the top sponsor

15、s, and the top Contract Research Organizations (CROs) involved. 2.3 Organizations Mentioned The companies mentioned in this whitepaper include Aderans Research Institute, Anterogen, Celgene, City of Hope, Great Ormond Steet Hospital, MediPost, Mesoblast, Microbot Medical, Nanfang Hospital, Neuralste

16、m, Pluristem Therapeutics, Samsung Medical Center, Stempeutics Research, TiGenix, University of California and Los Angeles, Universiti of Kebangsaan Malaysia, University of Miami, University of Texas, and US Stem Cell. Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072

17、016 Reference Code: GDHC1299EI Published: June 2017 Healthcare 5 GlobalData 2017. This product is licensed and is not to be photocopied. 3 Stem Cell Therapy Trial Landscape 3.1 Introduction GlobalData analyzed the number of trials carried out by industry and non-industry sponsors to determine the to

18、p sponsors involved in these clinical trials, as well as the top investigational drugs. Global Data also looked at the locations that hosted the most clinical trials, and studied the most popular therapy areas and the characteristics of the populations involved in the clinical trials. GlobalData ide

19、ntified 584 stem cell therapy clinical trials with a start date between 2007 and 2016. The total number of stem cell therapy trials featured a steady year-on-year increase from 2007 to 2012, from 31 to 70 clinical trials globally, followed by a small decrease to 67 in 2013. There was then a continuo

20、us increase until 2015, which saw the highest number of stem cell therapy trials at 74 globally. The 10 year period ended in 2016 with 69 trials. 3.2 Stem Cell Therapy Clinical Trials by Phase and Sponsor Type, 20072016 In this report, a small number of Phase 0, Phase I/II, Phase II/III, and Phase I

21、II/IV trials were combined with Phase I, Phase II, Phase III, and Phase IV trials, respectively. Overall, there was a predominance of Phase I and Phase II trials as compared to Phase III and Phase IV trials, except for 2007 when Phase III trials took second place instead of those in Phase II. The ye

22、arly contribution of Phase I stem cell therapy trials saw an increase from 16% in 2007 to 35% in 2009, followed by a decrease to 17% in 2012, as shown in Figure 1. The following five years saw continuous increases in contribution of Phase I trials to a 10-year peak of 38% in 2016. Phase II had the h

23、ighest contribution in 2012 and 2013 at 71% and 75%, respectively. From 2013 onwards there was a year-on-year decrease until 2016, which had the lowest contribution of Phase II trials at 48%. Phase III trials started off very strong at a peak of 32% of in 2007, then had a continual decrease and hit

24、an all-time low of 6% in 2010. From this year onwards there were fluctuations between 7% and 12% until 2016. The contribution of Phase IV trials presented the lowest contribution numbers overall. The highest contribution of Phase IV trials was 3% in 2016; between 2007 and 2010 there was no trial reg

25、istered at Phase IV. Stem cell therapy trials experienced their highest growth in 2015, with 74 trials being initiated in that year. Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016 Reference Code: GDHC1299EI Published: June 2017 Healthcare 6 GlobalData 2017. This

26、 product is licensed and is not to be photocopied. Figure 1: Stem Cell Therapy Clinical Trials by Phase , 20072016 Source: GlobalData Pharmaceutical Intelligence Center, Clinical Trials Database Accessed May 22, 2017 0 10 20 30 40 50 60 70 80 2007200820092010201120122013201420152016 Number of Trials

27、 Phase I Phase IIPhase IIIPhase IV Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016 Reference Code: GDHC1299EI Published: June 2017 Healthcare 7 GlobalData 2017. This product is licensed and is not to be photocopied. Over this period and across all stages of devel

28、opment, there were more trials sponsored by industry sponsors than non-industry sponsors. Non-industry sponsored trials saw an increase from 13 to 29 trials from 2007 to 2012, which was the highest amount of non-industry trials over the 10-year period. Industry trials saw an increase from 18 trials

29、in 2007 to their highest level at 53 trials in 2014, as shown in Figure 2. Figure 2: Stem Cell Therapy Clinical Trials by Sponsor Type, 20072016 Source: GlobalData Pharmaceutical Intelligence Center, Clinical Trials Database Accessed May 22, 2017 0 10 20 30 40 50 60 200720082009201020112012201320142

30、0152016 Number of Trials Industry SponsorNon-Industry Sponsor Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016 Reference Code: GDHC1299EI Published: June 2017 Healthcare 8 GlobalData 2017. This product is licensed and is not to be photocopied. 3.3 Single-Country a

31、nd Multinational Stem Cell Therapy Trials, 20072016 There were, on average, 7.1 times as many single-country trials as multinational trials over the 10- year period. As shown in Figure 3, the total number of multinational trials was at its largest in 2014 at 12 trials, and was at an all-time low in

32、2009 at two trials. Single-country trials saw an increase between 2007 and 2012, from 22 trials to 61 trials, their highest level in the 10-year period. The biggest decrease of single-country trials was seen from 2015 to 2016, where it fell by 22%, as shown in Figure 3. Figure 3: Stem Cell Therapy S

33、ingle-Country and Multinational Trials, 20072016 Source: GlobalData Pharmaceutical Intelligence Center, Clinical Trials Database Accessed May 22, 2017 0 10 20 30 40 50 60 70 2007200820092010201120122013201420152016 Single CountryMultinational Global Trends in Stem Cell Therapy Clinical Trials A 10-Y

34、ear Retrospective, 20072016 Reference Code: GDHC1299EI Published: June 2017 Healthcare 9 GlobalData 2017. This product is licensed and is not to be photocopied. 3.4 Average Size of Stem Cell Therapy Clinical Trials, 20072016 The average size of clinical trials in terms of number of subjects planned

35、across both multinational and single-country trials saw a decrease of 59%, from 92 to 38 for patient subject trials between 2007 and 2016. In contrast, the average size of clinical trials involving healthy subjects increased by 429%, from 17 to 90 between 2007 and 2016. The largest number of average healthy participants was seen in 2015. This was primarily due to a multinational trial sponsored by Mesoblast and carried out with assistance of Quintiles. However, when comparing the number of this trials participants to the whole dataset, its deviation from the mean

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