GlobalData-干细胞生命医学应用临床报告（英文）-20176-23页

Global Trends in Stem Cell Therapy Clinical Trials (2007-2016) Summary

Core Content

This report provides a 10-year retrospective analysis of global stem cell therapy clinical trials from 2007 to 2016, highlighting trends in trial phases, sponsor types, locations, therapy areas, and interventions. The data were sourced from GlobalData's Clinical Trials Database, which recorded 584 trials during this period.

Main Features of the Report

• Total Trials: The number of stem cell therapy trials increased steadily from 2007 to 2012, peaking at 70 in 2012, then slightly declined to 67 in 2013, followed by a continuous increase until 2015, which had the highest number of trials at 74, and ended in 2016 with 69 trials.
• Trial Phases:
  • Phase I and II trials dominated the landscape, with Phase I increasing from 16% in 2007 to 38% in 2016.
  • Phase II trials peaked at 75% in 2013 and decreased to 48% in 2016.
  • Phase III and IV trials were less common, with Phase III reaching a low of 6% in 2010 and Phase IV contributing only 3% in 2016.
• Sponsor Types:
  • Industry sponsors were the most active, with their number increasing from 18 in 2007 to 53 in 2014.
  • Non-industry sponsors saw an increase from 13 to 29 trials between 2007 and 2012.
• Trial Locations:
  • Single-country trials were significantly more common than multinational ones, with an average ratio of 7.1:1.
  • The US hosted the most trials (180), followed by South Korea (63) and China (55).
• Therapy Areas:
  • Oncology had the highest number of trials (269), followed by Cardiovascular (245), Central Nervous System (137), Musculoskeletal Disorders (88), and Immunology (87).
• Top Indications:
  • Myocardial infarction had the most trials, followed by graft versus host disease, congestive heart failure, critical limb ischemia, and osteoarthritis.
  • Industry sponsors were more prevalent in most indications, with osteoarthritis showing the highest ratio (11.5 times more industry trials than non-industry).
• Trial Status:
  • 26% of trials reported results, with 88.2% achieving primary endpoints, 5.9% not achieving them, 3.3% inconclusive, and 2.6% partially achieved.
  • Industry sponsors dominated in completed, suspended/terminated/withdrawn (S/T/W), not recruiting, and planned trials. Non-industry sponsors were more active in recruiting and recruiting by invitation trials.
• Top Sponsors:
  • Industry: Mesoblast was the top sponsor, followed by Anterogen, Celgene, Stempeutics Research, US Stem Cell, Pluristem Therapeutics, Microbot Medical, MediPost, TiGenix, and Neuralstem.
  • Non-Industry: Nanfang Hospital, Samsung Medical Center, and University of California and Los Angeles were the top sponsors, followed by University of Miami, City of Hope, and others.
• Top Interventions:
  • The top 10 drugs investigated included Remestemcel-L (13 trials), Stempeucel (12 trials), MA09-Hrpe, HuCNS-SC, and ALLO-ASC (each with 11 trials). Most trials were Phase II, with no Phase IV trials recorded for any of these drugs.
• Average Trial Size:
  • The average number of patient subjects per trial decreased by 59% from 92 to 38.
  • The average number of healthy subjects per trial increased by 429% from 17 to 90.
  • The average number of trial locations in single-country trials decreased from 5.3 in 2007 to 2.8 in 2011, with a peak in 2012 at 6.3 locations.

Key Information

• Data Source: Clinical Trials Database of GlobalData's Pharma Intelligence Center.
• Time Period: 2007 to 2016.
• Total Trials: 584.
• Major Trends:
  • A steady increase in the number of trials over the decade, with a peak in 2015.
  • Dominance of Phase I and II trials, especially in later years.
  • Industry sponsors were the main contributors, with a notable rise in their participation.
  • The US was the leading country for stem cell therapy trials, likely due to supportive regulatory policies.
  • Oncology and Cardiovascular were the most investigated therapy areas.
  • The majority of trials involved patient participants, with a few exceptions involving healthy subjects.

Conclusion

The decade from 2007 to 2016 saw a significant growth in stem cell therapy clinical trials globally. While the number of trials fluctuated slightly over the years, the overall trend was upward, with a peak in 2015. Industry sponsors led the field, especially in Phase I and II trials, and the US remained the most active region for such trials. Oncology and Cardiovascular were the primary areas of focus, and the majority of trials achieved their primary endpoints. The report underscores the increasing interest and investment in stem cell therapy research, with a notable shift in trial design and participant demographics over time.