干细胞治疗临床试验的全球趋势_2007–2016十年回顾（英文版）_23页_494kb

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

Core Content

This report provides a comprehensive analysis of global stem cell therapy clinical trials initiated between 2007 and 2016. The data is sourced from the Clinical Trials Database of GlobalData's Pharma Intelligence Center, which recorded 584 trials meeting the inclusion criteria. The analysis covers trends in trial phases, sponsor types, locations, therapy areas, and top interventions, offering insights into the growth and distribution of stem cell therapy research over the past decade.

Main Trends and Findings

1. Trial Volume Trends

• The number of stem cell therapy trials increased steadily from 2007 to 2012, peaking at 70 in 2012.
• A slight decrease occurred in 2013, followed by a continuous rise until 2015, which saw the highest number of trials at 74.
• The total number of trials decreased slightly to 69 in 2016.

2. Trial Phases

• Phase I and II trials dominated the landscape, with Phase I contributing up to 38% in 2016.
• Phase II trials had the highest contribution in 2012 and 2013, reaching 75%.
• Phase III and IV trials were less common, with Phase III peaking at 32% in 2007 and Phase IV contributing only 3% in 2016.
• Phase IV trials were rare, with none registered between 2007 and 2010.

3. Sponsor Types

• Industry sponsors were the majority, accounting for most trials across all phases and therapy areas.
• Non-industry sponsors increased from 13 to 29 trials between 2007 and 2012, reaching their peak.
• The top industry sponsors included Mesoblast, Anterogen, Celgene, Stempeutics Research, US Stem Cell, Pluristem Therapeutics, Microbot Medical, MediPost, TiGenix, and Neuralstem.
• The top non-industry sponsors were Nanfang Hospital, Samsung Medical Center, University of California and Los Angeles, University of Miami, City of Hope, University of Texas, Universiti of Kebangsaan Malaysia, and Great Ormond Street Hospital.

4. Trial Locations

• Single-country trials were significantly more common than multinational trials, with an average ratio of 7.1:1.
• Multinational trials peaked in 2014 at 12 trials and reached a low in 2009 at 2 trials.
• The US hosted the most trials (180), followed by South Korea (63) and China (55).

5. Therapy Areas

• Oncology had the largest number of trials (269), followed by Cardiovascular (245), Central Nervous System (137), Musculoskeletal Disorders (88), and Immunology (87).
• Oncology, Musculoskeletal Disorders, Cardiovascular, and Central Nervous System were predominantly sponsored by industry.
• Immunology had a higher proportion of non-industry-sponsored trials.

6. Top Indications

• The most common indications were myocardial infarction, graft versus host disease, congestive heart failure, critical limb ischemia, and osteoarthritis.
• Osteoarthritis had the highest ratio of industry to non-industry trials (11.5:1).
• Graft versus host disease had nearly equal representation between industry and non-industry sponsors.

7. Trial Status

• 26% of the 584 trials reported results.
• 88.2% of these trials achieved primary endpoints, while 5.9% did not achieve them, 3.3% were inconclusive, and 2.6% were partially achieved.
• Industry sponsors dominated completed, planned, and suspended/terminated/withdrawn (S/T/W) trials.
• Non-industry sponsors were more prominent in recruiting and recruiting by invitation trials.

8. Trial Size

• The average number of participants in patient trials decreased by 59%, from 92 to 38.
• The average number of healthy participants increased by 429%, from 17 to 90.
• The average number of trial locations per country decreased from 5.3 to 2.8 between 2007 and 2011.
• In 2012, the average number of locations per single-country trial reached a 10-year high of 6.3 in the US.

9. Top Interventions

• The top two interventions were Remestemcel-L (13 trials) and Stempeucel (12 trials).
• Other notable interventions included MA09-Hrpe, HuCNS-SC, ALLO-ASC, PLX-PAD, NSI-566, PF-05285401, Cenplacel-L, and AdipoCell.
• Most trials were in Phase II, with no Phase IV trials recorded for any of the top drugs.

Key Information

• Industry dominance: Industry sponsors accounted for the majority of trials across all phases and therapy areas.
• Geographic concentration: The US was the most active country in hosting stem cell therapy trials, with 180 trials.
• Trial phases: Phase I and II trials were the most common, with Phase III and IV being less prevalent.
• Non-industry contributions: While less common, non-industry sponsors played a significant role, especially in Immunology and recruiting trials.
• CRO involvement: 5.8% of trials used Contract Research Organizations (CROs), with Reliance Life Sciences being the leading CRO.

Conclusion

Over the 10-year period from 2007 to 2016, stem cell therapy clinical trials showed a consistent upward trend, with the US leading in trial initiation and hosting. Industry sponsors were the primary drivers of research, particularly in oncology, cardiovascular, and musculoskeletal disorders. While Phase I and II trials were most prevalent, Phase III and IV trials remained relatively rare. Non-industry sponsors, especially in academic and hospital settings, played a growing role, particularly in the Immunology field and in recruiting trials. The report highlights the evolving landscape of stem cell therapy research, emphasizing the importance of understanding sponsor dynamics, geographic trends, and therapeutic focus.