Introduction to Stem Cell Clinical Trials

Stem cell clinical trials play a crucial role in evaluating the safety and efficacy of new treatments. Accessing information about these trials is facilitated through dedicated registries like ClinicalTrials.gov and the WHO International Clinical Trial Registry Platform.

Key Resources for Stem Cell Clinical Trials

ClinicalTrials.gov

• Purpose and History: Established under the FDA Modernization Act to provide comprehensive information on clinical studies.
• Accessibility: Offers updated information directly from study sponsors or principal investigators.

WHO International Clinical Trial Registry Platform

• Supplementary Information: Provides additional details complementing ClinicalTrials.gov, enhancing accessibility and usability for researchers and participants.

Geographic Distribution and Focus Areas of Stem Cell Trials

• Location Trends: Predominantly conducted in the U.S. followed by Europe, as evidenced by data from ClinicalTrials.gov.

Phases of Clinical Trials

Global Distribution

Overview of Trial Phases

• Phase 0 to Phase IV: Sequential stages from initial safety assessments to post-marketing studies, each serving distinct purposes in drug development and evaluation.

Types of Stem Cell Clinical Trials

Interventional Studies

• Purpose: Volunteers are assigned interventions to evaluate biomedical or health outcomes based on specific protocols.
• Inclusion of Observational Studies: Descriptions of observational studies and expanded access programs for investigational drugs are also included.

Funding Sources for Stem Cell Trials

Analysis of Funding

• Primary Funders: Includes the National Institutes of Health (NIH), other federal agencies, industry partners, and diverse entities such as universities and community-based organizations.
• Impact of Funding: Highlights the diversity of financial support influencing stem cell research outcomes and accessibility.

Conclusion

Understanding the structure and resources of stem cell clinical trials is crucial for both researchers and participants seeking innovative treatments. Access to comprehensive trial information supports informed decision-making and advances in medical research.